Key result
Co-administration of fimasartan and rosuvastatin significantly reduced sitting systolic blood pressure by an additional 15.03 mmHg compared to rosuvastatin alone in patients with hypertension and dyslipidemia.
Why the study?
Does co-administration of fimasartan and rosuvastatin improve blood pressure and LDL-C in patients with hypertension and hypercholesterolemia?
RCT (n=140)
Double-blind
1:1:1
Yes
Does co-administration of fimasartan and rosuvastatin improve blood pressure and LDL-C in patients with hypertension and hypercholesterolemia?
Effect estimate: LSM difference -15.03 mmHg (95% CI -21.75 to -8.31)
Absolute Event Rate: -21.89% vs -6.86%
p-value: p=<0.001
Co-administration of fimasartan and rosuvastatin is efficacious and safe for simultaneously managing hypertension and hypercholesterolemia.
Supports co-administration for hypertension with dyslipidemia; extends RCT evidence for additive BP lowering with statins.
BACKGROUND: Hypertension and dyslipidemia are major risk factors of cardiovascular disease (CVD) events. The objective of this study was to evaluate the efficacy and safety of the co-administration of fimasartan and rosuvastatin in patients with hypertension and hypercholesterolemia. METHODS: We conducted a randomized double-blind and parallel-group trial. Patients who met eligible criteria after 4 weeks of therapeutic life change were randomly assigned to the following groups. 1) co-administration of fimasartan 120 mg/rosuvastatin 20 mg (FMS/RSV), 2) fimasartan 120 mg (FMS) alone 3) rosuvastatin 20 mg (RSV) alone. Drugs were administered once daily for 8 weeks. RESULTS: Of 140 randomized patients, 135 for whom efficacy data were available were analyzed. After 8 weeks of treatment, the FMS/RSV treatment group showed greater reductions in sitting systolic (siSBP) and diastolic (siDBP) blood pressures than those in the group receiving RSV alone (both p < 0.001). Reductions in siSBP and siDBP were not significantly different between the FMS/RSV and FMS alone groups (p = 0.500 and p = 0.734, respectively). After 8 weeks of treatment, FMS/RSV treatment showed greater efficacy in percentage reduction of low-density lipoprotein cholesterol (LDL-C) level from baseline than that shown by FMS alone treatment (p < 0.001). The response rates of siSBP with FMS/RSV, FMS alone, and RSV alone treatments were 65.22, 55.56, and 34.09%, respectively (FMS/RSV vs. RSV, p = 0.006). The LDL-C goal attainment rates with FMS/RSV, RSV alone, and FMS alone treatments were 80.43%, 81.82%, and 15.56%, respectively (FMS/RSV vs. FMS, p < 0.001). Incidence of adverse drug reactions with FMS/RSV treatment was 8.33%, which was similar to those associated with FMS and RSV alone treatments. CONCLUSION: This study demonstrated that the co-administration of fimasartan and rosuvastatin to patients with both hypertension and hypercholesterolemia was efficacious and safe. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02166814 . 16 June 2014.
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Rhee et al. (2017) conducted an RCT in Hypertension and dyslipidemia (n=140). Fimasartan and rosuvastatin vs. Rosuvastatin 20 mg alone or fimasartan 120 mg alone was evaluated on Change from baseline in mean sitting systolic blood pressure (siSBP) at 8 weeks (LSM difference -15.03 mmHg, 95% CI -21.75 to -8.31, p=<0.001). Co-administration of fimasartan and rosuvastatin significantly reduced sitting systolic blood pressure by an additional 15.03 mmHg compared to rosuvastatin alone in patients with hypertension and dyslipidemia.
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