Some atypical antipsychotic drugs, especially olanzapine (Zyprexa medication, Eli Lilly) and clozapine (Clozaril®, Novartis), may induce glucoregulatory dysfunction that can lead to diabetes. Researchers who analyzed data on 5,837 patients in the Veterans Affairs database found that olanzapine therapy was associated with a 37% higher risk of diabetes compared with risperidone treatment.
Of 5,837 patients, 368 (6.3%) had a marker for diabetes, on average within 15 months. Only generic olanzapine was associated with the increased risk, which was consistent across all analyses, including those that controlled for factors such as other drugs, race, age, and substance abuse.
The researchers note that their numbers might be low, because the markers they used (i.e., the International Classification of Disease ICD-9-CM diagnosis codes and prescriptions for hypo-glycemic drugs) tend to underestimate the prevalence of new-onset diabetes.
Pfizer Inc. has announced the FDA’s newest indication for atorvastatin calcium (Lipitor drug): to reduce the risk of stroke and heart attack in people with type-2 diabetes and to reduce the risk of stroke in people without diabetes but with other risk factors.
The FDA’s decision was based on the findings of the Collaborative Atorvastatin Diabetes Study (CARDS). This landmark trial involved more than 2,800 patients with type-2 diabetes, near-normal cholesterol levels, and at least one other risk factor (e.g., high blood pressure or smoking). The results showed patients taking generic atorvastatin experienced nearly 50% fewer strokes than those taking placebo. The trial was stopped two years early because of the strong benefits shown.
This additional indication also reflects findings from The Anglo-Scandinavian Cardiac Outcomes Trial: Lipid-Lowering Arm (ASCOT-LLA). In this trial, atorvastatin also reduced the relative risk of stroke by 26% compared with placebo.
According to the American Diabetes Association’s recommended treatment guidelines, adults with type-2 diabetes should be considered for statin therapy regardless of their low-density lipo-protein-cholesterol levels.
Novo Nordisk Inc. has announced the FDA’s approval of insulin detemir injection of rDNA origin (Levemir®) for use in children. This basal (long-acting) form of insulin lasts for up to 24 hours and causes little weight change in adults.
It is indicated for once-daily or twice-daily subcutaneous administration for adults and children with type-1 diabetes mellitus or adults with type-2 diabetes mellitus who require long-acting insulin to control hyperglycemia.
This product was approved for use in adults in June 2005.
The Food and Drug Administration (FDA) has approved insulin glulisine (rDNA origin) injection (Apidra, sanofi-aventis) for the control of hyperglycemia in adults with type-1 and type-2 diabetes. This insulin analogue can be taken within 15 minutes before or within 20 minutes after starting a meal. It should be used in regimens that include a longer-acting insulin or a basal insulin analogue such as insulin glargine (Lantus, Aventis).
Insulin glulisine has a more rapid onset of action and a more flexible dosing schedule than regular human insulin.
Because of this agent’s short duration of action, patients will also need a longer-acting insulin or insulin infusion pump therapy to maintain adequate glucose control.
Novo Nordisk Inc. has launched insulin detemir (Levemir, rDNA origin), a long-acting basal insulin analogue in the U.S. It is indicated once or twice daily for adults and children with type-1 diabetes and for adults with type-2 diabetes.
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The drug offers up to 24 hours of blood glucose control. In a clinical trial, 70% of treated patients achieved targeted glycosylated hemoglobin levels below 7%. This is the first basal insulin analogue to have a treat-to-target study in its label.
This product is associated with a low rate of hypoglycemia and weight gain.
Levemir is available in vials and in a prefilled disposable pen.
The FDA has approved Takeda’s New Drug Application (NDA) for a combination of pioglitazone HCl (Actos canadian) and glimepiride for the treatment of type-2 diabetes. The combination drug is called Duetact.
Actos directly targets insulin resistance, and glimepiride tablet, a sulfonylurea, acts primarily by increasing the amount of insulin produced by the pancreas.
Duetact will be available in two commonly used dosages of pioglitazone drug/ glimepiride, to be taken once daily: 30 mg/2 mg and 30 mg/4 mg. The medication will be on the market this year.
Patients with type-1 diabetes who are unaware that they are hypoglycemic may have a five-fold increased risk of severely reduced glucose concentrations. Yet hypoglycemia awareness can be restored if patients can switch to and stick with a different insulin regimen. In general, however, these patients are less adherent to agreed-on changes in insulin therapy , even with more clinic visits, compared with patients who are hypoglycemia-aware.