Recently released information about a safety trial on the asthma drug Serevent indicates that blacks who took the drug were four times as likely to have life threatening respiratory episodes or deaths as blackks who did not take the drug. No similar dicrepancy was observed among whites, however.
The trial, conducted in 2003, was terminated early and the findings resulted in the FDA requiring the addition of a “black box” warning on the product label for both of GlaxoSmithKline’s (GSK) asthma drugs Serevent and Advair.
Of the 13,176 subjects treated with Serevent for 28 weeks, 13 died. Only three deaths were reported among the 13,179 participants who did not take the drug.
Significantly, of the 13 deaths, seven were black (53.8%) despite the fact that blacks represented only 18% of the total study population.
The results of the trial, called Salmeterol Multicenter Asthma Research Trial (SMART), appear in the January issue of the journal Chest.
These significant findings were first reported to the Food and Drug Administration in 2003
These significant findings were first reported to the Food and Drug Administration in 2003. As mentioed above, thisa resulted in Serevent and Advair being required to have a black-box warnings added to their labels.
The warning states that use of the drug in the clinical study caused a “small but significant increase in asthma-related deaths.” A separate advisory states: “Data from this study further suggests that the risk might be greater in African-American patients.”
Dr. Harold S. Nelson, a professor of medicine at Denver’s National Jewish Medical and Research Center, said that the apparent racial difference found in the study is probably not due to genetic or other physiologic differences between blacks and whites.
Dr. Nelson, who lead the research (and is also a consultant and speaker for GSK), believes that economically disadvantaged black participants may have had poorer control of their underlying disease.
According to Nelson, a disproportionate number of black patients who died or had life-threatening asthma-related events in the study were not taking an inhaled corticosteroid. “In the patients who were not on inhaled corticosteroids, [Serevent] may have relieved their symptoms but masked their worsening asthma.”
Dr. Steven E. Gay, a member of the FDA advisory panel that evaluated the safety of long-acting beta-antagonists
Dr. Steven E. Gay, a member of the FDA advisory panel that evaluated the safety of long-acting beta-antagonists like Serevent, Advair, and Foradil (Schering-Plough), said that these drugs are excellent for providing additional relief to those patients who are also using inhaled corticosteroids to manage their asthma condition. As a result, the panel recommended that the drugs be kept on the market in the U.S.
As a long-acting beta-agonists, Serevent and Advair treat the symptoms of asthma but not the inflammation that causes it. Both Serevent and Advair contain the active ingredient salmeterol, but Advair also contains an inhaled corticosteroid.
Currently long-acting beta-agonists are recommended only as an additional treatment. for asthma patients. Patients using the durg should also be taking an inhaled corticosteroid to reduce inflammation and treat the underlying cause of their condition.
Gay says that further research is needed to determine if Serevent and other long-acting beta-agonists are truly dangeous to blacks. In the meantime it is the repsonsibility of doctors to insure they are used properly and to monitor patients carefully. He believes these “drugs clearly still have a role in the treatment of asthma. I monitor my African-American patients who are on the drugs closely for changes in their asthma, as I do all my patients who take them.”