A randomized, double-blind clinical trial to evaluate the efficacy and safety of a fixed-dose combination of amlodipine/rosuvastatin in patients with dyslipidemia and hypertension
| Autor: | Chang-Hoon Lee, Young Keun Ahn, Chang Gyu Park, Cheol Woong Yu, Seok Yeon Kim, Jinho Shin, Eun Joo Cho, Mi Kyung Kim, Jeong Cheon Ahn, Yong Jin Kim, Ung Kim, Duk Hyun Kang, Kiyuk Chang, Sang Hak Lee, Shin Jae Kim, Kyoung Im Cho, Woohyeun Kim |
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| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Endocrinology Diabetes and Metabolism Fixed-dose combination Urology Blood Pressure Therapeutics 030204 cardiovascular system & hematology Double blind 03 medical and health sciences 0302 clinical medicine Double-Blind Method Republic of Korea Internal Medicine medicine Humans Rosuvastatin 030212 general & internal medicine Amlodipine Rosuvastatin Calcium Adverse effect Antihypertensive Agents Dyslipidemias business.industry nutritional and metabolic diseases medicine.disease Clinical trial Blood pressure Treatment Outcome Hypertension Drug Therapy Combination Cardiology and Cardiovascular Medicine business Dyslipidemia medicine.drug |
| Zdroj: | J Clin Hypertens (Greenwich) |
| ISSN: | 1751-7176 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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