Post-marketing surveillance study of valsartan/amlodipine combination in Taiwanese hypertensive patients.
OBJECTIVE
To assess safety and efficacy of valsartan/amlodipine combination in hypertensive Taiwanese patients.


METHODS
This 12-week, multi-center, prospective, observational, post-marketing study enrolled 1029 patients to receive valsartan/amlodipine combination alone or as add-on to other antihypertensives. Efficacy was evaluated by blood pressure (BP) control rate (in mmHg; non-diabetics, < 140/90; diabetics, < 130/80) at Week 12 and BP-lowering ability at Weeks 4 and 12. Additionally, responder rate (sitting-SBP < 140 for baseline SBP ≥ 140 or sitting-DBP < 90 for baseline DBP ≥ 90, or SBP reduction > 20 or DBP reduction > 10 from baseline) was determined.


RESULTS
Adverse events (AEs) were reported in 12.15% patients; dizziness, cough, and peripheral edema were the most commonly reported AEs. Overall BP control rate was 48.27%. Greater BP reduction was noted at Week 12 than at Week 4 between all groups and subgroups. Greater SBP/DBP reduction was observed in patients with stage 2 hypertension than stage 1 hypertension at baseline. The overall responder rate was 78.52%. Subgroup analysis showed greater BP reduction in non-diabetics than diabetics; only SBP reduction reached statistical significance (- 13.7 [18.3] vs. - 10.7 [17.4] mmHg; p < 0.0093).


CONCLUSIONS
Valsartan/amlodipine combination was well tolerated, with no safety concerns identified and an effective treatment option for hypertensive Taiwanese patients.
Department of Cardiology, Tri-Service General Hospital, Taipei, Taiwan.
Shu-Meng
SM
Cheng
Guang-Yuan
GY
Mar
Shih-Chung
SC
Huang
Chung-Sen
CS
Chen
Chih-Min
CM
Hsieh
Lien-Chi
LC
Huang
Kwo-Chang
KC
Ueng
D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage* / Q000009:adverse effects; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D044466:Asian People; D001794:Blood Pressure; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D013624:Taiwan / Q000453:epidemiology; D013777:Tetrazoles / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D014633:Valine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000068756:Valsartan
D000959:Antihypertensive Agents; D013777:Tetrazoles; D017311:Amlodipine; D000068756:Valsartan; D014633:Valine