Drug Topics - April 14, 2008 - (Page HSE14)

14 HSE DRUG TOPICS APRIL 14, 2008 www.drugtopics.com > > > Clinical Practice Studied extensively, new drug-eluting stent said to be very safe Sherree Geyer he Food & Drug Administration recently approved for use Endeavor, the first zotarolimuseluting coronary stent manufactured by Minneapolis-based Medtronic, Inc. Endeavor provides a minimally invasive alternative to open-heart bypass surgery for patients undergoing an angioplasty. Heath Jennings, director of pharmacy acute care services, the University of Chicago Medical Center, commented, “The same patients who get the CYPHER and TAXUS stents will get the Endeavor, including those with acute coronary disease, instability of the angina, myocardial infarction, NSTEMI and STEMI.” Similar to the i m mu n o s u ppr e s s a nt sirolimus used on CYA stent is a tiny wire mesh tube used to PHER stents, zotaroliprop open a coronary artery after it has been cleared of a blockage in a minimally mus prevents restenosis invasive procedure called balloon angioplasty. The balloon is inflated to compress and repeat angioplasty procedures. the plaque against the wall of the artery and to expand the stent. Sean Salmon, VP and general manager of Medtronic's coronary and peripheral vascular business, said zotarolimus offers greater stability and a longer shelf life than sirolimus. He called zotarolimus “much more responsive in tissue and much quicker to release.” Jennings said zotarolimus “prevents the hyper production of endothelial cells associated with late-stage restenosis.” Zotarolimus, an analog rapamycin used in organ transplants, represents “a very safe agent,” one that doesn’t destroy cell function, he added. Salmon pointed out that Endeavor’s platform design distinguishes it from other drug-eluting stents (DESs) on the market. Pooled safety data from Medtronic’s clinical program put Endeavor’s post-implant rate of thrombosis at less than 1% for the first year and .08% from one to three years. Salmon attributed the low rate to Endeavor’s biocompatible polymer coating. “The drug is gone in 28 days. What remains is the polymer. That stays in the body for the rest of the patient’s life,” he said. Jennings, who said, “Recent data point to the stent coating as the culprit behind restenosis,” added that T THE AUTHOR is a freelance writer who specializes in health care. Illustration: Courtesy of Medtronic, Inc. “the polymer coating makes it (Endeavor) less likely to cause contact problems with blood vessels. The coating is similar to the surface of red blood cells, not like a foreign substance that could cause a clot.” Salmon said the clinical program for Endeavor —the first DES to be approved by the FDA since 2004—represents the largest DES regulatory submission in the United States. Conducted over four years, Medtronic provided the FDA with data from seven randomized controlled clinical trials and registries that involved more than 4,100 patients. Post-market follow-up to assess Endeavor’s long-term safety and effectiveness and risk of thrombosis will include 22,500 patients and take five years to complete. “We had to call more patients because zotarolimus is a new molecular entity,” Salmon explained. “The FDA required a minimum of 2,000 patients studied over a 30-day exposure period. Later, because of safety issues, the FDA required twice the amount of data. The FDA required us to follow up with everyone for five years,” he remarked. To prevent stent thrombosis and restenosis, Endeavor’s clinical studies included a regimen of the antiplatelet drugs, clopidogrel and ticlopidine, for a minimum of three to six months both pre- and post-procedure. “Current guidelines recommend that patients receive aspirin indefinitely,” states Endeavor’s “Instructions for Use.” Jennings, who advises that “for anyone with a stent, it’s aspirin for life,” noted that 12 months of post-surgical antiplatelet drugs help to prevent platelet activity and encourage the endothelial process. “Once the stent is embedded into the tissue, you don’t need antiplatelet drugs because it becomes part of the body,” he added. Medtronic launched Endeavor in February and expects initial shipments to U.S. hospitals to total 100,000 units. Salmon said the stent “is priced in the middle of the market.” Besides Endeavor, another DES is expected to hit the market. It’s Abbott’s XIENCE V, an everolimuseluting stent. Approved for use in Europe and Japan, this stent prevents vasculopathy in cardiac-allograft patients and may be approved domestically in the second quarter. http://www.drugtopics.com

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Drug Topics - March 14, 2008 Contents Latebreakers Letters: Students Need Grounding in Chemistry Pharmacy Directors Wary of Heparin Shortages Some E-prescribing Standards are Ready to Go, Others are Not News Briefs Nanotechnology: Big Stakes in a Small World Pay for Performance is Coming to Pharmacy Patient Safety Organizations Still Very Much in Planning Stage Reconciling Medications in Specialty Patients Poses More Challenges Pharmacy Outsourcing Still Much in Use by Hospitals Studied Extensively, New Drug-Eluting Stent Said to be Very Safe Prevention is Key in Treating C. Difficile Infections E-prescribing Grows in Massachusetts, but Other States Lag Behind Active Metabolite Gives New Life to Antidepressant NSAIDS not Recommended for Long-term Use in Osteoarthritis This Time R.Ph.s and States Are Ready for Tamper-Resistant Rx Pads Cardinal Caught Between DEA and Pharmacies over Diversion Control Medicating Kids: Still More Questions than Answers Schnucks Pharmacy: Drug Topics' Chain of the Year Panel Will Ask for a System for R.Ph. Practice Across State Lines FDA Safety Page: How to use Fentora Safely The Shining OTC/HBC Stars of 2007 Take a Look at These OTCs for Eye Health Technology Update: Google Offers a Sneak Peak at its Electronic Records Initiative Recent Advancements in HIV/AIDS Treatment New Products Advertisers Index Classified Viewpoint: Are State Boards of Pharmacy Abusing Their Power?

Drug Topics - April 14, 2008

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