Nadolol plus spironolactone in the prophylaxis of first variceal bleed in nonascitic cirrhotic patients: A preliminary study

Liver Unit, Hospital de Gastroenterología B. Udaondo, Buenos Aires, Argentina.
Hepatology (Impact Factor: 11.06). 02/2003; 37(2):359-65. DOI: 10.1053/jhep.2003.50032
Source: PubMed


Treatment with beta-blockers fails to decrease portal pressure in nearly 40% of cirrhotic patients. Recent studies have suggested that treatment with spironolactone reduces pressure and flow in the portal and variceal systems. This trial was designed to assess if nadolol plus spironolactone is more effective than nadolol alone to prevent the first variceal bleeding. One hundred patients with medium and large varices who had never bled and were without ascites were included in a prospective, randomized, multicenter, double-blind, placebo-controlled trial. The patients were randomized into 2 groups: 51 received nadolol plus placebo (N + P) and 49 received nadolol plus spironolactone 100 mg/d (N + S). Hepatic venous pressure gradient (HVPG) and activity of the renin-aldosterone system (plasma renin activity/plasma aldosterone levels) were measured in 24 patients. There were no significant differences in the appearance of variceal bleeding and ascites between groups at a mean follow-up of 22 +/- 16 months. However, analyzing both complications together, the incidence was significantly higher in the N + P group than in the N + S group (39% vs. 20%; P <.04). Clinical ascites was also higher in patients in the N + P group than in the N + S group (21% vs. 6%; P <.04). Significant increases in plasma renin activity and plasma aldosterone levels were only observed in patients in the N + S group (P <.01). The cumulative probabilities of remaining free of bleeding and ascites were similar in both groups after 70 months of follow-up. In conclusion, these results suggest that nadolol plus spironolactone does not increase the efficacy of nadolol alone in the prophylaxis of the first variceal bleeding. However, when bleeding and ascites were considered together, the combined therapy effectively reduced the incidence of both portal-hypertensive complications.

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Available from: Eduardo Fassio, Oct 07, 2015
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    ABSTRACT: Pharmacologic therapy for portal hypertension is effective in the treatment and prevention of hemorrhage from esophagogastric varices. Acute hemorrhage from varices can be treated with intravenous agents such as somatostatin or terlipressin, either alone or in combination with endoscopic sclerotherapy or band ligation. Intravenous octreotide has not shown effectiveness as monotherapy, but it appears to be beneficial when combined with endoscopic treatment. The prevention of rebleeding after initial hemorrhage is best accomplished with non-selective beta blockers, endoscopic band ligation of varices, or a combination of endoscopic and pharmacologic therapies. The addition of oral nitrates may further decrease rebleeding rates, but more data from randomized trials are needed. Beta blockers are currently the only agents recommended for the primary prevention of variceal hemorrhage.
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