A randomized, double-blind, multicenter, phase III study on the efficacy and safety of a combination treatment involving fimasartan, amlodipine, rosuvastatin in patients with essential hypertension and dyslipidemia who fail to respond adequately to fimasartan monotherapy
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Background: To assess the efficacy and safety of a combination therapy involving fimasartan, amlodipine, and rosuvastatin in patients with essential hypertension and dyslipidemia who fail to respond to fimasartan monotherapy. Methods: This phase III, randomized, double-blind, multicenter study was conducted in adults aged 19-70 years. Patients who voluntarily consented were screened for eligibility to enroll in the study. Patients who failed to respond to 4 weeks of fimasartan monotherapy were randomized with a 1:1:1 ratio to the fimasartan 60 mg/amlodipine 10 mg + rosuvastatin 20 mg (FMS/ALD + RSV) as study group, fimasartan 60 mg/amlodipine 10 mg (FMS/ALD) as control 1 group, and fimasartan 60 mg + rosuvastatin 20 mg (FMS + RSV) as control 2 group. The primary efficacy endpoints were the change in the sitting systolic blood pressure and the rate of change in the low-density lipoprotein cholesterol (LDL-C) level from baseline to 8 weeks. The adverse events, adverse drug reactions, physical examination findings, laboratory test results, electrocardiograms, and vital signs were evaluated to assess safety in the study. Results: Of 138 randomized patients, 131 were conducted efficacy analysis, and 125 completed the study. For the change in LDL-C and sitting SBP (SiSBP) as primary efficacy assessments, the change in LDL-C at week 8 was significantly reduce in the FMS/ALD + RSV group than in the control 1 group (P < 0.001). The change in SiSBP at week 8 were greater reduce in the FMS/ALD + RSV group than in the FMS + RSV group (both P < 0.001). For the safety evaluation, there were no differences among the treatment groups in the incidence of adverse drug reactions. Conclusions: The fimasartan/amlodipine + rosuvastatin combination therapy can effectively and safely lower blood pressure and improve lipid levels in patients with essential hypertension and dyslipidemia who fail to respond adequately to fimasartan monotherapy. Trial registration: NCT03156842, Registered 17 May 2017.
Abstract
Background: To assess the efficacy and safety of a combination therapy involving fimasartan, amlodipine, and rosuvastatin in patients with essential hypertension and dyslipidemia who fail to respond to fimasartan monotherapy. Methods: This phase III, randomized, double-blind, multicenter study was conducted in adults aged 19-70 years. Patients who voluntarily consented were screened for eligibility to enroll in the study. Patients who failed to respond to 4 weeks of fimasartan monotherapy were randomized with a 1:1:1 ratio to the fimasartan 60 mg/amlodipine 10 mg + rosuvastatin 20 mg (FMS/ALD + RSV) as study group, fimasartan 60 mg/amlodipine 10 mg (FMS/ALD) as control 1 group, and fimasartan 60 mg + rosuvastatin 20 mg (FMS + RSV) as control 2 group. The primary efficacy endpoints were the change in the sitting systolic blood pressure and the rate of change in the low-density lipoprotein cholesterol (LDL-C) level from baseline to 8 weeks. The adverse events, adverse drug reactions, physical examination findings, laboratory test results, electrocardiograms, and vital signs were evaluated to assess safety in the study. Results: Of 138 randomized patients, 131 were conducted efficacy analysis, and 125 completed the study. For the change in LDL-C and sitting SBP (SiSBP) as primary efficacy assessments, the change in LDL-C at week 8 was significantly reduce in the FMS/ALD + RSV group than in the control 1 group (P < 0.001). The change in SiSBP at week 8 were greater reduce in the FMS/ALD + RSV group than in the FMS + RSV group (both P < 0.001). For the safety evaluation, there were no differences among the treatment groups in the incidence of adverse drug reactions. Conclusions: The fimasartan/amlodipine + rosuvastatin combination therapy can effectively and safely lower blood pressure and improve lipid levels in patients with essential hypertension and dyslipidemia who fail to respond adequately to fimasartan monotherapy. Trial registration: NCT03156842, Registered 17 May 2017.
참고문헌 (19)
- Littlejohn TW 3rd, "Telmisartan plus amlodipine in patients with moderate or severe hypertension : results from a subgroup analysis of a randomized, placebo-controlled, parallel-group, 4 x 4 factorial study", Postgrad Med, 121, pp.5~14 (2009)
- Chrysant SG, "The combination of olmesartan medoxomil and amlodipine besylate in controlling high blood pressure : COACH, a randomized, double-blind, placebo-controlled, 8-week factorial efficacy and safety study", Clin Ther, 30, pp.587~604 (2008)
- Philipp T, "Two multicenter, 8-week, randomized, double-blind, placebo-controlled, parallelgroup studies evaluating the efficacy and tolerability of amlodipine and valsartan in combination and as monotherapy in adult patients with mild to moderate essential hypertension", Clin Ther, 29, pp.563~580 (2007)
- Lee SE, "Efficacy and tolerability of fimasartan, a new angiotensin receptor blocker, compared with losartan(50", 100 mg) : a 12-week, phase III, multicenter, prospective, randomized, double-blind, parallel-group, dose escalation clinical trial with an optional 12-week extension phase in adult Korean patients with mild-to-moderate hypertension, 2012, pp.34, 552~568
- Atlas SA, "The renin-angiotensin aldosterone system : pathophysiological role and pharmacologic inhibition", J Manag Care Pharm, 13(8 Suppl B), pp.9~20 (2007)
- Ridker PM, "Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein", N Engl J Med, 359, pp.2195~2207.7 (2008)
- Jones PH, "Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses(STELLAR* Trial)", Am J Cardiol, 92, pp.152~160 (2003)
- National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III), "Third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report", Circulation, 106, pp.3143~3421 (2002)
- Lee HY, "A randomized, multicenter, double-blind, placebo-controlled, 3 × 3 factorial design, phase II study to evaluate the efficacy and safety of the combination of fimasartan", amlodipine in patients with essential hypertension, 2015, pp.37, 2581~2596
- Kim KI, "A randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of fimasartan", amlodipine combined therapy versus fimasartan monotherapy in patients with essential hypertension unresponsive to fimasartan monotherapy, 2016, pp.38, 2159~2170
- Rhee MY, "The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia", BMC Pharmacol Toxicol, 18, pp.2~ (2017)
- Torre JJ, "American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the diagnosis and treatment of hypertension", Endocr Pract, 12, pp.193~222 (2006)
- Zeng F, "Adherence and persistence of single-pill ARB", CCB combination therapy compared to multiple-pill ARB, Curr Med Res Opin, pp.2010, 26[DOI]
- Kostis JB, "The importance of managing hypertension and dyslipidemia to decrease cardiovascular disease", Cardiovasc Drugs Ther, 21, pp.297~309 (2007)
- Rhee MY, "Efficacy of fimasartan", hydrochlorothiazide combination in hypertensive patients inadequately controlled by fimasartan monotherapy, 2015, pp.9, 2847~2854
- Wald DS, "Combination therapy versus monotherapy in reducing blood pressure : meta-analysis on 11, 000participants from 42 trials", Am J Med, 122, pp.290~300 (2009)
- Kronish IM, "Meta-analysis : impact of drug class on adherence to antihypertensives", Circulation, 123, pp.1611~1621 (2011)
- Makani H, "Effect of renin-angiotensin system blockade on calcium channel blocker-associated peripheral edema", Am J Med, 124, pp.128~135 (2011)
- Julius S, "Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine : the VALUE randomised trial", Lancet, 363, pp.2022~2031 (2004)