A multicenter, non-comparative study to evaluate the efficacy and safety of fixed- dose olmesartan/amlodipine in hypertensive patients

Background: Uncontrolled blood pressure (BP) is a major healthcare issue and responsible for high risk of cardiovascular disease (CVD) mortality and morbidity. Physicians of Bangladesh had been using amlodipine and Olmesartan combination for a long period of time but have very limited evidence-based information regarding the efficacy and safety of this combination. The aim of this study was to evaluate the efficacy and safety of fixed dose combination of olmesartan/amlodipine in hypertensive patients. Methods: This open-label, non-randomized, non-comparative observational study was conducted in different centers of Bangladesh during the period from January 2020 to November 2020. In total 443 Bangladeshi adult patients with hypertension were selected as the study population. Proper written consent was taken from all the participants before collecting data. Inter-group differences in the baseline characteristics were compared using analysis of variance (ANOVA). Two-tailed p-values of less than 0.05 were considered to be statistically significant. Statistical analyses were conducted by using SPSS for Windows, version 25 (SPSS Inc., Chicago, IL, USA). Results: Among all the participants, more than 70% were above 46 years of age and 55% were male. More than 60% of them were either overweight or obese. Among them, dyslipidemia, diabetes, and Chronic renal failure (CRF) was found among 14.22%, 28.44%, and 4.29% participants respectively Mean systolic (SBP) and diastolic blood pressures (DBP) were reduced to 36.61 and 18.69 mm of Hg respectively after 12 weeks of therapy. Besides these, the targeted SBP was achieved among 92% and targeted DBP was achieved among 98.3% of participants after 12 weeks. Achievement of BP goal in respect to Body mass index (BMI) of the patient (P-value 0.019), family history of hypertension (P-value 0.028), and dose of the drug in initial visit (P-value 0.001) was found statistically significant. There was no discontinuation of study medication due to intolerance or adverse events. Conclusion: Olmesartan/Amlodipine is an effective combination for reducing the blood pressure along with achievement of BP goal. Future studies on Olmesartan/Amlodipine in Bangladesh could be conducted with a longer treatment duration to examine the maintenance of effect and long-term safety.