Pharmacy & Therapeutics - December 2008 - (Page 694)

DRUG FORECAST Scale scores. Investigators also explored changes in CGI scores and in cognitive, functional, and behavioral assessments. The adjusted mean chorea scores for the withdrawal group increased by 5.3 units from days one to three; for the other two groups, it increased by 3.0 units (P = 0.0773). When the investigators performed a post hoc analysis of change in chorea scores adjusted for baseline motor scores (because of a significant imbalance at baseline), the results were similar (P = 0.1202). A post hoc analysis of the linear trend was positive for re-emergent chorea (P = 0.0486). No statistically significant differences were found in the secondary efficacy or exploratory endpoints. Adverse reactions to sudden treatment withdrawal were generally mild and were considered unlikely to be related to the study pro cedures. Overall, the Frank study demonstrated a significant trend in the re-emergence of chorea after sudden withdrawal of tetrabenazine, indicating the agent’s efficacy in reducing chorea. Even so, there was no statistically significant difference between the three groups between days one and three. This study also indicated that a sudden discontinuation of tetrabenazine after chronic use, up to a dose of 150 mg/day, seemed safe. order of Families. Baltimore: The Johns Hopkins University Press, 1989. Bonelli RM, Hofmann P. A systematic review of the treatment studies in Huntington’s disease since 1990. Exp Opin Pharmacother 2006;7(17):1–13. Paleacu D. Tetrabenazine in the treatment of Huntington’s disease. Neuropsychiatr Dis Treat 2007;3(5):545–551. Product information. Xenazine (tetrabenazine). Deerfield, IL: Ovation Pharmaceuticals; Inc., 2008. Masson J, Sagne C, Hamon M, Mestikawy SE. Neurotransmitter transporters in the central nervous system. Pharmacol Rev 1999;51(3):439–463. Schuldiner S. A molecular glimpse of vesicular monoamine transporters. J Neurochem 1994;62(6):2067–2078. Kenney C, Jankovic J. Tetrabenazine in the treatment of hyperkinetic movement disorders. Exp Rev Neurother 2006;6(1): 7–17. Reches A, Burke RE, Kuhn CM, et al. Tetrabenazine, an amine-depleting drug, also blocks dopamine receptors in rat brain. J Pharmacol Exp Ther 1983;225: 515–521. Login IS, Cronin MJ, MacLeod RM. Tetrabenazine has properties of a dopamine receptor antagonist. Ann Neurol 1982;12:257–262. Burke RE, Reches A, Traub MM, et al. Tetrabenazine induces acute dystonic reactions. Ann Neurol 1985;17:200–202. Roberts MS, McLean S, Millingen KS, Galloway HM. The pharmacokinetics of tetrabenazine and its hydroxy metabolite in patients treated for involuntary movement disorders. Eur J Clin Pharmacol 1986;29:703–708. Roberts MS, Watson HM, McLean S, Millingen KS. Determination of therapeutic plasma concentrations of tetrabenazine and an active metabolite by high-performance liquid chromatography. J Chromatogr 1981;226:175–182. Mehvar R, Jamali F, Watson MW, Skelton D. Pharmacokinetics of tetrabenazine and its major metabolite in man and rat: Bioavailability and dose dependency studies. Drug Metab Dispos 1987;15: 250– 255. Food and Drug Administration, Center for Drug Evaluation and Research. Application No. 21-894: Tetrabenazine. Medical Review (Online). Available at: www. fda.gov. Accessed October 20, 2008. Kenney C, Hunter C, Davidson A, Jankovic J. Short-term effects of tetrabenazine on chorea associated with Huntington’s disease. Mov Disord 2007;22(1):10– 13. Huntington Study Group. Tetrabenazine as antichorea therapy in Huntington disease: A randomized controlled trial. Neurology 2006;66(3):366–372. Frank S, Ondo W, Fahn S, et al. A study of chorea after tetrabenazine withdrawal in patients with Huntington disease. Clin Neuropharmacol 2008;31:127–133. I NEW DRUGS continued from page 689 DRUG NEWS 4. 5. 6. 7. 8. 9. 10. 11. Name: Flair Endovascular Stent Graft Manufacturer: C. R. Bard Inc., Murray Hill, N.J. Approval Date: October 29, 2008 Use Classification: This stent graft is indicated to treat stenosis in synthetic arteriovenous bypass grafts. Description: A self-expanding Nitinol stent is encapsulated within the ePTFE (Teflon) graft material. This model has been slightly modified from an older one that was approved in 2007. Purpose: The stent graft restores blood flow and keeps the area open. Benefit: This is the first interventional device to show superiority to balloon angioplasty for maintaining access patency. In a six-month study, placement of the stent graft resulted in more than twice the patency of balloon angioplasty. Sources: www.pharmacyonesource. com; FDA, www.fda.gov/cdrh/MDA/ DOCS/p060002.html 12. 13. COST Pricing information is not yet available from the manufacturer or from wholesalers. 14. CONCLUSION Although tetrabenazine has been available in other countries for many years, this is the first FDA-approved medication for the treatment of chorea secondary to HD. Antipsychotic agents have also been used to manage this movement disorder, but tetrabenazine may provide therapeutic benefit with a different side-effect profile and represents an appropriate treatment alternative to help manage this debilitating and progressive disease. 15. 16. 17. REFERENCES 1. Walker FO. Huntington’s disease. Lancet 2007;369:218–228. 2. Fahn S. Huntington disease. In: Rowland LP, ed. Merritt’s Neurology, 11th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:803–807. 3. Folstein S. Huntington’s Disease: A Dis- 18. 19. Future Anti-clotting Study Several competing manufacturers of drugs and medical devices plan to collaborate to find the best way to prevent potentially deadly blood clots from forming in heart patients who have received implanted arterial stents. Each year, from 800,000 to one million American patients need one or more stents to keep an artery open after it has been unblocked by angioplasty. The question centers on how long patients may need anticoagulant drugs. From 25,000 to 30,000 patients who have had one of the tiny metal-mesh tubes implanted in a heart artery will participate in the multicenter study. Enrollment will most likely begin in late 2008 or in early 2009. Most patients will receive drug-coated stents, which release medication over time, and at least 5,000 patients will be receiving the older bare-metal stents. Sources: www.pharmacyonesource. com; Associated Press WorldStream, October 16, 2008 I 694 P&T® • December 2008 • Vol. 33 No. 12 http://www.pharmacyonesource.com http://www.fda.gov/cdrh/MDA/DOCS/p060002.html http://www.pharmacyonesource.com http://www.fda.gov/cdrh/MDA/DOCS/p060002.html http://www.fda.gov http://www.fda.gov http://www.pharmacyonesource.com http://www.pharmacyonesource.com

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Pharmacy & Therapeutics - December 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Interpreting Estimates of Treatment Effects Chemotherapy Foundation Symposium XXVI: Innovative Cancer Therapy for Tomorrow Third Annual Onmark National Payor/Provider Forum Fourth Annual Ophthalmic Drug Development and Delivery Summit Classification and Pharmacological Management Of Obesity CE Test and Forms Season’s Greetings: Thanks to Our Readers and Reviewers

Pharmacy & Therapeutics - December 2008

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