Data di Pubblicazione:
2006
Citazione:
The effect of telithromycin in acute exacerbations of asthma / S.L. Johnston, F.B.A. Blasi, P.N. Black, R.J. Martin, D.J. Farrell, R.B. Nieman. - In: NEW ENGLAND JOURNAL OF MEDICINE. - ISSN 0028-4793. - 354:15(2006), pp. 1589-1600.
Abstract:
Background
We conducted a double-blind, randomized, placebo-controlled study to evaluate the
efficacy of telithromycin in patients with acute exacerbations of asthma.
Methods
A total of 278 adults with diagnosed asthma were enrolled within 24 hours after an
acute exacerbation of asthma requiring short-term medical care. The patients were
randomly assigned to receive 10 days of oral treatment with telithromycin (at a dose
of 800 mg daily) or placebo in addition to usual care. Primary efficacy end points
were a change from baseline over the treatment period in symptoms (as recorded
by patients in a diary card) and in the peak expiratory flow in the morning at home.
The presence of Chlamydophila pneumoniae or Mycoplasma pneumoniae was ascertained
by serologic analysis, polymerase chain reaction, and culture.
Results
Of the two prespecified primary outcomes, only asthma symptoms showed a significantly
greater reduction among patients receiving telithromycin than among those
receiving placebo. Mean (±SD) scores on a test of asthma symptoms (on a 7-point
scale, with 0 denoting no symptoms and 6 denoting severe symptoms) were 3.0±1.4
at baseline and 1.7±1.1 at the end of treatment for the telithromycin group and
2.8±1.3 at baseline and 2.0±1.0 at the end of treatment for the placebo group. The
mean decrease in symptom scores during the treatment period was 1.3 for telithromycin
and 1.0 for placebo (mean difference, −0.3; 95 percent confidence interval,
−0.5 to −0.1; P = 0.004). There was no significant treatment effect on the other primary
outcome measure, a change in morning peak expiratory flow. Nausea was more
common among patients in the telithromycin group than in the placebo group
(P = 0.01). Although 61 percent of patients had evidence of infection with C. pneumoniae,
M. pneumoniae, or both, there was no relationship between bacteriologic status and
the response to asthma treatment.
Conclusions
This study provides evidence of the benefit of telithromycin in patients with acute
exacerbations of asthma; the mechanisms of benefit remain unclear.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
asma ; infezioni ; antibiotici
Elenco autori:
S.L. Johnston, F.B.A. Blasi, P.N. Black, R.J. Martin, D.J. Farrell, R.B. Nieman
Link alla scheda completa: