A randomised trial of three counselling strategies for lifestyle changes in patients with hypercholesterolemia treated with ezetimibe on top of statin therapy (TWICE).
OBJECTIVE
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 (10mg/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 1,496 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.
Steg
Philippe Gabriel
PG
Inserm U-698, université Paris-VII-Denis-Diderot, hôpital Bichat-Claude-Bernard, AP-HP, 46, rue Henri-Huchard 75018 Paris, France. gabriel.steg@bch.aphp.fr
Verdier
Jean-Claude
JC
Carré
François
F
Darne
Bernadette
B
Ducardonnet
Alain
A
Jullien
Gérard
G
Farnier
Michel
M
Giral
Philippe
P
Haïat
Robert
R
D000368:Aged; D000924:Anticholesteremic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001384:Azetidines / Q000009:adverse effects / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000097:blood / Q000209:etiology / Q000517:prevention & control*; D008078:Cholesterol, LDL / Q000097:blood; D003131:Combined Modality Therapy; D018752:Diet, Fat-Restricted; D037001:Directive Counseling / Q000379:methods*; D004359:Drug Therapy, Combination; D015444:Exercise; D000069438:Ezetimibe; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000097:blood / Q000150:complications / Q000188:drug therapy / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009042:Motivation; D011358:Product Surveillance, Postmarketing; D040242:Risk Reduction Behavior; D013997:Time Factors; D016896:Treatment Outcome
D000924:Anticholesteremic Agents; D001384:Azetidines; D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000069438:Ezetimibe