A Phase III, Randomized Double-Blind, Double-Dummy, Parallel Assignment, Comparative Study to Evaluate the Safety and Efficacy of Fixed Drug Combination of Telmisartan, Amlodipine and Hydrochlorothiazide in Uncontrolled Essential Hypertension

Abstract

e 31Conclusion: Telephone and network remote health education to middle-aged and elderly hypertension can control hypertension effectively, decrease the incidence of cardio-cerebrovascular complication.Background: Drugs with complementary mechanisms, even at low-doses, may produce synergistic action resulting in equivalent/superior efficacy with better therapeutic outcome & clinical response.Objective: To determine the safety and efficacy of two strengths of fixed dose combination (TAH)Telmisartan 20/40 mg+Amlodipine 2.5/5 mg+ Hydrochlorothiazide(HCTZ)6.25/12.5 mg administered o.d in patients with essential hypertension compared to TH-Telmisartan40/80mg+HCTZ12.5 mg to achieve normalization of blood pressure (NBP). Method:In this Phase 3, Double-Blind, Double-Dummy, 8weekstudy, subjects were randomized into four groups based on their BP stratification. Therapy was initiated with low dose of medicationsfor four weeks. If N-BP was achieved at week4, same was continued till week8; if not, dose was up-titrated.Result: Enrolled subjects (n = 512) with uncontrolled hypertension and on medications(s), had a mean duration of disease of 47.7 months. Dose up-titration required in was less with TAH(27.34%, 70/256) compared to TH(35.16%, 90/256). NBP was seen in 346 subjects(TAH-183&TH-163) in Intent to treat(ITT) population at week8. There was a statistically significant improvement in NBP in the Modified ITT(mITT, p = 0.041) and Per Protocol (PP, p = 0.041) populations. Among nondiabetics, significantly better NBP was seen in ITT (p = 0.025), mitt (p = 0.015), PP population (p = 0.016). Early therapeutic response was seen among diabetic subjects in ITT(p = 0.043), mITT(p = 0.036), PP population (p = 0.041) at week4 and overall in ITT (p = 0.22), mITT (p = 0.015) populations. There were significant diastolic BP responders in TAH (PP population, p = 0.046) arm. There were 77(50 subjects)non-serious adverse events (AE) and six serious AEs.Conclusion: TAH,with constituents half the strength of comparatordemonstratedequi-efficacyas that of TH(attributed to possible complimentary action and physiological synergy), good safety profileand better tolerability.Background: Hypertension is the silent killer. Approximately 85% to 90% of hypertension cases have unknown cause (primary hypertension). Previous studies revealed that prooxidant effect of uric acid causes an increase in blood pressure. However, other studies revealed that uric acid was not an independent risk factor of hypertension. The difference in these results lead the author interested in conducting this research.