P1656Large number of real world evidence studies confirmed effectiveness and safety in treatment with Val/Aml and Val/Aml/HCT worldwide across various ethical groups, disease severities and co-morbidities

Abstract

Background: Real world evidence (RWE) studies are of high importance to validate the results observed in clinical trials in larger populations including various ethnical groups and patients with comorbidities like diabetes and CKD. Most patients with hypertension require combination treatment to be able to control their blood pressure (BP). Purpose: To evaluate the outcome of RWE studies carried out with Val/Aml and Val/Aml/HCT in patients with essential hypertension across different countries, ethnical groups and comorbidities like diabetes, metabolic syndrome and renal insufficiency. Results: The cumulative patient exposure from valsartan and its formulations is estimated to be more than 114.5 million patient years and more than 700.000 patients from over 30 countries have been included in prospective or retrospective real world studies of valsartan and its formulations. Thirteen large prospective RWE studies have been carried out with Val/Aml in more than 60.000 patients with hypertension and additional risk factors, like diabetes, metabolic risk or renal insufficiency. The 26 countries involved were Bahrain, Bangladesh, Belgium, China, Egypt, Germany, Kuwait, Lebanon, Malaysia, Middle East Countries, Oman, Pakistan, Qatar, Russia, Saudi Arabia, Turkey, United Arab Emirates, Indonesia, India, Hong Kong, Pakistan, Philippines, South Korea, Thailand, Taiwan and South‐Central US. The duration of the studies was 8‐26±8 weeks. Mean age was between 48‐64 years. Baseline blood pressure (BP) ranged from 148/86 to 169/100 for mSBP/mDBP. The mean reduction in SBP/DBP at study end was between ‐40.1 to ‐19.6, and ‐27.1 to ‐6.5mmHg, dependent on respective baseline BP. BP control rates achieved ranged from 39% to 78%, dependent on hypertension severities. With the fixed‐dose triple combination Val/Aml/HCT 2 large RWE studies had been carried out in over 8000 hypertensive patients across 14 countries. Mean age was 55 to 65 years, baseline BP for mSBP/mDBP reached from 159/92 to 172/99. Mean reduction in SBP was in the range of ‐43.9 to ‐23.7mmHg and for DBP from ‐21.9 to ‐11.3mmHg. 46.8% to 71.3% of patients achieved BP control. Aml/Val and Aml/Val/HCT was well tolerated with a similar tolerability profile as seen in randomized clincal trials. Conclusion: Data from RWE studies in over 68.000 patients confirms that combination therapy with Val/Aml and Val/Aml/HCT FDC is achieving high rates of BP reduction leading to better BP control across different ethical groups, disease severities and patients with co‐morbidities and was well tolerated.