Drug Topics - December 10, 2007 - (Page HSE12)

12 HSE DRUG TOPICS DECEMBER 10, 2007 www.drugtopics.com Special Report (compared with atorvastatin alone) in phase III trials. Niacin and its extended-release versions (e.g., Niaspan, Abbott) remain the only substantial hoisters of HDL, but the long-known side effect of flushing has turned many patients away from this old-time B vitamin. In addressing this dilemma, Merck has developed an investigational prostaglandin D2 (PGD2)-receptor antagonist (laropiprant) to overcome niacin-triggered release of prostaglandin, a vasodilator known to cause cutaneous flushing. A combination product, Cordaptive, containing laropiprant and niacin ER, has been shown in phase III studies to reduce niacin-induced flushing at both the initiation and maintenance of treatment, “potentially allowing physicians to start at the 1-gm dose and advance to a 2-gm dose,” said John Paolini, M.D., Ph.D., clinical researcher at Merck Research Laboratories. With Merck already eyeing a Cordaptive/simvastatin combo and Abbott developing a simvastatin/niacin extended-release product, it appears that the pharmaceutical industry has jumped on the niacin bandwagon. Forecasters caution, however, that ultimate success of a niacin product hinges on the ability of laropiprant to reduce niacin-induced flushing more effectively than aspirin and on the strength of emerging clinical evidence demonstrating the cardiovascular benefits of raising HDL cholesterol. Cardiovascular disease In the related cardiovascular arena, a new platelet inhibitor (prasugrel), codeveloped by Daiichi Sankyo and Eli Lilly, may be approved in 2008 as a competitor to the widely used clopidogrel (Plavix, Bristol-Myers Squibb). Prasugrel acts similarly to clopidogrel, inhibiting platelet activation and subsequent aggregation by blocking the P2Y12 adenosine diphosphate (ADP) receptor on the platelet surface. Expected to initially receive an indication for patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI), prasugrel was shown in earlier studies to produce greater inhibition of platelet aggregation and a lower rate of nonresponse in stable aspirin-treated patients with coronary artery disease compared with those given clopidogrel. Recently, however, Lilly appears to have hit a research glitch, announcing that “enrollment of new patients and administration of prasugrel in two small pharmacodynamic clinical trials are being suspended until protocol amendments can be made relating to a dose adjustment in certain subpopulations.” (For more on prasugrel, see page 2HSE.) Ambulatory drugs in 2008 pipeline Generic name Uses Oncology vatalanib satraplatin efaproxyn enzastaurin L-glutamine suspension Metastatic colon cancer Prostate cancer Brain cancer Non-Hodgkin’s lymphoma Chemotherapy-induced mucositis Psychotropic agents In the area of psychotropic drugs, Medco’s drug trend report forecasts that serotonin-norepinephrine reuptake inhibitors (SNRIs) will likely generate the most growth—and not just in the treatment of depression. Wyeth’s SNRI desvenlafaxine, an active metabolite of its antidepressant venlafaxine (Effexor), may be approved in 2008 for the treatment of depression and, potentially, for vasomotor symptoms (VMS) of menopause. A study presented at the 63rd Annual Meeting of the American Society for Reproductive Medicine (ASRM) showed that women who received 100 to 150 mg per day of desvenlafaxine experienced a significant reduction in moderate to severe hot flashes and night sweats, compared with placebo. “Desvenlafaxine doesn’t appear to have any significant advantages over other agents in the treatment of depression,” said Peterson, but its potential VMS indication may come in handy now that the use of hormone replacement therapy is dwindling. Other notable agents that may make a 2008 entrance are shown on the table on this page. THE AUTHOR Diabetes vildagliptin liraglutide vildagliptin + metformin Type 2 diabetes Type 2 diabetes Type 2 diabetes Gastroenterology methylnaltrexone renzapride teduglutide Opioid-induced constipation Irritable bowel syndrome Short bowel syndrome Musculoskeletal and rheumatology zoledronic acid (once-yearly injection) bazedoxifene + conjugated estrogen Osteoporosis Osteoporosis, postmenopausal symptoms Respiratory fluticasone nasal spray (new formulation) denufosol olopatadine nasal spray Allergic rhinitis Cystic fibrosis Allergic rhinitis Based on the 2007 Drug Trend Report by Medco Health Solutions, which can be accessed at http://medco.mediaroom.com/file.php/129/2007+DRUG+TREND+REPORT.pdf. is a writer and hospital pharmacist in New Jersey. http://www.drugtopics.com http://medco.mediaroom.com/file.php/129/2007+DRUG+TREND+REPORT.pdf

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Drug Topics - December 10, 2007 Latebreakers Latebreakers in Depth Letters Health-System Edition - Cover Story Clinical Practice Professional Practice Special Report Technology Community Practice Unraveling Medicare 150 Years of American Pharmacy Rx Care In the Pipeline Cover Story: Fair or foul? Self-Care Chains and Business Government and Law Continuing Education: Natural Medicines for Bone Health New Products Advertisers Index Classified Viewpoint

Drug Topics - December 10, 2007

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