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Background Nonselective beta-adrenergic blockers decrease portal pressure and prevent variceal hemorrhage. Their effectiveness in preventing varices is unknown.
Methods We randomly assigned 213 patients with cirrhosis and portal hypertension (minimal hepatic venous pressure gradient [HVPG] of 6 mm Hg) to receive timolol, a nonselective beta-blocker (108 patients), or placebo (105 patients). The primary end point was the development of gastroesophageal varices or variceal hemorrhage. Endoscopy and HVPG measurements were repeated yearly.
Results During a median follow-up of 54.9 months, the rate of the primary end point did not differ significantly between the timolol group and the placebo group (39 percent and 40 percent, respectively; P=0.89), nor were there significant differences in the rates of ascites, encephalopathy, liver transplantation, or death. Serious adverse events were more common among patients in the timolol group than among those in the placebo group (18 percent vs. 6 percent, P=0.006). Varices developed less frequently among patients with a baseline HVPG of less than 10 mm Hg and among those in whom the HVPG decreased by more than 10 percent at one year and more frequently among those in whom the HVPG increased by more than 10 percent at one year.
Conclusions Nonselective beta-blockers are ineffective in preventing varices in unselected patients with cirrhosis and portal hypertension and are associated with an increased number of adverse events. (ClinicalTrials.gov number, NCT00006398
[ClinicalTrials.gov]
.)
Source Information
From the Veterans Affairs Connecticut Healthcare System, West Haven (R.J.G., G.G.-T.); Yale University School of Medicine, New Haven, Conn. (R.J.G., G.G.-T., H.G., R.M.); Hospital Clinic I Provincial de Barcelona, Barcelona (J.B., A.E., J.C.G.-P.); Brigham and Women's Hospital, Boston (N.D.G.); Faulkner Hospital, Jamaica Plain, Mass. (N.D.G., D.S.M.); the Royal Free Hospital and School of Medicine, London (A.K.B., D.P.); and Hospital Germans Trias I Pujol, Badalona, Spain (R.P.).
Drs. Groszmann and Garcia-Tsao contributed equally to the article.
Address reprint requests to Dr. Groszmann at the Yale University School of Medicine, VA CT Healthcare System, Digestive Disease Section/111H, 950 Campbell Ave., West Haven, CT 06516.
Related Letters:
Beta-Blockers to Prevent Gastroesophageal Varices in Cirrhosis
Post A. B., Assy N. N., Schlesinger S. E., Hussein O. A., Groszmann R. J., Garcia-Tsao G., Bosch J.
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N Engl J Med 2006;
354:1318-1320, Mar 23, 2006.
Correspondence
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