Magazine article Drug Topics

Medical Community Divided on Need for New Asthma Drugs

Magazine article Drug Topics

Medical Community Divided on Need for New Asthma Drugs

Article excerpt

The first truly new asthma therapy in 20 years-leukotriene drugs-- have demonstrated that they can produce significant benefits. Some physicians, however, think the two long-awaited leukotriene drugs are unnecessary.

The negative comments emerged mainly at a symposium at the American Academy of Allergy, Asthma & Immunology convention, held recently at New Orleans. There, several speakers cited studies showing problems in implementing current therapies and indicated that focus should go to better use of existing drugs to solve treatment dilemmas.

Fans of the new leukotriene drugs, however, pointed to the same long string of studies showing widespread ignorance or disregard of asthma treatment guidelines. Also disturbing, they noted, are the years of increased mortality rates for asthma. Faced with these and other asthma dilemmas, physicians should welcome an effective new medication to help control asthma, according to some observers.

Supporters of the leukotriene drugs closest to approval-zileuton (Abbott Laboratories) and zafirlukast (Zeneca Pharmaceuticals)-also cite new data showing the long-anticipated drugs' safety and efficacy. Some data came from posters at the allergy meeting. A recently published Journal of the American Medical Association (JAMA) study also supports zileuton.

Soon after the March convention, a Food & Drug Administration advisory committee did not recommend zafirlukast for approval, because laboratory data showed the drug could interact with terfenadine (Seldane, Hoechst Marion Roussel) and Coumadin (warfarin sodium, DuPont Merck). Zeneca said a study already is in progress to supply more information about such potential interactions.

The committee earlier had sent zileuton back to the manufacturer requesting more data after a minority of patients showed elevated liver function tests. But Abbott recently gave the FDA data clarifying and resolving the safety issue, according to several physicians interviewed by Drug Topics at the convention. Physicians had only heard about and had not actually seen the data that allegedly showed elevations in a very small percentage of patients within the first 90 days of therapy; those levels were easily reversible. At the convention, Abbott had not released the data, but a new study in JAMA (March 27) showed similar trends.

The latest research released on zileuton came from a European study presented at the convention. Zileuton tablets given with low-dose beclomethasone (200 micrograms b.i.d.) showed efficacy similar to a higherdose regimen of beclomethasone alone (400 mcg b. …

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