Journal of Biomedical and Pharmaceutical Research Available Online at www.jbpr.in CODEN: - JBPRAU (Source: - American Chemical Society) PubMed (National Library of Medicine): ID: (101671502) Index Copernicus Value 2018: 88.52 Original Research Article Volume 9, Issue 1: January-February: 2020, 61-68 ISSN (Online): 2279-0594 ISSN (Print): 2589-8752 61 | Page AN EFFECTIVENESS, SAFETY AND TOLERABILITY STUDY OF AZILSARTAN AND TELMISARTAN IN PATIENTS OF ESSENTIAL HYPERTENSION: A RANDOMIZED AND OPEN-LABEL STUDY Shreya Lal 1 , Satish Chandra 2 , Subhankar Choudhury 3 , Manju Gari 4 1,2,3,4 Department of Pharmacology, Rajendra Institute of Medical Sciences (RIMS), Ranchi Article Info: Received 10 January 2020; Accepted 18 February 2020 DOI: https://doi.org/10.32553/jbpr.v9i1.717 Corresponding author: Dr. Shreya Lal Conflict of interest statement: No conflict of interest 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 INTRODUCTION Hypertension is one of the significant contributory factor of wide array of cardiovascular diseases like congestive heart failure, myocardial infarction, coronary heart diseases, stroke, renal failure and many more, ultimately leading to morbidity and untimely death in majority of the affected population. [1,2] Essential hypertension is defined as elevated blood pressure in which other causes of hypertension such as renovascular disease, renal failure, pheochromocytoma, aldosteronism, or other causes of secondary hypertension or mendelian forms (monogenic) can be ruled out. [3] India launched the fourth National Family Health Survey (NFHS-4) in 2014-2015. This survey covered all the 29 states along with the 6 union territories. The data collected from this survey projected the mean prevalence of blood pressure to be 22.4%. Maximum number of people in the survey had their systolic blood pressure 140-159 mm of Hg and/or diastolic blood pressure 90-99 mm of Hg which is 6.7 % in case of women and 10.4% for men. [4] The primary aim of initiating antihypertensive therapy is to de-escalate the incidence and prevalence of cardiovascular accidents such as coronary disease, stroke and heart failure. This decrease in the blood pressure prevents damage to blood vessels and reduces both morbidity and mortality in people suffering from hypertension. [5,6] A decrease in systolic blood pressure by 10 mm Hg and diastolic blood pressure by 5 mm Hg curtails the risk of stroke and coronary heart disease by 33-48% and 17-27% respectively. [7] Angiotensin receptor blockers (ARBs) are antagonists of angiotensin II receptors (AT 1 ) receptor. According to JNC-8, it is now one of the first line drug in treatment of hypertension. These drugs have very high affinity for the AT 1 receptor. These drug acts by decreasing the total peripheral resistance (afterload) as well as cardiac venous return (preload). [8] Azilsartan is the eighth and latest drug of the ARB group. Its prodrug is known as azilsartan-medoxomil and once