Efficacy and safety of co-administered telmisartan/amlodipine and rosuvastatin in subjects with hypertension and dyslipidemia

Abstract

Single risk factors, such as hypertension and dyslipidemia, can combine to exacerbate the development and severity of cardiovascular disease. Treatment goals may be more effectively achieved if multiple disease factors are targeted with combination treatment. We enrolled 202 patients who were randomly divided into the following three groups: telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg, telmisartan 80 mg + rosuvastatin 20 mg, and telmisartan/amlodipine 80/5 mg. The primary efficacy variables were changes from baseline in mean sitting systolic blood pressure (MSSBP) between telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan 80 mg + rosuvastatin 20 mg at 8 weeks, and the percent changes from baseline in low-density lipoprotein (LDL) cholesterol between telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan/amlodipine 80/5 mg at 8 weeks. The secondary efficacy variables were changes in MSSBP, mean sitting diastolic blood pressure (MSDBP), LDL cholesterol and other lipid levels at 4 weeks and 8 weeks, as well as observed adverse events during follow-up. There were no significant differences between the three groups in demographic characteristics and no significant difference among the three groups in terms of baseline characteristics for the validity evaluation variables. The mean overall treatment compliance in the three groups was, respectively, 98.42%, 96.68%, and 98.12%, indicating strong compliance for all patients. The Least-Square (LS) mean (SE) for changes in MSSBP in the two (telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan 80 mg + rosuvastatin 20 mg) groups were -19.3 (2.68) mm Hg and -6.69 (2.76) mm Hg. The difference between the two groups was significant (-12.60 (2.77) mm Hg, 95% CI -18.06 to -7.14, P < .0001). The LS Mean for the percent changes from baseline in LDL cholesterol in the two (telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan/amlodipine 80/5 mg) groups were -52.45 (3.23) % and 2.68 (3.15) %. The difference between the two groups was significant (-55.13 (3.20) %, 95% CI -61.45 to -48.81, P < .0001). There were no adverse events leading to discontinuation or death. Combined administration of telmisartan/amlodipine 80/5 mg and rosuvastatin 20 mg for the treatment of hypertensive patients with dyslipidemia significantly reduces blood pressure and improves lipid control. ClinicalTrials.gov identifier: NCT03067688.

Keywords: amlodipine; dyslipidemia; hypertension; rosuvastatin; telmisartan.

Conflict of interest statement

Moo‐Yong 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.; fees for consulting from Hanmi Pharm. Co. Ltd. and Shin Poong Pharma. Co. Ltd.; and research grants from Boryung Pharmaceutical Co. Ltd. and Dong‐A Pharmaceutical Co. Ltd. Hana Lee and Yoonhwa Cho are salaried employees of Yuhan Corporation. The other authors have indicated that they have no other conflicts of interest regarding the content of this article. The sponsor, Yuhan Corporation supported the supply of the study drug, laboratory tests, data collection, and data analysis. The sponsor had no role in data interpretation, the writing of the original draft of manuscript, or the decision to submit the article for publication.

© 2020 The Authors. The Journal of Clinical Hypertension published by Wiley Periodicals LLC.

Figures

FIGURE 1

Subject disposition

FIGURE 2

Primary end points: MSSBP and LDL‐C changes at week 8. A, the least‐square mean values (LS Means, SE) of the MSSBP in the two (telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan 80 mg + rosuvastatin 20 mg) groups. B, the LS Means for LDL cholesterol reduction in the two (telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan/amlodipine 80/5 mg) groups

FIGURE 3

Secondary end points at week 4 and week 8. A, the LS Means for LDL cholesterol reduction in all groups. B, the LS Means for total cholesterol reduction in all groups. C, the LS Means for triglyceride reduction in all groups. D, the LS Means for HDL cholesterol increase in all groups