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Although use of the cyclooxygenase (COX)-2 inhibitor celecoxib has demonstrated benefit in preventing premalignant colorectal adenomas, generally the agent should not be recommended for this purpose due to the risk of cardiovascular events, according to 1 recent trial. In a second study of celecoxib use and adenomas, treatment with celecoxib 400 mg/d markedly lowered the incidence of colorectal adenomas within 2 years after the removal of polyps.

In a randomized, double-blind, placebo-controlled trial recently published in Lancet, the thiazolidinedione (or "glitazone") rosiglitazone statistically significantly reduced the incidence of new-onset diabetes when given to patients diagnosed with prediabetes but lacking a prior history of cardiovascular disease. The benefits of using thiazolidinediones in the treatment of patients with diabetes are well known, but the current finding that thiazolidinediones can prevent prediabetics from progressing to diabetes is novel.

In a randomized, double-blind, placebo-controlled trial, the angiotensin-converting enzyme (ACE) inhibitor ramipril, when administered to patients with prediabetes but no previous cardiovascular disease, failed to demonstrate a statistically significant reduction in the primary composite end point of new-onset diabetes or death.

So far this year, Formulary has examined 10 newly approved or investigational drugs of interest to pharmacy and therapeutics committee members through our "Focus on" articles. Because many readers have expressed that this information is useful when making formulary decisions for their hospitals, health systems, or managed care organizations, Formulary has compiled this late-year review of these new and emerging agents, along with updates on the regulatory status of each.

FDA recently released an information sheet advising healthcare professionals about a potential pharmacodynamic interaction between low-dose aspirin (81 mg/d) and ibuprofen 400 mg when they are dosed concomitantly. This interaction may attenuate aspirin's anti-platelet cardioprotective effect in patients taking aspirin for secondary prevention of myocardial infarction.

Lisdexamfetamine (NRP104, Shire/New River Pharmaceuticals) for the treatment of pediatric attention-deficit/hyperactivity disorder (ADHD)

FDA Actions in Brief

FDA granted 2 additional indications for rituximab (Rituxan, Genentech/Biogen Idec) in the treatment of patients with CD-20-positive, B-cell non-Hodgkin's lymphoma (NHL). The agent is now approved as first-line treatment of previously untreated patients with follicular NHL in combination with cyclophosphamide, vincristine, and prednisolone (CVP) chemotherapy, and in the treatment of patients with low-grade NHL with stable disease, or in those with partial or complete response following first-line treatment with CVP chemotherapy.

Infliximab

Infliximab acts through the inhibition of tumor necrosis factor (TNF)-alpha, which is responsible for the induction of inflammatory cytokines, the enhancement of leukocyte migration, and the activation of neutrophil and eosinophil functional activity. Infliximab was approved on September 27, 2006, for the treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

Vorinostat

This agent targets the overexpression of histone deacetylase (HDAC) or the aberrant recruitment of HDACs to oncogenic transcription factors in cancer cells. Vorinostat was approved on October 6, 2006, for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent, or recurrent disease following 2 systemic therapies.

A 0.5-mg/kg dose of a low molecular weight heparin, enoxaparin, resulted in less non-coronary-artery bypass grafting (CABG) bleeding compared with unfractionated heparin in the first 48 hours after elective percutaneous coronary intervention (PCI), according to a prospective, open-label, multicenter, randomized trial reported in the New England Journal of Medicine.

Intensive lipid lowering with high-dose 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) provides a significant benefit over standard-dose statin therapy in preventing nonfatal cardiovascular outcomes and also may reduce the incidence of cardiovascular death, according to results of a meta-analysis published in the Journal of the American College of Cardiology.

Intensive lipid lowering with high-dose 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) provides a significant benefit over standard-dose statin therapy in preventing nonfatal cardiovascular outcomes and also may reduce the incidence of cardiovascular death, according to results of a meta-analysis published in the Journal of the American College of Cardiology.