Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients
In two randomized trials comparing the PCSK9 inhibitor bococizumab with placebo, bococizumab had no benefit with respect to major adverse cardiovascular events in the lower-risk group but did have a significant benefit in the higher-risk group. Monoclonal antibodies that inhibit proprotein convertas...
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| Published in | The New England journal of medicine Vol. 376; no. 16; pp. 1527 - 1539 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Massachusetts Medical Society
20.04.2017
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| Subjects | |
| Online Access | Get full text |
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| Abstract | In two randomized trials comparing the PCSK9 inhibitor bococizumab with placebo, bococizumab had no benefit with respect to major adverse cardiovascular events in the lower-risk group but did have a significant benefit in the higher-risk group.
Monoclonal antibodies that inhibit proprotein convertase subtilisin–kexin type 9 (PCSK9) lower levels of plasma low-density lipoprotein (LDL) cholesterol and are promising agents for vascular risk reduction.
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Patients who have received the fully human monoclonal antibodies evolocumab and alirocumab, for example, have had reductions in cardiovascular events in preliminary analyses; these drugs are under evaluation in large-scale trials involving patients with known cardiovascular disease.
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Bococizumab is a third inhibitor of PCSK9 that, unlike evolocumab and alirocumab, is a humanized monoclonal antibody in which approximately 3% of the murine sequence remains in the antigen-binding complementarity-determining region. As part of the Studies . . . |
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| AbstractList | Bococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and reduces levels of low-density lipoprotein (LDL) cholesterol. We sought to evaluate the efficacy of bococizumab in patients at high cardiovascular risk. In two randomized trials comparing the PCSK9 inhibitor bococizumab with placebo, bococizumab had no benefit with respect to major adverse cardiovascular events in the lower-risk group but did have a significant benefit in the higher-risk group. Monoclonal antibodies that inhibit proprotein convertase subtilisin–kexin type 9 (PCSK9) lower levels of plasma low-density lipoprotein (LDL) cholesterol and are promising agents for vascular risk reduction. 1 Patients who have received the fully human monoclonal antibodies evolocumab and alirocumab, for example, have had reductions in cardiovascular events in preliminary analyses; these drugs are under evaluation in large-scale trials involving patients with known cardiovascular disease. 2 , 3 Bococizumab is a third inhibitor of PCSK9 that, unlike evolocumab and alirocumab, is a humanized monoclonal antibody in which approximately 3% of the murine sequence remains in the antigen-binding complementarity-determining region. As part of the Studies . . . Bococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and reduces levels of low-density lipoprotein (LDL) cholesterol. We sought to evaluate the efficacy of bococizumab in patients at high cardiovascular risk. In two parallel, multinational trials with different entry criteria for LDL cholesterol levels, we randomly assigned the 27,438 patients in the combined trials to receive bococizumab (at a dose of 150 mg) subcutaneously every 2 weeks or placebo. The primary end point was nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina requiring urgent revascularization, or cardiovascular death; 93% of the patients were receiving statin therapy at baseline. The trials were stopped early after the sponsor elected to discontinue the development of bococizumab owing in part to the development of high rates of antidrug antibodies, as seen in data from other studies in the program. The median follow-up was 10 months. At 14 weeks, patients in the combined trials had a mean change from baseline in LDL cholesterol levels of -56.0% in the bococizumab group and +2.9% in the placebo group, for a between-group difference of -59.0 percentage points (P<0.001) and a median reduction from baseline of 64.2% (P<0.001). In the lower-risk, shorter-duration trial (in which the patients had a baseline LDL cholesterol level of ≥70 mg per deciliter [1.8 mmol per liter] and the median follow-up was 7 months), major cardiovascular events occurred in 173 patients each in the bococizumab group and the placebo group (hazard ratio, 0.99; 95% confidence interval [CI], 0.80 to 1.22; P=0.94). In the higher-risk, longer-duration trial (in which the patients had a baseline LDL cholesterol level of ≥100 mg per deciliter [2.6 mmol per liter] and the median follow-up was 12 months), major cardiovascular events occurred in 179 and 224 patients, respectively (hazard ratio, 0.79; 95% CI, 0.65 to 0.97; P=0.02). The hazard ratio for the primary end point in the combined trials was 0.88 (95% CI, 0.76 to 1.02; P=0.08). Injection-site reactions were more common in the bococizumab group than in the placebo group (10.4% vs. 1.3%, P<0.001). In two randomized trials comparing the PCSK9 inhibitor bococizumab with placebo, bococizumab had no benefit with respect to major adverse cardiovascular events in the trial involving lower-risk patients but did have a significant benefit in the trial involving higher-risk patients. (Funded by Pfizer; SPIRE-1 and SPIRE-2 ClinicalTrials.gov numbers, NCT01975376 and NCT01975389 .). Background: Bococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and reduces levels of low-density lipoprotein (LDL) cholesterol. We sought to evaluate the efficacy of bococizumab in patients at high cardiovascular risk. Methods: In two parallel, multinational trials with different entry criteria for LDL cholesterol levels, we randomly assigned the 27,438 patients in the combined trials to receive bococizumab (at a dose of 150 mg) subcutaneously every 2 weeks or placebo. The primary end point was nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina requiring urgent revascularization, or cardiovascular death; 93% of the patients were receiving statin therapy at baseline. The trials were stopped early after the sponsor elected to discontinue the development of bococizumab owing in part to the development of high rates of antidrug antibodies, as seen in data from other studies in the program. The median follow-up was 10 months. Results: At 14 weeks, patients in the combined trials had a mean change from baseline in LDL cholesterol levels of -56.0% in the bococizumab group and +2.9% in the placebo group, for a between-group difference of -59.0 percentage points (P<0.001) and a median reduction from baseline of 64.2% (P<0.001). In the lower-risk, shorter-duration trial (in which the patients had a baseline LDL cholesterol level of ≥70 mg per deciliter [1.8 mmol per liter] and the median follow-up was 7 months), major cardiovascular events occurred in 173 patients each in the bococizumab group and the placebo group (hazard ratio, 0.99; 95% confidence interval [CI], 0.80 to 1.22; P=0.94). In the higher-risk, longer-duration trial (in which the patients had a baseline LDL cholesterol level of ≥100 mg per deciliter [2.6 mmol per liter] and the median follow-up was 12 months), major cardiovascular events occurred in 179 and 224 patients, respectively (hazard ratio, 0.79; 95% CI, 0.65 to 0.97; P=0.02). The hazard ratio for the primary end point in the combined trials was 0.88 (95% CI, 0.76 to 1.02; P=0.08). Injection-site reactions were more common in the bococizumab group than in the placebo group (10.4% vs. 1.3%, P<0.001). Conclusions: In two randomized trials comparing the PCSK9 inhibitor bococizumab with placebo, bococizumab had no benefit with respect to major adverse cardiovascular events in the trial involving lower-risk patients but did have a significant benefit in the trial involving higher-risk patients. (Funded by Pfizer; SPIRE-1 and SPIRE-2 ClinicalTrials.gov numbers, NCT01975376 and NCT01975389 .). BACKGROUNDBococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and reduces levels of low-density lipoprotein (LDL) cholesterol. We sought to evaluate the efficacy of bococizumab in patients at high cardiovascular risk.METHODSIn two parallel, multinational trials with different entry criteria for LDL cholesterol levels, we randomly assigned the 27,438 patients in the combined trials to receive bococizumab (at a dose of 150 mg) subcutaneously every 2 weeks or placebo. The primary end point was nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina requiring urgent revascularization, or cardiovascular death; 93% of the patients were receiving statin therapy at baseline. The trials were stopped early after the sponsor elected to discontinue the development of bococizumab owing in part to the development of high rates of antidrug antibodies, as seen in data from other studies in the program. The median follow-up was 10 months.RESULTSAt 14 weeks, patients in the combined trials had a mean change from baseline in LDL cholesterol levels of -56.0% in the bococizumab group and +2.9% in the placebo group, for a between-group difference of -59.0 percentage points (P<0.001) and a median reduction from baseline of 64.2% (P<0.001). In the lower-risk, shorter-duration trial (in which the patients had a baseline LDL cholesterol level of ≥70 mg per deciliter [1.8 mmol per liter] and the median follow-up was 7 months), major cardiovascular events occurred in 173 patients each in the bococizumab group and the placebo group (hazard ratio, 0.99; 95% confidence interval [CI], 0.80 to 1.22; P=0.94). In the higher-risk, longer-duration trial (in which the patients had a baseline LDL cholesterol level of ≥100 mg per deciliter [2.6 mmol per liter] and the median follow-up was 12 months), major cardiovascular events occurred in 179 and 224 patients, respectively (hazard ratio, 0.79; 95% CI, 0.65 to 0.97; P=0.02). The hazard ratio for the primary end point in the combined trials was 0.88 (95% CI, 0.76 to 1.02; P=0.08). Injection-site reactions were more common in the bococizumab group than in the placebo group (10.4% vs. 1.3%, P<0.001).CONCLUSIONSIn two randomized trials comparing the PCSK9 inhibitor bococizumab with placebo, bococizumab had no benefit with respect to major adverse cardiovascular events in the trial involving lower-risk patients but did have a significant benefit in the trial involving higher-risk patients. (Funded by Pfizer; SPIRE-1 and SPIRE-2 ClinicalTrials.gov numbers, NCT01975376 and NCT01975389 .). BackgroundBococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin–kexin type 9 (PCSK9) and reduces levels of low-density lipoprotein (LDL) cholesterol. We sought to evaluate the efficacy of bococizumab in patients at high cardiovascular risk.MethodsIn two parallel, multinational trials with different entry criteria for LDL cholesterol levels, we randomly assigned the 27,438 patients in the combined trials to receive bococizumab (at a dose of 150 mg) subcutaneously every 2 weeks or placebo. The primary end point was nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina requiring urgent revascularization, or cardiovascular death; 93% of the patients were receiving statin therapy at baseline. The trials were stopped early after the sponsor elected to discontinue the development of bococizumab owing in part to the development of high rates of antidrug antibodies, as seen in data from other studies in the program. The median follow-up was 10 months.ResultsAt 14 weeks, patients in the combined trials had a mean change from baseline in LDL cholesterol levels of −56.0% in the bococizumab group and +2.9% in the placebo group, for a between-group difference of –59.0 percentage points (P<0.001) and a median reduction from baseline of 64.2% (P<0.001). In the lower-risk, shorter-duration trial (in which the patients had a baseline LDL cholesterol level of ≥70 mg per deciliter [1.8 mmol per liter] and the median follow-up was 7 months), major cardiovascular events occurred in 173 patients each in the bococizumab group and the placebo group (hazard ratio, 0.99; 95% confidence interval [CI], 0.80 to 1.22; P=0.94). In the higher-risk, longer-duration trial (in which the patients had a baseline LDL cholesterol level of ≥100 mg per deciliter [2.6 mmol per liter] and the median follow-up was 12 months), major cardiovascular events occurred in 179 and 224 patients, respectively (hazard ratio, 0.79; 95% CI, 0.65 to 0.97; P=0.02). The hazard ratio for the primary end point in the combined trials was 0.88 (95% CI, 0.76 to 1.02; P=0.08). Injection-site reactions were more common in the bococizumab group than in the placebo group (10.4% vs. 1.3%, P<0.001).ConclusionsIn two randomized trials comparing the PCSK9 inhibitor bococizumab with placebo, bococizumab had no benefit with respect to major adverse cardiovascular events in the trial involving lower-risk patients but did have a significant benefit in the trial involving higher-risk patients. (Funded by Pfizer; SPIRE-1 and SPIRE-2 ClinicalTrials.gov numbers, NCT01975376 and NCT01975389.) |
| Author | Glynn, Robert J Gregoire, Jean Lorenzatti, Alberto Yunis, Carla Amarenco, Pierre Tardif, Jean-Claude Brunell, Robert Revkin, James Schwartz, Pamela F Civeira, Fernando Jukema, J. Wouter Kastelein, John J.P Shear, Charles L Murin, Jan Ridker, Paul M Nissen, Steven Santos, Raul D Vrablik, Michal Curto, Madelyn Miller, Michael Karpov, Yuri Masiukiewicz, Urszula Wright, R. Scott Soran, Handrean White, Harvey Koenig, Wolfgang Nicolau, Jose C Flather, Marcus Manga, Pravin Ponikowski, Piotr Mosterd, Arend |
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University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); 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Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 8 givenname: Robert J surname: Glynn fullname: Glynn, Robert J organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; 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Wouter surname: Jukema fullname: Jukema, J. Wouter organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 11 givenname: Yuri surname: Karpov fullname: Karpov, Yuri organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 12 givenname: John J.P surname: Kastelein fullname: Kastelein, John J.P organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 13 givenname: Wolfgang surname: Koenig fullname: Koenig, Wolfgang organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 14 givenname: Alberto surname: Lorenzatti fullname: Lorenzatti, Alberto organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 15 givenname: Pravin surname: Manga fullname: Manga, Pravin organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 16 givenname: Urszula surname: Masiukiewicz fullname: Masiukiewicz, Urszula organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 17 givenname: Michael surname: Miller fullname: Miller, Michael organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 18 givenname: Arend surname: Mosterd fullname: Mosterd, Arend organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 19 givenname: Jan surname: Murin fullname: Murin, Jan organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 20 givenname: Jose C surname: Nicolau fullname: Nicolau, Jose C organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 21 givenname: Steven surname: Nissen fullname: Nissen, Steven organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 22 givenname: Piotr surname: Ponikowski fullname: Ponikowski, Piotr organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 23 givenname: Raul D surname: Santos fullname: Santos, Raul D organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 24 givenname: Pamela F surname: Schwartz fullname: Schwartz, Pamela F organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 25 givenname: Handrean surname: Soran fullname: Soran, Handrean organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 26 givenname: Harvey surname: White fullname: White, Harvey organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 27 givenname: R. Scott surname: Wright fullname: Wright, R. Scott organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 28 givenname: Michal surname: Vrablik fullname: Vrablik, Michal organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 29 givenname: Carla surname: Yunis fullname: Yunis, Carla organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 30 givenname: Charles L surname: Shear fullname: Shear, Charles L organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) – sequence: 31 givenname: Jean-Claude surname: Tardif fullname: Tardif, Jean-Claude organization: From Brigham and Women’s Hospital and Harvard Medical School, Boston (P.M.R., R.J.G.); Pfizer, New York (J.R., R.B., M.C., U.M., P.F.S., C.Y., C.L.S.); Paris-Diderot, Sorbonne Paris Cité University, Paris (P.A.); Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain (F.C.); University of East Anglia, Norwich (M.F.), and Central Manchester University Hospital, Manchester (H.S.) — both in the United Kingdom; the Montreal Heart Institute, Université de Montréal, Montreal (J.G., J.-C.T.); Leiden University Medical Center, Leiden (J.W.J.), Academic Medical Center of the University of Amsterdam, Amsterdam (J.J.P.K.), and Meander Medical Center, Amersfoort (A.M.) — all in the Netherlands; Russian Cardiology Research and Production Center, Moscow (Y.K.); Deutsches Herzzentrum München, Technische Universität München, Munich Heart Alliance, Munich, Germany (W.K.); Cordoba Hospital, Cordoba, Argentina (A.L.); University of the Witwatersrand, Johannesburg (P.M.); University of Maryland, Baltimore (M.M.); University of Comenius, Bratislava, Slovakia (J.M.); Heart Institute, University of São Paulo Medical School (J.C.N.), and Lipid Clinic Heart Institute, University of São Paulo Medical School Hospital (R.D.S.), São Paulo; Cleveland Clinic Foundation, Cleveland (S.N.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Mayo Clinic, Rochester, MN (R.S.W.); and First Faculty of Medicine, Charles University, Prague, Czech Republic (M.V.) |
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| Copyright | Copyright © 2017 Massachusetts Medical Society. All rights reserved. Distributed under a Creative Commons Attribution 4.0 International License |
| Copyright_xml | – notice: Copyright © 2017 Massachusetts Medical Society. All rights reserved. – notice: Distributed under a Creative Commons Attribution 4.0 International License |
| CorporateAuthor | SPIRE Cardiovascular Outcome Investigators |
| CorporateAuthor_xml | – name: SPIRE Cardiovascular Outcome Investigators |
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| DOI | 10.1056/NEJMoa1701488 |
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| References | Preiss, D, Seshasai, SRK, Welsh, P (r008) 2011; 305 Boekholdt, SM, Hovingh, GK, Mora, S (r012) 2014; 64 Ridker, PM, Pradhan, A, MacFadyen, JG, Libby, P, Glynn, RJ (r007) 2012; 380 Lotta, LA, Sharp, SJ, Burgess, S (r009) 2016; 316 Collins, R, Reith, C, Emberson, J (r006) 2016; 388 Sabatine, MS, Giugliano, RP, Wiviott, SD (r002) 2015; 372 Ridker, PM, Mora, S, Rose, L (r013) 2016; 37 Seidah, NG, Prat, A (r001) 2012; 11 Ridker, PM, Tardif, J-C, Amarenco, P (r005) 2017; 376 Schmidt, AF, Swerdlow, DI, Holmes, MV (r011) 2017; 5 Ference, BA, Robinson, JG, Brook, RD (r010) 2016; 375 Ridker, PM, Amarenco, P, Brunell, R (r004) 2016; 178 Robinson, JG, Farnier, M, Krempf, M (r003) 2015; 372 28495986 - Circ Res. 2017 May 12;120(10):1537-1539 r010 r011 r001 r012 r006 r007 r008 r009 r002 r013 r003 r004 r005 |
| References_xml | – volume: 375 start-page: 2144 year: 2016 end-page: 2153 ident: r010 article-title: Variation in and and risk of cardiovascular disease and diabetes. publication-title: N Engl J Med contributor: fullname: Brook, RD – volume: 316 start-page: 1383 year: 2016 end-page: 1391 ident: r009 article-title: Association between low-density lipoprotein cholesterol-lowering genetic variants and risk of type 2 Diabetes: a meta-analysis. publication-title: JAMA contributor: fullname: Burgess, S – volume: 37 start-page: 1373 year: 2016 end-page: 1379 ident: r013 article-title: Percent reduction in LDL cholesterol following high-intensity statin therapy: potential implications for guidelines and for the prescription of emerging lipid-lowering agents. publication-title: Eur Heart J contributor: fullname: Rose, L – volume: 11 start-page: 367 year: 2012 end-page: 383 ident: r001 article-title: The biology and therapeutic targeting of the proprotein convertases. publication-title: Nat Rev Drug Discov contributor: fullname: Prat, A – volume: 376 start-page: 1517 year: 2017 end-page: 1526 ident: r005 article-title: Lipid-reduction variability and antidrug-antibody formation with bococizumab. publication-title: N Engl J Med contributor: fullname: Amarenco, P – volume: 305 start-page: 2556 year: 2011 end-page: 2564 ident: r008 article-title: Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a meta-analysis. publication-title: JAMA contributor: fullname: Welsh, P – volume: 64 start-page: 485 year: 2014 end-page: 494 ident: r012 article-title: Very low levels of atherogenic lipoproteins and the risk for cardiovascular events: a meta-analysis of statin trials. publication-title: J Am Coll Cardiol contributor: fullname: Mora, S – volume: 388 start-page: 2532 year: 2016 end-page: 2561 ident: r006 article-title: Interpretation of the evidence for the efficacy and safety of statin therapy. publication-title: Lancet contributor: fullname: Emberson, J – volume: 372 start-page: 1489 year: 2015 end-page: 1499 ident: r003 article-title: Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. publication-title: N Engl J Med contributor: fullname: Krempf, M – volume: 372 start-page: 1500 year: 2015 end-page: 1509 ident: r002 article-title: Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. publication-title: N Engl J Med contributor: fullname: Wiviott, SD – volume: 380 start-page: 565 year: 2012 end-page: 571 ident: r007 article-title: Cardiovascular benefits and diabetes risks of statin therapy in primary prevention: an analysis from the JUPITER trial. publication-title: Lancet contributor: fullname: Glynn, RJ – volume: 5 start-page: 97 year: 2017 end-page: 105 ident: r011 article-title: PCSK9 genetic variants and risk of type 2 diabetes: a mendelian randomisation study. publication-title: Lancet Diabetes Endocrinol contributor: fullname: Holmes, MV – volume: 178 start-page: 135 year: 2016 end-page: 144 ident: r004 article-title: Evaluating bococizumab, a monoclonal antibody to PCSK9, on lipid levels and clinical events in broad patient groups with and without prior cardiovascular events: rationale and design of the Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) Lipid Lowering and SPIRE Cardiovascular Outcomes Trials. publication-title: Am Heart J contributor: fullname: Brunell, R – ident: r011 doi: 10.1016/S2213-8587(16)30396-5 – ident: r005 doi: 10.1056/NEJMoa1614062 – ident: r008 doi: 10.1001/jama.2011.860 – ident: r009 doi: 10.1001/jama.2016.14568 – ident: r010 doi: 10.1056/NEJMoa1604304 – ident: r013 doi: 10.1093/eurheartj/ehw046 – ident: r004 doi: 10.1016/j.ahj.2016.05.010 – ident: r012 doi: 10.1016/j.jacc.2014.02.615 – ident: r002 doi: 10.1056/NEJMoa1500858 – ident: r003 doi: 10.1056/NEJMoa1501031 – ident: r001 doi: 10.1038/nrd3699 – ident: r007 doi: 10.1016/S0140-6736(12)61190-8 – ident: r006 doi: 10.1016/S0140-6736(16)31357-5 |
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| Snippet | In two randomized trials comparing the PCSK9 inhibitor bococizumab with placebo, bococizumab had no benefit with respect to major adverse cardiovascular events... Bococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and reduces levels of low-density... BackgroundBococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin–kexin type 9 (PCSK9) and reduces levels of low-density... BACKGROUNDBococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and reduces levels of low-density... Background: Bococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and reduces levels of... |
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| SubjectTerms | Angina Antibodies - blood Antibodies, Monoclonal, Humanized - adverse effects Antibodies, Monoclonal, Humanized - immunology Antibodies, Monoclonal, Humanized - therapeutic use Anticholesteremic Agents - adverse effects Anticholesteremic Agents - immunology Anticholesteremic Agents - therapeutic use Cardiac and Cardiovascular Systems Cardiovascular disease Cardiovascular diseases Cardiovascular Diseases - prevention & control Cerebral infarction Cholesterol Cholesterol, LDL - blood Clinical Medicine Clinical trials Disease prevention Double-Blind Method Female Follow-Up Studies Human health and pathology Humans Hypercholesterolemia - drug therapy Immunoglobulins Injections, Subcutaneous - adverse effects Kardiologi Kexin Klinisk medicin Life Sciences Lipids Lipids - blood Low density lipoprotein Male Medical and Health Sciences Medicin och hälsovetenskap Middle Aged Monoclonal antibodies Myocardial infarction Proprotein Convertase 9 - antagonists & inhibitors Proprotein Convertase 9 - immunology Proprotein convertases Risk Factors Risk groups Stroke Subtilisin Treatment Failure |
| Title | Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients |
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