GlaxoSmithKline’s diabetes medication rosiglitazone (buy Avandia) will now carry a strong boxed warning that the drug might cause heart attacks. The company plans to design a trial to compare the drug with Takeda’s pioglitazone (Actos) to see whether the risk is unique to Avandia. Avandia and Actos already carry warnings about the risk of heart failure.
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.
Bristol-Myers Squibb and AstraZeneca have announced the FDA’s approval of saxagliptin (Onglyza), a dipeptidyl peptidase-4 (DPP-4) inhibitor, as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. DPP-4 inhibitors stimulate the pancreas to make more insulin after meals. Merck’s Januvia is the only other DPP-4 inhibitor on the market.
A common diabetes drug might be able to reduce tumors faster and prolong remission in mice longer than chemotherapy alone by targeting cancer stem cells, according to Harvard researchers.
Qualitest Pharmaceuticals, Inc., has issued a voluntary nationwide recall of two Accusure insulin syringes:
• 1/2 cc, 31 G, Short Needle, Lot No. 6JCB1; expiration date, October
2011; NDC 0603-7001-21, distributed between January 2007 and June 2007
• 1 cc, 31 G, Short Needle, Lot No. 7CPT1; expiration date, March
2012; NDC 0603-7002-21, distributed between May 2007 and June 2008
Actovegin (Nycomed), a deproteinized derivative of calf blood, may improve neuropathic symptoms, sensory nerve function, and mental health in patients with neuropathy related to type-2 diabetes. According to findings from a randomized, double-blind study of 567 patients, the main difference for the changes on the symptoms scale was 0.86—a clinically meaningful effect, the researchers say.
The FDA has approved an oral suspension of colesevelam (Welchol) (alone or with a statin) for patients with difficulty swallowing tablets. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes and to reduce elevated LDL-C levels in adults with primary hyperlipidemia (Fredrickson type IIa). Colesevelam is also used as an adjunct to diet and exercise for reducing elevated LDL-C levels in boys and menarchal girls 10 to 17 years of age and who have heterozygous familial hypercholesteremia after they have tried dietary modifications. The recommended dose is one 3.75-gram packet once daily.
To avoid esophageal distress, patients should not take the suspension in its dry form. The suspension contains 48 mg of phenylalanine per 3.75-gram dose.
Source: Daiichi Sankyo, October 7, 2009
