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Abstract

A COMPARATIVE STUDY TO EVALUATE TOLERABILITY AND EFFICACY OF TWO FIXE DOSE-COMBINATIONS OF AMLODIPINE/TELMISARTAN VERSUS AMLODIPINE/HYDROCHLOROTHIAZIDE IN STAGE II HYPERTENSION.

Manan B. Dave , Indermeet S. Anand* 

ABSTRACT

The aim of this study was to evaluate the efficacy and tolerability of FDC of Amlodipine (5mg) + Telmisartan (40mg) compared with FDC of Amlodipine (5mg) + Hydrochlorothiazide (12.5mg) in Indian patients with stage II hypertension. Patient between the age group 18 to 65 years with stage II hypertension were treated with oral FDC of A + T or FDC of A + HCTZ once a day before breakfast for 8 week. Primary efficacy end point was reduction in systolic BP/ diastolic BP and number of responders (SBP/DBP <130/<80 mmHg). Tolerability was accessed by comparing the incidence of adverse events. The Percentage reduction in SBP in A + T group was 23.1% as compared to 14.94 % in A + HCTZ group. Similarly the percentage reduction in DBP in A + T group was 14.68 % as compared to 8.3 % in A + HCTZ group. From the result obtained FDC of A + T seems to be significantly more effective in controlling blood pressure as compared to FDC of A + HCTZ. 12/60 patients in A + T group achieved target SBP <130 mmHg. The prevalence of adverse events was similar in both treatment groups. All AEs were mild to moderate in severity and did not require any rescue medication. Although the occurrence of peripheral edema was more in A + HCTZ group (30 %) as compared to A + T group (10 %). Both the treatment regimens were well tolerated.

Keywords: Amlodipine, Telmisartan, Hydrochlorothiazide, Stage II hypertension.


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