Comparison of populations in REAL-life environment and randomized controlled studies receiving combined antihypertensive treatment containing valsartan

In this study, similarities and/or differences in demographic characteristics and baseline clinical characteristics of patient populations included in Randomized Controlled Clinical Trials (RCCTs) and Real-World Studies (RWSs) conducted with valsartan combinations used in antihypertensive treatment were demonstrated and the results were discussed over both study types (RCCTs and RWSs). As the molecule, valsartan was selected due to the large number of clinical studies in the literature, and 7 different combinations in total were included in the statistical analysis: Valsartan/Amlodipine in 5 different dosage forms and Valsartan/Amlodipine/Hydrochlorothiazide in 2 different dosage forms. Considering the analysis results of 6 parameters (age, gender, body mass index (BMI), systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse) which were the evaluation criteria of this study, it has been determined that there was a variable difference in 4 of 6 parameteres (age, BMI, SBP, DBP) between RCCT and RWS populations. The means of age and DBP in 4 of 7 different combinations and the means of BMI and SBP in 5 of 7 different combinations were found to be statistically significant (p<0.05) in RCTs and RWSs. In line with these differences; it is clear that more adaptive RCTs are needed in order to predict more accurately ages and blood pressure values to transition double and triple combinations in hypertension treatments, as well as risky patient profiles according to body mass indexes in the routine clinical settings. As the result, conducting synchronously of the designed RCCTs and RWSs which reflect the routine clinical environment to a great extent can be a method to increase the reliability and applicability of the study results.