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首页> 外文期刊>Current therapeutic research, clinical and experimental. >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 TEAMSTA-10 Studies
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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 TEAMSTA-10 Studies

机译：最初未由氨氯地平控制5-10 mg血压的患者，替米沙坦40-80 mg加氨氯地平5或10 mg的单药组合的长期耐受性和功效：开放标签，长期随访TEAMSTA-5和TEAMSTA-10研究

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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 (>6 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: 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 >90 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 >=90 mm Hg were uptitrated to T80/A10. In both studies, add-on antihypertensive medication was allowed if DBP was not at goal.RESULTS: Treatment compliance in both follow-up studies was >=98.4%. 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 lowCONCLUSIONS: In patients not achieving DBP goal with either A5 or A10 monotherapy, the vast majority achieved DBP goal with single-pill combinations of T40-T8O/A5-A10. Long-term treatment was well tolerated with high compliance, promoting treatment adherence regardless of telmisartan/amlodipine dose. ClinicalTrials.gov identifiers: NCT00614380 (TEAMSTA-5 Follow-up) and NCT00624052 (TEAMSTA-10 Follow-up).
机译：背景：两项为期8周的随机，双盲，对照研究先前评估了替米沙坦40-80 mg /氨氯地平5-10 mg（T40-80 / A5-10）单药组合的疗效和耐受性氨氯地平5 mg单药（A5）（TEAMSTA-5）或氨氯地平10 mg单药（A10）（TEAMSTA-10）6周后未达到舒张压（DBP）目标（DBP <90 mm Hg）的高血压。现在已在两项成功完成TEAMSTA-5或TEAMSTA-10的患者的2项开放标签研究中评估了T40-T80 / A5-A10单药组合的长期（> 6个月）耐受性和疗效（方法：在TEAMSTA-5随访中，有976例最初通过服用A5不能控制血压的患者接受了40或8周的T40 / A5治疗，并连续升至T80如果DBP> 90 mm Hg，则为/ A5。在TEAMSTA-10随访中，最初未使用A10实现血压控制的838位患者在随机分配至T40 / A10或T80 / A10之前接受了T40 / A10疗程4周。 4周后，将DBP> = 90 mm Hg的患者随机分配至T40 / A10，并升高至T80 / A10。在两项研究中，如果DBP均未达到目标，则允许加用降压药。结果：两项随访研究中治疗依从性均> = 98.4％。 T40-T80 / A5-A10的单药组合可进一步降低临床相关的血压，并且67％至93％的患者达到DBP目标（<90 mm Hg）;只有1％至19％的患者接受了额外的高血压药物治疗，其中29％至76％的患者达到了DBP目标。 T40-T80 / A5-A10的长期治疗耐受性良好，所有替米沙坦/氨氯地平联合用药的不良事件特征均相当。最常见的药物相关不良事件为外周水肿（1.9％-3-9％）和头晕（仅在T80 / A5组为1.5％）;这些与已知的替米沙坦/氨氯地平组合的耐受性特征一致。结论：不良事件导致的总体治疗终止率很低。结论：在未通过A5或A10单一疗法达到DBP目标的患者中，绝大多数通过T40-T8O / A5-A10单药组合达到DBP目标。长期治疗耐受性好，依从性高，无论替米沙坦/氨氯地平剂量如何，均可提高治疗依从性。 ClinicalTrials.gov标识符：NCT00614380（TEAMSTA-5跟踪）和NCT00624052（TEAMSTA-10跟踪）。

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