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

Xuan Jin, Moo Hyun Kim, Ki Hoon Han, Soon Jun Hong, Jeong Cheon Ahn, Jung Hoon Sung, Jin Man Cho, Han Cheol Lee, So Yeon Choi, Kyounghoon Lee, Woo Shik Kim, Moo Yong Rhee, Ju Han Kim, Seung Pyo Hong, Byung Su Yoo, Eun Joo Cho, Jae Hwan Lee, Pum Joon Kim, Chang Gyu Park, Min Su HyonJin Ho Shin, Sang Hyun Lee, Ki Chul Sung, Jinyong Hwang, Kihwan Kwon, In Ho Chae, Jeong Sook Seo, Hyungseop Kim, Hana Lee, Yoonhwa Cho, Hyo Soo Kim

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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.

Original languageEnglish
Pages (from-to)1835-1845
Number of pages11
JournalJournal of Clinical Hypertension
Volume22
Issue number10
DOIs
StatePublished - 1 Oct 2020

Keywords

  • amlodipine
  • dyslipidemia
  • hypertension
  • rosuvastatin
  • telmisartan

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