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

被引:17
作者
Jin, Xuan [1 ]
Kim, Moo Hyun [1 ]
Han, Ki Hoon [3 ]
Hong, Soon Jun [4 ]
Ahn, Jeong-Cheon [5 ]
Sung, Jung-Hoon [6 ]
Cho, Jin-Man [7 ]
Lee, Han Cheol [8 ]
Choi, So-Yeon [9 ]
Lee, Kyounghoon [10 ]
Kim, Woo-Shik [11 ]
Rhee, Moo-Yong [12 ]
Kim, Ju Han [13 ]
Hong, Seung Pyo [14 ]
Yoo, Byung Su [15 ]
Cho, Eun Joo [16 ]
Lee, Jae-Hwan [17 ]
Kim, Pum-Joon [18 ]
Park, Chang-Gyu [19 ]
Hyon, Min Su [20 ]
Shin, Jin Ho [21 ]
Lee, Sang Hyun [22 ]
Sung, Ki Chul [23 ]
Hwang, Jinyong [24 ]
Kwon, Kihwan [25 ]
Chae, In-Ho [26 ]
Seo, Jeong-Sook [27 ]
Kim, Hyungseop [28 ]
Lee, Hana [29 ]
Cho, Yoonhwa [29 ]
Kim, Hyo-Soo [2 ]
机构
[1] Dong A Univ Hosp, Dept Cardiol, Busan, South Korea
[2] Seoul Natl Univ, Seoul Natl Univ Hosp, Div Cardiol, Dept Internal Med,Coll Med, Seoul, South Korea
[3] Asan Med Ctr, Dept Internal Med, Div Cardiol, Seoul, South Korea
[4] Korea Univ, Div Cardiol, Dept Cardiovasc Ctr, Anam Hosp, Seoul, South Korea
[5] Korea Univ, Dept Internal Med, Ansan Hosp, Ansan, South Korea
[6] CHA Univ, Dept Cardiol, CHA Bundang Med Ctr, Seongnam, South Korea
[7] Kyung Hee Univ Hosp Gangdong, Div Cardiol, Dept Internal Med, Seoul, South Korea
[8] Pusan Natl Univ Hosp, Div Cardiol, Dept Internal Med, Busan, South Korea
[9] Ajou Univ, Dept Cardiol, Sch Med, Suwon, South Korea
[10] Gachon Univ, Gil Med Ctr, Div Cardiol, Incheon, South Korea
[11] Kyung Hee Univ Hosp, Dept Internal Med, Seoul, South Korea
[12] Dongguk Univ, Cardiovasc Ctr, Ilsan Hosp, Goyang, South Korea
[13] Chonnam Natl Univ Hosp, Dept Internal Med, Div Cardiol, Gwangju, South Korea
[14] Daegu Cathol Univ, Div Cardiol, Med Ctr, Daegu, South Korea
[15] Yonsei Univ, Wonju Coll Med, Wonju Severance Christian Hosp, Div Cardiol,Dept Internal Med, Wonju, South Korea
[16] Catholic Univ Korea, Yeouido St Marys Hosp, Dept Internal Med, Div Cardiol, Seoul, South Korea
[17] Chungnam Natl Univ, Coll Med, Chungnam Natl Univ Hosp, Dept Cardiol Internal Med, Daejeon, South Korea
[18] Catholic Univ Korea, Coll Med, Dept Internal Med, Seoul St Marys Hosp, Seoul, South Korea
[19] Korea Univ, Guro Hosp, Dept Internal Med, Seoul, South Korea
[20] Soonchunhyang Univ, Seoul Hosp, Dept Internal Med, Div Cardiol, Seoul, South Korea
[21] Hanyang Univ, Coll Med, Dept Internal Med, Seoul, South Korea
[22] Pusan Natl Univ Yangsan Hosp, Dept Internal Med, Div Cardiol, Yangsan, South Korea
[23] Sungkyunkwan Univ, Kangbuk Samsung Hosp, Dept Internal Med, Div Cardiol, Seoul, South Korea
[24] Gyeongsang Natl Univ, Coll Med, Dept Internal Med, Jinju, South Korea
[25] Ewha Womans Univ, Coll Med, Dept Cardiol, Seoul, South Korea
[26] Seoul Natl Univ, Bundang Hosp, Cardiovasc Ctr, Seongnam, South Korea
[27] Inje Univ, Coll Med, Busan Paik Hosp, Dept Internal Med, Busan, South Korea
[28] Keimyung Univ, Dongsan Med Ctr, Dept Internal Med, Div Cardiol, Daegu, South Korea
[29] Yuhan Corp, Yuhan Res Inst, Yongin, South Korea
关键词
amlodipine; dyslipidemia; hypertension; rosuvastatin; telmisartan; FIXED-DOSE COMBINATIONS; BLOOD-PRESSURE; DOUBLE-BLIND; METAANALYSIS; AMLODIPINE; PARTICIPANTS; MULTICENTER; MANAGEMENT; STATINS;
D O I
10.1111/jch.13893
中图分类号
R6 [外科学];
学科分类号
1002 ; 100210 ;
摘要
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.
引用
收藏
页码:1835 / 1845
页数:11
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