Long-Term Tolerability and Efficacy of Single-Pill Combinations of Telmisartan 40-80 mg Plus Amlodipine 5 or 10 mg in Patients Whose Blood Pressure Was Not Initially Controlled by Amlodipine 5-10 mg: Open-Label, Long-Term Follow-Ups of the TEAMSTA-5 and T

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• 作者：Steen Neldam ; MDp>1p>p> ; p>p>neldam@dadlnet.dkp> ; Colin Edwards ; PhDp>2p> ; Margreet Lang ; PhDp>3p> ; Russell Jones ; MScp>4p> ; TEAMSTA-5 ; TEAMSTA-10 Investigators
• 关键词：amlodipine ; angiotensin II receptor blocker ; calcium channel blocker ; essential hypertension ; single-pill combination ; telmisartan
• 刊名：Current Therapeutic Research
• 出版年：2012
• 期刊代码：75_0011393x
• 类别：med
• 出版时间：February-April, 2012
• 卷：73
• 期：1-2
• 页码：65-84
• 文件大小：659 K

摘要

Background

Two 8-week, randomized, double-blind, controlled studies previously evaluated the efficacy and tolerability of single-pill combinations of telmisartan 40-80 mg/amlodipine 5-10 mg (T40-80/A5-10) in patients with hypertension not at diastolic blood pressure (DBP) goal (DBP <90 mm Hg) after 6 weeks of amlodipine 5 mg monotherapy (A5) (TEAMSTA-5) or amlodipine 10 mg monotherapy (A10) (TEAMSTA-10). The long-term (鈮? months) tolerability and efficacy of single-pill combinations of T40-T80/A5-A10 have now been evaluated in 2 open-label studies in patients who had successfully completed either TEAMSTA-5 or TEAMSTA-10 (TEAMSTA-5 and TEAMSTA-10 Follow-Ups).

Methods

<p>In the TEAMSTA-5 Follow-Up, 976 patients whose blood pressure was not initially controlled by taking A5 received T40/A5 for 4 or 8 weeks, with consecutive uptitration to T80/A5 if DBP was 鈮?0 mm Hg. In TEAMSTA-10 Follow-Up, 838 patients not initially achieving blood pressure control using A10 received T40/A10 for 4 weeks before randomization to T40/A10 or T80/A10; after 4 weeks, patients randomized to T40/A10 with DBP 鈮?0 mm Hg were uptitrated to T80/A10. In both studies, add-on antihypertensive medication was allowed if DBP was not at goal.

Results

<p>Treatment compliance in both follow-up studies was 鈮?8.4%. Single-pill combinations of T40-T80/A5-A10 resulted in additional clinically relevant blood pressure reductions and 67%to 93%of patients achieved DBP goal (<90 mm Hg); only 1%to 19%of patients received additional medication for hypertension, of whom 29%to 76%achieved DBP goal. Long-term treatment with T40-T80/A5-A10 was well tolerated, with comparable adverse event profiles for all telmisartan/amlodipine combinations. The most common drug-related adverse events were peripheral edema (1.9%-3.9%) and dizziness (1.5%in the T80/A5 group only); these were consistent with the known tolerability profiles of telmisartan/amlodipine combinations. Overall treatment discontinuation rates due to adverse events were low (0.7%-1.5%).

Conclusions

<p>In patients not achieving DBP goal with either A5 or A10 monotherapy, the vast majority achieved DBP goal with single-pill combinations of T40-T80/A5-A10. Long-term treatment was well tolerated with high compliance, promoting treatment adherence regardless of telmisartan/amlodipine dose. identifiers: (TEAMSTA-5 Follow-up) and (TEAMSTA-10 Follow-up).