Efficacy and Safety of Fimasartan/Indapamide Combination Therapy versus Fimasartan Monotherapy in Patients with Essential Hypertension Inadequately Responding to Fimasartan 30 mg (FINEDUO): A Randomized, Double-Blind, Multicenter, Phase III Study

Purpose: Effective blood pressure (BP) control in hypertension frequently requires combination therapy, particularly in patients whose BP is inadequately controlled by monotherapy. This study evaluated the efficacy and safety of fimasartan (FMS) and indapamide (IND) sustained release (SR) combination therapy. Patients and Methods: In this randomized, double-blind, phase III trial, patients with hypertension who remained uncontrolled after a 4-week run-in with FMS 30 mg, were randomized to FMS 30 mg/IND SR 1.5 mg or FMS 30 mg, followed by forced titration to FMS 60 mg/IND SR 1.5 mg or FMS 60 mg after 4 weeks. The primary endpoint was the change in sitting systolic BP (SiSBP) at week 8. Secondary endpoints included changes in sitting diastolic BP (SiDBP), BP control rates, response rates, and safety outcomes. Results: Two hundred forty-eight patients were randomized (FMS/IND SR, n=126; FMS, n=122). At week 8, the least square mean reduction in SiSBP was greater with FMS/IND SR than with FMS (−17.9 vs −7.4 mmHg, P<0.0001). Significant improvements were also observed for SiSBP at week 4, SiDBP at week 4 and 8, and BP control rates and response rates. The safety profile was comparable between groups, with no significant differences in adverse events, including patients aged 65 years and older. Conclusion: FMS/IND SR combination therapy demonstrated superior antihypertensive efficacy, rapid BP control, and comparable safety to FMS monotherapy. This regimen may serve as an effective therapeutic option, particularly in elderly or high-risk hypertensive patients. Clinical Trial Registration: https://www.clinicaltrials.gov, NCT05878561.