Dose-response effects of bepridil in patients with persistent atrial fibrillation monitored with transtelephonic electrocardiograms - A multicenter, randomized, placebo-controlled, double-blind study (J-BAF study)

Circulation Journal

Volumn 73, Issue 6, 2009, Pages 1020-1027

  Yamashita, Takeshi ^a,o   Ogawa, Satoshi ^a   Sato, Toshiaki ^a   Aizawa, Yoshifusa ^b   Atarashi, Hirotsugu ^c   Fujiki, Akira ^d   Inoue, Hiroshi ^d   Ito, Makoto ^e   Katoh, Takao ^f   Kobayashi, Youichi ^g   Koretsune, Yukihiro ^h   Kumagai, Koichiro ⁱ   Niwano, Shinichi ^j   Okazaki, Osamu ^k   Okumura, Ken ^l   Saku, Keijiro ^m   Tanabe, Teruhisa ⁿ   Origasa, Hideki ^d  

^a KEIO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b NIIGATA UNIVERSITY GRADUATE SCHOOL OF MEDICAL AND DENTAL SCIENCES   (Japan)

^c NIPPON MEDICAL SCHOOL TAMA NAGAYAMA HOSPITAL   (Japan)

^d UNIVERSITY OF TOYAMA   (Japan)

^e SHIGA UNIVERSITY OF MEDICAL SCIENCE   (Japan)

^f NIPPON MEDICAL SCHOOL   (Japan)

^g SHOWA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^h OSAKA NATIONAL HOSPITAL   (Japan)

ⁱ INTERNATIONAL UNIVERSITY OF HEALTH AND WELFARE   (Japan)

^j KITASATO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^k NATIONAL CENTER FOR GLOBAL HEALTH AND MEDICINE   (Japan)

^l HIROSAKI UNIVERSITY   (Japan)

^m FUKUOKA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

ⁿ TOKAI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^o THE CARDIOVASCULAR INSTITUTE   (Japan)

more..

Author keywords

Atrial fibrillation; Bepridil; Clinical trial

Indexed keywords

BEPRIDIL; PLACEBO;

ADULT; ARTICLE; BRADYCARDIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIAGNOSTIC VALUE; DISEASE COURSE; DISEASE DURATION; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; ELECTROCARDIOGRAM; FEMALE; HEART ATRIUM FIBRILLATION; HEART VENTRICLE TACHYCARDIA; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; QT PROLONGATION; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RECURRENT DISEASE; RISK FACTOR; SIDE EFFECT; SINUS RHYTHM; SINUS TACHYCARDIA; SUDDEN DEATH; SYNCOPE; TRANSTELEPHONIC ELECTOCARDIOGRAM; TREATMENT DURATION; TREATMENT RESPONSE;

AGED; ANTI-ARRHYTHMIA AGENTS; ATRIAL FIBRILLATION; BEPRIDIL; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; ELECTROCARDIOGRAPHY; ENDPOINT DETERMINATION; FEMALE; HEART RATE; HUMANS; MALE; MIDDLE AGED; MONITORING, PHYSIOLOGIC; QUALITY OF LIFE; RECURRENCE; TELECOMMUNICATIONS; TREATMENT OUTCOME;

EID: 67649874721     PISSN: 13469843     EISSN: 13474820     Source Type: Journal    
DOI: 10.1253/circj.CJ-08-1061     Document Type: Article

References (32)

1. Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: The Framingham Heart Study. Circulation 1998; 8: 946-952. (Pubitemid 28446646)
2. Vidaillet H, Granada JF, Chyou PH, Maassen K, Ortiz M, Pulido JN, et al. A population-based study of mortality among patients with atrial fibrillation or flutter. Am J Med 2002; 113: 365-370. (Pubitemid 35223607)
3. Krahn AD, Manfreda J, Tate RB, Mathewson FA, Cuddy TE. The natural history of atrial fibrillation: Incidence, risk factors, and prognosis in the Manitoba Follow-Up Study. Am J Med 1995; 98: 476-484.
4. Le Heuzey JY, Paziaud O, Piot O, Said MA, Copie X, Lavergne T, et al. Cost of care distribution in atrial fibrillation patients: The COCAF study. Am Heart J 2004; 147: 121-126. (Pubitemid 38037407)
5. Stewart S, Murphy NF, Walker A, McGuire A, McMurray JJ. Cost of an emerging epidemic: An economic analysis of atrial fibrillation in the UK. Heart 2004; 90: 286-292. (Pubitemid 38250721)
6. Ohsawa M, Okayama A, Sakata K, Kato K, Itai K, Onoda T, et al. Rapid increase in estimated number of persons with atrial fibrillation in Japan: An analysis from national surveys on cardiovascular diseases in 1980, 1990 and 2000. J Epidemiol 2005; 15: 194-196.
7. Inoue H, Fujiki A, Origasa H, Ogawa S, Okumura K, Kubota I, et al. Prevalence of atrial fibrillation in the general population of Japan: An analysis based on periodic health examination. Int J Cardiol 2008 (in press).
8. Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, et al. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med 2002; 347: 1825-1833. (Pubitemid 35417773)
9. Van Gelder IC, Hagens VE, Bosker HA, Kingma JH, Kamp O, Kingma T, et al. A comparison of rate control and rhythm control in patients with recurrent persistent atrial fibrillation. N Engl J Med 2002; 347: 1834-1840. (Pubitemid 35417774)
10. Ogawa S, Yamashita T, Yamazaki T, Aizawa Y, Atarashi H, Inoue H, et al. Optimal treatment strategy for patients with paroxysmal atrial fibrillation: J-RHYTHM Study. Circ J 2009; 73: 242-248.
11. AFFIRM First Antiarrhythmic Drug Substudy Investigators. Maintenance of sinus rhythm in patients with atrial fibrillation: An AFFIRM substudy of the first antiarrhythmic drug. J Am Coll Cardiol 2003; 42: 20-29. (Pubitemid 36763590)
12. Yatani A, Brown AM, Schwartz A. Bepridil block of cardiac calcium and sodium channels. J Pharmacol Exp Ther 1986; 237: 9-17. (Pubitemid 16116336)
13. Cohen CJ, Spires S, Van Skiver D. Block of T-type Ca channels in guinea pig atrial cells by antiarrhythmic agents and Ca channel antagonists. J Gen Physiol 1992; 100: 703-728.
14. Kamiya K, Kodama I, Lu Z. Effects of Bepridil on Ikr and Iks of rabbit ventricular myocytes. Environment Med 2002; 46: 95-97.
15. Kobayashi S, Reien Y, Ogura T, Saito T, Masuda Y, Nakaya H. Inhibitory effect of Bepridil on hKv1.5 channel current: Comparison with Amiodarone and E-4031. Eur J Pharmacol 2001; 430: 149-157. (Pubitemid 33050033)
16. Berger F, Borchard U, Hafner D. Effects of the calcium entry blocker Bepridil on repolarizing and pacemaker currents in sheep cardiac Purkinje fibres. Naunyn Schmiedebergs Arch Pharmacol 1989; 339: 638-646. (Pubitemid 19159821)
17. Hara Y, Nakaya H. SD-3212, a new class I and IV antiarrhythmic drug: A potent inhibitor of the muscarinic acetylcholine-receptor-operated potassium current in guinea-pig atrial cells. Br J Pharmacol 1995; 116: 2750-2756.
18. Sato T, Costa AD, Saito T, Ogura T, Ishida H, Garlid KD, et al. Bepridil, an antiarrhythmic drug, opens mitochondrial KATP channels, blocks sarcolemmal KATP channels, and confers cardioprotection. J Pharmacol Exp Ther 2006; 316: 182-188. (Pubitemid 41832595)
19. Perelman MS, McKenna WJ, Rowland E, Krikler DM. A comparison of Bepridil with Amiodarone in the treatment of established atrial fibrillation. Br Heart J 1987; 58: 339-344. (Pubitemid 17152512)
20. Fujiki A, Tsuneda T, Sugao M, Mizumaki K, Inoue H. Usefulness and safety of Bepridil in converting persistent atrial fibrillation to sinus rhythm. Am J Cardiol 2003; 92: 472-475. (Pubitemid 36959891)
21. Miyaji K, Tada H, Fukushima Kusano K, Hashimoto T, Kaseno K, Hiramatsu S, et al. Efficacy and safety of the additional Bepridil treatment in patients with atrial fibrillation refractory to class I antiarrhythmic drugs. Circ J 2007; 71: 1250-1257. (Pubitemid 47195342)
22. Fujiki A, Tsuneda T, Sakabe M, Nakagawa K, Mizumaki K, Hirai T, et al. Maintenance of sinus rhythm and recovery of atrial mechanical function after cardioversion with Bepridil or in combination with aprindine in long-lasting persistent atrial fibrillation. Circ J 2004; 68: 834-839. (Pubitemid 39243804)
23. Nakazato Y, Yasuda M, Sasaki A, Iida Y, Kawano Y, Nakazato K, et al. Conversion and maintenance of sinus rhythm by Bepridil in patients with persistent atrial fibrillation. Circ J 2005; 69: 44-48.
24. Fujiki A, Sakamoto T, Iwamoto J, Nishida K, Nagasawa H, Mizumaki K, et al. Pharmacological cardioversion of persistent atrial fibrillation with and without a history of drug-resistant paroxysmal atrial fibrillation. Circ J 2006; 70: 1138-1141. (Pubitemid 44386993)
25. Yamashita T, Kumagai K, Koretsune Y, Mitamura H, Okumura K, Ogawa S, et al. A new method for evaluating quality of life specific to patients with atrial fibrillation: Atrial fibrillation Quality of Life Questionnaire (AFQLQ). Jpn J Electrocardiol 2003; 23: 332-343 (in Japanese).
26. Yamashita T, Komatsu T, Kumagai K, Uno K, Niwano S, Fijiki A, et al. Internal consistency and reproducibility of Atrial fibrillation Quality of Life Questionnaire (AFQLQ). Jpn J Electrocardiol 2005; 25: 488-494 (in Japanese).
27. Yamashita T, Ogawa S, Aizawa Y, Atarashi H, Inoue H, Ohe T, et al on behalf of the J-RHYTHM Investigators. Investigation of the optimal treatment strategy for atrial fibrillation in Japan: The JRHYTHM (Japanese Rhythm Management Trial for Atrial Fibrillation) Study design. Circ J 2003; 67: 738-741. (Pubitemid 37071231)
28. Fukuhara S, Suzukamo Y. Manual of SF-36v2™ Japanese version. Tokyo: Pubtic Health Research Foundation, 2004.
29. Ohsawa M, Tanaka F, Kunugita F, Saito H, Nakamura M, Shiroto T, et al. A case of sick sinus syndrome that developed torsades de pointes, pacing failure and sensing failure during administration of Bepridil. Jpn Heart J 2003; 44: 783-788. (Pubitemid 41518979)
30. Gaku S, Naoshi K, Teruhiko A. A case of Bepridil induced interstitial pneumonitis. Heart 2003; 89: 1415. (Pubitemid 37465237)
31. Yasuda M, Nakazato Y, Sasaki A, Kawano Y, Nakazato K, Tokano T, et al. Clinical evaluation of adverse effects during Bepridil administration for atrial fibrillation and flutter. Circ J 2006; 70: 662-666. (Pubitemid 43797774)
32. Suzuki S, Yamashita T, Ohtsuka T, Sagara K, Uejima T, Oikawa Y, et al. Prevalence and prognosis of patients with atrial fibrillation in Japan: A prospective cohort of Shinken Database 2004. Circ J 2008; 72: 914-920.