Single-Pill Combination of Telmisartan/Amlodipine Versus Amlodipine Monotherapy in Diabetic Hypertensive Patients: An 8-Week Randomized, Parallel-Group, Double-Blind Trial

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• 作者：Arya M. Sharma ; MD ; PhD ; FRCPC¹ ; ^{amsharm@ualberta.ca} ; George Bakris ; MD² ; Joel M. Neutel ; MD³ ; Thomas W. Littlejohn ; MD ; FAAFP ; CPI⁴ ; ^鈦?/sup> ; Maureen Kobe ; MBA⁵ ; Naitee Ting ; PhD⁵ ; Ludwin Ley ; MD⁶
• 关键词：hypertension ; metabolic syndrome ; obesity ; single-pill combination ; telmisartan/amlodipine ; type 2 diabetes mellitus
• 刊名：Clinical Therapeutics
• 出版年：2012
• 期刊代码：65_01492918
• 类别：med
• 出版时间：March, 2012
• 卷：34
• 期：3
• 页码：537-551
• 文件大小：767 K

摘要

Background

Hypertensive patients with diabetes often require combination therapy to achieve a blood pressure (BP) goal, and evidence suggests that time to BP goal is crucial to decrease cardiovascular risk.

Objective

The aim of the study was to investigate whether the single-pill combination of telmisartan and amlodipine was superior to amlodipine alone as initial antihypertensive therapy in patients with diabetes and hypertension.

Methods

An 8-week, randomized, parallel-group, double-blind international trial comparing the once-daily single-pill combination of telmisartan 80 mg and amlodipine 10 mg (T/A; n = 352) with once-daily amlodipine 10 mg (A; n = 354) in patients with type 2 diabetes mellitus and stage 1 or 2 hypertension (systolic BP [SBP] >150 mm Hg).

Results

Patient demographics were similar between treatment groups, with an mean (SD) age of 60.5 (10.1) years; 51.7%were male, the mean (SD) body mass index was 32.0 (6.1) and the mean (SD) duration of hypertension was 8.8 (7.9) years. After 8 weeks (primary end point) as well as after 1, 2, and 4 weeks (key secondary end points), significantly greater decreases in the in-clinic mean seated trough cuff SBP with T/A versus A were achieved (鈭?9.0 mm Hg vs 鈭?2.9 mm Hg at 8 weeks; P < 0.0001). After 8 weeks, 71.4%versus 53.8%of patients achieved the BP goal (<140/90 mm Hg) with T/A versus A, with mean SBPs of 131.9 and 137.9 mm Hg, respectively. Similar results were observed in the obese (metabolic syndrome) subpopulation. The more stringent goal (<130/80 mm Hg) was achieved by 36.4%and 17.9%patients in the T/A and A groups, respectively. The most common adverse events were peripheral edema, headache, and dizziness.

Conclusions

In this selected population of patients with diabetes and hypertension, T/A provided prompt and greater BP decreases compared with A monotherapy, with the majority of patients achieving the BP goal (<140/90 mm Hg).