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• W2032060910 abstract "See “Primary prophylaxis of spontaneous bacterial peritonitis delays hepatorenal syndrome and improves survival in cirrhosis” by Fernandez J, Navasa M, Planas R, et al, on page 818. See “Primary prophylaxis of spontaneous bacterial peritonitis delays hepatorenal syndrome and improves survival in cirrhosis” by Fernandez J, Navasa M, Planas R, et al, on page 818. The past 25 years have witnessed an incredible increase in our database regarding complications of cirrhosis and a much more complete picture of how these complications work together to shorten the life of the patient. The explosion of information that I described almost 20 years ago regarding the pathogenesis, diagnosis, and treatment of spontaneous bacterial peritonitis (SBP) has continued.1Runyon B.A. Spontaneous bacterial peritonitis: an explosion of information.Hepatology. 1988; 8: 171-175Crossref PubMed Scopus (138) Google Scholar Prevention of SBP was a concept that was still in its infancy in 1988. Diuresis had been shown to increase ascitic fluid opsonic activity and theoretically provide better defense against colonizing bacteria.2Runyon B.A. Van Epps D. Diuresis of cirrhotic ascites increases its opsonic activity and may help prevent spontaneous bacterial peritonitis.Hepatology. 1986; 6: 396-399Crossref PubMed Scopus (55) Google Scholar The early studies which described risk factors for SBP, for example, low-protein ascites, gastrointestinal hemorrhage, and prior SBP, then led to randomized trials proving that selective intestinal decontamination in these subgroups of patients helped to prevent this potentially fatal infection.3Runyon B.A. Low-protein-concentration ascitic fluid is predisposed to spontaneous bacterial peritonitis.Gastroenterology. 1986; 91: 1343-1346Abstract PubMed Google Scholar, 4Bleichner G. Boulanger R. Squara P. et al.Frequency of infections in cirrhotic patients presenting with acute gastrointestinal hemorrhage.Br J Surg. 1986; 73: 724-726Crossref PubMed Scopus (137) Google Scholar, 5Tito L. Rimola A. Gines P. et al.Recurrence of spontaneous bacterial peritonitis in cirrhosis: frequency and predictive factors.Hepatology. 1988; 8: 27-31Crossref PubMed Scopus (350) Google Scholar, 6Soriano G. Guarner C. Teixido M. et al.Selective intestinal decontamination prevents spontaneous bacterial peritonitis.Gastroenterology. 1991; 100: 477-481Abstract PubMed Google Scholar, 7Rimola A. Bory F. Teres J. et al.Oral, nonabsorbable antibiotics prevent infection in cirrhotics with gastrointestinal hemorrhage.Hepatology. 1985; 5: 463-467Crossref PubMed Scopus (236) Google Scholar, 8Gines P. Rimola A. Planas R. et al.Norfloxacin prevents spontaneous bacterial peritonitis recurrence in cirrhosis: results of a double-blind, placebo-controlled trial.Hepatology. 1990; 12: 716-724Crossref PubMed Scopus (525) Google Scholar A more recent randomized trial has shown that IV ceftriaxone is even better than oral norfloxacin in preventing infections in the setting of gut bleeding; this study helps to solve the dilemma of how to deliver an oral medication to patients who are frequently vomiting blood.9Fernandez J. Ruiz del Arbol L. et al.Norfloxacin vs ceftriaxone in the prophylaxis of infections in patients with advanced cirrhosis and hemorrhage.Gastroenterology. 2006; 131: 1049-1056Abstract Full Text Full Text PDF PubMed Scopus (351) Google Scholar Why should selective intestinal decontamination prevent SBP? Most of the organisms that cause SBP originate in the gut.10Runyon B.A. Canawati H.N. Akriviadis E.A. Optimization of ascitic fluid culture technique.Gastroenterology. 1988; 95: 1351-1355Abstract PubMed Google Scholar As cirrhosis progresses, the gut appears to become less able to contain bacteria, which can then translocate to extraintestinal sites.11Runyon B.A. Squier S.U. Borzio M. Translocation of gut bacteria in rats with cirrhosis to mesenteric lymph nodes partially explains the pathogenesis of spontaneous bacterial peritonitis.J Hepatol. 1994; 21: 792-796Abstract Full Text PDF PubMed Scopus (197) Google Scholar Overgrowth of a particular organism in the gut predictably leads to translocation of that organism.12Guarner C. Runyon B.A. Young S. et al.Intestinal bacterial overgrowth and bacterial translocation in an experimental model of cirrhosis in rats.J Hepatol. 1997; 26: 1372-1378Abstract Full Text PDF PubMed Scopus (217) Google Scholar Once these bacteria escape the gut, they can then colonize and infect a locus minoris resistenciae, that is, an area of the body that is lacking in defenses, such as low-protein ascites. Simplistically, selective intestinal decontamination reduces the bacterial numbers in the gut and can thus prevent translocation, SBP, and even prolong the survival of rats with cirrhosis and ascites.13Runyon B.A. Borzio M. Young S. et al.Effect of selective bowel decontamination with norfloxacin on spontaneous bacterial peritonitis, translocation, and survival in an animal model of cirrhosis.Hepatology. 1995; 21: 1719-1724PubMed Google Scholar, 14Guarner C. Runyon B.A. Heck M. et al.Effect of long-term trimethoprim-sulfamethoxazole prophylaxis on ascites formation, bacterial translocation, spontaneous bacterial peritonitis and survival in cirrhotic rats.Dig Dis Sci. 1999; 44: 1957-1962Crossref PubMed Scopus (48) Google Scholar Primary prophylaxis was shown to prolong the survival of rats with cirrhosis in 1999.14Guarner C. Runyon B.A. Heck M. et al.Effect of long-term trimethoprim-sulfamethoxazole prophylaxis on ascites formation, bacterial translocation, spontaneous bacterial peritonitis and survival in cirrhotic rats.Dig Dis Sci. 1999; 44: 1957-1962Crossref PubMed Scopus (48) Google Scholar When SBP was first described in detail in 1964, mortality was 100%.15Conn H.O. Spontaneous peritonitis and bacteremia in Laennec’s cirrhosis caused by enteric organisms.Ann Intern Med. 1964; 60: 568-580Crossref PubMed Scopus (197) Google Scholar As of 1999, hospitalization mortality was reduced to 10%.16Sort P. Navasa M. Arroyo V. et al.Effect of intravenous albumin on renal impairment and mortality in patients with cirrhosis and spontaneous bacterial peritonitis.N Engl J Med. 1999; 341: 403-409Crossref PubMed Scopus (1267) Google Scholar A reduction in mortality by 90% in 35 years is real medical progress. How did this happen? The recognition that SBP was common and that paracentesis was safe, combined with a high index of suspicion and a low threshold for diagnostic paracentesis, frequently led to detection of this infection at an early treatable phase.1Runyon B.A. Spontaneous bacterial peritonitis: an explosion of information.Hepatology. 1988; 8: 171-175Crossref PubMed Scopus (138) Google Scholar, 17Runyon B.A. Paracentesis of ascitic fluid: a safe procedure.Arch Intern Med. 1986; 146: 2259-2261Crossref PubMed Scopus (237) Google Scholar, 18Runyon B.A. Management of adult patients with ascites caused by cirrhosis.Hepatology. 2004; 39: 841-856Crossref PubMed Scopus (338) Google Scholar Paracentesis was routinely performed at the time of admission of patients with cirrhosis and ascites or when there were symptoms or signs consistent with SBP, such as abdominal pain, fever, confusion, azotemia, leukocytosis, or acidosis.18Runyon B.A. Management of adult patients with ascites caused by cirrhosis.Hepatology. 2004; 39: 841-856Crossref PubMed Scopus (338) Google Scholar Bedside culture of the fluid in blood culture bottles was shown to be superior to older methods of culture (and explained the culture-negative cases of the past) and frequently confirmed the presence of bacteria and permitted narrowing the spectrum of antibiotic coverage.10Runyon B.A. Canawati H.N. Akriviadis E.A. Optimization of ascitic fluid culture technique.Gastroenterology. 1988; 95: 1351-1355Abstract PubMed Google Scholar, 19Runyon B.A. Hoefs J.C. Culture-negative neutrocytic ascites: a variant of spontaneous bacterial peritonitis.Hepatology. 1984; 4: 1209-1211Crossref PubMed Scopus (226) Google Scholar, 20Runyon B.A. Antillon M.R. Akriviadis E.A. et al.Bedside inoculation of blood culture bottles with ascitic fluid is superior to delayed inoculation in the detection of spontaneous bacterial peritonitis.J Clin Microbiol. 1900; 28: 2811-2812Google Scholar Cefotaxime was shown to be superior with less nephrotoxicity compared with aminoglycoside-based regimens.21Felisart J. Rimola A. Arroyo V. et al.Cefotaxime is more effective than is ampicillin-tobramycin in cirrhotics with severe infections.Hepatology. 1985; 5: 457-462Crossref PubMed Scopus (275) Google Scholar Albumin was shown to help prevent hepatorenal syndrome in the setting of SBP.16Sort P. Navasa M. Arroyo V. et al.Effect of intravenous albumin on renal impairment and mortality in patients with cirrhosis and spontaneous bacterial peritonitis.N Engl J Med. 1999; 341: 403-409Crossref PubMed Scopus (1267) Google Scholar Thus, fatal renal failure owing to aminoglycosides or the infection itself could be avoided. SBP and gastrointestinal hemorrhage were shown to work together to harm the patient. Hemorrhagic shock was shown to increase translocation.22Llovet J.M. Bartoli R. Planas R. et al.Selective intestinal decontamination with norfloxacin reduces bacterial translocation in ascitic cirrhotic rats exposed to hemorrhagic shock.Hepatology. 1996; 23: 781-787Crossref PubMed Google Scholar Bacterial infection was shown to be associated with uncontrollable variceal hemorrhage.23Goulis J. Armonis A. Patch D. et al.Bacterial infection is independently associated with failure to control bleeding in cirrhotic patients with gastrointestinal hemorrhage.Hepatology. 1988; 27: 1207-1212Crossref Scopus (343) Google Scholar Antibiotic prophylaxis was not only shown to prevent infection in the setting of gut bleeding, but was also shown to help prevent rebleeding.24Hou M.-C. Lin H.-C. Liu T.-T. et al.Antibiotic prophylaxis after endoscopic therapy prevents rebleeding in acute variceal hemorrhage: a randomized trial.Hepatology. 2004; 39: 746-753Crossref PubMed Scopus (331) Google Scholar A study that reported a reduction in mortality in variceal hemorrhage from 43% to 15% over a 20-year period demonstrated that antibiotic prophylaxis was independently associated with improved survival.25Carbonell N. Pauwels A. Serfaty L. et al.Improved survival after variceal bleeding in patients with cirrhosis over the past two decades.Hepatology. 2004; 40: 652-659Crossref PubMed Scopus (621) Google Scholar With survival of SBP improved dramatically, prevention came more sharply into focus. Clearly patients in these subgroups who were at high risk for SBP benefited from selective intestinal decontamination.5Tito L. Rimola A. Gines P. et al.Recurrence of spontaneous bacterial peritonitis in cirrhosis: frequency and predictive factors.Hepatology. 1988; 8: 27-31Crossref PubMed Scopus (350) Google Scholar, 6Soriano G. Guarner C. Teixido M. et al.Selective intestinal decontamination prevents spontaneous bacterial peritonitis.Gastroenterology. 1991; 100: 477-481Abstract PubMed Google Scholar, 7Rimola A. Bory F. Teres J. et al.Oral, nonabsorbable antibiotics prevent infection in cirrhotics with gastrointestinal hemorrhage.Hepatology. 1985; 5: 463-467Crossref PubMed Scopus (236) Google Scholar The benefit of selective intestinal decontamination in patients who did not meet these criteria were less clear. One randomized trial was performed comparing primary continuous prophylaxis with norfloxacin to inpatient-only prophylaxis in patients with cirrhosis and ascitic fluid total protein level ≤1.5 g/dL or serum bilirubin level >2.5 mg/dL.22Llovet J.M. Bartoli R. Planas R. et al.Selective intestinal decontamination with norfloxacin reduces bacterial translocation in ascitic cirrhotic rats exposed to hemorrhagic shock.Hepatology. 1996; 23: 781-787Crossref PubMed Google Scholar SBP was reduced in the continuous treatment group at the expense of more resistance of gut flora to norfloxacin in that group.26Novella M. Sola R. Soriano G. et al.Continuous versus inpatient prophylaxis of the first episode of spontaneous bacterial peritonitis with norfloxacin.Hepatology. 1997; 25: 532-536Crossref PubMed Scopus (181) Google Scholar This brings us to the study at hand. The authors enrolled patients with cirrhosis and low-protein ascites (<1.5 g/dL) plus either (a) advanced liver failure (Child-Pugh score ≥9 points with serum bilirubin ≥3 mg/dL) or (b) impaired renal function defined as serum creatinine ≥1.2 mg/dL, blood urea nitrogen ≥25 mg/dL or serum sodium ≤130 mEq/L; they were randomized to norfloxacin or placebo.27Fernandez J. Navasa M. Planas R. et al.Primary prophylaxis of spontaneous bacterial peritonitis delays hepatorenal syndrome and improves survival in cirrhosis.Gastroenterology. 2007; 133: 818-824Abstract Full Text Full Text PDF PubMed Scopus (543) Google Scholar This is one of the first trials in this area of investigation to choose survival as a primary endpoint. Other trials were not designed to look at this endpoint and therefore did not demonstrate a survival advantage (Table 1). In fact, in the treatment of any complication of advanced cirrhosis, it has been traditionally extremely difficult to show a survival advantage. Trials regularly demonstrated better control of the complication under investigation, but the patients died anyway. They developed a new fatal complication. Frequently even meta-analyses have failed to demonstrate a survival advantage. This is always discouraging. The study at hand is one of a small, elite group that demonstrates a survival advantage, as well as a reduction in SBP and a reduction in hepatorenal syndrome.27Fernandez J. Navasa M. Planas R. et al.Primary prophylaxis of spontaneous bacterial peritonitis delays hepatorenal syndrome and improves survival in cirrhosis.Gastroenterology. 2007; 133: 818-824Abstract Full Text Full Text PDF PubMed Scopus (543) Google Scholar This is indeed remarkable. It is probable that translocation is common and silent in patients with advanced cirrhosis. Pieces of bacterial DNA can be found in the serum and ascitic fluid of such patients and the presence of DNA correlates with shorter survival.28Zapater P. Frances R. Gonzalez-Navajas J.M. et al.La presencia de AND bacterianoes un oredictor pronostico a corto plazo en pacientes cirrotocos con ascitis Resultados de un studio multicentrico nacional.Gastroenterol Hepatol. 2006; 29: 117PubMed Google Scholar Reducing the bacterial content of the gut with selective intestinal decontamination would be predicted to reduce SBP and the hepatorenal syndrome that can follow. Intuitively, one could envision that this could improve survival as it was shown to do in rats with cirrhosis and ascites. It is interesting that the survival advantage was quite impressive at three months (94% vs 62%; P = .003), but only 60% versus 48% by 1 year (P = .05). Bacteria become resistant to antibiotics predictably over time.29Aparicio J.R. Such J. Pascual S. et al.Development of quinolone-resistant strains of Escherichia coli in stools of patients with cirrhosis undergoing norfloxacin prophylaxis: clinical consequences.J Hepatol. 1999; 31: 277-283Abstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar Perhaps the narrowing of the difference in the survival curves at 1 year is due to development of resistance followed by overgrowth and translocation of the resistant bacteria.11Runyon B.A. Squier S.U. Borzio M. Translocation of gut bacteria in rats with cirrhosis to mesenteric lymph nodes partially explains the pathogenesis of spontaneous bacterial peritonitis.J Hepatol. 1994; 21: 792-796Abstract Full Text PDF PubMed Scopus (197) Google Scholar, 12Guarner C. Runyon B.A. Young S. et al.Intestinal bacterial overgrowth and bacterial translocation in an experimental model of cirrhosis in rats.J Hepatol. 1997; 26: 1372-1378Abstract Full Text PDF PubMed Scopus (217) Google Scholar, 13Runyon B.A. Borzio M. Young S. et al.Effect of selective bowel decontamination with norfloxacin on spontaneous bacterial peritonitis, translocation, and survival in an animal model of cirrhosis.Hepatology. 1995; 21: 1719-1724PubMed Google Scholar, 14Guarner C. Runyon B.A. Heck M. et al.Effect of long-term trimethoprim-sulfamethoxazole prophylaxis on ascites formation, bacterial translocation, spontaneous bacterial peritonitis and survival in cirrhotic rats.Dig Dis Sci. 1999; 44: 1957-1962Crossref PubMed Scopus (48) Google Scholar Mother Nature abhors a vacuum; if the usual flora are reduced, more unusual organisms take their place.Table 1Prevention of Spontaneous Bacterial PeritonitisStudy designNResultsPMortalityPNorfloxacin vs no drug in inpatients with AFTP <1.5 g/dL63SBP 0% vs 23%<.05Infection-related mortality (0% vs 13%)NSHospitalization mortality (6% vs 16%)NSNorfloxacin vs placebo in patients with prior SBP80SBP recurrence (12% vs 35%).01418% vs 25%NSNorfloxacin vs no drug in patients with cirrhosis & gut hemorrhage119Infection (10% vs 37%).0017% vs 12%NSNorfloxacin vs ceftriaxone in patients with cirrhosis and gut hemorrhage111Infection (33% vs 11%).0039% vs 11%NSTrimethoprim/sulfamethoxazole vs no drug in patients with cirrhosis and ascites67SBP or bacteremia (3% vs 27%).0257% vs 20%.15AFTP, ascitic fluid total protein; NS, not significant; SBP, spontaneous bacterial peritonitis.Adapted with permission from Runyon.18Runyon B.A. Management of adult patients with ascites caused by cirrhosis.Hepatology. 2004; 39: 841-856Crossref PubMed Scopus (338) Google Scholar Open table in a new tab AFTP, ascitic fluid total protein; NS, not significant; SBP, spontaneous bacterial peritonitis. Adapted with permission from Runyon.18Runyon B.A. Management of adult patients with ascites caused by cirrhosis.Hepatology. 2004; 39: 841-856Crossref PubMed Scopus (338) Google Scholar Why not just give all patients with cirrhosis selective intestinal decontamination? This became popular shortly after selective intestinal decontamination was shown to prevent SBP in early trials. Fortunately, this practice seems to have waned. We should reserve use of selective intestinal decontamination for patients who meet the inclusion criteria of the randomized trials.6Soriano G. Guarner C. Teixido M. et al.Selective intestinal decontamination prevents spontaneous bacterial peritonitis.Gastroenterology. 1991; 100: 477-481Abstract PubMed Google Scholar, 7Rimola A. Bory F. Teres J. et al.Oral, nonabsorbable antibiotics prevent infection in cirrhotics with gastrointestinal hemorrhage.Hepatology. 1985; 5: 463-467Crossref PubMed Scopus (236) Google Scholar, 8Gines P. Rimola A. Planas R. et al.Norfloxacin prevents spontaneous bacterial peritonitis recurrence in cirrhosis: results of a double-blind, placebo-controlled trial.Hepatology. 1990; 12: 716-724Crossref PubMed Scopus (525) Google Scholar, 18Runyon B.A. Management of adult patients with ascites caused by cirrhosis.Hepatology. 2004; 39: 841-856Crossref PubMed Scopus (338) Google Scholar, 27Fernandez J. Navasa M. Planas R. et al.Primary prophylaxis of spontaneous bacterial peritonitis delays hepatorenal syndrome and improves survival in cirrhosis.Gastroenterology. 2007; 133: 818-824Abstract Full Text Full Text PDF PubMed Scopus (543) Google Scholar There are disadvantages to selective intestinal decontamination. Prolonged exposure to quinolones pretransplant was shown to be a risk factor for posttransplant fungal infections in a prospective study.30Wade J.J. Rolando N. Hayllar K. et al.Bacterial and fungal infections after liver transplantation: an analysis of 248 patients.Hepatology. 1995; 21: 1328-1336Crossref PubMed Scopus (245) Google Scholar The risks must be weighed against the benefits when the use of any drug is being considered in patients with advanced cirrhosis. Primary Prophylaxis of Spontaneous Bacterial Peritonitis Delays Hepatorenal Syndrome and Improves Survival in CirrhosisGastroenterologyVol. 133Issue 3PreviewBackground & Aims: Norfloxacin is highly effective in preventing spontaneous bacterial peritonitis recurrence in cirrhosis, but its role in the primary prevention of this complication is uncertain. Methods: Patients with cirrhosis and low protein ascitic levels (<15 g/L) with advanced liver failure (Child–Pugh score ≥ 9 points with serum bilirubin level ≥ 3 mg/dL) or impaired renal function (serum creatinine level ≥ 1.2 mg/dL, blood urea nitrogen level ≥ 25 mg/dL, or serum sodium level ≤ 130 mEq/L) were included in a randomized controlled trial aimed at comparing norfloxacin (35 patients) vs placebo (33 patients) in the primary prophylaxis of spontaneous bacterial peritonitis. Full-Text PDF" @default.
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• W2032060910 date "2007-09-01" @default.
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• W2032060910 title "A Pill a Day Can Improve Survival in Patients With Advanced Cirrhosis" @default.
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