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Efficacy and Safety of Nebivolol and Rosuvastatin Combination Treatment in Patients with Concomitant Hypertension and Hyperlipidemia
Drug Design, Development and Therapy ( IF 4.7 ) Pub Date : 2020-11-17 , DOI: 10.2147/dddt.s280055 Moo-Yong Rhee 1 , Cheol Ho Kim 2 , Youngkeun Ahn 3 , Joon-Han Shin 4 , Seung Hwan Han 5 , Hyun-Jae Kang 6 , Soon Jun Hong 7 , Hae-Young Kim 8
Drug Design, Development and Therapy ( IF 4.7 ) Pub Date : 2020-11-17 , DOI: 10.2147/dddt.s280055 Moo-Yong Rhee 1 , Cheol Ho Kim 2 , Youngkeun Ahn 3 , Joon-Han Shin 4 , Seung Hwan Han 5 , Hyun-Jae Kang 6 , Soon Jun Hong 7 , Hae-Young Kim 8
Affiliation
Purpose: We evaluated the efficacy and safety of nebivolol and rosuvastatin combination treatment in patients with hypertension and hyperlipidemia.
Patients and Methods: Eligible patients, after more than 4 weeks of therapeutic lifestyle change, were randomly assigned to three groups: 5 mg nebivolol plus 20 mg rosuvastatin (NEBI/RSV), 20 mg rosuvastatin (RSV), or 5 mg nebivolol (NEBI). Treatments lasted 8 weeks.
Results: Efficacy was analyzed using data from 276 patients. Sitting systolic and diastolic blood pressures differed between the NEBI/RSV and RSV groups (LSmean difference = − 5.89 and − 5.99 mmHg; 95% confidence interval [CI] = − 9.88 to − 1.90 mmHg and − 8.13 to − 3.84 mmHg, respectively). Reductions in the two pressures did not differ between the NEB/RSV and NEB groups. The percent reduction in low-density lipoprotein (LDL) cholesterol differed between the NEBI/RSV and NEBI groups (LSmean difference = − 47.76%, 95% CI = − 52.69 to − 42.84%) but not between the NEBI/RSV and RSV groups. The blood pressure (BP) control rate was higher in the NEBI/RSV group than in the RVS group (51.09% vs 29.67%, p = 0.003). The LDL cholesterol goal achievement rate was higher in the NEBI/RSV group than in the NEBI group (85.87% vs 11.83%, p < 0.001). The incidence of adverse drug reactions in the NEBI/RSV, RSV, and NEBI groups was 8.51%, 7.45%, and 8.60%, respectively (p = 0.950).
Conclusion: Nebivolol plus rosuvastatin treatment is effective in reducing BP and LDL cholesterol levels and is safe in patients with hypertension and hypercholesterolemia without the loss of BP or the LDL cholesterol-lowering effect of each drug.
Trial Registration: CRIS registration number KCT0002148.
Keywords: hypertension, hypercholesterolemia, nebivolol, rosuvastatin
中文翻译：
奈必洛尔和瑞舒伐他汀联合治疗高血压和高脂血症患者的疗效和安全性
目的：我们评估了奈比洛尔和瑞舒伐他汀联合治疗高血压和高脂血症患者的疗效和安全性。
患者和方法：经过超过 4 周的生活方式改变治疗后，符合条件的患者被随机分配到三组：5 mg 奈必洛尔加 20 mg 瑞舒伐他汀 (NEBI/RSV)、20 mg 瑞舒伐他汀 (RSV) 或 5 mg 奈必洛尔 (NEBI) ）。治疗持续8周。
结果：使用 276 名患者的数据分析疗效。NEBI/RSV 组和 RSV 组之间的坐位收缩压和舒张压不同（LS 平均差值分别 = − 5.89 和 − 5.99 mmHg；95% 置信区间 [CI] = − 9.88 至 − 1.90 mmHg 和 − 8.13 至 − 3.84 mmHg） 。NEB/RSV 组和 NEB 组之间两种压力的降低没有差异。NEBI/RSV 组和 NEBI 组之间的低密度脂蛋白 (LDL) 胆固醇降低百分比存在差异（LS 平均值差异 = − 47.76%，95% CI = − 52.69 至 − 42.84%），但 NEBI/RSV 和 RSV 组之间没有差异。NEBI/RSV 组的血压 (BP) 控制率高于 RVS 组 (51.09% vs 29.67%, p = 0.003)。NEBI/RSV 组的 LDL 胆固醇目标实现率高于 NEBI 组（85.87% vs 11.83%，p < 0.001）。NEBI/RSV、RSV和NEBI组的药物不良反应发生率分别为8.51%、7.45%和8.60%（p =0.950）。
结论：奈必洛尔联合瑞舒伐他汀治疗可有效降低血压和低密度脂蛋白胆固醇水平，对于高血压和高胆固醇血症患者是安全的，且不损失每种药物的血压或低密度脂蛋白胆固醇降低作用。
试用注册： CRIS注册号KCT0002148。
关键词：高血压，高胆固醇血症，奈必洛尔，瑞舒伐他汀
更新日期：2020-11-17
Patients and Methods: Eligible patients, after more than 4 weeks of therapeutic lifestyle change, were randomly assigned to three groups: 5 mg nebivolol plus 20 mg rosuvastatin (NEBI/RSV), 20 mg rosuvastatin (RSV), or 5 mg nebivolol (NEBI). Treatments lasted 8 weeks.
Results: Efficacy was analyzed using data from 276 patients. Sitting systolic and diastolic blood pressures differed between the NEBI/RSV and RSV groups (LSmean difference = − 5.89 and − 5.99 mmHg; 95% confidence interval [CI] = − 9.88 to − 1.90 mmHg and − 8.13 to − 3.84 mmHg, respectively). Reductions in the two pressures did not differ between the NEB/RSV and NEB groups. The percent reduction in low-density lipoprotein (LDL) cholesterol differed between the NEBI/RSV and NEBI groups (LSmean difference = − 47.76%, 95% CI = − 52.69 to − 42.84%) but not between the NEBI/RSV and RSV groups. The blood pressure (BP) control rate was higher in the NEBI/RSV group than in the RVS group (51.09% vs 29.67%, p = 0.003). The LDL cholesterol goal achievement rate was higher in the NEBI/RSV group than in the NEBI group (85.87% vs 11.83%, p < 0.001). The incidence of adverse drug reactions in the NEBI/RSV, RSV, and NEBI groups was 8.51%, 7.45%, and 8.60%, respectively (p = 0.950).
Conclusion: Nebivolol plus rosuvastatin treatment is effective in reducing BP and LDL cholesterol levels and is safe in patients with hypertension and hypercholesterolemia without the loss of BP or the LDL cholesterol-lowering effect of each drug.
Trial Registration: CRIS registration number KCT0002148.
Keywords: hypertension, hypercholesterolemia, nebivolol, rosuvastatin
中文翻译：
奈必洛尔和瑞舒伐他汀联合治疗高血压和高脂血症患者的疗效和安全性
目的：我们评估了奈比洛尔和瑞舒伐他汀联合治疗高血压和高脂血症患者的疗效和安全性。
患者和方法：经过超过 4 周的生活方式改变治疗后，符合条件的患者被随机分配到三组：5 mg 奈必洛尔加 20 mg 瑞舒伐他汀 (NEBI/RSV)、20 mg 瑞舒伐他汀 (RSV) 或 5 mg 奈必洛尔 (NEBI) ）。治疗持续8周。
结果：使用 276 名患者的数据分析疗效。NEBI/RSV 组和 RSV 组之间的坐位收缩压和舒张压不同（LS 平均差值分别 = − 5.89 和 − 5.99 mmHg；95% 置信区间 [CI] = − 9.88 至 − 1.90 mmHg 和 − 8.13 至 − 3.84 mmHg） 。NEB/RSV 组和 NEB 组之间两种压力的降低没有差异。NEBI/RSV 组和 NEBI 组之间的低密度脂蛋白 (LDL) 胆固醇降低百分比存在差异（LS 平均值差异 = − 47.76%，95% CI = − 52.69 至 − 42.84%），但 NEBI/RSV 和 RSV 组之间没有差异。NEBI/RSV 组的血压 (BP) 控制率高于 RVS 组 (51.09% vs 29.67%, p = 0.003)。NEBI/RSV 组的 LDL 胆固醇目标实现率高于 NEBI 组（85.87% vs 11.83%，p < 0.001）。NEBI/RSV、RSV和NEBI组的药物不良反应发生率分别为8.51%、7.45%和8.60%（p =0.950）。
结论：奈必洛尔联合瑞舒伐他汀治疗可有效降低血压和低密度脂蛋白胆固醇水平，对于高血压和高胆固醇血症患者是安全的，且不损失每种药物的血压或低密度脂蛋白胆固醇降低作用。
试用注册： CRIS注册号KCT0002148。
关键词：高血压，高胆固醇血症，奈必洛尔，瑞舒伐他汀
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