Abstract
Background: This study was a multicenter, randomized, double-blinded, placebo-controlled phase III clinical trial to investigate the efficacy and safety of an olmesartan/amlodipine single pill plus rosuvastatin combination treatment for patients with concomitant hypertension and dyslipidemia. Methods: Patients with both hypertension and dyslipidemia aged 20–80 were enrolled from 36 tertiary hospitals in Korea from January 2017 to April 2018. Patients were randomized to three groups in a 1:1:0.5 ratio, olmesartan/amlodipine single pill plus rosuvastatin (olme/amlo/rosu) or olmesartan plus rosuvastatin (olme/rosu) or olmesartan/amlodipine single pill (olme/amlo) combination. The primary endpoints were change of sitting systolic blood pressure (sitSBP) from baseline in the olme/amlo/rosu vs. olme/rosu groups and the percentage change of low-density lipoprotein cholesterol (LDL-C) from baseline in the olme/amlo/rosu vs. olme/amlo groups after 8 weeks of treatment. Results: A total of 265 patients were randomized, 106 to olme/amlo/rosu, 106 to olme/rosu and 53 to olme/amlo groups. Baseline characteristics among the three groups did not differ. The mean sitSBP change was significantly larger in the olme/amlo/rosu group with −24.30 ± 12.62 mmHg (from 153.58 ± 10.90 to 129.28 ± 13.58) as compared to the olme/rosu group, −9.72 ± 16.27 mmHg (from 153.71 ± 11.10 to 144.00 ± 18.44 mmHg). The difference in change of sitSBP between the two groups was −14.62± 1.98 mmHg with significance (95% CI −18.51 to −10.73, p < 0.0001). The mean LDL-C reduced significantly in the olme/amlo/rosu group, −52.31 ± 16.63% (from 154.52 ± 30.84 to 72.72 ± 26.08 mg/dL) as compared to the olme/amlo group with no change, −2.98 ± 16.16% (from 160.42 ± 32.05 to 153.81 ± 31.57 mg/dL). Significant difference in change was found in LDL-C between the two groups with −50.10 ± 2.73% (95% CI −55.49 to −44.71, p < 0.0001). Total adverse drug reaction rates were 10.48%, 5.66% and 3.7% in the olme/amlo/rosu, olme/rosu and olme/amlo groups, respectively with no statistical significance among the three groups. Serious adverse drug reactions did not occur. Conclusions: Olmesartan/amlodipine single pill plus rosuvastatin combination treatment for patients with both hypertension and dyslipidemia is effective and safe as compared to either olmesartan plus rosuvastatin or olmesartan plus amlodipine treatment.
Highlights
Single pill combination (SPC) of two or more antihypertensive drugs has shown promising results in improving drug compliance, lowering blood pressure and potentially providing better clinical outcomes [1,2,3,4].There have been many clinical trials to evaluate the efficacy and safety of the SPC of 2–3 classes of antihypertensive or dyslipidemia drug [5,6,7]
This multicenter double blind phase III clinical trial was performed from January 2017 to April 2018 in 36 tertiary hospitals in Korea
A total of 646 patients participated in the study from 29 tertiary hospitals in Korea
Summary
Single pill combination (SPC) of two or more antihypertensive drugs has shown promising results in improving drug compliance, lowering blood pressure and potentially providing better clinical outcomes [1,2,3,4].There have been many clinical trials to evaluate the efficacy and safety of the SPC of 2–3 classes of antihypertensive or dyslipidemia drug [5,6,7]. SPCs with both antihypertensive and anti-dyslipidemia drugs have been developed and tested [4,8,9,10,11] Most of these studies showed promising efficacy and safety data as compared to monotherapy or equivalent doses of separate pill combinations. Reflecting these results, recent guidelines regarding hypertension management indicated the use of single-pill combinations for the simple purpose of improving drug adherence [12]. This study was a multicenter, randomized, double-blinded, placebo-controlled phase III clinical trial to investigate the efficacy and safety of an olmesartan/amlodipine single pill plus rosuvastatin combination treatment for patients with concomitant hypertension and dyslipidemia. The mean sitSBP change was significantly larger in the olme/amlo/rosu group with
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