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NEW OPTION FOR TREATING PCP IN AIDS PATIENTS DEMONSTRATES BENEFIT

 /ADVANCE/RESEARCH TRIANGLE PARK, N.C., May 26 /PRNewswire/ -- A newly published study supports the conclusion that Mepron(R) brand atovaquone is a beneficial treatment for mild to moderate cases of Pneumocystis carinii pneumonia (PCP) in AIDS patients intolerant to standard therapy.
 Appearing in the May 27 issue of The New England Journal of Medicine, the study reports the results of a clinical trial that compared Mepron with trimethoprim-sulfamethoxazole (TMP-SMX) for treatment of PCP, the most common and often deadly opportunistic infection associated with AIDS.
 The study was conducted in major medical centers in the United States, Europe and Canada, and compared Mepron to TMP-SMX in 322 patients with mild to moderate PCP. Data from the study showed TMP-SMX to be the more effective of the two drugs in fighting PCP infection. However, its substantial side effects, including vomiting, nausea, fever, rash, liver damage, kidney failure, headache and chills, significantly limited the number of patients who could take TMP-SMX. Conversely, Mepron showed considerable anti-PCP activity while also being tolerated by a much higher percentage of patients.
 "The results of this study show that physicians have another useful medication for managing patients with mild to moderate PCP," said Sandra Nusinoff Lehrman, M.D., vice president of infectious disease, immunology and biotechnology at Burroughs Wellcome Co. "The availability of an effective and easily tolerated alternative to TMP-SMX will improve treatment options for PCP in patients with HIV infection."
 In the double-blind study, led by Dr. Walter Hughes at St. Jude's Children's Research Hospital in Memphis, Tenn., patients were randomized and given either Mepron or TMP-SMX for 21 days unless lack of response or drug toxicity occurred.
 Of the 160 PCP patients treated with Mepron, 28 (20 percent) failed to respond, while 10 (7 percent) of the 162 patients in the TMP-SMX group were non-responders. However, only 11 patients (7 percent) in the Mepron group experienced treatment-limiting side effects compared with 33 (20 percent) in the TMP-SMX group.
 Therapeutic success in the study was defined as sustained improvement in clinical and respiratory measures at least four weeks after discontinuing study medication without having the discontinuation due to treatment failure or adverse effects. Overall, the therapeutic success rates were similar in both groups of patients (62 percent Mepron; 64 percent TMP-SMX).
 More than half of patients with AIDS experience adverse effects when treated with either TMP-SMX or intravenous pentamidine, the other marketed drug for PCP treatment. Pentamidine is associated with treatment limiting side effects which include hypotension, hypoglycemia, renal failure and cardiac arrhythmias.
 "Physicians have been limited in treating PCP if patients either failed TMP-SMX therapy or couldn't withstand its side effects," said Lehrman. "We are especially pleased that Mepron fills an unmet need in the treatment of patients with PCP."
 Mepron was released for marketing in November 1992 by the U.S. Food & Drug Administration for the acute oral treatment of mild to moderate PCP in patients intolerant of TMP-SMX. Its profile has been well documented in clinical trials and expanded use programs involving more than 1,300 individuals. Side effects most commonly associated with Mepron include headache, nausea, diarrhea, rash, fever and elevated liver enzymes.
 The study was sponsored by Burroughs Wellcome Co. and supported in part by the AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases and the Department of Critical Care Medicine, Clinical Center, National Institutes of Health.
 Burroughs Wellcome Co., a research-based pharmaceutical company with headquarters in Research Triangle Park, N.C., continues to support a broad research program to develop innovative therapies for a number of serious illnesses, including HIV infection. The company is a member of The Wellcome Group which discovers, develops, produces and markets quality healthcare products worldwide.
 -0- 5/26/93/1800
 /EDITOR'S NOTE: For a complete listing of co-authors and participating investigators, please call (919)248-8611.
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 /CONTACT: Kathy Bartlett, 919-248-4302, or Doug Stokke, 919-248-8611, both of Burroughs Wellcome Co./


CO: Burroughs Wellcome Co. ST: North Carolina IN: MTC SU: PDT

SB -- CH008 -- 3607 05/26/93 13:54 EDT
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Date:May 26, 1993
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