Study 1 (n=109) involved patients on background treatment with diet only. The placebo-subtracted treatment differences, which are summarized below, were statistically significant for both variables in all of these studies. ![]() The treatment effects on HbA1c levels and one-hour postprandial glucose levels are summarized for four placebo-controlled, double-blind, randomized studies conducted in the United States in Tables 2 and 3, respectively. PRECOSE regimen was superior to lower doses, but there were no statistically significant differences from 50 to 200 mg t.i.d.Ĭlinical Experience in Type 2 Diabetes Mellitus Patients on Monotherapy, or in Combination with Sulfonylureas, Metformin or Insulin: PRECOSE was studied as monotherapy and as combination therapy to sulfonylurea, metformin, or insulin treatment. * PRECOSE was statistically significantly different from placebo at all doses with respect to effect on one-hour postprandial plasma glucose. Results from these six fixed-dose, monotherapy studies were also combined to derive a weighted average of the difference from placebo in mean change from baseline for one-hour postprandial plasma glucose levels as shown in the following figure: † Although studies utilized a maximum dose of 200 or 300 mg t.i.d., the maximum recommended dose for patients 60 kg is 100 mg t.i.d. Although there were no statistically significant differences among the mean results for doses ranging from 50 to 300 mg t.i.d., some patients may derive benefit by increasing the dosage from 50 to 100 mg t.i.d. * PRECOSE was statistically significantly different from placebo at all doses. Table 1 Mean Placebo-Subtracted Change in HbA1c in Fixed-Dose Monotherapy Studies Dose of PRECOSE * There is little if any clinically significant interaction between PRECOSE and metformin. However, the peak plasma level of metformin was reduced by approximately 20% when taking PRECOSE due to a slight delay in the absorption of metformin. The amount of metformin absorbed while taking PRECOSE was bioequivalent to the amount absorbed when taking placebo, as indicated by the plasma AUC values. PRECOSE may affect digoxin bioavailability and may require dose adjustment of digoxin by 16% (90% confidence interval: 8-23%), decrease mean C max of digoxin by 26% (90% confidence interval: 16–34%) and decreases mean trough concentrations of digoxin by 9% (90% confidence limit: 19% decrease to 2% increase). PRECOSE did not interfere with the absorption or disposition of the sulfonylurea glyburide in diabetic patients. Studies in healthy volunteers have shown that PRECOSE has no effect on either the pharmacokinetics or pharmacodynamics of nifedipine, propranolol, or ranitidine. ![]() ![]() In addition, PRECOSE diminishes the insulinotropic and weight-increasing effects of sulfonylureas.Īcarbose has no inhibitory activity against lactase and consequently would not be expected to induce lactose intolerance. In diabetic patients, this enzyme inhibition results in a delayed glucose absorption and a lowering of postprandial hyperglycemia.īecause its mechanism of action is different, the effect of PRECOSE to enhance glycemic control is additive to that of sulfonylureas, insulin or metformin when used in combination. Pancreatic alpha-amylase hydrolyzes complex starches to oligosaccharides in the lumen of the small intestine, while the membrane-bound intestinal alpha-glucosidases hydrolyze oligosaccharides, trisaccharides, and disaccharides to glucose and other monosaccharides in the brush border of the small intestine. The antihyperglycemic action of acarbose results from a competitive, reversible inhibition of pancreatic alpha-amylase and membrane-bound intestinal alpha-glucoside hydrolase enzymes. In contrast to sulfonylureas, PRECOSE does not enhance insulin secretion.
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