NUEVO FÁRMACO PARA LA DIABETES

El 19 de Octubre la FDA has approved sitagliptin phosphate tablets for use with diet and exercise to improve blood glucose control in adult patients with type 2 diabetes mellitus. The once-daily agent can be used alone or in combination with metformin or thiazolidinediones, such as pioglitazone HCl and rosiglitazone maleate, when treatment with either drug alone provides inadequate glucose control. The tablets are available in 25-, 50-, and 100-mg strengths, and the recommended dose is 100 mg once daily with or without food. This dose has been shown to provide a 24-hour glucose response at mealtime, between meals, and overnight.

• Two trials of sitagliptin monotherapy in patients with mild to moderate hemoglobin A_1c elevations showed that once-daily sitagliptin therapy yielded significant decreases in hemoglobin A_1c levels relative to placebo (-0.8% and -0.6%, respectively; P < .001). As with other antidiabetic agents, the mean glucose-lowering response to sitagliptin appears to increase with baseline hemoglobin A_1c level. Pooled data from both monotherapy studies showed that patients with mild, moderate, and high elevations in hemoglobin A_1c levels at baseline experienced mean changes of -0.6%, -0.7% and -1.4%, respectively at 18 weeks. The add-on indication for sitagliptin was based on separate 24-week studies, showing that the addition of sitagliptin to metformin or pioglitazone therapy yielded significant mean changes from placebo in hemoglobin A_1c level (-0.7; P < .001 for both), with mean decreases of 0.7% and 0.9% from baseline hemoglobin A_1c levels of 8.0% and 8.1% for metformin and pioglitazone, respectively.
• Adverse events related to sitagliptin may include stuffy or runny nose and sore throat, upper respiratory tract infection, and headache as well as some gastrointestinal effects. Sitagliptin therapy was not associated with weight changes or an increased incidence of hypoglycemia vs placebo in clinical trials.
• No dosage adjustments are required for patients with mild to moderate hepatic insufficiency or in patients with mild renal insufficiency (CrCl, > 50 mL/minute). Patients with moderate (CrCl, 30 to <>