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Norfloxacin yields survival gains in certain patients with advanced cirrhosis

01 Oct 2018

The fluoroquinolone norfloxacin does not appear to reduce 6-month mortality in patients with advanced cirrhosis, according to a study. However, the drug confers survival benefits among those with low ascites fluid protein concentrations.

A total of 291 adult patients with Child-Pugh class C cirrhosis who had not received recent fluoroquinolone therapy were randomized to treatment with norfloxacin 400 mg (n=144) or placebo (n=147) once-daily for 6 months.

Patients were evaluated monthly for the first 6 months and at 9 and 12 months thereafter. The primary endpoint was 6-month mortality, estimated by the Kaplan-Meier method, which censored spontaneous bacterial peritonitis, liver transplantation or loss during follow up.

The 6-month mortality estimate did not differ significantly between the two treatment groups, 14.8 percent with norfloxacin vs 19.7 percent with placebo (p=0.21).

However, competing risk analysis taking liver transplantation into account showed that the cumulative incidence of death at 6 months was less common in the norfloxacin group than in the placebo group (subdistribution hazard ratio [SHR], 0.59; 95 percent CI, 0.35–0.99).

The protective effect of the drug on the risk of death at 6 months was pronounced among patients with lower ascites fluid protein concentrations (<15 g/L; SHR, 0.35; 0.13–0.93) and absent among those with higher ascites fluid protein concentrations (15 g/L; SHR, 1.39; 0.42–4.57).

Norfloxacin substantially reduced the incidence of any and Gram-negative bacterial infections without increasing infections caused by Clostridium difficile or multiresistant bacteria. This suggests that the drug may prevent some infections, but not the development of spontaneous bacterial peritonitis and other noninfectious, liver-related complications, as researchers pointed out.

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Most Read Articles
6 days ago
The choice between nonvitamin K antagonist oral anticoagulants (NOACs) or vitamin K antagonists (VKAs) for stroke prevention appears to be complex and largely heterogenous across different, countries, a new study has found.
Yesterday
Monotherapy with tenofovir disoproxil fumarate increases virologic response for up to 240 weeks in pretreated patients with hepatitis B virus infection (HBV) who are resistant to entecavir and/or adefovir, a new study has found.
Elvira Manzano, Yesterday
Long-term treatment with the interleukin-5 receptor alpha-directed cytolytic monoclonal antibody benralizumab led to long-term control of asthma, improvement in pulmonary function, and was safe in patients with severe eosinophilic asthma in the 2-year integrated analysis of the SIROCCO, CALIMA, and ZONDA pivotal studies plus the BORA extension study reported at ATS 2019.
Pearl Toh, 2 days ago
Emerging evidence is showing that the two major new classes of antidiabetic drugs — SGLT2* inhibitors and GLP-1** receptor agonists (RAs) — not only confer cardiovascular (CV) benefits to patients with type 2 diabetes (T2D), they also delay the loss of kidney function among these patients, potentially providing nephrologists with an additional tool in their armamentarium for managing patients with chronic kidney disease (CKD) in the future.