Clinical therapeutics · 2016
Comparison of the Efficacy and Safety of Fixed-dose S-Amlodipine/Telmisartan and Telmisartan in Hypertensive Patients Inadequately Controlled with Telmisartan: A Randomized, Double-blind, Multicenter Study.
Клиническое исследование III фазыСравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Park Chang Gyu, Ahn Tae Hun, Cho Eun Ju, Kim Won, Kim Hyung Seob, Yang Ju Yeong, Ryu Jae Geun, Kim Cheol Ho, Hyeon Min Soo, Tak Seung Je, Im Se Jung, Ha Jong Won, Pyeon Wook Beom, Jae Je Geon, Han Gyu Rok, Doh Jun Hyung, Im Sang Wook, Lee Myeong Muk
Аннотация
PURPOSE: The objective of this study was to evaluate the efficacy and safety of the fixed-dose combination S-amlodipine plus telmisartan (S-AM/TEL) compared with TEL monotherapy in patients with hypertension inadequately controlled by TEL monotherapy.
METHODS: this study was a randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare the superiority of the S-AM/TEL 2.5/40-mg and S-AM/TEL 5/40-mg combinations with TEL 80-mg mono-therapy. The primary end point was the change in the mean sitting diastolic blood pressure from baseline (week 0) after 8 weeks of therapy between treatment groups.
FINDINGS: Of 325 patients screened, 183 were randomly assigned to 3 groups (61 in the S-AM/TEL 2.5/40-mg group, 60 in the S-AM/TEL 5/40-mg group, and 62 in the TEL 80-mg group). Mean (SD) age was 53.9 (7.5) years, and male patients comprised 87%. No significant differences were found among the 3 groups in baseline characteristics. The primary end points, the changes of mean (SD) diastolic blood pressure at week 8 from the baseline were -10.56 (7.23) mm Hg in the S-AM/TEL 2.5/40-mg group, -12.32 (9.23) mm Hg in the S-AM/TEL 5/40-mg group, and -2.44 (7.92) mm Hg in the TEL 80-mg group. Both the S-AM/TEL 2.5/40-mg group and the S-AM/TEL 5/40-mg group had a statistically superior hypotensive effect compared with the TEL 80-mg group (P < 0.0001 for both). For evaluation of the safety profile, the frequencies of adverse events (AEs) among the groups were also not significantly different (S-AM/TEL 2.5/40-mg group, 18.6%; S-AM/TEL 5/40-mg group, 20%; and TEL 80-mg group, 22.6%), and the incidences of AEs were not different among the groups. The most common AEs were respiratory disorders, followed by headache, dizziness, and peripheral edema.
IMPLICATIONS: Treatment with S-AM/TEL 2.5/40 mg and S-AM/TEL 5/40 mg was superior to increasing the TEL dose in terms of hypotensive effect in patients with hypertension inadequately controlled by TEL monotherapy. S-AM/TEL fixed-dose combinations are an effective and tolerable option for patients inadequately responding to TEL monotherapy and also a good option for improving patients' medication adherence. ClinicalTrials.gov identifier: NCT011426100.
METHODS: this study was a randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare the superiority of the S-AM/TEL 2.5/40-mg and S-AM/TEL 5/40-mg combinations with TEL 80-mg mono-therapy. The primary end point was the change in the mean sitting diastolic blood pressure from baseline (week 0) after 8 weeks of therapy between treatment groups.
FINDINGS: Of 325 patients screened, 183 were randomly assigned to 3 groups (61 in the S-AM/TEL 2.5/40-mg group, 60 in the S-AM/TEL 5/40-mg group, and 62 in the TEL 80-mg group). Mean (SD) age was 53.9 (7.5) years, and male patients comprised 87%. No significant differences were found among the 3 groups in baseline characteristics. The primary end points, the changes of mean (SD) diastolic blood pressure at week 8 from the baseline were -10.56 (7.23) mm Hg in the S-AM/TEL 2.5/40-mg group, -12.32 (9.23) mm Hg in the S-AM/TEL 5/40-mg group, and -2.44 (7.92) mm Hg in the TEL 80-mg group. Both the S-AM/TEL 2.5/40-mg group and the S-AM/TEL 5/40-mg group had a statistically superior hypotensive effect compared with the TEL 80-mg group (P < 0.0001 for both). For evaluation of the safety profile, the frequencies of adverse events (AEs) among the groups were also not significantly different (S-AM/TEL 2.5/40-mg group, 18.6%; S-AM/TEL 5/40-mg group, 20%; and TEL 80-mg group, 22.6%), and the incidences of AEs were not different among the groups. The most common AEs were respiratory disorders, followed by headache, dizziness, and peripheral edema.
IMPLICATIONS: Treatment with S-AM/TEL 2.5/40 mg and S-AM/TEL 5/40 mg was superior to increasing the TEL dose in terms of hypotensive effect in patients with hypertension inadequately controlled by TEL monotherapy. S-AM/TEL fixed-dose combinations are an effective and tolerable option for patients inadequately responding to TEL monotherapy and also a good option for improving patients' medication adherence. ClinicalTrials.gov identifier: NCT011426100.