Adding Fiber to Weight-Loss Drug Eases Digestive Side Effects
A new trial shows that combining dietary fiber with a newer weight-loss medication reduces gastrointestinal problems compared to older alternatives. The finding could improve patient compliance with obesity treatments, a key commercial and public health challenge as demand for weight-management drugs surges globally.
Originaltitel: Effect of dietary counseling and dietary fiber on tolerability during weight management with EMP16 and conventional orlistat: a single-blind randomized pilot trial.
Kombinationen av kostråd och fibertillskott minskar mag-tarmbiverkningar under viktminskning med kontrollerad-släpp orlistat-akarbos (EMP16), vilket öppnar vägen för bättre tolerans vid behandling av fetma. I denna randomiserade pilotforskning deltog 36 vuxna med fetma och tidigare mag-tarmbesvär. Deltagare fick antingen EMP16 med psylliumfiber eller konventionell orlistat med placebo under 39 dagar tillsammans med kostrådgivning. EMP16 med fiber gav större viktminskning än orlistat-placebo (p = 0,026) och liknande LDL-kolesterolsänkning (~10 procent). Mag-tarmhändelserna var färre än förväntat i båda grupperna, men EMP16-gruppen rapporterade kortare tid till första biverkning. Uppsala universitet och Empros Pharma AB genomförde studien. För kliniker och inköpschefer innebär detta att dietistsamtal kan reducera orlistat-relaterade biverkningar hos känsliga patienter, potentiellt förbättrad adherens och terapiresultat.
The aim of this trial was to assess whether dietary counseling together with supplemental fiber improves gastrointestinal (GI) tolerability during dose escalation with controlled-release orlistat-acarbose (EMP16) in adults who had reported prior GI side effects. In this randomized, single-blind, phase 2 pilot trial, adults with obesity (BMI ≥ 30 kg/m² or ≥ 27 kg/m² with risk factors) and prior GI problems to conventional orlistat or EMP16 were randomized 1:2 to EMP16 plus psyllium-based fiber or conventional orlistat plus maltodextrin placebo for 39 days, both with diet counseling. The primary endpoint was the composite gastrointestinal tolerability events (GITE) area-under-the-curve (AUC) score (diarrhea, oily spotting, flatulence with discharge, fecal incontinence) from daily electronic diaries. Additional endpoints included investigator-assessed GI adverse events, anthropometry, and cardiometabolic markers. Thirty-six participants completed treatment. GI event rates were much lower than expected in both arms, and GITE AUC differences were not statistically significant. Total events and time to first GI event favored EMP16 plus fiber. Greater relative weight loss occurred with EMP16 plus fiber vs. conventional orlistat plus placebo (p = 0.026), with similar ~ 10% LDL-cholesterol reductions. Dietary counseling during treatment with EMP16 or conventional orlistat may mitigate GI side effects in adults with prior GI side effects and co‑administration of fiber might further enhance tolerability and efficacy.