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LFF571 had comparable safety, efficacy to vancomycin for treatment of CDI
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WASHINGTON, D.C. — Semi-synthetic thiopeptide LFF571 was non-inferior to vancomycin and well-tolerated for treatment of moderate primary Clostridium difficile infection or first recurrence, according to clinical trial data presented at ICAAC 2014.
LFF571 “was not inferior to vancomycin at the end point that this study was powered for, which is clinical cure,” Jennifer A. Leeds, PhD, Novartis Institutes for Biomedical Research, and one of the inventors of LFF571, told Healio.com/Gastroenterology.
Jennifer A. Leeds
To evaluate the safety and efficacy of LFF571 compared with vancomycin, researchers performed a multi-center, randomized clinical trial involving 72 adult patients with primary episodes or first recurrences of moderate C. difficile infection (CDI). Patients received 200 mg LFF571 (n=46) or 125 mg vancomycin four times daily for 10 days, and were evaluated for clinical cure, time to diarrhea resolution and recurrence.
Clinical cure rate was 90.6% in the LFF571 group compared with 78.3% for the vancomycin group. In the per-protocol population sustained cure rates through 30 days were 56.7% and 65%, respectively, and 58.7% and 60% in the modified intent-to-treat population. Recurrence in toxin-confirmed cases among the per-protocol population occurred in 19% of the LFF571 group compared with 25% of the vancomycin group. Adverse events occurred in 76.1% for LFF571 compared with 69.2% for vancomycin, though 32.6% and 38.5% (LFF571 vs. vancomycin) of these events were suspected to be study drug-related. In one patient who discontinued treatment with LFF571, it was attributed to an adverse event.
“LFF571 was non-inferior to vancomycin for clinical cure of primary or first recurrent moderate [CDI],” the researchers wrote. “Sustained cure rates were lower for LFF571, although toxin-confirmed recurrences were reduced compared to vancomycin.
“LFF571 was generally safe and well-tolerated,” they added.
Leeds felt that the number of patients enrolled that had recurrence was too small to make any kind of claim for improvement in the recurrence. “You have to go to a larger number of patients in order to make any kind of real statement about that,” she said. – by Adam Leitenberger
For more information:
Mullane K. Abstract F-250. Presented at: Interscience Conference on Antimicrobial Agents and Chemotherapy; Sept. 5-9, 2014; Washington, D.C.
Disclosure: Mullane reports multiple research, speaker and advisory relationships with various pharmaceutical companies. Visit the ICAAC website for a full list of the co-authors’ relevant financial disclosures.