Finasteride (Propecia, Merck), an inhibitor of 5a-reductase, prevents or delays the appearance of prostate cancer by 24.8% (P<.001), according to researchers from the University of Texas Health Science Center, San Antonio, Texas.
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Three different drugs at half the standard dose are estimated to reduce the risk of stroke by 63% and ischemic heart disease (IHD) events by 46% for those aged 60 to 69 years, according to a study in BMJ. Another study published in the same issue recommends that those with known occlusive vascular disease and everyone aged 55 years or older take a "polypill," including the combination of blood pressure-lowering drugs, a statin, folic acid, and aspirin.
5-HT3 receptor antagonist indicated to prevent delayed CINV
First combination therapy for treating hepatitis C in children
Approved as monotherapy for pediatric epilepsy
FDA actions
FDA pipeline
Combination therapy for acute bipolar mania
Phosphodiesterase inhibitor for the treatment of ED
New statin approved for the treatmentof various lipid disorders
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In these tight economic times, hospitals and managed care organizations are looking to eliminate unnecessary costs.
Asthma is a chronic inflammatory disease of the airways affecting 5%–7% of the US and European populations. It accounts for nearly 400,000 hospitalizations and 5,000 deaths per year. Acute asthma comprises those asthmatics with severe symptoms, despite attempts at appropriate control. Typically these patients will present to a local emergency department for evaluation and treatment. This review examines the pharmaceutical treatment options made available to these patients in emergency settings, including their risks, benefits, side effects and overall effectiveness. (Formulary 2003;38:537–543.)
Lumiracoxib (Prexige, Novartis) appears to be the next COX-2 specific inhibitor that will be marketed in the United States. Currently, lumiracoxib is being studied for the treatment of osteoarthritis, rheumatoid arthritis, and acute pain. Lumiracoxib has been shown in vitro to be more selective for the COX-2 isoenzyme compared to rofecoxib and celecoxib, but clinical head-to-head studies between these agents are lacking. Small controlled trials, presented in abstract form, have shown lumiracoxib to have comparable efficacy to diclofenac and celecoxib in osteoarthritis. It has an adverse effect profile similar to other COX-2 inhibitors and superior to traditional NSAIDs concerning gastrointestinal safety, but cardiovascular and renal safety data are still not available. While existing clinical data on lumiracoxib are minimal and only published in abstract form, research is ongoing, including comparing lumiracoxib to ibuprofen and naproxen in the largest arthritis trial undertaken to date. When the results of this study are published, lumiracoxib?s efficacy and safety profile will be better understood. (Formulary 2003;38:528?536.)
Antiepileptic approved for long-term maintenance treatment of bipolar disorder
New treatment for non-Hodgkin's lymphoma
Protease inhibitor for once-daily administration
Estrogen plus progestin therapy does not prevent mild cognitive impairment (MCI) in women aged 65 years and older, and it increases the risk for probable dementia in this group, according to researchers from the Women's Health Initiative Memory Study (WHIMS).
Individuals with diabetes are more prone to cardiovascular morbidity and mortality. However, because their low-density lipoprotein (LDL) cholesterol is similar to that of the general population, they do not usually receive statin or other cholesterol-lowering therapy.
The product label for ezetimibe (Zetia, Merck/Schering-Plough) has been revised to include hypersensitivity reactions, including rash and angioedema, as part of the adverse reactions section, according to Schering-Plough. The companies submitted an updated product label to FDA in April based on post-marketing surveillance, and the new label entered the market in July.
Cyclooxygenase-2 selective inhibitiors, better known as coxibs, may not be cost-effective for treatment of chronic arthritis pain in patients at average risk for ulcer complications as compared with nonselective nonsteroidal anti-inflammatory drugs (NSAIDs), according to a study recently published in the Annals of Internal Medicine. Using a coxib versus a NSAID cost an incremental $275,809 per year to gain 1 additional quality-adjusted life-year (QALY). For patients with a history of bleeding ulcers, however, the incremental cost per QALY gained decreased to $55,803.
Fondaparinux (Arixtra, Organon/Sanofi-Synthelabo) is at least as effective and safe as the low molecular weight heparin (LMWH) dalteparin for the prevention of venous thromboembolism (VTE) following major abdominal surgery, according to results from the Pentasaccharide in General Surgery Study (PEGASUS). Fondaparinux is the first and only synthetic selective Factor Xa inhibitor indicated for the prophylaxis of deep vein thrombosis (DVT).
Current medical therapy for chronic stable angina (CSA) is targeted at reducing the frequency of anginal symptoms and improving exercise tolerance by increasing myocardial oxygen supply and/or reducing myocardial oxygen demand. Pharmacological therapy for CSA is limited since traditional agents provide pain relief by reducing the work of the heart or dilating arterioles in an attempt to enhance supply. Combinations of these agents can induce profound reductions in blood pressure that limit the aggressive dosing needed in some patients. Metabolic modulators seek to overcome this issue through a novel mechanism of action. Ranolazine (Renexa, CV Therapeutics) is a partial fatty oxidase (pFOX) inhibitor that increases the amount of ATP produced from glucose and increases the ability of the myocardium to retain functionality despite a reduced oxygen supply. (Formulary 2003;38:461?476)
Patients with diabetes are at extremely high risk for cardiovascular disease. Because glucose control is associated with only modest reductions in macrovascular complications, efforts must be made to specifically target other cardiovascular risk factors. Diabetes is associated with a characteristic lipid profile: low high-density lipoprotein cholesterol (HDL-C) and high triglyceride levels with or without high low-density lipoprotein cholesterol (LDL-C) levels. This profile is also found in patients with early-onset coronary heart disease and correlates with increased atherogenesis. Multiple clinical trials have demonstrated that lipid-modifying therapy in patients with diabetes decreases cardiovascular risk. Management targeting all lipid abnormalities may represent the best treatment strategy since many patients with diabetes do not have elevated LDL-C levels. Combining lipid-modifying agents is also an attractive option for normalizing multiple lipid abnormalities. (Formulary 2003;38:478-497)
Alzheimer's disease currently has no cure and is estimated to cost in excess of $100 billion per year.
Statin indicated for reduction in the risk of recurrent cardiac events
Approved for pediatric chronic myeloid leukemia
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