Efficacy and Safety of Nebivolol and Rosuvastatin Combination Treatment in Patients with Concomitant Hypertension and Hyperlipidemia

Drug Des Devel Ther. 2020 Nov 17:14:5005-5017. doi: 10.2147/DDDT.S280055. eCollection 2020.

Abstract

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: hypercholesterolemia; hypertension; nebivolol; rosuvastatin.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Humans
  • Hyperlipidemias / drug therapy
  • Hypertension / drug therapy*
  • Male
  • Middle Aged
  • Nebivolol / administration & dosage
  • Nebivolol / therapeutic use*
  • Rosuvastatin Calcium / administration & dosage
  • Rosuvastatin Calcium / therapeutic use*
  • Young Adult

Substances

  • Nebivolol
  • Rosuvastatin Calcium

Grants and funding

The primary study was initiated and supported financially by Elyson Pharmaceutical Co., LTD. The company was involved in all stages of the study conduct and design. Elyson Pharmaceutical Co., LTD. also took responsibility for all costs associated with the development and publishing of the manuscript. This research was supported by the Ministry of Trade, Industry and Energy (Korea), the Korea Evaluation Institute of Industrial Technology (Korea) grant (No.10052298).