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Treating severe asthma attacks with azithromycin, a popular antibiotic better known as Zithromax, Z-Pak or Zmax, does not appear to improve patient symptoms or speed recovery, according to the findings of new research.
In a study published this week in the medical journal JAMA Internal Medicine, researchers compared individuals treated with azithromycin to those who received no treatment, or placebo, following severe asthma attacks. They concluded patient symptoms were the same from the onset of symptoms through day 10, following the asthma attack.
Researchers from the Azithromycin Against Placebo in Exacerbations of Asthma (AZALEA) clinical trial focused on adults who needed emergency care for acute asthma attacks.
The randomized, double-blind, clinical trial was conducted from September 2011 to April 2014 in United Kingdom emergency rooms.
Adults with a history of asthma for more than 6 months were recruited in emergency rooms within 48 hours of the onset of acute asthma symptoms that required a course of oral antibiotics or corticosteroids. Patients were then randomized into one of two groups. One group was given 500 mg of azithromycin daily for three days, the other group was given a placebo for three days.
More than 4,500 patients were screened at 31 centers. Among the many patients, nearly 2,000 weren’t recruited simply because they had already been given antibiotics by their ER doctor or received a round of antibiotics in the 28 days before the study began.
Nearly 200 people were included in the study. The average time from the onset of symptoms to being given a drug or placebo was 22 hours.
Overall, researchers concluded the symptom scores of patients who received antibiotics and those that received the placebo were very similar and had no significant difference. Patients were scored on symptoms such as wheezing, breathlessness, and coughing at onset and again each day until day 10.
Patients who took azithromycin had average asthma scores of 4.14 at onset of symptoms and were reduced to 2.09 by day 10. Comparatively, patients who received the placebo had average asthma scores of 4.18 at onset and scores were reduced to 2.2 by day 10.
Researchers said there was no significant difference in symptom scores between azithromycin and a placebo at day 10, or on any day between onset of symptoms and day 10.
Adverse events occurred more often in the azithromycin group, mostly experiencing gastrointestinal problems. However, azithromycin side effects have been linked to more serious conditions, including heart problems.
The FDA issued an azithromycin drug safety communication in March 2013, warning that the antibiotic can cause serious and potentially fatal abnormal heart activity. The FDA indicated that azithromycin can disrupt the electrical activity of the heart. The agency’s conclusions came after an investigation into the risk of azithromycin heart issues that was started in May 2012, examining data from a number of studies.
In May 2012, a study published in the New England Journal of Medicine first warned about the potential heart risks. Researchers found patients were 2.5 times more likely to die due to heart related problems on a five day azithromycin treatment when they compared it to treatment with other antibiotics or no antibiotic therapy.
Health officials are also concerned with how frequently most Americans use antibiotics, linking the overuse to the development of drug resistant “superbugs.”
Drug resistant bacteria caused nearly two million illnesses and 23,000 deaths in the U.S. each year. One in three antibiotic prescriptions written in U.S. is considered unnecessary.