Isosorbide mononitrate in the prevention of first variceal bleed in patients who cannot receive β-blockers

Juan Carlos García-Pagán, Candido Villanueva, Maria Carme Vila, Agustin Albillos, Joan Genescà, Luis Ruiz-del-Arbol, Ramón Planas, Manuel Rodriguez, Jose Luis Calleja, Antonio González, Ricard Solà, Joaquim Balanzó, Jaume Bosch, Angels Escorsell, Eduardo Moitinho, Eduardo Llach, Joan Rodés, Josep Mióana, German Soriano, Judith MarquezMaria Dolors Gimenez, Francisco Domper, Jose Luis Martinez, Juan Carlos Lopez-Talavera, Rafael Esteban, Mónica Gonzalez, Jesus Urman, Regina Serradilla, Rosa Maria Morillas, Jaume Boix, Nieves Sotorrío, Luis Rodrigo, Joaquin De la Peña, Fernando Pons, Rafael Bañares, Angel Piñar, Manuel Jimenez

Research output: Contribution to journalArticleResearchpeer-review

109 Citations (Scopus)


Background & Aims: Nonselective beta-blockers (β-blockers) are very effective in preventing first variceal bleeding (FVB) in patients with cirrhosis. However, 15%-25% of patients have contraindications or develop severe side effects precluding its use. The present study evaluates whether isosorbide-5-mononitrate (Is-MN) effectively prevents variceal bleeding in patients with contraindications or who could not tolerate β-blockers. Methods: One hundred thirty-three consecutive cirrhotic patients with gastro-esophageal varices and contraindications or intolerance to β-blockers were included in a multicenter, prospective, double-blind randomized controlled trial. Sixty-seven were randomized to receive Is-MN, and 66 to receive placebo. Results: There were no significant differences in the 1- and 2-year actuarial probability of experiencing a FVB between the 2 treatment groups. Presence of variceal red signs at endoscopy was the only variable independently associated with an increased risk of variceal bleeding on follow-up (relative risk 3.4; P<0.01). Survival and adverse events were similar in the 2 groups. There were no significant differences in the incidence of ascites or changes in renal function. Conclusions: Is-MN does not reduce the incidence of FVB in patients with cirrhosis and esophageal varices who cannot be treated with β-blockers because contraindications or intolerance to these drugs, suggesting that Is-MN has no place in the primary prophylaxis of variceal bleeding.
Original languageEnglish
Pages (from-to)908-914
Publication statusPublished - 1 Jan 2001


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