Macimorelin (AEZS-130)-Stimulated Growth Hormone (GH) Test: Validation of a Novel Oral Stimulation Test for the Diagnosis of Adult GH Deficiency
Context:In the absence of panhypopituitarism and low serum IGF-I levels, the diagnosis of adult GH deficiency (AGHD) requires confirmation with a GH stimulation test. Macimorelin is a novel, orally active ghrelin mimetic that stimulates GH secretion.Objective:The objective of the study was to determ...
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| Published in | The journal of clinical endocrinology and metabolism Vol. 98; no. 6; pp. 2422 - 2429 |
|---|---|
| Main Authors | , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Bethesda, MD
Oxford University Press
01.06.2013
Copyright by The Endocrine Society Endocrine Society |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Context:In the absence of panhypopituitarism and low serum IGF-I levels, the diagnosis of adult GH deficiency (AGHD) requires confirmation with a GH stimulation test. Macimorelin is a novel, orally active ghrelin mimetic that stimulates GH secretion.Objective:The objective of the study was to determine the diagnostic efficacy and safety of macimorelin in AGHD.Design:This was a multicenter open-label study comparing the diagnostic accuracy of oral macimorelin with that of arginine+GHRH in AGHD patients and healthy, matched controls. After 43 AGHD patients and 10 controls were tested, the GHRH analog Geref Diagnostic [GHRH(1–29)NH2] became unavailable in the United States. The study was completed by testing 10 additional AGHD patients and 38 controls with macimorelin alone.Main Outcome Measure:Peak GH area under the receiver operating characteristic curve after macimorelin was measured.Results:Fifty AGHD subjects and 48 controls were evaluated. Peak GH levels in AGHD patients and controls after macimorelin were 2.36 ± 5.69 and 17.71 ± 19.11 ng/mL, respectively (P < .0001). With macimorelin, the receiver operating characteristic analysis yielded an optimal GH cut point of 2.7 ng/mL, with 82% sensitivity, 92% specificity, and 13% misclassification rate. For subjects receiving both tests, macimorelin showed discrimination comparable with arginine+GHRH (area under the receiver operating characteristic curve 0.99 vs 0.94, respectively, P = .29). Obesity (body mass index > 30 kg/m2) was present in 58% of subjects, and peak GH levels were inversely associated with body mass index in controls (r = −0.37, P = .01). Using the separate cut points of 6.8 ng/mL for nonobese and 2.7 for obese subjects reduced the misclassification rate to 11%. Only 1 drug-related serious adverse event, an asymptomatic QT interval prolongation on the electrocardiogram, was reported.Conclusion:Oral macimorelin is safe, convenient, and effective in diagnosing AGHD with accuracy comparable with the arginine+GHRH test. |
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| AbstractList | In the absence of panhypopituitarism and low serum IGF-I levels, the diagnosis of adult GH deficiency (AGHD) requires confirmation with a GH stimulation test. Macimorelin is a novel, orally active ghrelin mimetic that stimulates GH secretion.
The objective of the study was to determine the diagnostic efficacy and safety of macimorelin in AGHD.
This was a multicenter open-label study comparing the diagnostic accuracy of oral macimorelin with that of arginine+GHRH in AGHD patients and healthy, matched controls. After 43 AGHD patients and 10 controls were tested, the GHRH analog Geref Diagnostic [GHRH(1-29)NH2] became unavailable in the United States. The study was completed by testing 10 additional AGHD patients and 38 controls with macimorelin alone.
Peak GH area under the receiver operating characteristic curve after macimorelin was measured.
Fifty AGHD subjects and 48 controls were evaluated. Peak GH levels in AGHD patients and controls after macimorelin were 2.36 ± 5.69 and 17.71 ± 19.11 ng/mL, respectively (P < .0001). With macimorelin, the receiver operating characteristic analysis yielded an optimal GH cut point of 2.7 ng/mL, with 82% sensitivity, 92% specificity, and 13% misclassification rate. For subjects receiving both tests, macimorelin showed discrimination comparable with arginine+GHRH (area under the receiver operating characteristic curve 0.99 vs 0.94, respectively, P = .29). Obesity (body mass index > 30 kg/m(2)) was present in 58% of subjects, and peak GH levels were inversely associated with body mass index in controls (r = -0.37, P = .01). Using the separate cut points of 6.8 ng/mL for nonobese and 2.7 for obese subjects reduced the misclassification rate to 11%. Only 1 drug-related serious adverse event, an asymptomatic QT interval prolongation on the electrocardiogram, was reported.
Oral macimorelin is safe, convenient, and effective in diagnosing AGHD with accuracy comparable with the arginine+GHRH test. Context:In the absence of panhypopituitarism and low serum IGF-I levels, the diagnosis of adult GH deficiency (AGHD) requires confirmation with a GH stimulation test. Macimorelin is a novel, orally active ghrelin mimetic that stimulates GH secretion.Objective:The objective of the study was to determine the diagnostic efficacy and safety of macimorelin in AGHD.Design:This was a multicenter open-label study comparing the diagnostic accuracy of oral macimorelin with that of arginine+GHRH in AGHD patients and healthy, matched controls. After 43 AGHD patients and 10 controls were tested, the GHRH analog Geref Diagnostic [GHRH(1–29)NH2] became unavailable in the United States. The study was completed by testing 10 additional AGHD patients and 38 controls with macimorelin alone.Main Outcome Measure:Peak GH area under the receiver operating characteristic curve after macimorelin was measured.Results:Fifty AGHD subjects and 48 controls were evaluated. Peak GH levels in AGHD patients and controls after macimorelin were 2.36 ± 5.69 and 17.71 ± 19.11 ng/mL, respectively (P < .0001). With macimorelin, the receiver operating characteristic analysis yielded an optimal GH cut point of 2.7 ng/mL, with 82% sensitivity, 92% specificity, and 13% misclassification rate. For subjects receiving both tests, macimorelin showed discrimination comparable with arginine+GHRH (area under the receiver operating characteristic curve 0.99 vs 0.94, respectively, P = .29). Obesity (body mass index > 30 kg/m2) was present in 58% of subjects, and peak GH levels were inversely associated with body mass index in controls (r = −0.37, P = .01). Using the separate cut points of 6.8 ng/mL for nonobese and 2.7 for obese subjects reduced the misclassification rate to 11%. Only 1 drug-related serious adverse event, an asymptomatic QT interval prolongation on the electrocardiogram, was reported.Conclusion:Oral macimorelin is safe, convenient, and effective in diagnosing AGHD with accuracy comparable with the arginine+GHRH test. CONTEXT:In the absence of panhypopituitarism and low serum IGF-I levels, the diagnosis of adult GH deficiency (AGHD) requires confirmation with a GH stimulation test. Macimorelin is a novel, orally active ghrelin mimetic that stimulates GH secretion. OBJECTIVE:The objective of the study was to determine the diagnostic efficacy and safety of macimorelin in AGHD. DESIGN:This was a multicenter open-label study comparing the diagnostic accuracy of oral macimorelin with that of arginine+GHRH in AGHD patients and healthy, matched controls. After 43 AGHD patients and 10 controls were tested, the GHRH analog Geref Diagnostic [GHRH(1–29)NH2] became unavailable in the United States. The study was completed by testing 10 additional AGHD patients and 38 controls with macimorelin alone. MAIN OUTCOME MEASURE:Peak GH area under the receiver operating characteristic curve after macimorelin was measured. RESULTS:Fifty AGHD subjects and 48 controls were evaluated. Peak GH levels in AGHD patients and controls after macimorelin were 2.36 ± 5.69 and 17.71 ± 19.11 ng/mL, respectively (P < .0001). With macimorelin, the receiver operating characteristic analysis yielded an optimal GH cut point of 2.7 ng/mL, with 82% sensitivity, 92% specificity, and 13% misclassification rate. For subjects receiving both tests, macimorelin showed discrimination comparable with arginine+GHRH (area under the receiver operating characteristic curve 0.99 vs 0.94, respectively, P = .29). Obesity (body mass index > 30 kg/m) was present in 58% of subjects, and peak GH levels were inversely associated with body mass index in controls (r = −0.37, P = .01). Using the separate cut points of 6.8 ng/mL for nonobese and 2.7 for obese subjects reduced the misclassification rate to 11%. Only 1 drug-related serious adverse event, an asymptomatic QT interval prolongation on the electrocardiogram, was reported. CONCLUSION:Oral macimorelin is safe, convenient, and effective in diagnosing AGHD with accuracy comparable with the arginine+GHRH test. In the absence of panhypopituitarism and low serum IGF-I levels, the diagnosis of adult GH deficiency (AGHD) requires confirmation with a GH stimulation test. Macimorelin is a novel, orally active ghrelin mimetic that stimulates GH secretion.CONTEXTIn the absence of panhypopituitarism and low serum IGF-I levels, the diagnosis of adult GH deficiency (AGHD) requires confirmation with a GH stimulation test. Macimorelin is a novel, orally active ghrelin mimetic that stimulates GH secretion.The objective of the study was to determine the diagnostic efficacy and safety of macimorelin in AGHD.OBJECTIVEThe objective of the study was to determine the diagnostic efficacy and safety of macimorelin in AGHD.This was a multicenter open-label study comparing the diagnostic accuracy of oral macimorelin with that of arginine+GHRH in AGHD patients and healthy, matched controls. After 43 AGHD patients and 10 controls were tested, the GHRH analog Geref Diagnostic [GHRH(1-29)NH2] became unavailable in the United States. The study was completed by testing 10 additional AGHD patients and 38 controls with macimorelin alone.DESIGNThis was a multicenter open-label study comparing the diagnostic accuracy of oral macimorelin with that of arginine+GHRH in AGHD patients and healthy, matched controls. After 43 AGHD patients and 10 controls were tested, the GHRH analog Geref Diagnostic [GHRH(1-29)NH2] became unavailable in the United States. The study was completed by testing 10 additional AGHD patients and 38 controls with macimorelin alone.Peak GH area under the receiver operating characteristic curve after macimorelin was measured.MAIN OUTCOME MEASUREPeak GH area under the receiver operating characteristic curve after macimorelin was measured.Fifty AGHD subjects and 48 controls were evaluated. Peak GH levels in AGHD patients and controls after macimorelin were 2.36 ± 5.69 and 17.71 ± 19.11 ng/mL, respectively (P < .0001). With macimorelin, the receiver operating characteristic analysis yielded an optimal GH cut point of 2.7 ng/mL, with 82% sensitivity, 92% specificity, and 13% misclassification rate. For subjects receiving both tests, macimorelin showed discrimination comparable with arginine+GHRH (area under the receiver operating characteristic curve 0.99 vs 0.94, respectively, P = .29). Obesity (body mass index > 30 kg/m(2)) was present in 58% of subjects, and peak GH levels were inversely associated with body mass index in controls (r = -0.37, P = .01). Using the separate cut points of 6.8 ng/mL for nonobese and 2.7 for obese subjects reduced the misclassification rate to 11%. Only 1 drug-related serious adverse event, an asymptomatic QT interval prolongation on the electrocardiogram, was reported.RESULTSFifty AGHD subjects and 48 controls were evaluated. Peak GH levels in AGHD patients and controls after macimorelin were 2.36 ± 5.69 and 17.71 ± 19.11 ng/mL, respectively (P < .0001). With macimorelin, the receiver operating characteristic analysis yielded an optimal GH cut point of 2.7 ng/mL, with 82% sensitivity, 92% specificity, and 13% misclassification rate. For subjects receiving both tests, macimorelin showed discrimination comparable with arginine+GHRH (area under the receiver operating characteristic curve 0.99 vs 0.94, respectively, P = .29). Obesity (body mass index > 30 kg/m(2)) was present in 58% of subjects, and peak GH levels were inversely associated with body mass index in controls (r = -0.37, P = .01). Using the separate cut points of 6.8 ng/mL for nonobese and 2.7 for obese subjects reduced the misclassification rate to 11%. Only 1 drug-related serious adverse event, an asymptomatic QT interval prolongation on the electrocardiogram, was reported.Oral macimorelin is safe, convenient, and effective in diagnosing AGHD with accuracy comparable with the arginine+GHRH test.CONCLUSIONOral macimorelin is safe, convenient, and effective in diagnosing AGHD with accuracy comparable with the arginine+GHRH test. |
| Author | Biller, B. M. K. Cook, D. Bonert, V. Wang, C. Kyle, M. Kipnes, M. Molitch, M. E. Merriam, G. R. Yuen, K. C. J. Swerdloff, R. Dobs, A. Garcia, J. M. |
| AuthorAffiliation | Michael E. DeBakey Veterans Affairs Medical Center/Baylor College of Medicine (J.M.G.), Houston, Texas 77030; Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute (R.S., C.W.), Torrance, California 90502; Radiant Research, Inc (M.Ky.), Chicago, Illinois 60654; DGD Clinic (M.Ki.), San Antonio, Texas 78229; Massachusetts General Hospital/Harvard Medical School (B.M.K.B.), Boston, Massachusetts 02215; Oregon Health and Science University (D.C., K.C.J.Y.), Portland, Oregon 97239; Cedars-Sinai Medical Center (V.B.), Los Angeles, California 90048; Johns Hopkins Medical Institutions (A.D.), Baltimore, Maryland 21205; Northwestern University Feinberg School of Medicine (M.E.M.), Chicago, Illinois 60611; and Veterans Affairs Puget Sound HCS/University of Washington (G.R.M.), Seattle and Tacoma, Washington 98108 |
| AuthorAffiliation_xml | – name: Michael E. DeBakey Veterans Affairs Medical Center/Baylor College of Medicine (J.M.G.), Houston, Texas 77030; Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute (R.S., C.W.), Torrance, California 90502; Radiant Research, Inc (M.Ky.), Chicago, Illinois 60654; DGD Clinic (M.Ki.), San Antonio, Texas 78229; Massachusetts General Hospital/Harvard Medical School (B.M.K.B.), Boston, Massachusetts 02215; Oregon Health and Science University (D.C., K.C.J.Y.), Portland, Oregon 97239; Cedars-Sinai Medical Center (V.B.), Los Angeles, California 90048; Johns Hopkins Medical Institutions (A.D.), Baltimore, Maryland 21205; Northwestern University Feinberg School of Medicine (M.E.M.), Chicago, Illinois 60611; and Veterans Affairs Puget Sound HCS/University of Washington (G.R.M.), Seattle and Tacoma, Washington 98108 |
| Author_xml | – sequence: 1 givenname: J. M. surname: Garcia fullname: Garcia, J. M. email: jgarcia1@bcm.edu organization: 1Michael E. DeBakey Veterans Affairs Medical Center/Baylor College of Medicine (J.M.G.), Houston, Texas 77030 – sequence: 2 givenname: R. surname: Swerdloff fullname: Swerdloff, R. organization: 2Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute (R.S., C.W.), Torrance, California 90502 – sequence: 3 givenname: C. surname: Wang fullname: Wang, C. organization: 2Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute (R.S., C.W.), Torrance, California 90502 – sequence: 4 givenname: M. surname: Kyle fullname: Kyle, M. organization: 3Radiant Research, Inc (M.Ky.), Chicago, Illinois 60654 – sequence: 5 givenname: M. surname: Kipnes fullname: Kipnes, M. organization: 4DGD Clinic (M.Ki.), San Antonio, Texas 78229 – sequence: 6 givenname: B. M. K. surname: Biller fullname: Biller, B. M. K. organization: 5Massachusetts General Hospital/Harvard Medical School (B.M.K.B.), Boston, Massachusetts 02215 – sequence: 7 givenname: D. surname: Cook fullname: Cook, D. organization: 6Oregon Health and Science University (D.C., K.C.J.Y.), Portland, Oregon 97239 – sequence: 8 givenname: K. C. J. surname: Yuen fullname: Yuen, K. C. J. organization: 6Oregon Health and Science University (D.C., K.C.J.Y.), Portland, Oregon 97239 – sequence: 9 givenname: V. surname: Bonert fullname: Bonert, V. organization: 7Cedars-Sinai Medical Center (V.B.), Los Angeles, California 90048 – sequence: 10 givenname: A. surname: Dobs fullname: Dobs, A. organization: 8Johns Hopkins Medical Institutions (A.D.), Baltimore, Maryland 21205 – sequence: 11 givenname: M. E. surname: Molitch fullname: Molitch, M. E. organization: 9Northwestern University Feinberg School of Medicine (M.E.M.), Chicago, Illinois 60611 – sequence: 12 givenname: G. R. surname: Merriam fullname: Merriam, G. R. organization: 10Veterans Affairs Puget Sound HCS/University of Washington (G.R.M.), Seattle and Tacoma, Washington 98108 |
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| Keywords | Human Endocrinopathy Obesity Nutrition Deficiency Nutrition disorder Oral administration Exploration Metabolic diseases Stimulation Test validation Somatotropin Adenohypophyseal hormone Adult Diagnosis Endocrinology Nutritional status |
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| Snippet | Context:In the absence of panhypopituitarism and low serum IGF-I levels, the diagnosis of adult GH deficiency (AGHD) requires confirmation with a GH... CONTEXT:In the absence of panhypopituitarism and low serum IGF-I levels, the diagnosis of adult GH deficiency (AGHD) requires confirmation with a GH... In the absence of panhypopituitarism and low serum IGF-I levels, the diagnosis of adult GH deficiency (AGHD) requires confirmation with a GH stimulation test.... |
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| SubjectTerms | Administration, Oral Adult Aged Arginine Biological and medical sciences Body mass index Cross-Over Studies Diagnosis EKG Endocrine Care Endocrinopathies Feeding. Feeding behavior Female Fundamental and applied biological sciences. Psychology Ghrelin Ghrelin - analogs & derivatives Growth Hormone-Releasing Hormone Human Growth Hormone - blood Human Growth Hormone - deficiency Humans Indoles Insulin-like growth factor I Insulin-Like Growth Factor I - analysis Male Medical sciences Middle Aged Obesity ROC Curve Tryptophan - analogs & derivatives Vertebrates: anatomy and physiology, studies on body, several organs or systems Vertebrates: endocrinology |
| Title | Macimorelin (AEZS-130)-Stimulated Growth Hormone (GH) Test: Validation of a Novel Oral Stimulation Test for the Diagnosis of Adult GH Deficiency |
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