EFFECTS OF BEANO ON THE TOLERABILITY AND PHARMACODYNAMICS OF ACARBOSE

Acarbose is an alpha-glucosidase inhibitor approved for the treatment of type 2 diabetes mellitus. Acarbose inhibits carbohydrate digestion, allowing an excessive amount of undigested carbohydrate to reach the colon. Bacterial fermentation of the carbohydrate produces intestinal gas, which can cause flatulence and abdominal pain. Beano, an over-the -counter enzyme preparation (alpha-galactosidase), diminishes intestin al gas production by enhancing the breakdown of certain carbohydrates before they reach the lower intestine. This study was undertaken to in vestigate whether concomitant administration of Beano and acarbose cou ld reduce the flatulence associated with acarbose and, if so, whether Beano would interfere with the effects of acarbose on postprandial ser um glucose concentration. In this randomized, double-masked, placebo-c ontrolled, three-period crossover study, 37 patients with type 2 diabe tes mellitus received acarbose 100 mg, acarbose 100 mg plus Beano, or placebo. The study population consisted of 20 males and 17 females who ranged in age from 36 to 72 years (mean, 56 years) and in weight from 62 to 142 kg (mean, 92 kg). Each treatment period consisted of 3 days , during which both acarbose and Beano were given at the beginning of each of three meals. There was a 4-day washout interval between each t reatment period. The frequency and severity of flatulence were measure d using a score compiled from patient diaries. As an additional measur e of intestinal gas production, breath hydrogen concentration was meas ured on day 3 of each treatment period. Postprandial serum glucose con centration was measured at predetermined times after each morning dose to assess pharmacodynamic activity. Patients who took Beano with acar bose had a significantly lower flatulence score than did those who too k acarbose alone (0.79 vs 1.09). Consistent with this finding, breath hydrogen concentration was lower after administration of acarbose plus Beano than with acarbose alone (31.2 ppm vs 50.5 ppm), Beano had vari able effects on the ability of acarbose to reduce the postprandial ser um glucose concentration. Although postprandial serum glucose levels w ere higher in patients who received acarbose plus Beano than in those who received acarbose alone, both treatments (vr ich or without Beano) resulted in postprandial serum glucose levels that were significantly lower than those seen with placebo. Therefore, although Beano appeare d II, diminish the activity of acarbose, postprandial serum glucose co ncentrations still decreased significantly in patients taking Beano wi th acarbose. Beano has been shown to alleviate the flatulence accompan ying acarbose treatment, but it may also interfere with the glucose-lo wering effect of acarbose.