1. Clinical Utility of Single-Pill Amlodipine/Atorvastatin for the Attainment of Blood Pressure and Lipid Goals in Diabetic Patients of Diverse Ethnicity: Results from the GEMINI-AALA Study.
- Author
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Aguilar-Salinas, Carlos A., Hung-Fat Tse, Young Moo Ro, Howes, Laurence G., Chaves, Hilton, Erdine, Serap, Guindy, Ramez, Chopra, Pravin, Moller, Robert A., and Schou, Ishani M.
- Subjects
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AMLODIPINE , *STATINS (Cardiovascular agents) , *CARDIOVASCULAR agents , *BLOOD pressure , *BLOOD lipids , *PEOPLE with diabetes , *DRUG dosage - Abstract
This planned analysis of the GEMINI-AALA study evaluated the utility of single-pill amlodipine/atorvastatin for the attainment of blood pressure (BP) and lipid goals in diabetic patients of diverse ethnicity with hypertension (HTN) and dyslipidemia (DYS). GEMINI-AALA was a 14-week, multicenter, open-label study in patients with HTN/DYS from 27 countries across 5 continents. Eight dosages of single-pill amlodipine/atorvastatin (5/10-10/80 mg) were administered and electively titrated at Weeks 6, 10 (titration optional), and 12. The percentage of patients who attained JNC 7 and NCEP ATP III goals for BP (<130/80 mm Hg) and low-density lipoprotein cholesterol (LDL-C) (< 100 mg/dL) at Week 14 was assessed. Changes from baseline in BP and LDLC were also measured. Of the 1638 patients included in the intent-to-treat (ITT) population, 605 patients had type 2 diabetes. For diabetic patients, the mean dose of amlodipine/atorvastatin during the study was 6.2 mg/18.3 mg. Mean BP and LDL-C at baseline were 145.0/86.2 mmHg and 120.6 mg/dL, respectively. After 14 weeks treatment, 41.3% of diabetic patients reached both BP and LDL-C goals (0.0% at baseline), 46.3% reached BP goal (0.2% at baseline), and 84.6% reached LDL-C goal (30.6% at baseline). Mean BP reduction was 18.1/10.2 mmHg, and mean decrease in LDL-C was 40.5 mg/dL (27.5%). Attainment of both goals for the Middle East/Africa, Asia-Pacific, and Central/Southern America was 33.7%, 45.1%, and 40.6%, respectively. Among diabetic patients, 4.3% discontinued due to adverse events. Amlodipine/atorvastatin single-pill therapy was an effective and safe intervention that helped diabetic patients of diverse ethnicity with combined HTN/DYS to achieve BP and LDL-C goals. [ABSTRACT FROM AUTHOR]
- Published
- 2007