Efficacy and Safety of Triple Therapy With Telmisartan, Amlodipine, and Rosuvastatin in Patients With Dyslipidemia and Hypertension: The Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial

• Published in: Clinical therapeutics 2019-02, Vol.41 (2), p.233-248.e9
• Main Authors: Hong, Soon Jun, Jeong, Han Saem, Cho, Jin-Man, Chang, Kiyuk, Pyun, Wook Bum, Ahn, Youngkeun, Hyon, Min Su, Kang, Woong Chol, Lee, Jae-Hwan, Kim, Hyo-Soo
• Format: Article
• Language: English
• Subjects: Aged; amlodipine; Amlodipine - administration & dosage; Amlodipine - adverse effects; Angina pectoris; Anticholesteremic Agents - administration & dosage; Anticholesteremic Agents - adverse effects; Antihypertensive Agents - administration & dosage; Antihypertensive Agents - adverse effects; Blood pressure; Blood Pressure - drug effects; Cardiovascular disease; Cholesterol; Clinical trials; Diabetes; Double-Blind Method; Drug dosages; Drug Therapy, Combination; Dyslipidemia; Dyslipidemias - drug therapy; Effectiveness; Enzymes; Female; Heart attacks; Humans; hypercholesterolemia; Hypertension; Hypertension - drug therapy; Low density lipoprotein; Male; Mental disorders; Metabolic disorders; Middle Aged; Patients; Republic of Korea; Risk analysis; Risk factors; rosuvastatin; Rosuvastatin Calcium - administration & dosage; Rosuvastatin Calcium - adverse effects; Safety; Side effects; singe–pill combination; Statins; telmisartan; Telmisartan - administration & dosage; Telmisartan - adverse effects; Therapy; Thyroid gland
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/j.clinthera.2018.12.008

Fixed-dose combination therapy with telmisartan, amlodipine, and rosuvastatin is needed in patients with hypertension and dyslipidemia for better adherence and cost-effectiveness than free–equivalent combination therapies. This study aimed to compare the efficacy and safety of combination therapy with telmisartan, amlodipine, and rosuvastatin versus telmisartan plus amlodipine or telmisartan plus rosuvastatin in patients with hypertension and dyslipidemia. The Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial (J-TAROS-RCT) was an 8-week, multicenter, randomized, double-blind, parallel, Phase III clinical trial conducted at 9 hospitals in Korea. After a run-in period of >4 weeks, patients who fulfilled the criteria of the National Cholesterol Education Program Adult Treatment Panel III guidelines were eligible for randomization to receive 1 of 3 treatments for 8 weeks: (1) telmisartan/amlodipine 80 mg/10 mg plus rosuvastatin 20 mg, (2) telmisartan/amlodipine 80 mg/10 mg, or (3) telmisartan 80 mg plus rosuvastatin 20 mg. The primary end point was efficacy evaluation of combination therapy with telmisartan/amlodipine/rosuvastatin by comparing the change in mean sitting systolic blood pressure (msSBP) and mean percentage change in LDL-C from baseline after 8 weeks of treatment. Adverse events (AEs), clinical laboratory data, and vital signs were assessed in all patients. Among 148 patients, the changes in msSBP from baseline after 8 weeks of treatment were a mean (SD) of −24.41 (2.38) versus −9.31 (2.36) mm Hg in the telmisartan/amlodipine/rosuvastatin and telmisartan/rosuvastatin groups, respectively. Significantly more participants achieved the target BP at week 8 in the telmisartan/amlodipine/rosuvastatin group (41 patients [87.2%]) than in the telmisartan/rosuvastatin group (24 [50.0%], P