Formulary Watch

Cardiovascular disease (CVD) remains the leading cause of death in patients with diabetes mellitus, accounting for 50% of all deaths. Dyslipidemia is an important modifiable risk factor in diabetic patients and represents a key area for intervention in these patients. Diabetic patients have a lipid profile characterized by low high-density lipoprotein cholesterol (HDL-C) levels and an increase in triglyceride levels. Diabetics have increased numbers of low-density lipoprotein cholesterol (LDL-C) particles but with a shift to smaller, denser LDL-C particles. The net effect is that patients with type 2 diabetes do not have substantially higher LDL-C concentrations than patients without diabetes.

New molecular entity: Dalfampridine (Ampyra) was approved in January 2010, as a treatment to improve walking in patients with multiple sclerosis.

Naproxcinod, a cyclooxygenase-inhibiting nitric oxide donor, is pending FDA approval for the indications of knee and hip osteoarthritis. Treating osteoarthritis pain can be challenging because many agents commonly used for this indication carry potential risk for increased cardiovascular events including increased blood pressure, increased upper gastrointestinal bleeding, and increased hepatotoxicity.

New added financial incentives are slated to drive adoption of electronic health record systems by doctors and hospitals, and increased government funding may finally lead to standards for interoperability and e-health exchanges necessary for the free flow of secure health data.

Recent FDA approvals (through April 2010) related to Silenor, Carbaglu, Hizentra, Norditropin FlexPro, Xifaxan, Differin, Botox

Agents in late-stage development for the treatment of hepatitis C.

Results from a Phase 3 trial by Sanofi-aventis have shown that the investigational compound, cabazitaxel, and prednisone/prednisolone markedly enhanced overall and progression-free survival in patients with metastatic hormone-refractory prostate cancer where the disease advanced after treatment with docetaxel-based chemotherapy.

Adding Epiduo (adapalene and benzoyl peroxide) gel 0.1%/2.5% to doxycycline, 100 mg, may be an effective treatment for severe acne, according to results from a study sponsored by Galderma Laboratories.

More than 50 new indications for oncology and hematology drugs and biologics were cleared by the FDA?s Office of Oncology Drug Products from 2005 to 2007.

On February 22, 2010, FDA released a safety alert reminding healthcare professionals of the agency¹s ongoing concerns regarding the cardiovascular safety of rosiglitazone (Avandia, GlaxoSmithKline).

Agents in late-stage development for the treatment of diabetes mellitus.

New molecular entity: Tocilizumab (Actemra) was approved in January 2010, for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.

Recent FDA approvals (through March 2010) related to Iprivask, VPRIV, Mirapex ER, Cayston, Menveo, Lamictal XR, Rituxan, Oleptro, Xiaflex, Norvir, Benicar, Crestor.

Venous thromboembolism (VTE) is a debilitating and potentially fatal condition, often seen in the aging population. VTE results from clot formation in the venous circulation and presents as either deep-vein thrombosis or pulmonary embolism. A population-based study estimated that at least 201,000 new cases of VTE occur in the United States annually.

Etravirine is an HIV-1 specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) that was FDA approved for treatment-experienced adult patients with HIV-1 strains resistant to an NNRTI and other antiretroviral agents. In phase 3 trials of etravirine versus placebo, both in combination with darunavir/ritonavir, a background of nucleoside/nucleotide reverse transcriptase inhibitors with or without enfuvirtide demonstrated potent antiviral activity that was sustained through 48 weeks.

The main objectives of gout therapy are to treat the acute attack, provide prophylaxis to prevent flares, and prevent complications associated with the deposition of urate crystals in tissues. Obesity, alcohol intake, and certain foods and medications can contribute to hyperuricemia and should be identified. Pharmacologic management remains the mainstay of treatment for chronic gout and acute attacks.

New molecular entity: Liraglutide (Victoza) was approved January 25, 2010 to improve blood sugar control in adults with type 2 diabetes mellitus.

Recent FDA action (through March 2010) related to CPI-300, Ondansetron, Intravenous acetaminophen, Gabapentin enacarbil, Rifaximin, ENMD-2076, Ap301, CM-AT, Fingolimod, Nilotinib.

On February 18, 2010, FDA recommended drastic changes in the way long-acting beta2-adrenergic agonists are used in the treatment of asthma in order to limit their utilization.

Gout: Overview and newer therapeutic developments; Focus on etravirine; Agents in late-stage development for the treatment of diabetes mellitus

In the first year of a child's life, immunization with a rotavirus vaccine (Rotarix, Glaxo Smith Kline) may markedly lower incidence of severe virus gastroenteritis.

In the past decade, federal regulatory agencies have signed off on more new product approvals for treatment of so-called neglected diseases.

Currently, exenatide is the only FDA-approved GLP-1 receptor agonist and its use is limited by the need for twice-daily injections. A long-acting release formulation of exenatide is being evaluated in clinical trials to assess effects on glucose control and patient quality of life.

Postmenopausal osteoporosis is a worldwide health concern associated with significant complications including fracture, disability, and mortality. The economic burden of this disease is substantial and is expected to increase significantly as the population ages. It is becoming increasingly important to identify patients who will benefit from available and emerging therapies for the prevention and/or treatment of osteoporosis.

Approaching the ideal selective estrogen receptor modulator for prevention and treatment of postmenopausal osteoporosis; Exenatide LAR: A sustained-release formulation of exenatide for the treatment of type 2 diabetes; and Agents in late-stage development for renal diseases

Agents in late-stage development for renal disease