Issue 11 July 2002
MAP Helps to Provide Over $2.7 Million to Transplant Patients	The LIFE Trial	New Medications: Aranesp® (Darbepoetin alfa)

Map Helps to provide Over $2.7 Millions to Transplant Patients The Medication Access Program (MAP) is a statewide program for solid-organ transplant patients in Georgia that offers information about Medicare, Medicaid, and pharmaceutical manufacturer- sponsored medication assistance programs. The mission of MAP is to increase access to medications for solid-organ transplant patients who reside in the State of Georgia. MAP is available through a grant from the Carlos and Marguerite Mason Trust and the University of Georgia College of Pharmacy. Financial circumstances resulting from a lack of insurance for medication coverage may force transplant patients to become noncompliant with medications. Noncompliance with immuno-suppressants and other critical transplant medications may lead to organ rejection, increased health care cost, and decreased quality of life. MAP aids transplant patients in the enrollment process required to participate in medication assistance programs. If the patient meets selection criteria for a specific program, MAP personnel will assist the patient in the enrollment process. Additionally, MAP is a valuable resource to healthcare professionals and transplant patients by providing the most up-to-date information regarding available medication assistance programs. MAP provides information about assistance pro-grams that provide immuno-suppressant medications and medications for concomitant disease states that may develop in transplant patients. These disease states include, but are not limited to, hypertension, diabetes, chronic obstructive pulmonary disease and lipid disorders. From October 1999 through July 2002, MAP has aided over 260 Georgia solid-organ transplant patients. Through MAP's services, these patients have received over $2.7 million in medications, based on average wholesale prices. We encourage all transplant patients and healthcare professionals to contact MAP. MAP personnel may be reached Monday through Friday from 9:00 AM to 5:00 PM by calling (706) 721-0131 or 1-800-736-2273 ext. 0131.

The LIFE Trial The results the study entitled "Cardiovascular morbidity and mortality in the Losartan Intervention for Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol" was published in Lancet. Investigators found that losartan prevented more cardiovascular morbidity and death for a similar reduction in blood pressure, than atenolol. This study was a double-masked, randomized, parallel group trial consisting of 9193 essential hypertension participants with left ventricular hypertrophy (LVH). The participants' ages were from 55 to 80 years. Participants were assigned to once daily losartan-based or atenolol-based antihypertensive treatment for at least 4 years, and until 1040 participants had a primary cardiovascular event (death, myocardial infarction, and stroke). Results of the trial indicated a reduction of blood pressure by 30.2/16.6 (SD 18.5/10.1) and 29.1/16.8 mmHg (SD 19.2/10.1) in the losartan and atenolol groups, respectively. The primary composite endpoint occurred in 508 losartan and 588 atenolol patients (p=0.02). Investigators reported that 204 losartan and 234 atenolol patients died from cardiovascular disease (p=0.21); whereas, 198 losartan and 188 atenolol patients had fatal or non-fatal myocardial infarction (p=0.49). Two hundred and thirty-two losartan and 309 atenolol patients experienced a fatal or non-fatal stroke (p=0.001). It was also reported that new-onset diabetes was less frequent with losartan. Based on these results, the investigators concluded that losartan seems to have benefits beyond blood pressure reduction. For more information concerning this study refer to Lancet 2002;359:995-1003.

New Medications Aranesp® (Darbepoetin alfa) Aranesp® (Darbepoetin alfa) was approved by the FDA in September 2001 for the treatment of anemia in chronic renal failure patients. It stimulates red blood cell production by acting on erythroid progenitor cells, and can be administered either intravenously (IV) or subcutaneously (SC). Aranesp® is manufactured by Amgen, Inc. In clinical trials, Aranesp® has been evaluated for safety and efficacy in de novo users and in users who were previously on other recombinant erythropoietins. In one de novo study, Aranesp® 0.45mcg/kg SC administered once a week was found to be as effective in increasing hemoglobin levels as epoetin 50 U/kg SC given two or three times a week. Aranesp® increased hemoglobin levels within the first 4 weeks of treatment by an average of 1.1 g/dL in dialysis patients, and 1.38 g/dL in patients who were not receiving dialysis (Locatelli et al, Kidney Int 2001;60:741-747). Aranesp® is contraindicated in patients with uncontrolled hypertension, and in patients with known hypersensitivity to the active substance in it or to any of the excipients in the formulations. Like epoetin, darbepoetin is also associated with an increase in cardiovascular events, including vascular access thrombosis, stroke, and myocardial infarction with a hemoglobin increase of greater than 1g/dL in a two week period. Common adverse effects of Aranesp® include infection, hypotension, hypertension, myalgia, headache, and diarrhea. The recommended beginning dose of Aranesp® is 0.45mg/kg IV or SC given once a week. After initiation of Aranesp® therapy, increased hemoglobin levels usually require 2-6 weeks. If the hemoglobin concentration approaches 12g/dL or increases by greater than 1g/dL in a two week period, the dose should be decreased by 25%. The maintenance dose should be individualized, and determined by calculating the dose needed to achieve a hemoglobin level of 12g/dL. There have been no formal studies evaluating Aranesp® for drug interactions with other medications. Aranesp® is available as single-dose vials containing 25, 40, 60, 100, or 200 mcg of Aranesp® in either a polysorbate 80 or albumin (human) formulation. A patient assistance program is available for Aranesp®. For further information concerning the assistance program, please contact MAP at (706) 721-0131, or Amgen, Inc. at 1-800-272-9376. Authored by Cassandra Cobo

The MAP newsletter is published quarterly to present topics of interest to the transplant 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

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.