A randomised trial of three counselling strategies for lifestyle changes in patients with hypercholesterolemia treated with ezetimibe on top of statin therapy (TWICE)

• Published in: Archives of cardiovascular diseases Vol. 101; no. 11; pp. 723 - 735
• Main Authors: Steg, Philippe Gabriel, Verdier, Jean-Claude, Carré, François, Darne, Bernadette, Ducardonnet, Alain, Jullien, Gérard, Farnier, Michel, Giral, Philippe, Haïat, Robert
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier Masson SAS 01.11.2008; Elsevier
• Subjects: Aged; Anticholesteremic Agents - adverse effects; Anticholesteremic Agents - therapeutic use; Atherosclerosis (general aspects, experimental research); Azetidines - adverse effects; Azetidines - therapeutic use; Biological and medical sciences; Blood and lymphatic vessels; Cardiology. Vascular system; Cardiovascular; Cardiovascular Diseases - blood; Cardiovascular Diseases - etiology; Cardiovascular Diseases - prevention & control; Cholesterol, LDL - blood; Combined Modality Therapy; Diet, Fat-Restricted; Directive Counseling - methods; Disorders of blood lipids. Hyperlipoproteinemia; Drug Therapy, Combination; Exercise; Ezetimibe; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Hypercholesterolemia - blood; Hypercholesterolemia - complications; Hypercholesterolemia - drug therapy; Hypercholesterolemia - therapy; Hypercholestérolemie primaire; Internal Medicine; Lifestyle intervention; Male; Medical sciences; Mesures hygiéno-diététiques; Metabolic diseases; Middle Aged; Modèle de Prochaska; Motivation; Primary hypercholesterolemia; Product Surveillance, Postmarketing; Risk Reduction Behavior; Stages of change; Time Factors; Treatment Outcome; Étapes de changement; Étapes de changement; Modèle de Prochaska; Stages of change; Mesures hygiéno-diététiques; Ezetimibe; Lifestyle intervention; Primary hypercholesterolemia; Hypercholestérolemie primaire; Dietetics; Human; Measurement; Metabolic diseases; Lipids; Cardiovascular disease; Hyperlipoproteinemia; Statin derivative; Change; Lipoprotein; Cholesterol; Council; Hypercholesterolemia; Treatment; Primary; Strategy; Models; Dyslipemia; Cardiology; Life style
• ISSN: 1875-2136; 1875-2128
• DOI: 10.1016/j.acvd.2008.10.008

Summary Aims To compare the impact of three patient counselling strategies for lifestyle changes and to assess the safety and efficacy of ezetimibe on top of statin therapy in hypercholesterolemic high risk patients. Methods Open, cluster randomized 3-parallel group trial. Physicians were randomized between patient motivation on: diet or physical exercise or both. Counselling was adapted to the patient's baseline Prochaska stage of change. High cardiovascular risk patients, with LDL-C above or equal to 3 mmol/L despite statin therapy for at least 3 months, were enrolled. Ezetimibe (10 mg/day) and patient counselling were started at the same time. Target goal was defined as total cholesterol less than 5 mmol/L and LDL-C above 3 mmol/L. Results Overall 428 physicians enrolled 1496 patients. At baseline, LDL-C was 3.9 ± 0.9 mmol/L and total cholesterol was 6.1 ± 1.1 mmol/L. LDL-C decreased by −30.4 ± 19.3% and 869 (62%) patients achieved target goal. No difference was shown between randomisation groups. However, improvements in diet consumption patterns were more easily obtained than improvement in physical activity stage of change in non-active patient at baseline. Conclusions The marked short-term impact (−30%) on LDL-C, although similar between the three groups, slightly exceeds usual LDL-C reductions achieved by this dose of ezetimibe. Decreasing fat consumption seems easier than increasing physical activity. This study confirms the good efficacy, short-term tolerability and safety of ezetimibe on top of statins.