Investigation and Management of Stool Frequency and Consistency Associated With SGLT1 Inhibition by Reducing Dietary Carbohydrate: A Randomized Trial

Abstract

Treatment with licogliflozin, a dual SGLT1/2‐inhibitor is associated with increased stool frequency and loose stools, attributed to SGLT1 inhibition. To investigate the effect of carbohydrate content and supplements on licogliflozin‐induced stools, a randomized, open‐label, two‐part (N=24/part), three‐period crossover study was carried out in overweight or obese adults. Significantly higher (p<0.01) change from baseline in three‐day total number of bowel movements was observed following three days of licogliflozin treatment (50 mg q.d.) together with a 50% carbohydrate meal compared to a 25% and 0% carbohydrate meal. The number of stools with BSC score of 6 or 7 was also significantly lower following a 0% carbohydrate meal. Supplementation with psyllium 6g or calcium carbonate 1g had no effect on stool changes following treatment. Licogliflozin was generally safe and well tolerated. Loose stool associated with licogliflozin treatment and ingestion of meals can be managed by reducing the carbohydrate content of meals taken with licogliflozin.