Key result
In hypertensive patients with dyslipidemia, rosuvastatin 20 mg plus amlodipine 10 mg reduced mean sitting systolic blood pressure by 22.82 mm Hg and LDL-C by 52.53% at 8 weeks.
Why the study?
To evaluate the efficacy and safety of a rosuvastatin plus amlodipine combination compared with rosuvastatin or amlodipine monotherapy in hypertensive patients with dyslipidemia.
Does a fixed-dose combination of rosuvastatin 20 mg and amlodipine 10 mg improve blood pressure and LDL-C reduction compared to monotherapy in hypertensive patients with dyslipidemia?
RCT (n=106)
double-blind
randomized
Yes
Does a fixed-dose combination of rosuvastatin 20 mg and amlodipine 10 mg improve blood pressure and LDL-C reduction compared to monotherapy in hypertensive patients with dyslipidemia?
A fixed-dose combination of rosuvastatin 20 mg and amlodipine 10 mg effectively and safely reduces both blood pressure and LDL-C in patients with concurrent hypertension and dyslipidemia.
Supports fixed-dose rosuvastatin-amlodipine for dual BP and LDL-C control in hypertensive dyslipidemia; confirms concurrent efficacy in an RCT.
This multicenter, randomized, double-blind, parallel-group phase III clinical trial aimed to investigate the efficacy and safety of a rosuvastatin + amlodipine combination compared with that of rosuvastatin or amlodipine monotherapy in hypertensive patients with dyslipidemia. A total of 106 patients of 15 institutions in Korea were randomly assigned to 1 of 3 treatment groups: rosuvastatin 20 mg + amlodipine 10 mg, amlodipine 10 mg, or rosuvastatin 20 mg. After 8 weeks of treatment, the mean ± SD of change in mean sitting systolic blood pressure (msSBP) was -22.82 ± 12.99 mm Hg in the rosuvastatin + amlodipine group, the most decreased among the treatment groups. The percentage of patients whose msSBP decreased ≥20 mm Hg or msDBP decreased ≥10 mm Hg was also highest in this group (74.29%). The mean ± SD percentage change in low-density lipoprotein cholesterol (LDL-C) level from baseline after 8 weeks was -52.53% ± 11.21% in the rosuvastatin + amlodipine group, the most decreased among the treatment groups. More patients in the rosuvastatin + amlodipine group achieved their target LDL-C goal at 8 weeks, compared with the other treatment groups (97.14%). No serious adverse events or adverse drug reactions were observed in all groups. In hypertensive patients with dyslipidemia, combination treatment with rosuvastatin 20 mg + amlodipine 10 mg effectively reduced blood pressure and LDL-C levels while maintaining safety.
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Kim et al. (2020) conducted an RCT in dyslipidemia and hypertension (n=106). rosuvastatin + amlodipine vs. amlodipine 10 mg or rosuvastatin 20 mg was evaluated on change in mean sitting systolic blood pressure (msSBP). In hypertensive patients with dyslipidemia, rosuvastatin 20 mg plus amlodipine 10 mg reduced mean sitting systolic blood pressure by 22.82 mm Hg and LDL-C by 52.53% at 8 weeks.
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