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Anti-leukotrienes as add-on therapy to inhaled glucocorticoids in patients with asthma: systematic review of current evidence

BMJ 2002; 324 doi: https://doi.org/10.1136/bmj.324.7353.1545 (Published 29 June 2002) Cite this as: BMJ 2002;324:1545
  1. Francine M Ducharme (Francine.ducharme{at}muhc.mcgill.ca), associate professor
  1. Departments of Paediatrics and of Epidemiology and Biostatistics, McGill University Health Centre, Montreal, QC H3H 1P3, Canada
  • Accepted 13 December 2001

Abstract

Objectives: To examine the evidence for the efficacy and glucocorticoid sparing effect of oral anti-leukotrienes taken daily as add-on therapy to inhaled glucocorticoids in patients with asthma.

Design: Systematic review of randomised controlled trials of children and adults with asthma comparing the addition of anti-leukotrienes or placebo to inhaled glucocorticoids.

Main outcome measures: The rate of exacerbations of asthma requiring rescue systemic glucocorticoids when the intervention was compared to the same or double dose of inhaled glucocorticoids, and the glucocorticoid sparing effect when the intervention was aimed at tapering the glucocorticoid.

Results: Of 376 citations, 13 were included: 12 in adult patients and one in children. The addition of licensed doses of anti-leukotrienes to inhaled glucocorticoids resulted in a non-significant reduction in the risk of exacerbations requiring systemic steroids (two trials; relative risk 0.61, 95% confidence interval 0.36 to 1.05). No trials comparing the use of anti-leukotrienes with double the dose of inhaled glucocorticoids could be pooled. The use of anti-leukotrienes resulted in no overall group difference in the lowest achieved dose of inhaled glucocorticoids (three trials; weighted mean difference −44.43 μg/day, −147.87 to 59.02: random effect model) but was associated with a reduction in withdrawals owing to poor asthma control (four trials; relative risk 0.56, 0.35 to 0.89).

Conclusions: The addition of anti-leukotrienes to inhaled glucocorticoids may modestly improve asthma control compared with inhaled glucocorticoids alone but this strategy cannot be recommended as a substitute for increasing the dose of inhaled glucocorticoids. The addition of anti-leukotrienes is possibly associated with superior asthma control after tapering of glucocorticoids, but the glucocorticoids sparing effect cannot be quantified at present.

What is already known on this topic

What is already known on this topic Anti-leukotrienes are increasingly being used as add-on therapy to inhaled glucocorticoids

No systematic review of randomised controlled trials has examined the evidence to support this treatment strategy

What this study adds

What this study adds There is a shortage of relevant trials testing anti-leukotrienes at licensed doses as add-on therapy to inhaled glucocorticoids in patients, particularly children

Footnotes

  • Funding FMD was supported by a salary award of the Fonds de la Recherche en Santé du Québec. Ritz Kakuma was supported by the Canadian Cochrane Network.

  • Competing interests FMD has received travel support, research funds, and fees for speaking from both Zeneca Pharma, producer of zafirlukast, and from Merck Frosst, producer of montelukast. She has received some travel support for attending meetings, a research grant, and consulting fee from Glaxo Wellcome, producer of some inhaled corticosteroids preparations to which anti-leukotriene agents have been compared.

  • Accepted 13 December 2001
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