Neldam Steen, Edwards Colin, Lang Margreet, Jones Russell
Rødovre Centrum, Rødovre, Denmark.
Boehringer Ingelheim Ireland Ltd., Dublin, Ireland.
Curr Ther Res Clin Exp. 2012 Feb;73(1-2):65-84. doi: 10.1016/j.curtheres.2012.02.004.
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).
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.
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 low (0.7%-1.5%).
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. ClinicalTrials.gov identifiers: NCT00614380 (TEAMSTA-5 Follow-up) and NCT00624052 (TEAMSTA-10 Follow-up).
两项为期8周的随机双盲对照研究，之前评估了替米沙坦40 - 80毫克/氨氯地平5 - 10毫克（T40 - 80/A5 - 10）单一片剂组合，在接受氨氯地平5毫克单药治疗（A5）6周后（TEAMSTA - 5）或氨氯地平10毫克单药治疗（A10）6周后（TEAMSTA - 10），对未达舒张压（DBP）目标（DBP <90毫米汞柱）的高血压患者的疗效和耐受性。现在，在两项开放标签研究中评估了T40 - T80/A5 - A10单一片剂组合的长期（≥6个月）耐受性和疗效，这些研究的患者已成功完成TEAMSTA - 5或TEAMSTA - 10（TEAMSTA - 5和TEAMSTA - 10随访研究）。
在TEAMSTA - 5随访研究中，976例最初服用A5血压未得到控制的患者接受T40/A5治疗4周或8周，如果DBP≥90毫米汞柱，则连续滴定至T80/A5。在TEAMSTA - 10随访研究中，838例最初使用A10未实现血压控制的患者在随机分组接受T40/A10或T80/A10之前接受T40/A10治疗4周；4周后，随机分组接受T40/A10且DBP≥90毫米汞柱的患者滴定至T80/A10。在两项研究中，如果DBP未达目标，则允许加用抗高血压药物。
两项随访研究中的治疗依从性均≥98.4%。T40 - T80/A5 - A10单一片剂组合导致临床上进一步显著降低血压，67%至93%的患者实现DBP目标（<90毫米汞柱）；仅1%至19%的患者因高血压接受了额外药物治疗，其中29%至76%的患者实现了DBP目标。T40 - T80/A5 - A10的长期治疗耐受性良好，所有替米沙坦/氨氯地平组合的不良事件谱相当。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%）；这些与替米沙坦/氨氯地平组合已知的耐受性谱一致。因不良事件导致的总体治疗停药率较低（0.7% - 1.5%）。
在使用A5或A10单药治疗未实现DBP目标的患者中，绝大多数患者通过T40 - T80/A5 - A10单一片剂组合实现了DBP目标。长期治疗耐受性良好且依从性高，无论替米沙坦/氨氯地平剂量如何，均能促进治疗依从性。ClinicalTrials.gov标识符：NCT00614380（TEAMSTA - 5随访）和NCT00624052（TEAMSTA - 10随访）。
