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   DIR Return to: TECFIDERA (dimethyl fumarate, BG-12, Fumaderm)
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       #Post#: 492--------------------------------------------------
       (ACTRIMS/ECTRIMS) Bismuth subsalicylate may ease GI events due
       to Tecfidera
   DIR By: agate
       Date: September 22, 2014, 12:04 pm
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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]
       --- End Quote ---
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