Effect of Fimasartan versus Valsartan and Olmesartan on Office and Ambulatory Blood Pressure in Korean Patients with Mild-to-Moderate Essential Hypertension: A Randomized, Double-Blind, Active Control, Three-Parallel Group, Forced Titration, Multicenter, Phase IV Study (Fimasartan Achieving Systolic Blood Pressure Target (FAST) Study).

PURPOSE

Head-to-head comparison of the blood pressure (BP) lowering effect of fimasartan versus valsartan, with olmesartan as a reference, on office blood pressure and ambulatory BP.

PATIENTS AND METHODS

Of the 369 randomly assigned patients in this study, 365 hypertensive patients were referred as the full analysis set and divided into 3 groups with a 3:3:1 ratio (fimasartan group: 155, valsartan group: 157, olmesartan group: 53). After the 2-week single-blind placebo run-in period, initial standard doses of 60-mg fimasartan, 80-mg valsartan, and 10-mg olmesartan were administered for 2 weeks, then forcibly up-titrated higher doses (fimasartan 120 mg, valsartan 160 mg, olmesartan 20 mg) were given for 4 weeks. ABP was measured before and after the 6-week treatment. Primary endpoint was reduction of sitting office systolic BP (SiSBP) of fimasartan compared to valsartan after 6 weeks. Secondary endpoints were reduction of sitting office diastolic BP (SiDBP) and 24 hrs, day-time, and night-time mean systolic and diastolic ABP (ASBP, ADBP) after 6 weeks.

RESULTS

Patients' mean age was 58.34±7.68 years, and 289 patients were male (79.18%). After the 6-week treatment, SiSBP reduction of fimasartan and valsartan were -16.26±15.07 and -12.81±13.87 (p=0.0298) and SiDBP were -7.63±9.67 and -5.14±8.52 (p=0.0211). Reductions in 24 hrs mean ASBP were -15.22±13.33 and -9.45±12.37 (p=0.0009), and ADBPs were -8.74±7.55 and -5.98±7.85 (p=0.0140). Reductions of night-time ASBPs were -16.80±15.81 and -10.32±14.88 (p=0.0012), and those of night-time ADBPs were -8.89±9.93 and -5.55±9.70 (p=0.0152). Reduction of BP in olmesartan group did not demonstrate significant difference with fimasartan group in all end-points.

CONCLUSION

Fimasartan 120-mg treatment demonstrated superior efficacy in reduction of SiSBP, SiDBP, and 24 hrs ASBP and ADBP compared to valsartan 160 mg. Reduction of night-time ASBP from baseline was largest in fimasartan group, suggesting that fimasartan may be effective for recovering dipping pattern.

NCT NUMBER

NCT02495324 (Fimasartan Achieving SBP Target (FAST) study).