AN EFFECTIVENESS, SAFETY AND TOLERABILITY STUDY OF AZILSARTAN AND TELMISARTAN IN PATIENTS OF ESSENTIAL HYPERTENSION : A RANDOMIZED AND OPEN-LABEL STUDY

Abstract

BACKGROUND : The aim of this study was to compare effectiveness, safety and tolerability of azilsartan and telmisartan in terms of their blood pressure lowering capacity, effect on hematological and biochemical profile and side effects respectively in patients of essential hypertension.

METHODS : This was an observational, prospective, open label, randomized, parallel study. The study was conducted after getting approval from the ethics committee at RIMS, Ranchi. Total sample size was 108. Blood pressure recordings, hematologic and biochemical investigations were done at the beginning of  study and at every visit according to study design. The first group was prescribed tablet azilsartan 40mg once daily and the other tablet telmisartan 40 mg once daily at the beginning. Each patient was followed for 12 weeks and total study duration was 1 year.

RESULTS : The treatment arms showed significant reduction (p<0.05) in both systolic and diastolic blood pressure at the end of study period, although while doing inter-group comparison, the difference was not significant.  Safety profile of both drugs was similar. Notable side-effects included fatigue and dizziness apart from headache.

CONCLUSION : Azilsartan and telmisartan reduced the blood pressure significantly in 12 weeks when compared from the baseline, but the reduction was similar when an intergroup comparison was done. The drugs did not adversely affect the haematologic and biochemical parameters. Few side-effects were reported but these were mild in nature and did not require any specific intervention.

KEYWORDS : Angiotensin receptor blocker, Azilsartan, Effectiveness, Essential hypertension, Randomized, Safety, Telmisartan, Tolerability