Author Topic: (ACTRIMS/ECTRIMS) Bismuth subsalicylate may ease GI events due to Tecfidera  (Read 213 times)

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Offline agate

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Bismuth subsalicylate, AKA Pepto-Bismol.
From DocGuide News, September 15, 2014:

Quote
Bismuth Subsalicylate Eases Gastrointestinal Events Associated With Delayed-Release Dimethyl Fumarate

By Brian Hoyle

BOSTON -- Co-administration of bismuth subsalicylate (BS) and delayed-release dimethyl fumarate (DMF) in the first 4 weeks of an 8-week fumarate treatment can significantly reduce the severity and prevalence of flatulence and diarrhoea, according to research presented at the 30th European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

If these results hold in larger studies, therapeutic compliance with a DMF regimen in patients with relapsing multiple sclerosis may be aided by the early inclusion of BS, stated Carlo Tornatore, MD, Georgetown University Hospital, Washington, DC, speaking here at a poster presentation on September 11.

Phase 3 studies have established that delayed-release DMF is safe and effective in the treatment of relapsing-remitting multiple sclerosis; however, the benefits commonly are accompanied by gastrointestinal adverse events, including nausea, bloating, lower abdominal pain, diarrhoea, and flatulence, all of which may erode treatment compliance.

Dr. Tornatore and colleagues randomised 175 healthy volunteers who all received an 8-week regimen of twice daily oral DMF (120 mg or 240 mg for 4 weeks, followed by 240 mg for 4 weeks). The participants were randomised to a co-administration of either placebo (n = 87) or BS 524 mg (n = 88) during the first 4 weeks. Participants recorded symptoms during treatment using an electronic diary. Each diary was examined at weeks 2, 4, 6, and 8, and participants received a follow-up phone call at week 10.

The number of self-reported gastrointestinal adverse events was highest in the first week of treatment (50.0% for placebo, 55.7% for BS), and declined thereafter (26.6% for placebo, 21.3% for BS by week 8), with the weekly frequency being similar in both groups. During the 4 weeks of co-administration of placebo or BS with DMF, the prevalence of all gastrointestinal events and acute events was slightly higher in those receiving BS than in those receiving placebo. These rates were comparable to previous self-reported rates.

The mean time from the beginning of treatment to the development of a gastrointestinal event was similar in the groups, and the first event tended to be reported as mild in both groups.

When the data were parsed out according to the nature of the adverse events, however, a different picture emerged. The incidences of flatulence and diarrhoea in those receiving BS (38.6% and 36.4%, respectively) were much lower than in those receiving placebo (50.6% and 48.2%, respectively), but were not significantly different.

The group receiving BS also displayed lower mean worst severity scores for flatulence (1.1 vs 1.8; least square mean difference 0.7, 95% confidence interval [CI] 0.1 to 1.3) and diarrhoea (1.0 vs 1.6; least square mean difference 0.6, 95% CI 0.0 to 1.2). BS was associated, however, with comparatively greater prevalence of lower abdominal pain (42.0% vs 38.8%) and bloating (40.9% vs 37.6%).

The number of symptomatic days and the duration of each symptom were comparable in the 2 groups, with the exception of bloating, which was appreciably longer in the placebo group (median duration approximately 12.5 hours) than the BS group (median duration approximately 8 hours).

Participant rating of their symptoms as severe revealed a milder pattern in those receiving BS for flatulence (1.1% vs 5.9%) and diarrhoea (1.1% vs 9.4%), upper abdominal pain (0% vs 8.2%), and indigestion (0% vs 3.5%). Flushing of the skin was similar in both groups (about 70% in week 1 and declining steadily to week 8 values of 45.8% and 32.5% in the placebo and BS group, respectively.

Adverse events were reported by 146 of the 175 (83.4%) participants, including 72 (82.8%) in the placebo group and 74 (84.1%) in the BS group. One participant in each group discontinued the study.

The 2 groups were similar at baseline in age, gender proportion, race, body mass index, weight, and height.

[Presentation title: Effect of bismuth subsalicylate on gastrointestinal events associated with delayed-release dimethyl fumarate: a double-blind, placebo-controlled study. Abstract P052]
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SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.