Diabetes and Endocrinology

Although the prevalence of diabetes mellitus in hospitalized patients remains unknown, an estimated one-fourth of inpatients experience hyperglycemia.1 Hyperglycemia is linked to poor health outcomes, and there is evidence that intensive glucose control in the hospital reduces mortality, need for dialysis, infections, and length of stay.2 The American Diabetes Association (ADA) publishes clinical practice guidelines annually, which offer clinicians, patients, researchers, and payers current, evidence-based recommendations on all components of diabetes care, general treatment goals, and tools to evaluate the quality of care. The updated guidelines focus on changes in the recommendations for care of the hospitalized diabetes patient.

On March 29, 2013, FDA approved canagliflozin (Invokana, Janssen Pharmaceuticals, Inc.), a once-daily tablet, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

In November 2012, FDA approved tofacitinib (Xeljanz, Pfizer) 5 mg tablets for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have not had an adequate response to methotrexate or are intolerant to methotrexate. Tofacitinib, an oral non-biologic disease-modifying antirheumatic drug (DMARD) can be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. It is contraindicated for use with biologic DMARDs or with immunosuppressive agents, such as azathioprine and cyclosporine.

FDA’s recent approval of canagliflozin (Invokana, Janssen Pharmaceuticals) for adults with type 2 diabetes (T2DM), represents a new efficacy and unique approach to diabetes treatment, according to industry experts.

FDA’s recent approval of canagliflozin (Invokana, Janssen Pharmaceuticals) tablets to be used with diet and exercise, to improve glycemic control infor adults with type 2 diabetes (T2DM), represents a new efficacy and unique approach to diabetes treatment, according to industry experts.

Obesity has become a highly prevalent chronic condition that is associated with significant morbidity and mortality. Studies have demonstrated that even as little as 5% to 10% of weight loss is associated with an improvement in cardiovascular risk factors and a reduction in the incidence of type 2 diabetes in high-risk patients. Prior to the recent approval of lorcaserin and extended-release phentermine/topiramate, there had been no new pharmacologic agents approved for the treatment of obesity for 13 years. This article reviews the pharmacologic treatment of obesity including past treatment options, lessons learned in recent years, current short- and long-term treatment options, and future direction. Formulary considerations of currently available agents are discussed.

Patients with type 2 diabetes achieved 6% weight loss with liraglutide 3 mg in a phase 3a obesity trial, according to Novo Nordisk.

Patients with type 2 diabetes mellitus taking glucagonlike peptide 1 (GLP-1)-based therapies may have a higher risk of acute pancreatitis, according to a recent report published in JAMA Internal Medicine.

The cost of managing diabetes patients is extremely high, and many patients still experience poor glycemic control and renal complications, according to results of a study published online in the journal Diabetes Care.

FDA has announced more conservative dosing recommendations for erythropoiesis-stimulating agents (ESAs) when they are used to treat anemia in patients with chronic kidney disease (CKD) because of the increased risks of cardiovascular events such as stroke, thrombosis, and death.

New studies confirm the lower levels of vitamin D are associated with a higher risk of developing diabetes and diabetic retinopathy.

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.