24-Hour blood pressure response to lower dose (30 mg) fimasartan in Korean patients with mild to moderate essential hypertension
1
조회
0
다운로드
1
인용
0
참고문헌
키워드
초록
Background/Aims: Fimasartan is an angiotensin type 1 receptor blocker (ARB) which has comparable efficacy and tolerability with other ARBs. The aim of this study was to evaluate 24-hour blood pressure (BP) lowering efficacy and the tolerability of the low dose fimasartan compared with valsartan in patients with mild to moderate hypertension. Methods: This study was a phase II, prospective, multicenter, randomized, double- blind, parallel-grouped trial. A total of 75 hypertensive patients, whose mean ambulatory BP monitoring values were ≥ 135/85 mmHg, were randomized to either fimasartan 30 mg or valsartan 80 mg daily. The primary efficacy endpoint was the change in the mean 24-hour systolic BP (SBP) values from the baseline and at the week 8. Secondary endpoints included the change in the mean 24-hour diastolic BP values, the daytime and the nighttime mean BP values at week 8, the trough-to-peak (T/P) ratio and the smoothness index. Results: At week 8, the mean 24-hour SBP values significantly decreased in both groups; –10.5 ± 11.9 mmHg (p < 0.0001) in the fimasartan group and –5.5 ± 11.6 mmHg (p = 0.0307) in the valsartan group. The difference between two groups was 4.3 ± 2.9 mmHg but there was no statistical significance (p = 0.1392). The global T/P ratio in the fimasartan 30 mg groups were 0.48 and 0.40 in the valsartan 80 mg group, respectively (p = 0.3411). The most frequent adverse events (AEs) were acute pharyngitis and there were no cases of severe AEs. Conclusions: In mild-to-moderate hypertensive patients, low dose (30 mg) fimasartan showed comparable 24-hour BP lowering efficacy compared with valsartan (80 mg). There was no difference in tolerability between two groups.
Abstract
Background/Aims: Fimasartan is an angiotensin type 1 receptor blocker (ARB) which has comparable efficacy and tolerability with other ARBs. The aim of this study was to evaluate 24-hour blood pressure (BP) lowering efficacy and the tolerability of the low dose fimasartan compared with valsartan in patients with mild to moderate hypertension. Methods: This study was a phase II, prospective, multicenter, randomized, double- blind, parallel-grouped trial. A total of 75 hypertensive patients, whose mean ambulatory BP monitoring values were ≥ 135/85 mmHg, were randomized to either fimasartan 30 mg or valsartan 80 mg daily. The primary efficacy endpoint was the change in the mean 24-hour systolic BP (SBP) values from the baseline and at the week 8. Secondary endpoints included the change in the mean 24-hour diastolic BP values, the daytime and the nighttime mean BP values at week 8, the trough-to-peak (T/P) ratio and the smoothness index. Results: At week 8, the mean 24-hour SBP values significantly decreased in both groups; –10.5 ± 11.9 mmHg (p < 0.0001) in the fimasartan group and –5.5 ± 11.6 mmHg (p = 0.0307) in the valsartan group. The difference between two groups was 4.3 ± 2.9 mmHg but there was no statistical significance (p = 0.1392). The global T/P ratio in the fimasartan 30 mg groups were 0.48 and 0.40 in the valsartan 80 mg group, respectively (p = 0.3411). The most frequent adverse events (AEs) were acute pharyngitis and there were no cases of severe AEs. Conclusions: In mild-to-moderate hypertensive patients, low dose (30 mg) fimasartan showed comparable 24-hour BP lowering efficacy compared with valsartan (80 mg). There was no difference in tolerability between two groups.
참고문헌 (39)
- Ezzati M, "Rethinking the “diseases of affluence” paradigm: global patterns of nutritional risks in relation to economic development", PLoS Med, 2, pp.e133~ (2005)
- Neal B, "Effects of ACE inhibitors, calcium antagonists, and other blood-pressure-lowering drugs: results of prospectively designed overviews of randomised trials. Blood Pressure Lowering Treatment Trialists’ Collaboration", Lancet, 356, pp.1955~1964 (2000)
- Hae-Young Lee, "Impact of the β-1 adrenergic receptor polymorphism on tolerability and efficacy of bisoprolol therapy in Korean heart failure patients: association between β adrenergic receptor polymorphism and bisoprolol therapy in heart failure (ABBA) study", The Korean Journal of Internal Medicine, 31(2), pp.277~287 (2016), 대한내과학회[DOI]
- James PA, "2014 Evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8)", JAMA, 311, pp.507~520 (2014)
- Weber MA, "Clinical practice guidelines for the management of hypertension in the community: a statement by the American Society of Hypertension and the International Society of Hypertension", J Clin Hypertens (Greenwich), 16, pp.14~26 (2014)
- Mancia G, "2013 ESH", ESC guidelines for the management of arterial hypertension:the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC), 2013, pp.31, 1281~1357
- Jang Hoon Lee, "Angiotensin II type 1 receptor blockers as a first choice in patients with acute myocardial infarction", The Korean Journal of Internal Medicine, 31(2), pp.267~276 (2016), 대한내과학회[DOI]
- 최의근, "Angiotensin Receptor Blocker for Stroke Prevention in Atrial Fibrillation: beyond Blood Pressure Lowering?", Korean Circulation Journal, 46(3), pp.307~308 (2016), 대한심장학회[DOI]
- Abraham HM, "The comparative efficacy and safety of the angiotensin receptor blockers in the management of hypertension and other cardiovascular diseases", Drug Saf, 38, pp.33~54 (2015)
- Lee HY, "Fimasartan: a new angiotensin receptor blocker", Drugs, 76, pp.1015~1022 (2016)
- Lee H, "Ambulatory blood pressure response to once-daily fimasartan:an 8-week, multicenter, randomized, double-blind, active-comparator, parallel-group study in Korean patients with mild to moderate essential hypertension", Clin Ther, 35, pp.1337~1349 (2013)
- Lee H, "Efficacy and tolerability of once-daily oral fimasartan 20 to 240 mg", d in Korean patients with hypertension: findings from two phase II, randomized, double-blind, placebo-controlled studies, 2012, pp.34, 1273~1289
- Lee SE, "Efficacy and tolerability of fimasartan, a new angiotensin receptor blocker, com-pared 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
- Rhee MY, "Efficacy of fimasartan", hydrochlorothiazide combination in hypertensive patients inadequately controlled by fimasartan monotherapy, 2015, pp.9, 2847~2854
- Park JB, "Safety and efficacy of fimasartan in patients with arterial hypertension (Safe-KanArb study): an open-label observational study", Am J Cardiovasc Drugs, 13, pp.47~56 (2013)
- 장성아, "A Novel Angiotensin Type I Receptor Antagonist, Fimasartan, Prevents Doxorubicin-induced Cardiotoxicity in Rats", Journal of Korean Medical Science, 30(5), pp.559~568 (2015), 대한의학회
- Kim JW, "Increased systemic exposure of fimasartan, an angiotensin II receptor antagonist, by ketoconazole and rifampicin", J Clin Pharmacol, 53, pp.75~81 (2013)
- Lee J, "Pharmacokineticpharmacodynamic model of fimasartan applied to predict the influence of a high fat diet on its blood pressurelowering effect in healthy subjects", Eur J Clin Pharmacol, 69, pp.11~20 (2013)
- Chi YH, "Safety, tolerability, pharmacokinetics, and pharmacodynamics of fimasartan following single and repeated oral administration in the fasted and fed states in healthy subjects", Am J Cardiovasc Drugs, 11, pp.335~346 (2011)
- Shin KH, "The effect of the newly developed angiotensin receptor II antagonist fimasartan on the pharmacokinetics of atorvastatin in relation to OATP1B1 in healthy male volunteers", J Cardiovasc Pharmacol, 58, pp.492~499 (2011)
- Kim CO, "Influence of hepatic dysfunction on the pharmacokinetics and safety of fimasartan", J Cardiovasc Pharmacol, 62, pp.524~529 (2013)
- Lee HW, "Effect of age on the pharmacokinetics of fimasartan (BR-A-657)", Expert Opin Drug Metab Toxicol, 7, pp.1337~1344 (2011)
- Yi S, "Pharmacokinetic interaction of fimasartan, a new angiotensin II receptor antagonist, with amlodipine in healthy volunteers", J Cardiovasc Pharmacol, 57, pp.682~689 (2011)
- Jeon H, "Assessment of the drugdrug interactions between fimasartan and hydrochlorothiazide in healthy volunteers", J Cardiovasc Pharmacol, 59, pp.84~91 (2012)
- Yi S, "Effect of multiple doses of fimasartan, an angiotensin II receptor antagonist, on the steady-state pharmacokinetics of digoxin in healthy volunteers", Int J Clin Pharmacol Ther, 49, pp.321~327 (2011)
- Youn JC, "Efficacy and safety of 30-mg fimasartan for the treatment of patients with mild to moderate hypertension: an 8-week, multicenter, randomized, double-blind, phase III clinical study", Clin Ther, 36, pp.1412~1421 (2014)
- Diamant M, "Lisinopril versus enalapril:evaluation of trough:peak ratio by ambulatory blood pressure monitoring", J Hum Hypertens, 13, pp.405~412 (1999)
- Staessen JA, "Determining the trough-to-peak ratio in parallel-group trials: Systolic Hypertension in Europe (SYST-EUR) Trial Investigators", Hypertension, 29, pp.659~667 (1997)
- Staessen JA, "The troughto-peak ratio as an instrument to evaluate antihypertensive drugs: the APTH Investigators. Ambulatory Blood Pressure and Treatment of Hypertension Trial", Hypertension, 26, pp.942~949 (1995)
- Coca A, "Trough-to-peak ratio, smoothness index, and circadian blood pressure profile after treatment with once-daily fixed combination of losartan 100 and hydrochlorothiazide 25 in essential hypertension", J Cardiovasc Pharmacol, 39, pp.824~833 (2002)
- Parati G, "The smoothness index: a new, reproducible and clinically relevant measure of the homogeneity of the blood pressure reduction with treatment for hypertension", J Hypertens, 16, pp.1685~1691 (1998)
- Heran BS, "Blood pressure lowering efficacy of angiotensin receptor blockers for primary hypertension", Cochrane Database Syst Rev, (4), pp.CD003822~ (2008)
- Forclaz A, "Angiotensin II receptor blockade: is there truly a benefit of adding an ACE inhibitor?", Hypertension, 41, pp.31~36 (2003)
- Young-Il JO, "Effect of low-dose valsartan on proteinuria in normotensive immunoglobulin A nephropathy with minimal proteinuria: a randomized trial", The Korean Journal of Internal Medicine, 31(2), pp.335~343 (2016), 대한내과학회[DOI]
- Israili ZH., "Clinical pharmacokinetics of angiotensin II (AT1) receptor blockers in hypertension", J Hum Hypertens, 14(Suppl 1), pp.S73~S86 (2000)
- Taylor AA, "Angiotensin receptor blockers: pharmacology, efficacy, and safety", J Clin Hypertens (Greenwich), 13, pp.677~686 (2011)
- Morgan T, "Interaction of ACE inhibitors and AT(1)-receptor blockers on maximum blood pressure response in spontaneous hypertensive rats", J Renin Angiotensin Aldosterone Syst, 3, pp.16~18 (2002)
- Rose M, "Some problems with antihypertensive drug studies in the context of the new guidelines", Am J Hypertens, 3, pp.151~155 (1990)
- "Draft guidance: E12A principles for clinical evaluation of new antihypertensive drugs" (2000)[URL]