A Comparative Analysis (TIME-AIM Study) of Achieving Target Blood Pressure Goal in Hypertension Through Initial Dual Combination Therapy and Home Blood Pressure Monitoring

Objective: We aimed to evaluate and compare the effectiveness, and safety of the dual combination of olmesartan with amlodipine, and with chlorthalidone, along with home BP monitoring (HBPM) and its effect on the quality of life (QoL) in achieving the target blood pressure (BP) in hypertensive Indians.Method: It was an investigator-initiated, prospective, open-label, randomized, comparative study; that was conducted across 16 centers in India.Adult patients with uncontrolled BP receiving monotherapy, and/or newly diagnosed stage 2 de novo hypertension, were enrolled and randomized into one of the three treatment groups, (1) Olmesartan medoxomil 20mg + Amlodipine 5mg with HBPM (N=50).( 2) Olmesartan medoxomil 20mg + Chlorthalidone (CTLD) 6.25mg with HBPM (N=45).( 3) Standard of Care Treatment as per investigator's discretion without HBPM (N=38).Result: A total of 133 subjects consisting of 70 (53.3%)males, with a mean age of 53.11 13.17 years completed the study.Mean reductions in sitting SBP/DBP (mmHg) of the subjects on Olmesartan/Amlodipine, Olmesartan/CTLD, and standard of care arm were as follows, day-30 [18.06/10.06,11.13/8.71,6.08/4.68],day-60 [19.90/12.08,13.36/8.96,8.05/5.29],day-90 [22.22/13, 14.73/10.20,11.39/5.79],respectively.All three study arms showed a statistically significant reduction in BP from baseline to day-90.The QoL assessment did not report any difference in the groups and subjects with HBPM were satisfied.Conclusion: TIMES-AIM demonstrated that the initiation of combination therapy with Olmesartan/Amlodipine (20/5mg) and Olmesartan/CTLD (20/6.25mg), in a single pill, is effective and safe in significantly reducing SBP/DBP in Indian hypertensive patients in the real-world setup with good acceptability for HBPM.Trial Registration no.CTRI/2022/08/045166.