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Digestive Disease Week 2006: Pharmacologic studies review findings on ACE inhibitors, treatment of Crohn's disease

Focused on a diverse number of areas in the study of gastrointestinal health, Digestive Disease Week (DDW) 2006 in Los Angeles, Calif, yielded important information about the pharmacologic treatment of certain GI cancers and Crohn's disease.

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FDA actions in brief

FDA approved prednisolone orally disintegrating tablets (Orapred ODT, BioMarin/Alliant) for acute exacerbations of asthma as well as for persistent, severe asthma and for inflammation associated with certain conditions. It is the first orally disintegrating tablet formulation of prednisolone available in the United States.

Gardasil

Quadrivalent human papillomavirus (Types 6, 11, 16, 18) recombinant vaccine

Varenicline

The activity of varenicline in the aiding of smoking cessation is believed to be the result of the agent's action at a sub-type of the nicotinic receptor where it acts as an agonist while simultaneously preventing nicotine binding to alpha 4 beta 2 receptors. Varenicline was approved on May 10, 2006, as an aid to smoking cessation treatment.

Deal limitations, promotion of generic medications aim to stem rising drug costs, but threaten access

Federal Trade Commission (FTC) officials say they are concerned about an increasing trend of pharmaceutical companies paying makers of generic medications to delay marketing competitive products. FTC commissioner Jon Leibowitz, JD, has criticized "reverse payment" settlements, which involve a branded manufacturer compensating a generic medications manufacturer for agreeing to delay marketing efforts for a generic product until the innovator's patent expires.

Lower oral retinoid dose effective for psoriasis

A lower dose of the oral retinoid acitretin is effective for moderate-to-severe psoriasis and can minimize adverse effects, according to a study presented at the 64th Annual Meeting of the American Academy of Dermatology in San Francisco. Current practice is to administer the maximal tolerated dose of 25 mg to 50 mg acitretin daily.

New monoclonal antibody effective for plaque psoriasis

CNTO 1275, an anti-IL12p40, maintains efficacy in clearing plaque psoriasis for up to 24 weeks after 1 dose, according to results of a phase 2 study presented by researchers at the 64th Annual Meeting of the American Academy of Dermatology in San Francisco. The subcutaneously injected agent targets both interleukin 12 and 23, two key cytokines in type 1 immune responses, said study author Gerald G. Krueger, MD, of the department of dermatology, University of Utah Health Sciences Center, in Salt Lake City, Utah.

ACE inhibitors versus ARBs: comparison of practice guidelines and treatment selection considerations

Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) play a role in the treatment of hypertension (HTN) and heart failure (HF). The literature shows that in patients with HTN with comorbidities, such as HF, myocardial infarction (MI), diabetes mellitus, chronic kidney disease, and stroke, ACE inhibitors and ARBs appear to provide added benefit beyond solely lowering blood pressure. In addition, clinical trials have also demonstrated that ACE inhibitors and ARBs may be beneficial in the prevention of diabetes, atrial fibrillation (AF), and recurrent stroke. This review evaluates the practice guidelines and current literature to assess the implications for the use of ACE inhibitors or ARBs in HTN and HF.

Varenicline: An oral partial nicotine agonist for smoking cessation

Varenicline (Chantix, Pfizer) is a partial nicotine receptor agonist with a high affinity for the alpha-4 beta-2 nicotinic acetylcholine receptors, modulating dopamine levels associated with nicotine addiction and aiding in smoking cessation. Clinical studies have demonstrated favorable cessation rates compared with placebo and sustained-release bupropion, with an encouraging safety profile. The most common adverse effect seen in clinical trials was mild-to-moderate nausea. In November 2005, a New Drug Application (NDA) was submitted for varenicline, and the drug was subsequently granted a 6-month priority review. On May 10, 2006, varenicline became the first oral medication approved for smoking cessation since bupropion, representing an agent with a novel mechanism of action for smoking cessation.

Pipeline Preview (June 2006)

Human papillomavirus (HPV) (types 6, 11, 16, 18) vaccine (Gardasil, Merck) for female patients aged 9 years or older

FDA actions in brief

Thalidomide (Thalomid, Celgene) was approved in combination with dexamethasone for the treatment of patients with newly diagnosed multiple myeloma.

Rasagiline

Rasagiline is an irreversible monoamine oxidase (MAO) inhibitor that is thought to exert its effect by specifically inhibiting MAO-B, thereby causing an increase in the extracellular levels of dopamine in the striatum.

CMS addresses redundancies in Medicare drug plan as it composes formulary and coverage policies for 2007

In response to ongoing industry and beneficiary concerns about the Medicare Prescription Drug Plan, the Centers for Medicare and Medicaid Services (CMS) is clarifying the rules and reviewing the formularies of insurers who are applying to provide Part D coverage for next year. CMS is simultaneously crafting guidance and procedural improvements that aim to make the program operate more smoothly.