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Compounded Levofloxacin Triple Therapy is Safe and Effective for Refractory Helicobacter pylori

Mah XJ, Gupta V, Loch SN, Ahlenstiel G, Poorten DV

International journal of pharmaceutical compounding, 2017

93 participants

Abstract

Failure of first line and subsequent Helicobacter pylori therapy is a significant problem, as alternate treatments are cumbersome and difficult to access. The purpose of this study was to evaluate the efficacy and safety of a compounded levofloxacin triple therapy in clinical practice as a second or third-line salvage regimen for Helicobacter pylori. Patients referred after first or subsequent treatment failures were prescribed compounded levofloxacin 500 mg, amoxicillin 1 g, and esomeprazole 40 mg, all twice daily for 10 days. Eradication success was determined by 14C-urea breath test or histology at least 4 weeks after completion of therapy. The study included 93 patients, the majority of whom were female (57%) with a mean age of 44. The most common indication for treatment was dyspepsia/risk reduction (84%). Median number of previous treatments was 1 (range: 1 through 6) with treatment used as second line in 83%. Helicobacter pylori eradication was achieved in 89.2% (74/83) per protocol and 79.6% (74/93) on an intention-to-treat basis. Outcome was independent of gender, ethnicity, treatment indication, or number. Treatment was well tolerated, with minor adverse events in 8.4% and only one patient discontinuing therapy. Compounded levofloxacin triple therapy is an effective and safe second line treatment for Helicobacter pylori, with eradication rates comparable to standard levofloxacin-based regimens.

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