Valsartan for prevention of recurrent atrial fibrillation (New England Journal of Medicine (2009) 360, (1606-1617))

Delise, P.; Bertocchi, F.; Maiocchi, G.; Geraci, E.; Correale, E.; Lombardi, F.; Mugelli, A.; Urso, R.; Scardi, S.; Fabbri, G.; Bartolomei, B.; Barbato, G.; Carbonieri, E.; Ciricugno, S.; Cosmi, F.; Pratola, C.; Rossi, M.G.; Sciarra, L.; Zeni, P.; Ceseri, M.; Atzori, A.; Bambi, F.; Baviera, M.; Bianchini, F.; Fenicia, E.; Gianfriddo, M.; Lonardo, G.; Luise, A.; Nota, R.; Orlando, M.E.; Petrolo, R.; Pierattini, C.; Pierota, V.; Ragno, A.; Serio, C.; Tafi, A.; Tellaroli, E.; Masson, S.; Vago, T.; Gramenzi, S.; Orso, F.; Suliman, I.; Nicolis, E.; Casola, C.; Dall'Osso, D.; Gorini, M.; Bianchini, E.; Cabiddu, S.; Cangioli, I.; Carnaghi, A.; Cipressa, M.L.; Cipressa, L.; Galbiati, L.; Lorimer, A.; Priami, P.; Moccetti, T.; Vaghi, F.; Capello, A.F.; Rossetti, G.; Viada, E.; Morena, L.; Delucchi, M.; Reynaud, S.G.; Allemano, P.; Massobrio, N.; Gavazzi, A.; Taddei, F.; Mor, D.A.; Bortolini, F.; Lorini, M.; Inama, G.; Durin, O.; Pirelli, S.; Spotti, A.; Procopio, R.; Cuzzucrea, D.; Gentile, G.; Margonato, A.; Bassanelli, G.; Tavazzi, L.; Buzzi, M.P.; Rordorf, R.; Gualco, A.; Opasich, C.; Gronda, E.; Genovese, L.; Mattioli, R.; Donatelli, F.; Uriarte, J.A.; Rauhe, W.; Bertagnolli, C.; Canestrini, S.; Stefenelli, C.; Cioffi, G.; Giovanelli, C.; Rigatelli, G.; Boni, S.; Pasini, A.; Sitta, N.; Sacchetta, A.; Borgese, L.; Sciascia, R.; Targa, L.; Raviele, A.; Madalosso, M.; Bertaglia, E.; Zoppo, F.C.; Capanna, M.; Fiorencis, R.; Baracca, E.; Rossi, R.; Rossi, I.; Trappolin, R.; Morgera, T.; Barducci, E.; Baldin, M.G.; Gobbo, G.; Zardo, F.; Hrovatin, E.; Mos, L.; Vriz, O.; Sinagra, G.; Aleksova, A.; Mazzone, C.; Fresco, C.; Rubartelli, P.; Moroni, L.A.; Camerieri, A.; Piana, M.; Mureddu, R.; Bertoli, D.; Petacchi, R.; Pancaldi, L.G.; Gabrieli, L.; Urbinati, S.; Pedone, C.; Di Niro, M.; Brunelli, A.; Bosi, S.; Censi, S.; Moruzzi, P.; Pastori, P.; Modena, M.G.; Malavasi, V.; Mezzetti, M.; Melandri, F.; Zuppiroli, A.; Fazi, A.; Testa, R.; Venturini, E.; Mazzinghi, F.; Cosmi, D.; Santoro, G.M.; Minneci, C.; Galli, M.; Paperini, L.; Bovenzi, F.M.; Cortigiani, L.; Cocchieri, M.; Severini, D.; Arcuri, G.M.; Bagliani, G.; Bernardinangeli, M.; Proietti, G.; Bocconcelli, P.; Pierantozzi, A.; Monti, F.; Giamundo, L.; Tancredi, P.; Rossini, E.; Bianchi, C.; Bettiol, F.; Giovannini, E.; Fera, M.S.; Santini, M.; Bianconi, L.; Boccanelli, A.; Morosetti, P.; Volpe, M.; Facciolo, C.; Vacri, A.; Romanazzi, F.; Napoletano, C.; Piccioni, L.L.; Candelmo, F.; De Marco, G.; Arnese, M.R.; Vetrano, A.; Prinzi, D.; De Rosa, P.; Capuano, V.; Torre, S.; D'Onofrio, A.; Ammendola, E.; Chiariello, M.; Filardi, P.; Battista, R.; De Fusco, A.; Molero, U.; Iervoglini, A.; Stefanelli, S.; Fattore, L.; Bosco, B.; Liguori, A.; Padula, G.; De Luca, I.; Sorino, M.; Colonna, P.; D'Agostino, C.; Pierfelice, O.; Pettinati, G.; Muscella, A.; De Lorenzi, E.; Falco, M.; Giannattasio, C.; Baldi, N.; Clemente, M.A.; D'Alessandro, B.; Truncellito, L.; Arabia, F.; Ciconte, V.A.; Perticone, F.; Ruberto, C.; Buffon, A.; Tomaselli, C.; De Rosa, F.; Mazza, S.; Zampaglione, G.; Pirozzi, A.M.; Butera, A.; Levato, M.; Musacchio, D.; Polimeni, R.M.; Lacquaniti, V.; Pulitano, G.; Ruggeri, A.; Provenzano, A.; Cuccurullo, O.; Musolino, M.; Marrari, A.; Anastasio, L.; Schiavello, M.; Comito, M.G.; Gulizia, M.M.; Francese, G.M.; Vasquez, L.; Coppolino, C.; Casale, A.; D'Urso, G.; Oliva, G.; Giordano, U.; Andolina, S.; Sanfilippo, N.; Ingrilli, F.; Accardo, S.; Grasso, S.; Buffa, L.; Serra, E.; Disertori, M.; Latini, R.; Barlera, S.; Franzosi, M.G.; Staszewsky, L.; Maggioni, A.P.; Lucci, D.; Di Pasquale, G.; Tognoni, G.

Atrial fibrillation is the most common cardiac arrhythmia, and no current therapy is ideal for control of this condition. Experimental studies suggest that angiotensin II-receptor blockers (ARBs) can influence atrial remodeling, and some clinical studies suggest that they may prevent atrial fibrillation. We conducted a large, randomized, prospective, placebo-controlled, multicenter trial to test whether the ARB valsartan could reduce the recurrence of atrial fibrillation. We enrolled patients who were in sinus rhythm but had had either two or more documented episodes of atrial fibrillation in the previous 6 months or successful cardioversion for atrial fibrillation in the previous 2 weeks. To be eligible, patients also had to have underlying cardiovascular disease, diabetes, or left atrial enlargement. Patients were randomly assigned to receive valsartan or placebo. The two primary end points were the time to a first recurrence of atrial fibrillation and the proportion of patients who had more than one recurrence of atrial fibrillation over the course of 1 year. A total of 1442 patients were enrolled in the study. Atrial fibrillation recurred in 371 of the 722 patients (51.4%) in the valsartan group, as compared with 375 of 720 (52.1%) in the placebo group (adjusted hazard ratio, 0.97; 96% confidence interval [CI], 0.83 to 1.14; P=0.73). More than one episode of atrial fibrillation occurred in 194 of 722 patients (26.9%) in the valsartan group and in 201 of 720 (27.9%) in the placebo group (adjusted odds ratio, 0.89; 99% CI, 0.64 to 1.23; P=0.34). The results were similar in all predefined subgroups of patients, including those who were not receiving angiotensin-converting-enzyme inhibitors. Treatment with valsartan was not associated with a reduction in the incidence of recurrent atrial fibrillation. (ClinicalTrials.gov number, NCT00376272.) MEDLINE Background Atrial fibrillation is the most common cardiac arrhythmia, and no current therapy is ideal for control of this condition. Experimental studies suggest that angiotensin II-receptor blockers (ARBs) can influence atrial remodeling, and some clinical studies suggest that they may prevent atrial fibrillation. Methods We conducted a large, randomized, prospective, placebo-controlled, multicenter trial to test whether the ARB valsartan could reduce the recurrence of atrial fibrillation. We enrolled patients who were in sinus rhythm but had had either two or more documented episodes of atrial fibrillation in the previous 6 months or successful cardioversion for atrial fibrillation in the previous 2 weeks. To be eligible, patients also had to have underlying cardiovascular disease, diabetes, or left atrial enlargement. Patients were randomly assigned to receive valsartan or placebo. The two primary end points were the time to a first recurrence of atrial fibrillation and the proportion of patients who had more than one recurrence of atrial fibrillation over the course of 1 year. Results A total of 1442 patients were enrolled in the study. Atrial fibrillation recurred in 371 of the 722 patients (51.4%) in the valsartan group, as compared with 375 of 720 (52.1%) in the placebo group (adjusted hazard ratio, 0.97; 96% confidence interval [CI], 0.83 to 1.14; P=0.73). More than one episode of atrial fibrillation occurred in 194 of 722 patients (26.9%) in the valsartan group and in 201 of 720 (27.9%) in the placebo group (adjusted odds ratio, 0.89; 99% CI, 0.64 to 1.23; P=0.34). The results were similar in all predefined subgroups of patients, including those who were not receiving angiotensin-converting-enzyme inhibitors. Conclusions Treatment with valsartan was not associated with a reduction in the incidence of recurrent atrial fibrillation. (ClinicalTrials.gov number, NCT00376272 .) Pharma and Biotech Premium PRO In a randomized trial, 1442 patients with a history of atrial fibrillation were assigned to receive either valsartan, an angiotensin II–receptor blocker, or placebo. Antiarrhythmic therapy was administered according to the treating physician's preference. At 1 year, there was no difference between the groups in the rate of either a first recurrence or multiple recurrences of atrial fibrillation. Patients with a history of atrial fibrillation were assigned to receive either valsartan or placebo. At 1 year, there was no difference between the groups in the rate of either a first recurrence or multiple recurrences of atrial fibrillation. Atrial fibrillation is the most common cardiac arrhythmia. 1 – 5 Antiarrhythmic drugs have only moderate efficacy in preventing recurrences of atrial fibrillation and sometimes cause serious adverse reactions. 6 – 8 Ablation is a costly procedure, and accepted indications are limited. 9 , 10 Thus, new approaches to the management of atrial fibrillation continue to be the subject of interest and investigation. Some studies have shown that the recurrence of atrial fibrillation after cardioversion may be partially related to a biologic phenomenon known as remodeling, in which the electrical, mechanical, and structural properties of atrial tissue and cardiac cells are progressively and irreversibly altered, creating . . . Background Atrial fibrillation is the most common cardiac arrhythmia, and no current therapy is ideal for control of this condition. Experimental studies suggest that angiotensin II–receptor blockers (ARBs) can influence atrial remodeling, and some clinical studies suggest that they may prevent atrial fibrillation. Methods We conducted a large, randomized, prospective, placebo-controlled, multicenter trial to test whether the ARB valsartan could reduce the recurrence of atrial fibrillation. We enrolled patients who were in sinus rhythm but had had either two or more documented episodes of atrial fibrillation in the previous 6 months or successful cardioversion for atrial fibrillation in the previous 2 weeks. To be eligible, patients also had to have underlying cardiovascular disease, diabetes, or left atrial enlargement. Patients were randomly assigned to receive valsartan or placebo. The two primary end points were the time to a first recurrence of atrial fibrillation and the proportion of patients who had more than one recurrence of atrial fibrillation over the course of 1 year. Results A total of 1442 patients were enrolled in the study. Atrial fibrillation recurred in 371 of the 722 patients (51.4%) in the valsartan group, as compared with 375 of 720 (52.1%) in the placebo group (adjusted hazard ratio, 0.97; 96% confidence interval [CI], 0.83 to 1.14; P=0.73). More than one episode of atrial fibrillation occurred in 194 of 722 patients (26.9%) in the valsartan group and in 201 of 720 (27.9%) in the placebo group (adjusted odds ratio, 0.89; 99% CI, 0.64 to 1.23; P=0.34). The results were similar in all predefined subgroups of patients, including those who were not receiving angiotensin-converting–enzyme inhibitors. Conclusions Treatment with valsartan was not associated with a reduction in the incidence of recurrent atrial fibrillation. (ClinicalTrials.gov number, NCT00376272 [ClinicalTrials.gov] .) A study was conducted to determine whether administration of angiotensin II-receptor blockers (ARBs) could prevent atrial fibrillation which is a common cardiac arrhythmia. Results revealed that treatment with valsartan did not reduce the incidence of recurrent atrial fibrillation. BACKGROUND Atrial fibrillation is the most common cardiac arrhythmia, and no current therapy is ideal for control of this condition. Experimental studies suggest that angiotensin II-receptor blockers (ARBs) can influence atrial remodeling, and some clinical studies suggest that they may prevent atrial fibrillation. METHODS We conducted a large, randomized, prospective, placebo-controlled, multicenter trial to test whether the ARB valsartan could reduce the recurrence of atrial fibrillation. We enrolled patients who were in sinus rhythm but had had either two or more documented episodes of atrial fibrillation in the previous 6 months or successful cardioversion for atrial fibrillation in the previous 2 weeks. To be eligible, patients also had to have underlying cardiovascular disease, diabetes, or left atrial enlargement. Patients were randomly assigned to receive valsartan or placebo. The two primary end points were the time to a first recurrence of atrial fibrillation and the proportion of patients who had more than one recurrence of atrial fibrillation over the course of 1 year. RESULTS A total of 1442 patients were enrolled in the study. Atrial fibrillation recurred in 371 of the 722 patients (51.4%) in the valsartan group, as compared with 375 of 720 (52.1%) in the placebo group (adjusted hazard ratio, 0.97; 96% confidence interval [CI], 0.83 to 1.14; P = 0.73). More than one episode of atrial fibrillation occurred in 194 of 722 patients (26.9%) in the valsartan group and in 201 of 720 (27.9%) in the placebo group (adjusted odds ratio, 0.89; 99% CI, 0.64 to 1.23; P = 0.34). The results were similar in all predefined subgroups of patients, including those who were not receiving angiotensin-converting-enzyme inhibitors. CONCLUSIONS Treatment with valsartan was not associated with a reduction in the incidence of recurrent atrial fibrillation.

Valsartan for prevention of recurrent atrial fibrillation (New England Journal of Medicine (2009) 360, (1606-1617)) / P. Delise, F. Bertocchi, G. Maiocchi, E. Geraci, E. Correale, F. Lombardi, A. Mugelli, R. Urso, S. Scardi, G. Fabbri, B. Bartolomei, G. Barbato, E. Carbonieri, S. Ciricugno, F. Cosmi, C. Pratola, M.G. Rossi, L. Sciarra, P. Zeni, M. Ceseri, A. Atzori, F. Bambi, M. Baviera, F. Bianchini, E. Fenicia, M. Gianfriddo, G. Lonardo, A. Luise, R. Nota, M.E. Orlando, R. Petrolo, C. Pierattini, V. Pierota, A. Ragno, C. Serio, A. Tafi, E. Tellaroli, S. Masson, T. Vago, S. Gramenzi, F. Orso, I. Suliman, E. Nicolis, C. Casola, D. Dall'Osso, M. Gorini, E. Bianchini, S. Cabiddu, I. Cangioli, A. Carnaghi, M.L. Cipressa, L. Cipressa, L. Galbiati, A. Lorimer, P. Priami, T. Moccetti, F. Vaghi, A.F. Capello, G. Rossetti, E. Viada, L. Morena, M. Delucchi, S.G. Reynaud, P. Allemano, N. Massobrio, A. Gavazzi, F. Taddei, D.A. Mor, F. Bortolini, M. Lorini, G. Inama, O. Durin, S. Pirelli, A. Spotti, R. Procopio, D. Cuzzucrea, G. Gentile, A. Margonato, G. Bassanelli, L. Tavazzi, M.P. Buzzi, R. Rordorf, A. Gualco, C. Opasich, E. Gronda, L. Genovese, R. Mattioli, F. Donatelli, J.A. Uriarte, W. Rauhe, C. Bertagnolli, S. Canestrini, C. Stefenelli, G. Cioffi, C. Giovanelli, G. Rigatelli, S. Boni, A. Pasini, N. Sitta, A. Sacchetta, L. Borgese, R. Sciascia, L. Targa, A. Raviele, M. Madalosso, E. Bertaglia, F.C. Zoppo, M. Capanna, R. Fiorencis, E. Baracca, R. Rossi, I. Rossi, R. Trappolin, T. Morgera, E. Barducci, M.G. Baldin, G. Gobbo, F. Zardo, E. Hrovatin, L. Mos, O. Vriz, G. Sinagra, A. Aleksova, C. Mazzone, C. Fresco, P. Rubartelli, L.A. Moroni, A. Camerieri, M. Piana, R. Mureddu, D. Bertoli, R. Petacchi, L.G. Pancaldi, L. Gabrieli, S. Urbinati, C. Pedone, M. Di Niro, A. Brunelli, S. Bosi, S. Censi, P. Moruzzi, P. Pastori, M.G. Modena, V. Malavasi, M. Mezzetti, F. Melandri, A. Zuppiroli, A. Fazi, R. Testa, E. Venturini, F. Mazzinghi, D. Cosmi, G.M. Santoro, C. Minneci, M. Galli, L. Paperini, F.M. Bovenzi, L. Cortigiani, M. Cocchieri, D. Severini, G.M. Arcuri, G. Bagliani, M. Bernardinangeli, G. Proietti, P. Bocconcelli, A. Pierantozzi, F. Monti, L. Giamundo, P. Tancredi, E. Rossini, C. Bianchi, F. Bettiol, E. Giovannini, M.S. Fera, M. Santini, L. Bianconi, A. Boccanelli, P. Morosetti, M. Volpe, C. Facciolo, A. Vacri, F. Romanazzi, C. Napoletano, L.L. Piccioni, F. Candelmo, G. De Marco, M.R. Arnese, A. Vetrano, D. Prinzi, P. De Rosa, V. Capuano, S. Torre, A. D'Onofrio, E. Ammendola, M. Chiariello, P. Filardi, R. Battista, A. De Fusco, U. Molero, A. Iervoglini, S. Stefanelli, L. Fattore, B. Bosco, A. Liguori, G. Padula, I. De Luca, M. Sorino, P. Colonna, C. D'Agostino, O. Pierfelice, G. Pettinati, A. Muscella, E. De Lorenzi, M. Falco, C. Giannattasio, N. Baldi, M.A. Clemente, B. D'Alessandro, L. Truncellito, F. Arabia, V.A. Ciconte, F. Perticone, C. Ruberto, A. Buffon, C. Tomaselli, F. De Rosa, S. Mazza, G. Zampaglione, A.M. Pirozzi, A. Butera, M. Levato, D. Musacchio, R.M. Polimeni, V. Lacquaniti, G. Pulitano, A. Ruggeri, A. Provenzano, O. Cuccurullo, M. Musolino, A. Marrari, L. Anastasio, M. Schiavello, M.G. Comito, M.M. Gulizia, G.M. Francese, L. Vasquez, C. Coppolino, A. Casale, G. D'Urso, G. Oliva, U. Giordano, S. Andolina, N. Sanfilippo, F. Ingrilli, S. Accardo, S. Grasso, L. Buffa, E. Serra, M. Disertori, R. Latini, S. Barlera, M.G. Franzosi, L. Staszewsky, A.P. Maggioni, D. Lucci, G. Di Pasquale, G. Tognoni. - In: NEW ENGLAND JOURNAL OF MEDICINE. - ISSN 0028-4793. - 360:22(2009 Apr), pp. 2379-2379.