Blood Pressure-lowering Effect of Fimasartan Versus Comparators: A Cross-inference With a Systematic Review and Meta-analysis Through a Quality-management System.

Purpose: Fimasartan, one of the newest angiotensin receptor blockers (ARBs) available worldwide, has been investigated extensively since its initial development. Our study group conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) evaluating fimasartan and comparators for their blood pressure (BP)-lowering effect. Moreover, we employed a cross-inference (frequentist and Bayesian inference) system, which has never been used in the medical field, to confirm the results of our study. In addition, a quality management system was integrated throughout the study for data quality.

Methods: PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, ClinicalKey, and ClinicalTrial.gov were searched for RCT studies from March 1998 to March 2022. In each study, the mean differences (MD) and 95% CIs were identified for reductions in clinic sitting systolic and diastolic BP (SiSBP/SiDBP) or 24-hour mean systolic BP and diastolic BP by ambulatory BP monitoring (ASBP/ADBP) from baseline between the fimasartan and comparator groups, followed by meta-analysis. A subsequent meta-analysis was performed with frequentist and Bayesian inference as a tool in the cross-checking system.

Findings: Eleven RCTs with a total of 2459 subjects were included in the study. The clinic SiSBP/SiDBP-lowering effect of fimasartan was significantly greater relative to those of comparators (MD for clinic SiSBP, -2.58 mm Hg [95% CI, -4.35 to -0.81; P = 0.004]; MD for clinic SiDBP, -2.13 mm Hg [95% CI, -2.96 to -1.30; P = 0.00001]). The ASBP/ADBP-lowering effect of fimasartan was also significantly greater relative to those of comparators (MD for ASBP, -3.58 mm Hg [95% CI, -5.74 to -1.43; P = 0.001]; MD for ADBP, -1.99 mm Hg [95% CI, -3.34 to -0.63; P = 0.004]).

Implications: Fimasartan seems to be more effective in lowering BP than its comparators, including other ARBs. Although there is a limited amount of data and a minuscule number of study subjects available, the results of cross-inference (frequentist + Bayesian) were fairly consistent with the meta-analysis results through our quality management system.