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| MAP Helps Transplant Recipients Receive Over $3.3 Million in Medications | Statins and Risk of Polyneuropathy | New Medications: Bextra® (valdecoxib) ; Zelnorm® (tegaserod maleate) |
| MAP Helps
Transplant Recipients Receive Over $3.3 Million in Medications The mission of the Medication Access Program (MAP) is to increase access to medications for solid-organ transplant recipients who reside in the State of Georgia. From October 1999 through December 2002, MAP has aided over 300 Georgia solid-organ transplant recipients in the enrollment process required to participate in medication assistance programs. Through MAP’s services, these recipients have received over $3.3 million in medications, based on average wholesale prices. These medications mostly represent immunosuppressants, cardiovascular, antimicrobial, gastrointestinal, and other necessary prescription medications. MAP also serves as a valuable resource to healthcare professionals and transplant recipients by providing the most up-to-date information concerning medication assistance programs. MAP is made possible by the Carlos and Marguerite Mason Trust and the University of Georgia College of Pharmacy. For more information, MAP personnel may be reached Monday through Friday from 9AM to 5PM by calling (706) 721-0131 or 800-736-2273 ext. 0131. |
| Statins
and Risk of Polyneuropathy In a recent case controlled study in Denmark (Gaist et al, Neurology 2002, 58: 1333-37), a link was established between long term “statin” use and the incidence of polyneuropathy. Investigators identified 166 cases of first time diagnosis of idiopathic polyneuropathy from the Funen County hospital region. Thirty-five of these cases were considered definite polyneuropathy, 54 were probable, and 77 were classified as possible. Nine patients of the 35 definite cases were on “statin” therapy. The median time of therapy was 2.8 years. Doses and the “statin” used varied among patients. “Statin” users were at a 4- to 14- fold increase in developing idiopathic polyneuropathy compared to the general population. The mechanism of action of the polyneuropathy was unknown, although it appears to be a drug class effect related to “statins”, as several of the “statins” have been reported to cause the effect. A proposed mechanism is the inhibition of ubiquinone, which disturbs neuron energy utilization and therefore may induce neuropathy. Although this information is concerning, the role of “statins” in reducing cholesterol still makes them first line agents in treating hyperlipidemia. Authored by Shawn Konwick |
| New Medications Bextra® (valdecoxib) Bextra® (valdecoxib) is a nonsteroidal anti-inflammatory drug (NSAID) manufactured by Pharmacia/Pfizer. It decreases proinflammatory prostaglandin synthesis by selectively inhibiting cyclooxygenase (COX-2), and it is indicated for the treatment of osteoarthritis, rheumatoid arthritis, and primary dysmenorrhea. Bextra® is structurally similar to Celebrex® (celecoxib) and Vioxx® (rofecoxib). However, due to the inhibition of COX-2, Bextra® is less likely to cause upper gastrointestinal toxicity, as compared to other NSAIDS. Concurrent use with aspirin may increase the risk of gastrointestinal toxicity. This drug is metabolized by the cytochrome P450 isoenzymes, CYP3A4 and CYP2C9, therefore, there is a potential for drug interactions. Plasma concentrations peak in 3 hours, however, this peak occurs earlier when taken with food. Its half-life is about 8 to 11 hours. In clinical trials, Bextra® therapy was as effective in relieving pain and stiffness as naproxen, and was significantly more effective than placebo in osteoarthritis patients. In rheumatoid arthritis patients, it was shown to improve pain, function, erythrocyte sedimentation rate, tenderness, and swollen joints by 20% after 3 months of therapy. In relieving moderate-to-severe pain associated with menstruation, Bextra® was significantly more effective than placebo. Higher dosages were more effective and comparable to naproxen sodium. Bextra® is contraindicated in patients with known hypersensitivity to valdecoxib, and in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or NSAIDS. Adverse effects include dyspepsia, abdominal pain, headache, upper respiratory tract infection, nausea, and diarrhea. The recommended dosage for osteo- or rheumatoid arthritis is 10 mg once daily. For primary dysmenorrhea, the dosage should be 20 mg twice daily, as needed. Lower dosages of Bextra® may be needed for patients with hepatic or renal insufficiency. This drug may be taken with or without food. Bextra® is available in 10 mg and 20 mg tablets. A patient assistance program is available for Bextra®. For further information please contact MAP at (706) 721-0131 or Pharmacia/Pfizer at 1-888-4-BEXTRA. Authored by Sharita L. Golphin, Pharm.D. Zelnorm® (tegaserod maleate) Zelnorm® is now available by Novartis in 2 mg and 6 mg tablets for oral administration. It is FDA approved for short-term use in women with irritable bowel syndrome whose primary symptom is constipation. Zelnorm® is a serotonin derivative that activates the 5-HT4 receptors in the gastrointestinal tract (GIT), thereby increasing GIT motility and decreasing visceral sensation. Due to decreased bioavailibility, Zelnorm® should be taken 30-60 minutes prior to food ingestion. The recommended dosage is 6 mg orally twice daily before meals. Dosage adjustments are not required for age or mild to moderate renal insufficiency. Zelnorm® is contraindicated in patients with severe renal insufficiency, hepatic impairment, history of bowel obstruction, gall bladder disease, spinchter dysfunction, or intestinal adhesions. One clinical study suggests an approximate 12% reduction of constipation versus placebo (SA Muller-Lissner. 2001: 15(10): 1655-66, 2001 Oct). Improvement of symptoms generally begins within 1 week of treatment. No clinically significant drug interactions have been reported. The main side effect of Zelnorm® was diarrhea, which occurred in approximately 9% of patients, was usually limited to 1 episode which was resolved without discontinuing the medication. According to Drug Topics Red Book Update, September 2002, the AWP for 60 tablets of either strength was approximately $148. A patient assistance program is available. For more information, please contact the MAP office at (706) 721-0131 or Novartis at (973) 503-8300. Authored by Shaun Blum |
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community. If you would like to submit material to be considered for publication in the newsletter, please contact MAP at: Medication Access Program University of Georgia at the Medical College of Georgia Clinical Pharmacy Program CJ-1020 Augusta, Georgia 30912-2450 (706) 721-0131 or 1-800-736-2273 ext. 0131 E-mail - map@mapuga.com |
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The Medication
Access Program is a statewide program for solid-organ transplant patients
in Georgia that offers information about medication assistance programs
and helps with the enrollment into these programs.
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