Pharmacy & Therapeutics - March 2009 - (Page 129) NEW DRUGS continued from page 126 DRUG NEWS cancer was less likely to spread; in a third study, there was no effect. Bisphosphonates are not advised for all women with breast cancer. Many women taking hormonal therapy for breast cancer already take drugs to protect their bones. Hormonal therapy deprives the body of the bone-building effects of estrogen. Zoledronic acid and other bisphosphonates are approved to prevent further spread of cancer in bones. Zometa is indicated only for bone complications of cancer, such as fractures, but it is not approved as an osteoporosis drug. Researchers want to learn whether zoledronic acid might benefit patients to the same extent as chemotherapy or hormonal therapy alone. Sources: N Engl J Med 2009;360:679– 691; The New York Times, February 12, 2009 plasma levels of plasminogen activator inhibitor-1 (PAI-1) and coagulation factor VII, compared with their male counterparts. The novelty of the current study is that the effect of metabolic syndrome in hampering arterial recanalization appeared to be more marked in women than men. However, the study also revealed that the syndrome was an independent predictor of poor long-term outcomes in patients with acute stroke of the middle cerebral artery that had been treated with IV tissue-plasminogen activator (t-PA). Source: Stroke 2009;40:344–349 and in August 2009 for heparin. Source: U.S. Pharmacopeia, February 4, 2009, www.usp.org Can Osteoporosis Drugs Stop Spread of Breast Cancer? Premenopausal women with early hormone-responsive breast cancer who took bisphosphonates during adjuvant endocrine therapy appeared to have improved disease-free survival. Bisphosphonates are normally used to prevent and treat osteoporosis. Zoledronic acid (Zometa, Novartis), for example, is given to breast cancer patients who are receiving endocrine therapy to protect bone health. In the Austrian Breast and Colorectal Cancer Study Group trial, the addition of zoledronic acid reduced the risk of disease progression by 36% compared with adjuvant endocrine therapy alone. Toxicity was minimal. Zoledronic acid inhibits tumor-cell adhesion, invasion, and proliferation; induces tumor cell self-destruction; and stops cancer cells from growing new blood supplies. The new study involved 1,803 premenopausal women with estrogen-fueled tumors. Each woman received drugs to prevent the ovaries from making estrogen and medications to inhibit cancer cells from using estrogen to grow. The patients receiving zoledronic acid experienced a 36% reduction in cancer recurrence and metastasis, compared with controls. Cancer cells interact with osteoclasts, which break down bone. Breast cancer cells that migrate to the bones stimulate osteoclasts, which then produce substances that stimulate the cancer cells, resulting in a vicious circle. Osteoporosis drugs inhibit osteoclast activity. As the osteoclasts stop working, they die. In one study, when women took a bisphosphonate, cancer was less likely to spread and survival was prolonged. In another study, New Rules Protect Against Fake and Impure Drugs In recent times, counterfeit and adulterated medications have been posing an increasing risk to patients in the U.S. and throughout the world. In light of these events, the U.S. Pharmacopeial (USP) Convention has developed new standards for the anticoagulant heparin and the sweetener glycerin. These two products have been involved in episodes of adulteration resulting in patient deaths. More than 200 patients worldwide were reported to have died after batches of heparin were adulterated with oversulfated chondroitin sulfate, which can be derived from the chondroitin, a dietary supplement. Chondroitin sulfate can mimic heparin’s anticoagulant properties. Glycerin is used in many drugs, in cough syrups, and in toothpaste. It has been involved in episodes in which diethylene glycol, a poisonous chemical used in antifreeze, was added either intentionally or accidentally as a lowercost substitute for glycerin, most recently in Nigeria in 2008. After an opportunity for the public to comment, the standards are scheduled to be implemented in May 2009 for glycerin Good Hospital Practices Lead to Lower Death Rates From Heart Attacks Hospitals in western New York that used emergency treatment emphasizing evidence-based therapy and good communication among health care providers were able to reduce deaths from heart attacks by 19% for up to one year after patient discharge. Patients with acute coronar y syndromes (ACS) were admitted to the hospital via the emergency depar tment (ED). The lower mortality rate for these patients at one year after discharge indicated that they had continued their therapy after leaving the hospital. Improved communication among departments about the patients’ care appears to have made a significant difference in outcomes and the quality of care for these patients. This was the first study to investigate a critical-care pathway approach in patients with ACS. The pathway was initiated as soon as patients Vol. 34 No. 3 • March 2009 • P&T® 129 http://www.usp.org
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