Efficacy and Safety of Fixed-dose Combination Therapy With Telmisartan and Rosuvastatin in Korean Patients With Hypertension and Dyslipidemia: TELSTA-YU (TELmisartan-rosuvaSTAtin from YUhan), a Multicenter, Randomized, 4-arm, Double-blind, Placebo-controlled, Phase III Study

Gyu Chul Oh, Jung Kyu Han, Ki Hoon Han, Min Su Hyon, Joon Hyung Doh, Moo Hyun Kim, Jin Ok Jeong, Jang Ho Bae, Sang Hyun Kim, Byung Su Yoo, Sang Hong Baek, Moo Yong Rhee, Sang Hyun Ihm, Jung Hoon Sung, Young Jin Choi, Soo Joong Kim, Kyung Soon Hong, Byoung Kwon Lee, Jang Hyun Cho, Eun Seok ShinJay Young Rhew, Hyunsu Kim, Hyo Soo Kim

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Abstract

Purpose: Hypertension and dyslipidemia are 2 risk factors of cardiovascular disease that often present simultaneously. Traditionally, treatment of these multiple conditions required separate medications for each disease, which may result in poor compliance and thus lead to possible treatment failure. Fixed-dose combination (FDC) therapy with a single pill may be a solution in these situations. Methods: This multicenter, 8-week, randomized, double-blind, Phase III study evaluated the efficacy and safety of FDC treatment with telmisartan (80 mg) and rosuvastatin calcium (20 mg) in Korean patients with mild to moderate hypertension and dyslipidemia. Patients were randomly assigned to 4 groups: (1) FDC drug (80 mg of telmisartan and 20 mg of rosuvastatin); (2) 80 mg of telmisartan; (3) 20 mg of rosuvastatin; or (4) placebo. After 8 weeks of treatment, the change in mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) between the FDC group and the rosuvastatin group, and the percent change in LDL-C between the FDC group and the telmisartan group, were compared. Findings: A total of 210 patients were enrolled in the study (84 in the FDC group, 42 in the rosuvastatin group, 43 in the telmisartan group, and 41 in the placebo group). The reduction in blood pressure was significantly greater in the FDC group than in the rosuvastatin group after 8 weeks of treatment (least squares mean change from baseline, –16.1 [1.6] mm Hg vs –1.7 [2.2] mm Hg [P < 0.001] for MSSBP; –8.8 [1.0] mm Hg vs –1.6 [1.4] mm Hg [P < 0.001] for MSDBP). Least squares mean percent change in LDL-C from baseline was also significantly greater in the FDC group compared with the telmisartan group (–49.3% [2.2%] vs 1.5% [3.0%]; P < 0.001). FDC therapy also had a higher rate of achieving the treatment goal in both blood pressure (60% vs 45%; P = 0.024) and LDL-C (88.8% vs 16.3%; P < 0.001) compared with rosuvastatin or telmisartan alone, respectively. In regression analysis, higher baseline MSSBP, female sex, and lower body mass index were associated with increased reductions in MSSBP, whereas higher baseline LDL-C level and lower body mass index were associated with greater reductions in LDL-C. There were 48 adverse events in 36 patients (17.3% [36 of 208]), and 17 adverse drug reactions in 12 patients (5.8% [12 of 208]), indicating no significant differences in short-term safety among study groups. Implications: Treatment with an FDC drug containing telmisartan and rosuvastatin showed similar efficacy in lowering blood pressure and LDL-C levels compared with that of each single drug. ClinicalTrials.gov identifier: NCT01914432.

Original languageEnglish
Pages (from-to)676-691.e1
JournalClinical Therapeutics
Volume40
Issue number5
DOIs
Publication statusPublished - 2018 May

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

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    Oh, G. C., Han, J. K., Han, K. H., Hyon, M. S., Doh, J. H., Kim, M. H., Jeong, J. O., Bae, J. H., Kim, S. H., Yoo, B. S., Baek, S. H., Rhee, M. Y., Ihm, S. H., Sung, J. H., Choi, Y. J., Kim, S. J., Hong, K. S., Lee, B. K., Cho, J. H., ... Kim, H. S. (2018). Efficacy and Safety of Fixed-dose Combination Therapy With Telmisartan and Rosuvastatin in Korean Patients With Hypertension and Dyslipidemia: TELSTA-YU (TELmisartan-rosuvaSTAtin from YUhan), a Multicenter, Randomized, 4-arm, Double-blind, Placebo-controlled, Phase III Study. Clinical Therapeutics, 40(5), 676-691.e1. https://doi.org/10.1016/j.clinthera.2018.03.010