Effect of a fixed-dose combination of Telmisartan/S-amlodipine on circadian blood pressure compared with Telmisartan monotherapy: TENUVA-BP study
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Background: This study evaluated the circadian efficacy of a telmisartan 40 mg/S-amlodipine 2.5 mg fixed-dose combination (Telmisartan40/S-Amlodipine2.5) compared to telmisartan 80 mg (Telmisartan80) in patients with essential hypertension who did not respond to 2-4 weeks' treatment with telmisartan 40 mg. Methods: Eligible patients with essential hypertension (clinic mean sitting systolic blood pressure [MSSBP] ≥140 mmHg, or ≥ 130 mmHg in those with diabetes mellitus or chronic kidney disease) were randomly assigned to Telmisartan40/S-Amlodipine2.5 or Telmisartan80 for 8 weeks. All patients underwent ambulatory BP monitoring (ABPM) at baseline and 8 weeks later. Primary endpoints were changes in mean 24-h SBP and DBP on 24-h ABPM from baseline after 8 weeks. Secondary endpoints were changes in daytime, nighttime, and morning SBP and DBP, and clinic MSSBP and MSDBP. Results: A total of 316 Korean patients were enrolled, 217 patients were randomized to treatment, and 192 patients completed the study. Compared to Telmisartan80, Telmisartan40/S-Amlodipine2.5 showed significantly better reductions in 24-h mean SBP and DBP after 8 weeks. Telmisartan40/S-Amlodipine2.5 also significantly reduced secondary endpoints compared to Telmisartan80. Among 15 adverse events (7 [Telmisartan40/S-Amlodipine2.5] and 8 [Telmisartan80]), there were five adverse drug reactions; 14 events were mild, and none were identified with significant between-group differences. Conclusions: Telmisartan40/S-Amlodipine2.5 was tolerable and more effective than Telmisartan80 in lowering 24-h mean ambulatory BP in patients with essential hypertension not responding adequately to Telmisartan40. Our findings support the fact that the combination of S-amlodipine with telmisartan is more appropriate than increasing the dose of telmisartan monotherapy. Trial registration: ClinicalTrials.gov , NCT02231788 . Registered 4 September 2014.
Abstract
Background: This study evaluated the circadian efficacy of a telmisartan 40 mg/S-amlodipine 2.5 mg fixed-dose combination (Telmisartan40/S-Amlodipine2.5) compared to telmisartan 80 mg (Telmisartan80) in patients with essential hypertension who did not respond to 2-4 weeks' treatment with telmisartan 40 mg. Methods: Eligible patients with essential hypertension (clinic mean sitting systolic blood pressure [MSSBP] ≥140 mmHg, or ≥ 130 mmHg in those with diabetes mellitus or chronic kidney disease) were randomly assigned to Telmisartan40/S-Amlodipine2.5 or Telmisartan80 for 8 weeks. All patients underwent ambulatory BP monitoring (ABPM) at baseline and 8 weeks later. Primary endpoints were changes in mean 24-h SBP and DBP on 24-h ABPM from baseline after 8 weeks. Secondary endpoints were changes in daytime, nighttime, and morning SBP and DBP, and clinic MSSBP and MSDBP. Results: A total of 316 Korean patients were enrolled, 217 patients were randomized to treatment, and 192 patients completed the study. Compared to Telmisartan80, Telmisartan40/S-Amlodipine2.5 showed significantly better reductions in 24-h mean SBP and DBP after 8 weeks. Telmisartan40/S-Amlodipine2.5 also significantly reduced secondary endpoints compared to Telmisartan80. Among 15 adverse events (7 [Telmisartan40/S-Amlodipine2.5] and 8 [Telmisartan80]), there were five adverse drug reactions; 14 events were mild, and none were identified with significant between-group differences. Conclusions: Telmisartan40/S-Amlodipine2.5 was tolerable and more effective than Telmisartan80 in lowering 24-h mean ambulatory BP in patients with essential hypertension not responding adequately to Telmisartan40. Our findings support the fact that the combination of S-amlodipine with telmisartan is more appropriate than increasing the dose of telmisartan monotherapy. Trial registration: ClinicalTrials.gov , NCT02231788 . Registered 4 September 2014.
참고문헌 (33)
- 김현창, "Korea hypertension fact sheet 2020: analysis of nationwide population-based data", Clinical Hypertension, 27(2), pp.66~69 (2021), 대한고혈압학회[DOI]
- 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)
- 신진호, "2013 Korean Society of Hypertension guidelines for the management of hypertension. Part II—treatments of hypertension", Clinical Hypertension, 21(2), pp.1~13 (2015), 대한고혈압학회[DOI]
- Williams B, "2018 practice guidelines for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension", Blood Press, 27(6), pp.314~340 (2018)[DOI]
- 신진호, "Discordance between ambulatory versus clinic blood pressure according to global cardiovascular risk group", The Korean Journal of Internal Medicine, 30(5), pp.610~619 (2015), 대한내과학회[DOI]
- Asayama K, "Nocturnal blood pressure measured by home devices : evidence and perspective for clinical application", J Hypertens, 37(5), pp.905~916 (2019)[DOI]
- Head GA, "The importance and prognostic value of nocturnal blood pressure assessments using inexpensive domestic devices", J Hypertens, 35(3), pp.463~465 (2017)[DOI]
- Wald DS, "Combination therapy versus monotherapy in reducing blood pressure : meta-analysis on 11, 000participants from 42 trials", Am J Med, 122(3), pp.290~300 (2009)[DOI]
- Kjeldsen SE, "2018 practice guidelines for the management of arterial hypertension of the European Society of Hypertension", Blood Press, 27(6), pp.313~ (2018)[DOI]
- Liu L, "The Felodipine event reduction(FEVER)study : a randomized long-term placebo-controlled trial in Chinese hypertensive patients", J Hypertens, 23(12), pp.2157~2172 (2005)[DOI]
- Davis BR, "Benazepril plus amlodipine or hydrochlorothiazide for hypertension", N Engl J Med, 360(11), pp.1148~1149 (2009)
- Littlejohn TW 3rd, "Results of treatment with telmisartan-amlodipine in hypertensive patients", J Clin Hypertens(Greenwich), 11, pp.207~213 (2009)
- Neldam S, "Telmisartan and amlodipine single-pill combinations vs amlodipine monotherapy for superior blood pressure lowering and improved tolerability in patients with uncontrolled hypertension: results of the TEAMSTA-5 study", J Clin Hypertens (Greenwich), 13, pp.459~466 (2011)
- Kim SA, "Efficacy and safety profiles of a new S(-)-amlodipine nicotinate formulation versus racemic amlodipine besylate in adult Korean patients with mild to moderate hypertension : an 8-week, multicenter, randomized, double-blind, doubledummy, parallel-group, phase III, noninferiority clinical trial", Clin Ther, 30(5), pp.845~857 (2008)[DOI]
- Kakuta H, "Telmisartan has the strongest binding affinity to angiotensin II type 1 receptor : comparison with other angiotensin II type 1 receptor blockers", Int J Clin Pharmacol Res, 25(1), pp.41~46 (2005)
- Lacourcière Y, "Sustained antihypertensive activity of telmisartan compared with valsartan", Blood Press Monit, 9(4), pp.203~210 (2004)[DOI]
- Ihm SH, "Efficacy and safety of two fixed-dose combinations of S-amlodipine and telmisartan(CKD-828)versus S-amlodipine monotherapy in patients with hypertension inadequately controlled using S-amlodipine monotherapy : an 8-week, multicenter, randomized, double-blind, phase III clinical study", Drug Des Devel Ther, 10, pp.3817~3826 (2016)[DOI]
- Nordmann A, "Reliability of patients measuring blood pressure at home : prospective observational study", BMJ, 319(7218), pp.1172~ (1999)[DOI]
- Pickering TG, "Ambulatory blood-pressure monitoring", N Engl J Med, 354(22), pp.2368~2374 (2006)[DOI]
- Staessen JA, "Predicting cardiovascular risk using conventional vs ambulatory blood pressure in older patients with systolic hypertension. Systolic hypertension in Europe trial investigators", JAMA, 282(6), pp.539~546 (1999)[DOI]
- Fan HQ, "Prognostic value of isolated nocturnal hypertension on ambulatory measurement in 8711individuals from 10 populations", J Hypertens, 28(10), pp.2036~2045 (2010)[DOI]
- Kario K, "Morning surge in blood pressure as a predictor of silent and clinical cerebrovascular disease in elderly hypertensives : a prospective study", Circulation, 107(10), pp.1401~1406 (2003)[DOI]
- Li Y, "Is isolated nocturnal hypertension a novel clinical entity? Findings from a Chinese population study", Hypertension, 50(2), pp.333~339 (2007)[DOI]
- White WB, "Effects of telmisartan and amlodipine in combination on ambulatory blood pressure in stages 1-2 hypertension", Blood Press Monit, 15(4), pp.205~212 (2010)[DOI]
- Lund-Johansen P, "Long-term haemodynamic effects of amlodipine at rest and during exercise in essential hypertension", Postgrad Med J, 67(Suppl 5), pp.S20~S23 (1991)
- O'Rourke MF, "Arterial stiffness", J Hypertens, 17(1), pp.1~4 (1999)[DOI]
- Sander D, "Relationship between circadian blood pressure patterns and progression of early carotid atherosclerosis : a 3-year follow-up study", Circulation, 102(13), pp.1536~1541 (2000)[DOI]
- Parati G, "Impact of antihypertensive combination and monotreatments on blood pressure variability: assessment by old and new indices. Data from a large ambulatory blood pressure monitoring database", J Hypertens, 32(6), pp.1326~1333 (2014)[DOI]
- Higaki J, "The efficacy and long-term safety of a triple combination of 80 mg telmisartan, 5 mg amlodipine and 12.5 mg hydrochlorothiazide in Japanese patients with essential hypertension: a randomized, double-blind study with open-label extension", Hypertens Res, 40(1), pp.51~60 (2017)[DOI]
- Beckey C, "Lercanidipine in the treatment of hypertension", Ann Pharmacother, 41(3), pp.465~473 (2007)[DOI]
- Oh GC, "Quantification of pedal edema during treatment with S(-)-amlodipine nicotinate versus amlodipine besylate in female Korean patients with mild to moderate hypertension : a 12-week, multicenter, randomized, double-blind, active-controlled, phase IV clinical trial", Clin Ther, 34(9), pp.1940~1947 (2012)[DOI]
- National Kidney Foundation, "K", DOQI clinical practice guidelines for chronic kidney disease : evaluation, classification, and stratification, 2002, pp.39, S1~266
- Zhang XP, "Paradoxical release of nitric oxide by an L-type calcium channel antagonist, the R+ enantiomer of amlodipine", J Cardiovasc Pharmacol, 39(2), pp.208~214 (2002)[DOI]