T-004 EFFICACY OF TRIPLE COMBINATION OLMESARTAN 20MG + AMLODIPINE 5MG + HYDROCHLORTHIAZIDE 12.5MG VS DUALCOMBINATION OF OLMESARTAN 20MG + AMLODIPINE 5MG INPATIENTS WITH HYPERTENSION, A DOUBLE BLIND,RANDOMIZED, COMPARATIVE STUDY

Abstract

Background Patients with hypertension may require a combination of > 2 antihypertensivedrugs to achieve blood pressure control. Objective To compare the efficacy of triple Combination (Olmesartan 20 mg + Amlodipine 5 mg + Hydrochlorthiazide 12.5 mg) Vs Dual Combination (Olmesartan 20mg + Amlodipine 5 mg) in Patients with Hypertension. Methods This phase III, double blind, multicentre, parallel group, randomized,comparative study in which designed to evaluate efficacy of triple combination with dualcombination in Indian patients with hypertension. Eligible patients aged between18–60years, BP > 160/100 mm Hg were randomly assigned to one of the two treatment groupsas per the randomization schedule generated at Micro Labs Ltd. A total of 106 patientsassigned to triple combination and 102 patients were assigned to dual combination for 12weeks. The primary end point was change from baseline in mean SeSBP (Seated systolicblood pressure) &DeDBP (Seated Diastolic blood pressure). Secondary end point waspercentage of patients achieving JNC 7 BP goals at the end of 12 weeks. Results The mean change from baseline in SeSBP in triple combination was 42.4 mm ofHg and was 34.7 mm of Hg in dual combination (p = 0.0002) at the end of 12 weeks oftreatment. The mean change from baseline in SeDBP in triple combination was 18.2mmof Hg and was 14.9 mm of Hg for dual combination at the end of 12 weeks of treatment(p = 0.0071). More number of patients achieved JNC BP goals in triple combination group(72.64% 67.65%).Conclusion The triple drug combination is more efficacious than dual drug combinationin the treatment of patients with moderate to severe hypertension.