TREATMENT OF ATRIAL-FIBRILLATION AND PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA WITH BIDISOMIDE

Authors
KOREN MJ BUDA C HENRY W ELLISON WT MILAS JM MORGAN M SPRINKLE L MCGREEVY MJ GOLDBERG RK GERRY S BARRETT M CONNOLLY S MORRISON L ABRAHAMSON DC SOMOGYI C WEISS RJ ABISALIH DN RIDLEY C BROWNE KF MCGOWAN N HARIMAN RJ TULLY M BISSETT J MAY R HEYWOOD JT FABBRI S CRAWFORD W PLATT M BRAMLET D MORGAN C DILLON MC ROARK S MARQUIS N PAGE RL CANBY RC HORTON RP ASH G SHETTIGAR UR BARBIER G APPUNN D LEONELLI F MCFARLAND T RAJKOVICH K PRITCHETT ELC TORMEY MA WALKER JL CARLEY JE TRACY DM ANDERSON JL KARAGOUNIS LA SUMMERS K BARKER AH FOWLES RE PREECE MJ DORAN EN ROY D TALAJIC M DUBUC M BEAUDOIN D FUJIMURA O ACERON D ONUFER J BARCIANO R CAMERON D WELLER B DREHOBL M BRODKIN J JOSWIG B BARKER M SCHU D KREMERS MS WHISNANT D LURIE M BRINKLEY A POLLAK SJ NICHOLLS S BLOOMFIELD D DESTEFANO M KING N GERIS B GREEN M TANG ASL LUCE M ELSHAHAWY M WAGNER M RUDGE J STEINBERG JS TAN E YEE R KLEIN GJ BRANEY M BACKES R MILLER K BRANCO M MYERS D SUGGS T SHAH A HEUS B TRIZZINO C GROSSMAN WJ FLETCHER K LOH IK SMITH C DEGENNARO K SINGER I CICIC A LANGAN MN GOMES JA MEHTA D PE E SAGER PT PLOSS D ATTIN M LUEKEN M GRAY RJ CHELLIAH NN HAGEN K CARTER D GRAY C CURTIS AB CONTI JB SALVETTI L SHELDON R RITCHIE D ELLENBOGEN K WOOD MA MICHAELS N HALL JH FAUSSET D LINDEN P SCHULMAN C GERSHENGORN K SALTZ S KINSMAN E JACOBSON K LITTELL F MOSSBERG J DAUW K KARLSBERG RP GEREZ T TOBIS FM RASMUSSEN E CARLSON M WALKER B SILVERMAN B BANASIK S RUBIN M BUSCH J HACK TC CRIASIA M FLOREK R HAMLIN M FRIEDMAN J DINNING A MISALJEVIC Y KELLER M TRAJILLO N ANDERSON D WAGSHAL A ROFINO K MOTTA M BLOCK LS WISTRAN DC GROGAN EW SOMMERFELDT B ROTHROCK D BARON S STEDFIELD S SWENSON L GILBERT B BERNSTEIN V KERR C MACDONALD K MOONEY S BILSKER MS KAMERMAN M BRADLEY J PEACOCK T CHEN PS GOODMAN JS PETER CT SCHOENBAUM M CONTE S CURLEE P BOOKER R DICARLO LA KAPPLER JH WINSTON SA ADOLPHSON M HENTHORN R LIPPS J IBANEZ K JOHNSON WB POLICH M MARTIN DT WOODHEAD G MOORE SL MISHAK S MANHOLT S NOLL HE KELLEY JG PERLMAN R GUIDO J STAMBLER B SARGENT D STEIN J WILLIS R STOEVER WW COTHAM P MASON K GABER J WINTERS SL CURWIN JH BANAS JS ENRIGHT LJ BRODSKY M CHAIM S CARLSON H FURKA E DAUBERT J AKIYAMA T FLYNN D OCAMPO C ERDIN RA HEIGES TA KADEL K STUCKY ED RITTENHOUSE M MCANULTY J TIMBERG J MCNEER JF SMITH B MURRAY KT NORRIS K EDGETT C SORENSON JL ADELMAN B STONER D OFFENBERG H ARNOW L THIND G FAUGHN C WILLIAMS D HENDRICKS E FRIEDMAN B PAYNE W FUENZALIDA CE WASHAM M HEINSIMER J LENTINI MG WEINBERG DM FOX C MCCOWN R COOK FS ODONOGHUE S FENTON J CHUNG M KIDWELL GA JAEGER FJ HOLMES DR MORANT VA TROHMAN RG WILKOFF BL PINSKI SL TCHOU PJ HOLMES D KERIN NZ FAITEL K STAMATO NJ WHITING D BHALLA RK HICKS T BIANCHI P HAMILTON W CHILSON D BAXTER J CONTRAFATTO DS AFSHARI D GUARNIERI T BOLDERMAN K MARGOLIS PD DURHAM J MARTIN HM WAYAND CE MCGREW F WILSON B NADEMANEE K SMITH S SHARMA A ONEILL G SKADSEN A WARE D MALMBERG G WILSON M BEDNARCZYK E BATESON M ZINN PD ROBLES E CULLORS D CROSSLEY G DAVISOBRIEN K FRISHMAN WH ROOT L BLANCO B FURIA S GOODMAN L JONESLANIER S KOCHERIL A WINECOFF A PACKER D COSBERG K BARBEY JT HEWETTMEULMAN J WERTHEIMER J FIERSTEIN J BENENE C HURWITZ J ALEXANDER L WIMBERLY B OVERWEG N MEJIA V PACIFICO A FARRELL M STEINMAN R VALMEJIAS J PATTERSON P WILSON J ENRIGHT L DYCKMAN E HARRIS B RAINES P PAUL T BLACKMAN T PORTERFIELD JG PORTERFIELD LM ROTH J VAGNONI J
Citation
Mj. Koren et al., TREATMENT OF ATRIAL-FIBRILLATION AND PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA WITH BIDISOMIDE, Circulation, 96(8), 1997, pp. 2625-2632
Citations number
18
Categorie Soggetti
Peripheal Vascular Diseas",Hematology
Journal title
Circulation → ACNP
ISSN journal
00097322
Volume
96
Issue
8
Year of publication
1997
Pages
2625 - 2632
Database
ISI
SICI code
0009-7322(1997)96:8<2625:TOAAPS>2.0.ZU;2-U
Abstract
Background Atrial fibrillation and paroxysmal supraventricular tachyca rdia are common disorders of the heart rhythm for which antiarrhythmic drug therapy is commonly prescribed. The Atrial Fibrillation Investig ation with Bidisomide (AFIB) study was a randomized, placebo-controlle d clinical trial designed to accomplish three goals in a single protoc ol: (1) to determine the efficacy of the antiarrhythmic drug bidisomid e in the treatment of these two arrhythmias; (2) to establish the appr opriate dose range for bidisomide; and (3) to detect an adverse mortal ity effect of bidisomide if one were present in patients with atrial f ibrillation. Methods and Results In this clinical trial, 1227 patients with atrial fibrillation and 187 with paroxysmal supraventricular tac hycardia were randomly assigned to bidisomide (200, 400, or 600 mg BID ) or placebo; patient groups with each arrhythmia were analyzed separa tely. Symptomatic recurrences of atrial fibrillation and paroxysmal su praventricular tachycardia were documented with the use of transteleph onic ECG monitoring. The time to the first symptomatic arrhythmia recu rrence was measured in each patient and compared among treatment group s. Among the atrial fibrillation patients, there was no significant di fference in the time to first symptomatic recurrence between the place bo group and any of the three bidisomide treatment groups; the hazard ratios (placebo:treatment) were 1.19, 1.03, and 1.14 for bidisomide 20 0, 400, and 600 mg BID, respectively. Among paroxysmal supraventricula r tachycardia patients, there was a similar lack of a significant trea tment effect; the hazard ratios were 1.30, 1.93, and 1.59 for bidisomi de 200, 400, and 600 mg BID, respectively. In the primary safety analy sis of mortality, 3 of 493 patients taking placebo died, compared with 9 of 488 patients taking one of the two higher doses of bidisomide (P >.10). Conclusions Bidisomide in the doses tested did not have a clini cally important antiarrhythmic effect. The AFIB study provided a novel clinical trial design to test antiarrhythmic drugs for both safety an d efficacy.