Abstract
BackgroundHypertension 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.MethodsWe 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.ResultsOf 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.ConclusionThis study demonstrated that the co-administration of fimasartan and rosuvastatin to patients with both hypertension and hypercholesterolemia was efficacious and safe.Trial registrationClinicalTrials.gov Identifier: NCT02166814. 16 June 2014
Highlights
Hypertension and dyslipidemia are major risk factors of cardiovascular disease (CVD) events
The response rate of Sitting systolic blood pressure (siSBP) in the Fimasartan mg (FMS)/Rosuvastatin mg (RSV) treatment, FMS alone treatment, and RSV alone treatment groups was 65.22, 55.56, and 34.09%, respectively (FMS/RSV vs. RSV, groups was 80.43, 15.56, and 81.82%, respectively (FMS/RSV vs. FMS, difference = 64.88%, 95% confidence interval 49.27 to 80.49, p < 0.001)
The control rate of siSBP in FMS/ RSV treatment, FMS alone treatment, and RSV alone treatment groups was 65.22, 55.56, and 29.55%, respectively (FMS/RSV vs. RSV, difference = 35.67%, 95% confidence interval 16.41 to 54.94, p = 0.003)
Summary
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. Hypertension and hypercholesterolemia are major risk factors of cardiovascular disease (CVD) events. The coexistence of both risk factors is quite common. The prevalence of coexistence was estimated to be 30% in an epidemiologic study [1]. The co-existence of hypertension and hypercholesterolemia can act additively or synergistically to elevate CVD risk [2, 3]. Because of the increased risk of CVD with comorbidities, guidelines have recommended simultaneous treatment of both risk factors [4, 5]. Long-term reduction of both serum total cholesterol (TC) and systolic blood pressure (SBP) by 10% could reduce major CVD events by 45% [6]
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