Pharmacy & Therapeutics - February 2008 - (Page 96)

DRUG FORECAST Cardiac Events with Perindopril in Stable Coronary Artery Disease Investigators. Efficacy of perindopril in reduction of cardiovascular events among patients with stable coronar y ar ter y disease: Randomised, double-blind, placebocontrolled, multicentre trial (EUROPA study). Lancet 2003;362:782–788. Dahlof B, Devereux RB, Kjeldsen SE, et al. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint Reduction in Hyper tension Sudy (LIFE): A randomised trial against atenolol. Lancet 2002;359:995–1003. Brenner BM, Cooper ME, de Zeeuw D, et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med 2001;345:861–869. Lewis EJ, Hunsicker LG, Bain RP, Rohde RD. The effect of angiotensin-converting enzyme inhibition on diabetic nephropathy. The Collaborative Study Group. N Engl J Med 1993;329:1456–1462. Schmieder RE, Hilgers KF, Schlaich MP, et al. Renin–angiotensin system and cardiovascular risk. Lancet 2007;369: 1208–1219. Azizi M, Webb R, Nussberger J, et al. Renin inhibition with aliskiren: Where are we now, and where are we going? J Hypertens 2006;24(2):243–256. Product information: Tekturna tablets (aliskiren). East Hanover, NJ: Novartis; 2007. Stanton A, Jensen C, Nussberger J, et al. Blood pressure lowering in essential hypertension with an oral renin inhibitor, aliskiren. Hypertension 2003;42(6):1137– 1143. Strasser RH, Puig JG, Farsang C, et al. A comparison of the tolerability of the direct renin inhibitor aliskiren and lisinopril in patients with severe hypertension. J Hum Hypertens 2007;21(10):780–787. Gradman AH, Schmieder RE, Lins RL, et al. Aliskiren, a novel orally effective renin inhibitor, provides dose-dependent antihypertensive efficacy and placebolike tolerability in hypertensive patients. Circulation 2005;111:1012–1018. Villamil A, Chrysant SG, Calhoun D, et al. Renin inhibition with aliskiren provides additive antihypertensive efficacy when used in combination with hydrochlorothiazide. J Hypertens 2007;25(1):217–226. O’Brien E, Barton J, Nussberger J, et al. Aliskiren reduces blood pressure and suppresses plasma renin activity in combination with a thiazide diuretic, an angiotensin-converting enzyme inhibitor, or an angiotensin receptor blocker. Hyper tension 2007;49(2):276–284. Pool JL, Schmieder RE, Azizi M, et al. Aliskiren, an orally effective renin inhibitor, provides antihypertensive efficacy alone and in combination with valsartan. Am J Hypertens 2007;20(1):11–20. Pharmacy Society of Wisconsin. Available at: www.pswi.org/irx/Tekturna.pdf. Accessed December 21, 2007. I NEW DRUGS continued from page 91 DRUG NEWS Sources: www.pharmacyonesource. com; www.quantrx.com/NR_07_11.htm Devices in the News Product Liability. The Bush administration has told the Supreme Court that FDA-approved medical devices are shielded from product-liability lawsuits in state cour ts. This position suppor ts Medtronic in a case that has broad implications for devices makers. The concern is whether patients can sue the makers of medical devices through state law if the FDA has already approved a product. Medtronic argues that the Food, Drug, and Cosmetic Act expressly pre-empts state law claims brought by patients who were hurt by devices that received pre-market FDA approval. Unlike the case with medical devices, there is no statute providing preemption for drugs. Source: www.pharmalot.com Infusion Pump Recall. On October 29, 2007, Cardinal Health recalled its Alaris Infusion Pump module (formerly, the Medley Pump module), Model 8100. All Alaris infusion pumps shipped before September 27, 2007, are subject to this recall. A list of serial numbers of the pumps affected by the recall is available at the firm’s Web site (www.cardinal. com). The electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an IV, intra-arterial, epidural, or other route. During the manufacturing or servicing of the mechanism assembly, the occluder springs were misassembled, overlapping, missing, bent, or broken, possibly resulting in the potential for an inaccurate flow rate. This error can harm patients because of the resulting overinfusion. Sources: www.fda.gov/cdrh/recalls/ recall-102907.html I 5. 6. 7. 8. 9. 10. 11. only about four ounces of food. When the band is in place, the surgeon attaches the injection port to the abdominal wall beneath the skin. Using the injection port applier, the surgeon can complete this step in less than one minute, thereby decreasing the duration of anesthesia. The port enables doctors to inject or remove saline to tighten or loosen the band. The tighter the band, the more quickly the upper stomach fills up and the less food can be eaten. Adjustments can be made periodically according to patient needs. Purpose: The band is used for people with a body mass index (BMI) of at least 40 kg/m2 or a BMI of at least 35 kg/m2 with one or more comorbid conditions. Benefit: The gastric band is beneficial for morbidly obese patients who cannot lose weight with more conservative alternatives, such as supervised dietary, exercise, and behavior-modification programs. Sources: www.pharmacyonesource. com; www.ethiconendo.com; www.jnj. com Name: Follicle-Stimulating Hormone Immunoassay Test Manufacturer: QuantRx Biomedical Corporation, Doylestown, Pa. Approval Date: October 26, 2007 Use Classification: This over-thecounter fertility test is used to detect levels of follicle-stimulating hormone (FSH) at 10 ng/mL in women who wish to conceive. Description: This is the only one-step lateral flow test on the market. Its technology makes it ideal for testing urine. Purpose: The test determines ovarian reserve indirectly by measuring FSH in the first morning urine. The product is intended to aid women who are experiencing difficulty in conceiving. Benefit: Results are produced within 15 minutes, approximately half the time of the only other competing product. 12. 13. 14. 15. 16. 17. 96 P&T® • February 2008 • Vol. 33 No. 2 http://www.pharmacyonesource.com http://www.pharmacyonesource.com http://www.quantrx.com/NR_07_11.htm http://www.pharmalot.com http://www.pharmacyonesource.com http://www.ethiconendo.com http://www.jnj.com http://www.pharmacyonesource.com http://www.jnj.com http://www.cardinal.com http://www.cardinal.com http://www.fda.gov/cdrh/recalls/recall-102907.html http://www.pswi.org/irx/Tekturna.pdf http://www.fda.gov/cdrh/recalls/recall-102907.html

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Pharmacy & Therapeutics - February 2008 Contents Editorial Medication Errors Prescription: Washington The Language of (Forgive Us) Change, As P&T Enters the Digital Age New Drugs/Drug News/New Medical Devices Drug Forecast Use and Outcomes of Antifibrinolytic Therapy in Patients Undergoing Cardiothoracic Surgery at 20 Academic Medical Centers in the United States Evaluation of the Management of Acute Venous Thromboembolism and Its Outcomes: One Institution's Experience American Society of Hematology, 49th Annual Meeting Pharmaceutical Approval Update

Pharmacy & Therapeutics - February 2008

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