To evaluate the efficacy and safety of the fixed-dose combination S-amlodipine plus telmisartan compared with telmisartan monotherapy in patients with hypertensive patients inadequately controlled by telmisartan monotherapy.Design and Method:
This study was the randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare superiority of S-amlodipine/telmisartan (S-AM/TEL) 2.5/40 mg and S-AM/TEL 5/40 mg combinations with telmisartan 80 mg mono- therapy. The primary end point was the change in the mean sitting DBP from baseline (week 0) after 8 weeks of therapy between treatment groups.Results:
Of 325 patients screened, 183 were randomized 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 telmisartan 80 mg group). Mean (SD) age was 53.9 (7.5) years, and male patients comprised 87%. There were no significant differences between three among the 3groups in baseline characteristics. The primary end points, the changes of mean DBP (SD) at week 8 from the baseline were -10.56 (±7.23) mmHg in the S-AM/TEL 2.5/40 mg group, -12.32 (±9.23) mmHg in the S-AM/TEL 5/40 mg group, and -2.44 (±7.92) mmHg in the telmisartan 80 mg group. Both S-AM/TEL 2.5/40 mg group or S-AM/TEL 5/40 mg group showed statistically superior hypotensive effect compared to telmisartan 80 mg group (p < 0.0001, p < 0.0001). For evaluation of the safety profile, the frequencies of adverse events (AEs) between groups were also not significantly different (S-AM/TEL 2.5/40; 18.6%, S-AM/TEL 5/40; 20%, telmisartan 80; 22.6%), and the incidences of AEs were not different between groups. The most common AEs was respiratory disorders, followed by headache, dizziness and peripheral edema.Conclusions:
S-AM/TEL fixed-dose combinations is an effective and safe option for patients inadequately responding to telmisartan monotherapy and also a good option for improving patients’ medication compliance.