Single-pill therapy in the treatment of concomitant hypertension and dyslipidemia (the amlodipine/atorvastatin gemini study)

Abstract

The Gemini Study was a 14-week, open-label, non-comparative, office-based, multicenter trial to evaluate single-pill therapy in the treatment of concomitant hypertension and dyslipidemia. In addition to recommending lifestyle modifications, eight dosage strengths of amlodipine/atorvastatin single pill (5/10, 5/20, 5/40, 5/80, 10/10, 10/20, 10/40, and 10/80 mg) were electively titrated to improve blood pressure and lipid control. A total of 1220 patients with uncontrolled hypertension at baseline received study medication. At baseline, mean blood pressure was 146.6/87.9 mm Hg and mean low-density lipoprotein cholesterol concentration was 152.9 mg/dL. At study end, 57.7% of patients had achieved both their blood pressure and low-density lipoprotein cholesterol goals (51.9% of patients with uncontrolled low-density lipoprotein cholesterol at baseline). The mean dose of study medication at end point was amlodipine component 7.1 mg and atorvastatin component 26.2 mg. Fifty-eight patients (4.8%) discontinued therapy due to adverse events. Single-pill therapy is effective in reducing both blood pressure and lipid levels and in helping patients achieve goals for both hypertension and dyslipidemia.

Figure 1

Percentage of patients receiving each dose of study medication at baseline and end point. AML=amlodipine; ATO =atorvastatin

Figure 2

Goal attainment at end point overall and within each of the three cardiovascular risk groups for (A) joint blood pressure (BP) and low‐density lipoprotein cholesterol (LDL‐C) goals, (B) BP goal alone, and (C) LDL‐C goal“ alone. Error bars represent 95% confidence intervals. ”'Patients with uncontrolled LDL‐C at baseline

Figure 3

Distribution of systolic blood pressure (SBP)* vs. low‐density lipoprotein cholesterol (LDL‐C) values at baseline and end point for all intent‐to‐treat patients, analyzed by cardiovascular risk group. The horizontal and vertical lines show the goals for LDL‐C and SBP. Joint LDL‐C and blood pressure (BP) goal attainment is depicted by the shaded quadrant. *At study baseline, in accordance with the inclusion criteria, patients May have been at goal for SBP, but not at goal for diastolic BP.