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Weekly ciprofloxacin noninferior to daily norfloxacin for preventing bacterial peritonitis
By Rita Buckley
NEW YORK (Reuters Health) - Once-weekly ciprofloxacin is non-inferior to once-daily norfloxacin for preventing spontaneous bacterial peritonitis (SBP) in patients with cirrhosis of the liver and ascites, according to South Korean researchers.
"Although norfloxacin 400 mg per day is the current standard regimen for the prevention of SBP in patients with liver cirrhosis, ciprofloxacin once weekly could be a more convenient and more cost-effective option, if the efficacy is comparable to norfloxacin once daily," Dr. Soon Ho Um from Korea University Anam Hospital, in Ansan, and colleagues write in The American Journal of Gastroenterology, online June 27.
The team conducted an open-label trial in seven tertiary hospitals in South Korea, randomly assigning 124 patients with liver cirrhosis and ascites to take 400 mg of norfloxacin once a day or 750 mg of ciprofloxacin once a week. The patients' mean age at baseline was 55 years and 73% were men.
Forty-three percent of the patients had alcoholic liver disease. Their mean Child-Pugh score was 9.6, with 49% in Child-Pugh class C. Their mean model for end liver disease (MELD) score was 14.6, with a MELD-Na score of 18.0. Twelve percent had a prior history of spontaneous bacterial peritonitis.
Four patients in the norfloxacin group and three in the ciprofloxacin group had developed SBP at one year (7.3% vs. 5.3%, P=0.712). Seven patients in the norfloxacin group and five in the ciprofloxacin group were lost to follow-up.
At one year, the groups had comparable rates of transplant-free survival (72.7% vs. 73.7%). There were no significant differences in the incidence of hepatic complication, hepatorenal syndrome, hepatic encephalopathy or variceal bleeding either. Deaths were due to deterioration of underlying liver function.
The authors write, "Considering cost effectiveness, availability, and drug compliance, once weekly ciprofloxacin could be a good alternative to daily norfloxacin for SBP prophylaxis."
Dr. John E. Eaton, senior associate consultant in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minnesota, told Reuters Health by email, "Cost effectiveness, convenient treatment strategies to promote patient adherence, and therapeutic efficacy are all important research questions when examining alternative treatment approaches."
However, Dr. Eaton, who was not involved in the report, said the study "has a number of limitations that affect generalizability of the findings and their application in general practice."
He cited a lack of norfloxacin availability in the United States; too few high-risk patients with prior spontaneous bacterial peritonitis for an adequate subgroup study; exclusion of patients with advanced encephalopathy; and a need for further research to determine if bacterial resistance was more common in one group versus the other.
"The low number of events, the number of patients lost to follow-up, and the short duration of the study make it difficult to draw a firm conclusion of noninferiority," he said.
Dr. Eaton also took exception to the "authors' argument that a weekly antibiotic is better than a daily pill."
"Patients with advanced liver disease often have impaired cognition manifested by increased forgetfulness," he said. "Remembering to take a weekly medication is more difficult than taking medication once a day."
According to Dr. Eaton, "The study is insufficient to support a change in the standard medical care for prevention of spontaneous bacterial peritonitis."
Dr. Um did not respond to requests for comments.
The study had no commercial funding and the authors declared no competing interests.
SOURCE: https://bit.ly/2udgxXj
Am J Gastroenterol 2018.
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