[PP.12.23] A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PHASE III STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE TRIPLE COMBINATION OF AMLODIPINE/LOSARTAN/ROSUVASTATIN IN PATIENTS WITH ESSENTIAL HYPERTENSION. (September 2017)

• Record Type: Journal Article
• Authors: Lee, H.; Park, S.
• Is Part Of: Journal of hypertension. Volume 35(2017)Supplement 2
• Publication Date: 2017-09
• Subjects: Hypertension -- Periodicals; Hypertension -- Periodicals; 616.132005
• DOI: 10.1097/01.hjh.0000523533.01598.7c
• Languages: English
• ISSNs: 1473-5598

Abstract

Abstract : Objective: The objective of this study was to evaluate the efficacy and safety of the amlodipine / losartan / rosuvastatin triple combination in patients with hypertension combined with hypercholesterolemia in order to determine the best combination for the future single pill combination development. Design and method: Hypertensive patients, whose diastolic blood pressure (DBP) was between 90–110 mmHg and LDL-cholesterol levels over 130 mg/dl after 4 weeks' therapeutic lifestyle change with losartan 100 mg once daily, were randomized to losartan 100 mg/rosuvastatin 20 mg (L/R): amlodipine 5 mg/losartan 100 mg (A/L): amlodipine 5 mg/losartan 100 mg/rosuvastatin 20 mg (A/L/R) in 1:1:1 ratio for a 8 weeks' duration of treatment. The primary efficacy endpoint was the percent reduction in LDL-cholesterol levels from baseline in A/L/R group compared with A/L group after 8 week treatment. Also, another co-primary efficacy endpoint was change in sitting diastolic blood pressure (DBP) from baseline from baseline in A/L/R group compared with L/R group after 8 week treatment. Safety endpoint was treatment-emergent adverse events (TEAEs). Results: Of 296 subjects screened, 146 subjects were randomized to 3 groups (A/L/R = 55; A/L = 46; L/R = 45). Mean age was 59.9 [8.3] and male patients were 74.8%. Mean [SD] baseline LDL cholesterol levels were 153.6[32.0] mg/dl. Mean [SD] baseline SBP/DBP were 143.4[13.9]/95.0[7.0] mmHg. The percent reduction of LDL-cholesterol levels from baseline in A/L/R group was −48.4[2.8]%, which was significantly greater than the reduction in A/L group of −6.7[3.0]% after 8 week treatment (p < 0.0001). The changes of mean DBP of A/L/R group (−9.8[0.9] mmHg) was also significantly greater than L/R group (−1.7[1.0] mmHg) (p < 0.0001). For safety evaluation, the frequencies of adverse events (AE) between groups were also not significantly different. Conclusions: This is the first clinical study to evaluate the efficacy and safety of the triple combination of amlodipine/losartan/rosuvastatin. Triple combination therapy with amlodipine/losartan/rosuvastatin showed superior LDL cholesterol reduction than amlodipine losartan combination and better blood pressure reduction than losartan/rosuvastatin combination. In conclusion, amlodipine/losartan/rosuvastatin triple combination can be effective strategy for hypertensive patients combined with hypercholesterolemia.