The use of a single-pill calcium channel blocker/statin combination in the management of hypertension and dyslipidemia: a randomized, placebo-controlled, multicenter study

Abstract

Poor control of hypertension or dyslipidemia may at least in part be due to these risk factors being treated in isolation. The Caduet in Untreated Subjects Population (CUSP) trial was an 8-week, randomized, double-blind, placebo-controlled trial evaluating the efficacy/safety of the combination of a calcium channel blocker (amlodipine besylate) and a statin (atorvastatin calcium) in a single-pill form (5/20 mg) plus therapeutic lifestyle changes (TLC) compared with placebo plus TLC in patients with comorbid hypertension and dyslipidemia without evidence of cardiovascular disease. At week 4, additional antihypertensive/lipid-lowering medication was permitted. The primary end point was the proportion of patients in whom the dual goal of blood pressure (<140/90 mm Hg) and low-density lipoprotein cholesterol control (<100 mg/dL) was met at week 4. This dual goal attainment was significantly greater with amlodipine/atorvastatin plus TLC compared with placebo plus TLC at week 4 (47.6% vs 1.7%; P<.001), with further improvements at week 8. Most adverse events were mild to moderate. Therapy with single-pill amlodipine/atorvastatin plus TLC in these patients significantly increased dual blood pressure/low-density lipoprotein cholesterol goal attainment compared with placebo plus TLC.

Figure 1

Trial design. AML/ATO indicates amlodipine/atorvastatin single‐pill therapy; TLC, therapeutic lifestyle changes.

Figure 2

Flow of patients through the trial. *One patient was treated with AML/ATO but not randomized; this patient was excluded from all efficacy analyses but was included in the safety analysis. Another patient was randomized but not treated as he/she was not willing to participate after randomization. This patient was not included in any efficacy or safety analyses. AML/ATO indicates amlodipine/atorvastatin single‐pill therapy; TLC, therapeutic lifestyle changes.

Figure 3

Goal attainment. (A) Dual blood pressure (BP)/low‐density lipoprotein (LDL‐C) goal attainment; (B) dual systolic BP/diastolic BP goal attainment; and (C) LDL‐C goal attainment. AML/ATO indicates amlodipine/atorvastatin single‐pill therapy; CI, confidence interval; TLC, therapeutic lifestyle changes. ^aPrimary efficacy end point.