Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
PR Newswire - 27 December 1995
"Patients with advanced AIDS who are severely immunocompromised are at high risk for disseminated MAC," says Mark Pierce, M.D., of the Vanderbilt University School of Medicine. "When used as a preventive agent, clarithromycin can reduce the risk of disseminated MAC. The study has shown that the prophylactic use of clarithromycin extends the lives of patients with advanced AIDS."
While only approximately 3 percent of HIV-positive patients are diagnosed with disseminated MAC at the time of AIDS diagnosis, studies have shown that up to 40 percent of these patients show clinical evidence of disseminated MAC within two years. In addition, MAC has been confirmed post-mortem in up to 50 percent of patients with advanced AIDS.
Clinical trial results demonstrated that clarithromycin is effective in reducing the risk of developing disseminated MAC disease in patients with advanced AIDS. In a randomized, double-blind, placebo-controlled study conducted in the U.S. and Europe, patients with advanced AIDS (CD4 cell counts less than or equal to 100 cells) and a negative MAC blood culture received either clarithromycin 500 mg twice daily (n=341) or placebo twice daily (n=341). The median duration of treatment with clarithromycin was 10.6 months, as compared to a median duration of 8.2 months for the placebo-treated group. The risk of developing disseminated MAC was reduced by a statistically significant 69 percent in the clarithromycin-treated patient group, compared to placebo.
The clarithromycin regimen was well tolerated by study participants. The only adverse event significantly more common among patients treated with clarithromycin than placebo was taste perversion. Other adverse events occurring in 4 percent of more of the patients taking clarithromycin include abdominal pain (5 percent vs. 3.5 percent), diarrhea (7.7 percent vs. 4.1 percent), nausea (11.2 percent vs. 7.1 percent), and vomiting (5.9 percent vs. 3.2 percent). Clarithromycin should not be used in pregnant women except in circumstances where no alternative therapy is appropriate. Clarithromycin should not be used in patients receiving terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances.
A statistically significant survival benefit was observed with clarithromycin.
Mortality was reduced by 31 percent, 31 percent, and 20 percent at 6, 12, and 18 months, respectively. Since the analysis at 18 months includes patients no longer receiving prophylaxis, the survival benefit of clarithromycin may be underestimated.
Disseminated MAC developed in 19 of the 341 patients receiving clarithromycin.
Eleven of the patients developed strains of MAC which were resistant to clarithromycin. None of the 53 MAC isolates in the placebo group were resistant to clarithromycin.
Abbott Laboratories is a worldwide manufacturer of health care products, employing 50,000 people. In 1994, the company's sales and net earnings were $9.2 billion and $1.5 billion, respectively, with earnings per share of $1.87.
NOTE: Full prescribing information is available from Abbott Laboratories.
CONTACT: Douglas Petkus, 708-938-3531, or Laureen Cassidy, 708-938-7743, both of Abbott Laboratories/ 13:33 EST
Copyright (c) 1995/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
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