Type 2 Diabetes

Low-cost generic drug programs pioneered by Wal-Mart and other big-box retailers are a mixed blessing for patients with diabetes.

FDA announced May 18 to the public new restrictions to the prescribing, dispensing, and use of rosiglitazone-containing medications (Avandia, Avandamet, and Avandaryl, GlaxoSmithKline [GSK]) as part of a Risk Evaluation and Mitigation Strategy.

An FDA advisory panel recommended fenofibric acid (Trilipix, Abbott) still be marketed for use but voted unanimously that Abbott be required to conduct a new study to determine whether a Trilipix-statin combination reduces heart attacks.

There is no clear difference in benefit between drug classes when adding an antihyperglycemic as a third agent to the treatment of patients with type 2 diabetes who are already receiving metformin and a sulfonylurea, according to a meta-analysis published in the May 17 issue of Annals of Internal Medicine.

The pipeline continues to decline from 4 to 5 years ago where smaller molecules led the way, according to a current state of the pharmaceutical pipeline presentation at the Academy of Managed Care Pharmacy's 23rd Annual Meeting and Showcase in Minneapolis.

For the fourth consecutive year, diabetes therapy topped the list of contributors to drug use trends in therapeutic categories, contributing 16.1% to overall growth in drug spending in 2010 due to an increasing number of patients, according to the recently released 2011 Medco Drug Trend Report, which tracks utilization and spending.

In patients with chronic low back pain with comorbidities such as hypertension, diabetes, and cardiovascular disease, extended-release oxymorphone (Opana ER, Endo Pharmaceuticals) may be a safe and effective alternative, according to a study presented at the annual meeting of the American Academy of Pain Medicine, National Harbor, Md.

Hemoglobin A1c levels below 6% are associated with a small but significant increased risk of mortality in elderly patients, according to a retrospective cohort study published online in Diabetes Care.

Roche recently recalled its Accu-Chek FlexLink Plus infusion sets globally because they may under-deliver insulin to patients.

Evidence supports metformin as a first-line agent to treat type 2 diabetes, according to a study in the March 14, 2011, online edition of the Annals of Internal Medicine.

The management of type 2 diabetes mellitus needs to change in response to the evolving evidence base now available. Research from the ADVANCE and the ACCORD trials was presented during the American Diabetes Association 58th annual advanced postgraduate course in New York City.

FDA released a safety communication to update prescribers and patients about the ongoing review of insulin glargine (Lantus) that was initiated in July 2009.

The American College of Physicians recently issued 3 recommendations for use of intensive insulin therapy for the management of glycemic control in hospitalized patients.

FDA has announced that the physician labeling and patient medication guide for rosiglitazone (Avandia, GlaxoSmithKline) have been changed to include information on cardiovascular risks (including death) of this agent.

FDA has sent MannKind Corp. a complete response letter regarding the company?s NDA for Afrezza Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes for the control of hyperglycemia.

New combination: Saxagliptin and metformin extended release (Kombiglyze XR) was approved to improve glycemic control in adults with type 2 diabetes mellitus.

Antihypertensive therapy with an angiotensin receptor blocker is not associated with reductions in cardiovascular or all-cause mortality compared to non-ARB-based regimens in patients with type 2 diabetes, according to researchers at the Massachusetts College of Pharmacy and Health Sciences.

FDA has approved saxagliptin and metformin XR (Kombiglyze XR, AstraZeneca and Bristol-Myers Squibb) tablets for the treatment of type 2 diabetes in adults. Kombiglyze XR is the first and only once-a-day metformin XR plus DPP-4 inhibitor combination tablet offering strong glycaemic control across glycosylated hemoglobin levels, fasting plasma glucose and post-prandial glucose.

In a multinational, placebo-controlled, double-blind trial, the selective vitamin D receptor activator paricalcitol (Zemplar, Abbott Laboratories), at doses of 1 µg or 2 µg daily, reduced albuminuria in patients with type 2 diabetes, who were already being treated with renin-angiotensin-aldosterone system inhibitors.

Metformin, either alone or in combination with sulfonylurea, appears to increase 1-year and long-term survival in patients with type 2 diabetes mellitus and chronic heart failure, according to research published in the October 1 issue of the American Journal of Cardiology, HealthDay News reported.

A systematic review assessing the comparative effectiveness of oral antidiabetic drugs for preventing patients at high risk from progressing to type 2 diabetes has found glitazones, biguanides, and alpha-glucosidase inhibitors reduced the relative risk of diabetes by as much as 63%, whereas insulin secretagogues had no effect.

New molecular entity: Saxagliptin (Onglyza), a DPP-4 inhibitor, was approved on July 31, 2009, for the treatment of type 2 diabetes mellitus

Initiation of antipsychotic therapy associated with hyperglycemia in older diabetic patients

Liraglutide is a glucagon-like peptide-1 (GLP-1) analogue that is currently pending FDA approval for the treatment of type 2 diabetes. This agent mimics the actions of food-induced endogenous GLP-1 release, thus causing glucose-dependent increased insulin secretion, decreased glucagon secretion, and reduced appetite and gastric emptying.

Labeling updates and warnings through April 2009 for insulin pens and cartridges