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The CAMELOT Study: A Randomized Controlled Trial

Steven E. Nissen, MD; E. Murat Tuzcu, MD; Peter Libby, MD; Paul D. Thompson, MD; Magdi Ghali, MD; Dahlia Garza, MD; Lance Berman, MD; Harry Shi, MS; Ethel Buebendorf, BSN; Eric J. Topol, MD; for the CAMELOT Investigators

JAMA. 2004;292:2217-2225.

Context  The effect of antihypertensive drugs on cardiovascular events in patients with coronary artery disease (CAD) and normal blood pressure remains uncertain.

Objective  To compare the effects of amlodipine or enalapril vs placebo on cardiovascular events in patients with CAD.

Design, Setting, and Participants  Double-blind, randomized, multicenter, 24-month trial (enrollment April 1999-April 2002) comparing amlodipine or enalapril with placebo in 1991 patients with angiographically documented CAD (>20% stenosis by coronary angiography) and diastolic blood pressure <100 mm Hg. A substudy of 274 patients measured atherosclerosis progression by intravascular ultrasound (IVUS).

Interventions  Patients were randomized to receive amlodipine, 10 mg; enalapril, 20 mg; or placebo. IVUS was performed at baseline and study completion.

Main Outcome Measures  The primary efficacy parameter was incidence of cardiovascular events for amlodipine vs placebo. Other outcomes included comparisons of amlodipine vs enalapril and enalapril vs placebo. Events included cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, coronary revascularization, hospitalization for angina pectoris, hospitalization for congestive heart failure, fatal or nonfatal stroke or transient ischemic attack, and new diagnosis of peripheral vascular disease. The IVUS end point was change in percent atheroma volume.

Results  Baseline blood pressure averaged 129/78 mm Hg for all patients; it increased by 0.7/0.6 mm Hg in the placebo group and decreased by 4.8/2.5 mm Hg and 4.9/2.4 mm Hg in the amlodipine and enalapril groups, respectively (P<.001 for both vs placebo). Cardiovascular events occurred in 151 (23.1%) placebo-treated patients, in 110 (16.6%) amlodipine-treated patients (hazard ratio [HR], 0.69; 95% CI, 0.54-0.88 [P = .003]), and in 136 (20.2%) enalapril-treated patients (HR, 0.85; 95% CI, 0.67-1.07 [P = .16]. Primary end point comparison for enalapril vs amlodipine was not significant (HR, 0.81; 95% CI, 0.63-1.04 [P = .10]). The IVUS substudy showed a trend toward less progression of atherosclerosis in the amlodipine group vs placebo (P = .12), with significantly less progression in the subgroup with systolic blood pressures greater than the mean (P = .02). Compared with baseline, IVUS showed progression in the placebo group (P<.001), a trend toward progression in the enalapril group (P = .08), and no progression in the amlodipine group (P = .31). For the amlodipine group, correlation between blood pressure reduction and progression was r = 0.19, P = .07.

Conclusions  Administration of amlodipine to patients with CAD and normal blood pressure resulted in reduced adverse cardiovascular events. Directionally similar, but smaller and nonsignificant, treatment effects were observed with enalapril. For amlodipine, IVUS showed evidence of slowing of atherosclerosis progression.

Author Affiliations: Department of Cardiovascular Medicine, Cleveland Clinic Lerner School of Medicine, Cleveland, Ohio (Drs Nissen, Tuzcu, and Topol); Brigham and Women’s Hospital, Boston, Mass (Dr Libby); Department of Cardiology, Hartford Hospital, Hartford, Conn (Dr Thompson); Department of Cardiology, Iowa Heart Center, Des Moines (Dr Ghali); and Pfizer Inc, New York, NY (Drs Garza and Berman and Mr Shi and Ms Buebendorf).

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RELATED LETTERS

Antihypertensive Agents and Cardiovascular Events in Patients With Coronary Disease and Normal Blood Pressure
Victor Aboyans, Philippe Lacroix, and Claude Cassat
JAMA. 2005;293(10):1187.
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Antihypertensive Agents and Cardiovascular Events in Patients With Coronary Disease and Normal Blood Pressure
Taishiro Chikamori, Hirofumi Tomiyama, and Akira Yamashina
JAMA. 2005;293(10):1187-1188.
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Antihypertensive Agents and Cardiovascular Events in Patients With Coronary Disease and Normal Blood Pressure
Luca Mascitelli and Francesca Pezzetta
JAMA. 2005;293(10):1188.
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Antihypertensive Agents and Cardiovascular Events in Patients With Coronary Disease and Normal Blood Pressure—Reply
Steven E. Nissen and For the CAMELOT Investigators
JAMA. 2005;293(10):1188-1189.
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