Pharmacy & Therapeutics- July 2008 - (Page 389) NEW DRUGS by family members or professionals. (Source: J Substance Abuse Treat 2008; 34:460–463.) DRUG NEWS patients whose pulmonary valve must be replaced because of disease, malformation or malfunction of their own pulmonary valve, or as part of another surgical procedure. Benefit: Allograft (human) hear t valves are popular choices for children because they obviate the need for bloodthinning medications on a long-term basis. Allograft heart valves, compared with heart valves from a pig or cow, are less likely to calcify. In a study, the SynerGraft valve performed at least as well as traditional allograft valves. Source: FDA, February 7, 2008; www. fda.gov Name: iFix Interference Screws Manufacturer: Cayenne Medical, Inc., Scottsdale, Ariz. Approval Date: February 27, 2008 Use Classification: This iFix Screw System is used in reconstruction procedures for bones, tendons, and the anterior cruciate ligament (ACL). The ACL is the major stabilizing ligament of the knee and helps to prevent buckling or instability. Description: These screws use polyetheretherketone (PEEK), a form of plastic that is highly biocompatible, biomechanically strong, and radiolucent. Purpose: The screw system offers ACL reconstruction technology to surgeons who practice the bone–tendon– bone technique. Benefit: iFix surgical screws have better biomechanical strength than bioabsorbable and biocomposite interference screws. They are also superior to metallic screws, which can interfere with imaging. The iFix tip design is unique, and no tapping is necessary before insertion. Some patients react to foreign bodies or may have inflammator y responses to traditional screw materials. iFix screws overcome this problem because PEEK is biologically inert. Antihypertensive Agents Benefit All Age Groups Strong support for the use of medications to lower blood pressure in all adults, regardless of age, comes from a meta-analysis of 31 trials involving nearly 200,000 patients. The studies showed no clear difference between age groups in terms of antihypertensive effects, say researchers from the Blood Pressure Lowering Treatment Trialists’ Collaboration. Their findings, they suggest, should greatly simplify decision making for millions of health care providers. Although some guidelines advocate particular types of drugs according to a patient’s age on the basis of possible differences in effects, the researchers saw no evidence of differences between beta blockers and other classes of drugs in older and younger patients. Among patients older than age 65, there were usually perceived benefits from reducing blood pressure, and in no case was there evidence of harm. Moreover, the absolute benefits of treatment are likely to be great in older patients because of their higher average risk. As long as blood pressure is managed effectively, factors such as tolerability and cost are probably “reasonable” bases for choice. (Source: BMJ 2008;336:1121–1123, online.) University of California at Irvine have now discovered how polyketides form a unique ring-like shape. This can make it easier for chemists to manipulate polyketides into new drugs. The key is an enzyme called aromatase/cyclase, which forms a C-shaped mold in which polyketides can form one molecule at a time. By changing this mold, chemists can control the size and shape of the polyketide to form new drugs. Polyketide-based drugs include antibiotics (tetracycline, erythromycin); chemotherapy agents (doxorubicin); antioxidants (resveratrol); and statins. Green tea and red wine also contain polyketides. Bacteria, fungi, plants, and marine animals produce polyketides to kill predators. Before this study, it was not known how nature controlled the ring shape, which is essential for the antibiotic and anticancer properties. Researchers hope that the discovery of the ring pattern will lead to advances in cancer, obesity, and stem cell treatments. (Sources: Proc Natl Acad Sci online; Science Daily, April 9, 2008.) NEW MEDICAL DEVICES Marvin M. Goldenberg, PhD, RPh, MS Name: SynerGraft Valve Manufacturer: CryoLife, Inc., Kennesaw, Ga. Approval Date: February 7, 2008 Use Classification: The SynerGraft Valve is the first replacement heart valve obtained from donated human tissue in which the cells have been removed. Description: The tissue’s cells and cellular debris are removed, but a scaffold of connective tissue remains and functions like a human heart valve, potentially lowering the risk of an immune response and tissue rejection. The pulmonary valve directs blood flow from the right ventricle to the lungs. Purpose: The device is indicated for DRUG DEVELOPMENT Creating New Drugs With Polyketides Many drugs used to treat cancer and lower cholesterol are made from organic compounds called polyketides. These compounds are found in nature but are difficult for chemists to alter and reproduce in large quantities. Scientists at the Vol. 33 No. 7 • July 2008 • P&T® 389 http://www.fda.gov http://www.fda.gov
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