Core evidence place in therapy summary for vildagliptin 50 mg once or twice daily in adults with type 2 diabetes
| Outcome measure | Evidence | Implications |
|---|---|---|
| Disease-oriented evidence | ||
| Reduction in glycylated hemoglobin | Clear | Vildagliptin improves glycemic control more than placebo; 50 mg bid less effective than metformin 1 g bid; comparable to pioglitazone and rosiglitazone |
| Reduction in fasting and postprandial plasma glucose | Clear | Greater reduction with vildagliptin than with placebo; more sustained effect than rosiglitazone |
| Glycemic control in combination with metformin, pioglitazone, or glimepride | Clear | Adding vildagliptin to metformin, thiazolidinediones, or sulfonylureas causes a further improvement in glycemic control |
| Increase in postprandial GLP-1 | Clear | Greater increase with vildagliptin than placebo |
| Effects on postprandial insulin | Substantial | Similar with vildagliptin and placebo. Implies improved insulin secretion and sensitivity, shown by no change in insulin with lower glucose |
| Improvement in beta-cell function | Clear | Greater improvement with vildagliptin than placebo |
| Improvement in insulin sensitivity | Substantial | Greater improvement with vildagliptin than placebo |
| Patient-oriented evidence | ||
| Hypoglycemia | Clear | Similar frequency with vildagliptin and placebo, and with metformin or thiazolidinediones |
| Weight gain | Clear | Similar with vildagliptin and placebo; weight gain less than with thiazolidinediones, but greater than with metformin |
| Tolerability | Clear | Well tolerated with few adverse effects; nasopharyngitis, cough, and headache |
| Liver function | Limited | Unpublished data reveal similar elevations in liver enzymes compared with metformin, a thiazolidinedione, a sulfonylurea, or placebo. Liver function tests necessary before and during treatment with vildagliptin, and the drug should not be used in patients with liver impairment |
| Economic evidence | ||
| Cost effectiveness | No evidence | Studies required to verify the impact of vildagliptin alone or in combination with other oral agents on costs of illness |
bid, twice daily; GLP-1, glucagon-like peptide.