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

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:

• hypertension
• hypercholesterolemia
• nebivolol
• rosuvastatin

Acknowledgments

Investigators: Kyung Heon Won (Seoul Medical Center), Kiyuk Chang (The Catholic University of Korea Seoul St. Mary’s Hospital), Bong-Ki Lee (Kangwon National University Hospital), Sang Hoon Kim (CHA Bundang Medical Center), Dong-Bin Kim (The Catholic University of Korea St. Paul’s Hospital), Jinho Shin (Hanyang University Hospital), Kyoo-Rok Han (Kangdong Sacred Heart Hospital), Cheol Whan Lee (Asan Medical Center), Jung Hyun Choi (Pusan National University Hospital), Gee-Hee Kim (The Catholic University of Korea St. Vincent’s Hospital), Hyungseop Kim (Keimyung University Dongsan Medical Center), Tae-Ho Park (Dong-A University Hospital), Jin-Ok Jeong (Chungnam National University Hospital), Jin Bae Lee (Daegu Catholic University Medical Center), Sung-Ho Her (The Catholic University of Korea Daejeon St. Mary’s Hospital), Jeong Cheon Ahn (Korea University Ansan Hospital), Soo-Joong Kim (Kyung Hee University Hospital), Sang Kyoon Cho (Bundang Jesaeng Hospital), Dong Woon Jeon (National Health Insurance Service Ilsan Hospital), and Bum-Kee Hong (Gangnam Severance Hospital).

Abbreviations

CI, confidence interval; AEs, adverse events; ANCOVA, analysis of covariance; ASCVD, atherosclerotic cardiovascular disease; BP, blood pressure; bpm, beats per minute; FAS, full analysis set; LDL, low-density lipoprotein; LSmean, least-square mean; NCEP-ATP III, National Cholesterol Education Program Adult Panel III; NEBI/RSV, co-administration of nebivolol 5 mg and rosuvastatin 20 mg; NEBI, nebivolol 5 mg alone treatment; PPS, per-protocol set; RSV, rosuvastatin 20 mg alone treatment; SAF, safety analysis set; SD, standard deviation; sitDBP, sitting diastolic blood pressure; sitSBP, sitting systolic blood pressure; TLC, therapeutic lifestyle change.

Data Sharing Statement

We are not planning to share the data besides what is included in the manuscript.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

M.Y. Rhee has received lecture honoraria from Pfizer Inc., LG Life Sciences Ltd., Boehringer Ingelheim Pharma GmbH & Co. KG., Hanmi Pharm. Co. Ltd., Yuhan Co. Ltd., and Boryung Pharmaceutical Co. Ltd.; consulting fees from Hanmi Pharm. Co. Ltd. and Shin Poong Pharma. Co. Ltd.; research grants from Boryung Pharmaceutical Co. Ltd. and Dong-A Pharmaceutical Co. Ltd.; and reports personals fees from Pfizer Inc. and consulting fees from Hanmi Pharm. Co. Ltd and Shin Poong Pharma. Co. Ltd, during the conduct of the study.

Y. Ahn has received research grants from Medtronic Korea, Boston Scientific corporation, Abbott Corporation, and Qualitech Korea.

C.H. Kim has received lecture honoraria from GlaxoSmithKline and Hanmi Pharmaceutical Co. Ltd and research grant from Merck Sharp & Dohme, LG Life Sciences Ltd., and Boryung Pharmaceutical Co. Ltd.

The aforementioned authors report no other conflicts of interest and the remaining authors have indicated that they have no conflicts of interest with regard to this work.