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Circulation. 2011 Dec 13;124(24):2649-60. doi: 10.1161/CIRCULATIONAHA.111.072561. Epub 2011 Nov 14.

Efficacy and safety of celivarone, with amiodarone as calibrator, in patients with an implantable cardioverter-defibrillator for prevention of implantable cardioverter-defibrillator interventions or death: the ALPHEE study.

Collaborators (712)

Kowey PR, Aliot EM, Capucci A, Connolly SJ, Crijns HJ, Hohnloser SH, Kulakowski P, Roy D, Singh BM, Seltzer J, Knight BP, Kadish AH, Smith A, Crijns HJ, Blaauw J, Van Opstal J, Vernooy K, Van Empel V, Smid-Ter Bekke R, Guedon L, Kouakam C, Sadoul N, Blangy H, Freysz L, Mabo P, Leclercq C, Giniger A, Albina G, Sammartino V, Reyes I, Manzolillo H, Pantich R, Ruveda SM, Pozzer DL, Aguinaga L, Paterlini G, Edouardo H, Veronica L, Hill J, Yeshwant S, Butterly S, Indrajith M, Cox S, Perel R, Finn H, Heddle W, Burdeniuk C, Singleton C, McGavigan A, Benjamin P, Robert M, Judd J, Martin P, Ange N, Chao CY, Preston S, Camuglia A, Starmer G, Hillier S, Hunter J, Arumugam D, Perel R, Gomes RF, Pavia S, Pearson A, Armstrong CG, Paul V, Catanchin A, Shah A, Stoyanov N, Yeow W, Gattorna T, Stobie P, Cooke P, Di Camillo C, Thompson A, Anderson H, Ng J, Camuglia A, Starmer G, Hillier S, Hunter J, Leitch J, Barlow M, Collins N, William M, Choong WP, Wilsmore B, Wong T, Renganathan T, Jackson N, Bradley J, Mahar L, Worthley M, Worthley S, Ashby D, Tan R, McGill D, Kilborn M, Ilsar R, Brugada IT, Chierchia GB, De Asmundis C, Sarkozy A, Leroy J, Hausman P, Goethals M, Pollet P, Vijgen J, Dilling-Boer D, Geelen P, De Potter T, Peytchev P, Tavernier R, Duytschaever M, Vandekerckhove C, Coutu B, Costi P, Greiss I, Raymond JM, Mansour F, Santagata P, Dorian P, Ahmad K, Al-Hesaniah S, Korley V, Mangat I, Pinter A, Van Herendael H, Van Der Akker-Bermane L, Klein G, Leong-Sit P, Skanes A, Krahn A, Gula L, Yee R, Champagne J, O'Hara G, Blier L, Nault I, Molin F, Philippon F, Sarrazin JF, Marcel G, Kerr C, Chakrabarti S, Tung S, Yeung-Lai-Wah J, Bennet M, Sterns L, Agarwal S, Ayou R, Cromie N, Jones M, Leather R, Novak P, Sultan O, Tang A, Talajic M, Dubuc M, Gagné P, Macle L, Denis R, Bernard T, Paul K, Peter G, Léna R, Mitchell L, Duff H, Exner D, Gillis A, Kavanagh K, Quinn R, Sheldon R, Sumner G, Veenhuyzen G, Divakaramenon S, Connolly S, Healey J, Mirillo C, Nair G, Asenjo R, Cereceda M, Herrera E, Morris R, Kucera P, Belza T, Polasek R, Tousek F, Karpianus D, Osmera O, Rehouskova K, Heinc P, Doupal V, Fedorco M, Novak M, Dvorak I, Lipoldova J, Vykypel T, Parizek P, Haman L, Tauchman M, Sediva L, Janotka M, Petru J, Brandes A, Nielsen J, Kirkfeldt R, Johannessen A, Thomsen PE, Svendsen J, Køber L, Ersbøll M, Hassager C, Larsen L, Toivonen L, Lehto M, Pakarinen S, Virtanen V, Inkovaara J, Mäkynen H, Raatikainen P, Le Heuzey JY, Fiorina L, Marijon E, Davy JM, Cung TT, Pasquie JL, Raczka F, Aliot E, Blangy H, Sadoul N, Zinzius PY, Blanc JJ, Fatemi M, Kacet S, Guedon-Moreau L, Kouakam C, Marquie C, Defaye P, Jacon P, Mondesert B, Cassagneau R, Mabo P, Bodi S, Grezis SG, Leclercq C, Pavin D, Solnon A, Hohnloser S, Duray G, Ehrlich J, Fink A, Kaluzny M, Ercapic D, Schmitt J, Butter C, Möller V, Spitzer S, Károlyi L, Winkler J, Schumacher B, Barth S, Barth S, Langbein A, Willems S, Aydin A, Servatius H, Wilke I, Faluközy J, Masszi J, Lupkovics G, Lupkovics G, Németh B, Sztaniszláv A, Tomcsányi J, Nényei Z, Toldy-Schedel E, Simor T, Melczer L, Ruzsics B, Viskin S, Rogowski O, Rosso R, Steinvil A, Zeltser D, Freedberg N, Antonelli D, Feldman A, Peres D, Katz A, Fishman E, Khalameizer V, Samniah N, Hamoud M, Glikson M, Padeletti L, Michelucci A, Perrotta L, Pieragnoli P, Porciani C, Ricciardi G, Botto G, Mariconti B, Russo G, Favale S, Catucci S, Luzzi G, Nacci F, Palmisano P, Quadrini F, Calò L, De Ruvo E, Fagagnini A, Sciarra L, Zuccaro LM, Mascioli G, Bakhtadze N, Belvito C, Borrelli A, Lucca E, Kurita T, Akaiwa Y, Hirota T, Motoki K, Yasuoka R, Kamakura S, Aiba T, Aihara N, Noda T, Okamura H, Satomi K, Shimizu W, Suyama K, Yamada Y, Hagiwara N, Ejima K, Manaka T, Sato T, Serizawa N, Shiga T, Shoda M, Suzuki A, Suzuki T, Yagishita D, Sugi K, Ito N, Kujime S, Nakamura K, Noro M, Numata A, Sakata T, Aizawa Y, Furushima H, Aizawa Y, Furushima H, Hosaka Y, Izumi D, Fujii K, Date M, Higuchi Y, Imai M, Inoue K, Ito N, Iwakura K, Kimura R, Kurotobi T, Masuda M, Morisawa D, Nagai H, Nakatani S, Okamura A, Okazaki Y, Omiya S, Ozawa M, Shibuya M, Sotomi Y, Takagi T, Toyoshima Y, Colin L, Morales J, Kimman G, Ruiter J, Alings A, Simmers T, Crijns H, Limantoro I, Moens A, Pisters R, Weijs B, Blaauw Y, Kietselaer B, Ramdat Misier A, Elvan A, Ghani A, Rik H, Khan M, Henriks A, Sepehrkhouy S, Vos N, Herrman J, De Ruiter G, Jordaens L, De Groot N, Haitsma D, Szili-Torok T, Van Belle Y, Gjertsen E, Tøssebro M, Falang JE, Kulakowski P, Czepiel A, Makowska E, Swiatkowski M, Kornacewicz-Jach Z, Kazmierczak J, Wielusinski M, Drozdz J, Jakubowski P, Kaczmarek K, Oszczygiel A, Piestrzeniewicz K, Rosiak M, Lubinski A, Binkowski B, Bissinger A, Kubinski P, Kubica J, Fabiszak T, Stolarz P, Grabowski M, Steckiewicz R, Miekus P, Dulak E, Konarzewski M, Cunha P, Feliciano J, Olveira M, Almeida Santos S, Providencia L, António N, Mendes P, Monteiro P, Saraiva F, Teixeira R, Elvas L, Primo J, Adão L, Gonçalves H, Oliveira M, Shubik Y, Rivin A, Veleslavova O, Popov S, Antonchenko I, Batalov R, Krivolapov S, Berns S, Barbarash O, Gorbunova E, Kazachek Y, Khomenko E, Mikhailov S, Kireev K, Ostern O, Pyrov S, Bulatov D, Tsepennikova N, Gizatulina T, Zinin M, Kazantseva A, Duplyakov D, Mitronin A, Zemlyanova M, Novikova T, Zavaritskaya O, Perchatkin D, Sautova E, Hatala R, Hatalova K, Urban L, Stancak B, Misikova S, Olexa P, Ebrahim I, Badenhorst J, Blomerus P, Mont L, Tolosana JM, Sabaté X, Anguera I, Merino J, Cozar R, Peinado R, Pérez Silva A, Moreno Reviriego S, Fernández Lozano I, Castro V, Toquero J, Ros N, Garcia Seara FJ, Olague J, Sancho-Tello MJ, Osca J, Cano O, Diaz-Infante E, Cruz Fernández JM, Blomström-Lundqvist C, Blomström P, Lönnerholm S, Malmborg H, Mörtsell D, Ostrowska B, Sciaraffi E, Teder P, Kjellman B, Olson J, Kesek M, Rönn F, Wecke L, Ozin B, Atar I, Cakmak A, Turk E, Karabulut A, Kececi E, Adalet K, Atun I, Bilge A, Yalin K, Turkoglu C, Aliyev F, Karakozak D, Turhan N, Burton ME, Chazal R, Bounds D, Cannon L, Overton N, Levanovich P, Clark D, Macdonell A, Cossu S, Connelly T, Malone M, Dinerman J, Allison S, Tabereaux P, Drenning D, Gessler C, Haught WH, Vasquez A, Strickland W, Cheng SC, Engel G, Winkle R, Mead R, Smith N, Patrawala R, Good E, Pelosi F, Chugh A, Bogun F, Jongnarangsin K, Crawford T, Guguchev P, Filart R, Duran A, Alvarez L, Gupta D, Gupta R, Kamykowski P, Herre J, Bernstein R, Hobson J, Walsh R, Kaplan A, Ambrosia A, Kramer N, Wiles B, Skloven ZD, Kappler J, Shinn T, Han J, Greenstein R, Winston S, Kwasman M, Muelheims G, Goldberg HR, Lakkireddy D, Berenbom L, Dendi R, Emert M, Pimental R, Lee J, Brodine W, Christensen K, Sun D, Tung R, Leman R, Cuoco F, Gold M, Sturdivant JL, Clarke E, Adams A, Schulz M, Chilson D, Lessmeier T, Eteri B, Love J, Langburd L, Corsello A, Miller HM, Field M, Nadar V, Lewin S, Man D, Safwat AG, Onofer J, Woollett I, Hagan E, Dryer J, McMeekin J, Pires L, Hassan S, Sandler D, Cameron C, Cogert G, Sangrigoli R, Smith DL, Guarino JC, Boland DG, Sangrigoli RA, McGarvey J Jr, Gejer E, Grzywacz F, Harding JD, Chinitz L, Bernaski E, Aizer A, Holmes D, Morlote M, Bernstein N, Su W, Heuser R, Rhee E, Tung-Takher N, Thal S, Goldman S, Thai H, Juneman E, Movahed M, Yesenosky G, Trabachino S, Garibian G, Chough S, Nora M, O'Toole M, Kawasaki R, Saleem M, Gami A, Cash C, Kron J, Stecker E, Stajduhar K, Caruso A, Ngo M, Olsovsky M, Blonder R, Mikaelian B, Kuwana M, Greenberg D, Bedwell N, Alford C, Brown C, Hardy W, LeDoux J, Cardona F, Wassmer P, McGee T, Akers L, Beshai J, Burke M, Shah D, Weisberg I, Baez-Escudero J, Sherry D, Moyer D, O'Keefe L, Blanck Z, Teixeira J, Deraad R, Walder J, Pierce D, Backus N, Baird J, Boyer J, Brown D, Elliott J, Fairlamb J, Gallaway S, Hulett J, Kennett J, Klein D, Lucas J, Lutz K, Ravipudi S, Spaedy T, Tran T, Woods W, Jackson B, Kim G.

Abstract

BACKGROUND:

Celivarone is a new antiarrhythmic agent developed for the treatment of ventricular arrhythmias. This study investigated the efficacy and safety of celivarone in preventing implantable cardioverter-defibrillator (ICD) interventions or death.

METHODS AND RESULTS:

Celivarone (50, 100, or 300 mg/d) was assessed compared with placebo in this randomized, double-blind, placebo-controlled, parallel-group study. Amiodarone (200 mg/d after loading dose of 600 mg/d for 10 days) was used as a calibrator. A total of 486 patients with a left ventricular ejection fraction ≤40% and at least 1 ICD intervention for ventricular tachycardia or ventricular fibrillation in the previous month or ICD implantation in the previous month for documented ventricular tachycardia/ventricular fibrillation were randomized. Median treatment duration was 9 months. The primary efficacy end point was occurrence of ventricular tachycardia/ventricular fibrillation-triggered ICD interventions (shocks or antitachycardia pacing) or sudden death. The proportion of patients experiencing an appropriate ICD intervention or sudden death was 61.5% in the placebo group; 67.0%, 58.8%, and 54.9% in the celivarone 50-, 100-, and 300-mg groups, respectively; and 45.3% in the amiodarone group. Hazard ratios versus placebo for the primary end point ranged from 0.860 for celivarone 300 mg to 1.199 for celivarone 50 mg. None of the comparisons versus placebo were statistically significant. Celivarone had an acceptable safety profile.

CONCLUSIONS:

Celivarone was not effective for the prevention of ICD interventions or sudden death.

CLINICAL TRIAL REGISTRATION:

http://www.clinicaltrials.gov. Unique identifier: NCT00993382.

[Indexed for MEDLINE]
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