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Research Article

A post-marketing survey evaluating the safety and efficacy of a fixed-dose single-pill combination of cilnidipine and valsartan in patients with hypertension: Real-world JSH 2014 and 2019 implementations

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Pages 502-511 | Received 19 Aug 2019, Accepted 02 Jan 2020, Published online: 22 Jan 2020

References

  • Shimamoto K, Ando K, Fujita T, Hasebe N, Higaki J, Horiuchi M, Imai Y, Imaizumi T, Ishimitsu T, Ito M, et al. The Japanese Society of hypertension guidelines for the management of hypertension (JSH 2014). Hypertens Res. 2014;37:253–390.
  • Umemura S, Arima H, Arima S, Asayama K, Dohi Y, Hirooka Y, Horio T, Hoshide S, Ikeda S, Ishimitsu T, et al. The Japanese Society of hypertension guidelines for the management of hypertension (JSH 2019). Hypertens Res. 2019;42:1235–481.
  • Abegaz TM, Shehab A, Gebreyohannes EA, Bhagavathula AS, Elnour AA. Nonadherence to antihypertensive drugs: A systematic review and meta-analysis. Medicine (Baltimore). 2017;96:e5641. DOI:10.1097/MD.0000000000005641.
  • Nguyen TP, Schuiling-Veninga CC, Nguyen TB, Vu TH, Wright EP, Postma MJ. Adherence to hypertension medication: quantitative and qualitative investigations in a rural Northern Vietnamese community. PLoS One. 2017;12:e0171203. DOI:10.1371/journal.pone.0171203.
  • Gupta AK, Arshad S, Poulter NR. Compliance, safety, and effectiveness of fixed-dose combinations of antihypertensive agents: a meta-analysis. Hypertension. 2010;55:399–407. DOI:10.1161/HYPERTENSIONAHA.109.139816.
  • Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, et al. 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). Eur Heart J. 2013;34:2159–219.
  • Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, et al. ESC/ESH Guidelines for the management of arterial hypertension: the task force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension: the task force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension. J Hypertens. 2018;36:1953–2041.
  • Whelton PK, Carey RM, Aronow WS, Casey DE Jr., Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, et al. ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: executive summary: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines. Hypertension. 2018;71:1269–324.
  • Chiang CE, Wang TD, Ueng KC, Lin TH, Yeh HI, Chen CY, Wu YJ, Tsai WC, Chao TH, Chen CH, et al. guidelines of the Taiwan Society of cardiology and the Taiwan Hypertension society for the management of hypertension. J Chin Med Assoc. 2015;78:1–47.
  • Takahara A. Cilnidipine: a new generation Ca channel blocker with inhibitory action on sympathetic neurotransmitter release. Cardiovasc Ther. 2009;27:124–39. DOI:10.1111/j.1755-5922.2009.00079.x.
  • Uneyama H, Takahara A, Dohmoto H, Yoshimoto R, Inoue K, Akaike N. Blockade of N-type Ca2+ current by cilnidipine (FRC-8653) in acutely dissociated rat sympathetic neurones. Br J Pharmacol. 1997;122:37–42. DOI:10.1038/sj.bjp.0701342.
  • Bauer JH, Reams GP. The angiotensin II type 1 receptor antagonists. A new class of antihypertensive drugs. Arch Intern Med. 1995;155:1361–68. DOI:10.1001/archinte.1995.00430130027004.
  • Imai Y, Kario K, Shimada K, Kawano Y, Hasebe N, Matsuura H, Tsuchihashi T, Ohkubo T, Kuwajima I, Miyakawa M. The Japanese Society of hypertension guidelines for self-monitoring of blood pressure at home (Second Edition). Hypertens Res. 2012;35:777–95. DOI:10.1038/hr.2012.56.
  • Kario K, Matsuda S, Nagahama S, Kurose Y, Sugii H, Teshima T, Suzuki N. Single-pill combination of cilnidipine, an L-/N-type calcium channel blocker, and valsartan effectively reduces home pulse pressure in patients with uncontrolled hypertension and sympathetic hyperactivity: the HOPE-Combi survey. J Clin Hypertens. in press.
  • Nagahama S, Norimatsu T, Maki T, Yasuda M, Tanaka S. The effect of combination therapy with an L/N-Type Ca(2+) channel blocker, cilnidipine, and an angiotensin II receptor blocker on the blood pressure and heart rate in Japanese hypertensive patients: an observational study conducted in Japan. Hypertens Res. 2007;30:815–22. DOI:10.1291/hypres.30.815.
  • Gillman MW, Kannel WB, Belanger A, D’Agostino RB. Influence of heart rate on mortality among persons with hypertension: the Framingham study. Am Heart J. 1993;125:1148–54. DOI:10.1016/0002-8703(93)90128-V.
  • Jouven X, Empana JP, Schwartz PJ, Desnos M, Courbon D, Ducimetiere P. Heart-rate profile during exercise as a predictor of sudden death. N Engl J Med. 2005;352:1951–58. DOI:10.1056/NEJMoa043012.
  • Gillum RF, Makuc DM, Feldman JJ. Pulse rate, coronary heart disease, and death: the NHANES I epidemiologic follow-up study. Am Heart J. 1991;121:172–77. DOI:10.1016/0002-8703(91)90970-S.
  • Kario K, Ando S, Kido H, Nariyama J, Takiuchi S, Yagi T, Shimizu T, Eguchi K, Ohno M, Kinoshita O, et al. The effects of the L/N-type calcium channel blocker (cilnidipine) on sympathetic hyperactive morning hypertension: results from ACHIEVE-ONE. J Clin Hypertens (Greenwich). 2013;15:133–42.
  • Aoki S, Hosomi N, Nezu T, Teshima T, Sugii H, Nagahama S, Kurose Y, Maruyama H, Matsumoto M. Blood pressure control with cilnidipine treatment in Japanese post-stroke hypertensive patients: the CA-ATTEND study. Clin Exp Hypertens. 2017;39:225–34. DOI:10.1080/10641963.2016.1235183.
  • Nagahama S, Iwayama S. The safety and efficacy of administration with combination 10 mg cilnidipine and 80 mg valsartan in hypertensive patients. J New Rem Clin. 2016;65:792–802.
  • Hozawa A, Ohkubo T, Kikuya M, Ugajin T, Yamaguchi J, Asayama K, Metoki H, Ohmori K, Hoshi H, Hashimoto J, et al. Prognostic value of home heart rate for cardiovascular mortality in the general population: the Ohasama study. Am J Hypertens. 2004;17:1005–10.
  • Nauman J, Janszky I, Vatten LJ, Wisloff U. Temporal changes in resting heart rate and deaths from ischemic heart disease. JAMA. 2011;306:2579–87. DOI:10.1001/jama.2011.1826.
  • Hoshide S, Kario K, Ishikawa J, Eguchi K, Shimada K. Comparison of the effects of cilnidipine and amlodipine on ambulatory blood pressure. Hypertens Res. 2005;28:1003–08. DOI:10.1291/hypres.28.1003.
  • Sakata K, Shirotani M, Yoshida H, Nawada R, Obayashi K, Togi K, Miho N. Effects of amlodipine and cilnidipine on cardiac sympathetic nervous system and neurohormonal status in essential hypertension. Hypertension. 1999;33:1447–52. DOI:10.1161/01.HYP.33.6.1447.
  • Lee JH, Kim SH, Kang SH, Cho JH, Cho Y, Oh IY, Yoon CH, Lee HY, Youn TJ, Chae IH, et al. Blood pressure control and cardiovascular outcomes: real-world implications of the 2017 ACC/AHA hypertension guideline. Sci Rep. 2018;8:13155.
  • Zhou Y, Jia L, Lu B, Gu G, Hu H, Zhang Z, Bai L, Cui W. Updated hypertension prevalence, awareness, and control rates based on the 2017ACC/AHA high blood pressure guideline. J Clin Hypertens (Greenwich). 2019;21:758–65. DOI:10.1111/jch.13564.