OBJECTIVE To investigate the efficacy and safety of single-pill amlodipine/atorvastatin therapy for the simultaneous treatment of hypertension (HTN) and dyslipidemia in African Americans. PATIENTS AND METHODS Conducted between July 19, 2004, and August 9, 2005, the Clinical Utility of Caduet in Simultaneously Achieving Blood Pressure and Lipid End Points trial was a 20-week, open-label, noncomparative, multicenter trial of the efficacy and safety of single-pill amlodipine/atorvastatin in controlling elevated blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) in African Americans with concomitant HTN and dyslipidemia and either no additional risk factors, 1 or more cardiovascular risk factors, or coronary heart disease or a risk equivalent. Eight dosage strengths of single-pill amlodipine/atorvastatin were flexibly titrated. The primary efficacy assessment of the main trial was the percentage of patients who attained the LDL-C treatment goals of both the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure and the National Cholesterol Education Program Adult Treatment Panel III. RESULTS Of the 1170 African American patients screened, 501 were enrolled in the study and 499 received drug therapy. At end point, 236 (48.3%) of 489 patients reached both their BP and LDL-C goals (vs 4 [0.8%] of 484 at baseline); 280 (56.8%) of 493 reached BP goals (vs 7 [1.4%] of 494 at baseline); and 361 (73.7%) of 490 reached LDL-C goals (vs 138 [28.5%] of 484 at baseline). Among the 499 patients receiving drug therapy, common treatment-related adverse events were peripheral edema (17 patients [3.4%]), headache (11 [2.2%]), myalgia (11 [2.2%]), and constipation (10 [2.0%]). CONCLUSION Single-pill amlodipine/atorvastatin therapy was well tolerated and effectively targeted HTN and dyslipidemia in this population of African Americans who were at risk of cardiovascular disease.
