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Beclomethasone

Classification: A

Drug products: AeroBec, AeroBec Autohaler, Beclomet® Easyhaler, Becotide®, Becotide® Nasal, Innovair, Innovair nexthaler

ATC code: R01AD01, R03AK08, R03BA01

Summary

A subgroup analysis of a large RCT study showed no sex differences in the effect of beclomethasone nasal aerosol. Larger controlled regarding sex differences in effect are lacking.

A cohort study in children showed that boys using corticosteroids as inhalation had a higher fracture risk than girls. Published controlled studies regarding sex differences in adverse effects are lacking.

A smaller study found generally poorer inhalation technique in women leading to lower effective dose.

Additional information

COPD (chronic obstructive pulmonary disease) affects more women than men and women often get a more serious and rapidly progressive disease [1]. Adult asthma is more common in women while childhood asthma is more common in boys. The reversal of this sex difference in prevalence occurs around puberty which suggests that sex hormones may play a role in the etiology of asthma [2]. However, some studies suggest that there are sex differences in expression and diagnosing of asthma, and it has been discussed if women are under-treated for respiratory diseases or not [3, 4].

Pharmacokinetics and dosing

The influence of sex on the pharmacokinetics of QVAR REDIHALER (beclomethasone dipropionate HFA) has not been studied [5]. 

Effects

In a subgroup analysis of a randomized, double-blind, placebo-controlled study of the efficacy of beclomethasone dipropionate nasal aerosol, no significant sex differences in efficacy were found. However, it was hard to draw conclusions from the subgroup analysis because of the small sample size of the subgroup [6].

Adverse effects

In a population-based cohort of children aged 4-17 years in the UK, it was found that the use of inhaled corticosteroids (beclomethasone dipropionate or equivalent) was associated with an increased fracture incidence and the risk of fractures for boys was generally higher than that for girls [7].

Reproductive health issues

Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).

Other information

In a retrospective population-based cohort study  investigating sex-specific drug utilization patterns in pediatric outpatient populations in Italy, no sex differences were found for acute inhaled beclomethasone. However, the prevalence of recurrent use of inhaled beclomethasone was higher in boys. This could suggest greater recurrent asthma episodes/exacerbation in boys and subsequently confirming the relationship between drug intake and prevalence of such disease in boys [8].

In a study on inhalation technique using metered dose inhalers (33 men, 26 women), 75% of the participants had an incorrect inhalation technique, especially women, regardless of age. Only 4% of women and 43% of men had an acceptable inhalation technique. The authors speculate that this may add to the worse asthma prognosis in women, shown in a meta-analysis of six trials of randomly assigned asthma treatment [9].

Several studies have shown worse prognosis for women with asthma. In an observational registry study (416 men, 498 women), women were found to have more asthmatic symptoms, worse quality of life and require more health care due to their asthma [10]. In a Danish prospective study on hospitalization due to asthma (6104 men of whom 2.5% had asthma, 7436 women of whom 2.2% had asthma), women had a 1.7 higher relative risk to be hospitalized [11]. An observational study from Singapore found hospitalization due to asthma to be more common in boys than girls aged 0-4 years (boys/girls ratio 1.69). In adults aged 35-64 years, women were more hospitalized (men/women ratio 0.81) [12].

Updated: 2021-01-25

Date of litterature search: 2020-12-02

References

  1. Nationella riktlinjer för vård vid astma och kroniskt obstruktiv lungsjukdom (KOL). Socialstyrelsen. [updated 2018-01-29, cited 2020-09-14]. länk
  2. Dharmage SC, Perret JL, Custovic A. Epidemiology of Asthma in Children and Adults. Front Pediatr. 2019;7:246. PubMed
  3. Dales RE, Mehdizadeh A, Aaron SD, Vandemheen KL, Clinch J. Sex differences in the clinical presentation and management of airflow obstruction. Eur Respir J. 2006;28:319-22. PubMed
  4. Tantisira KG, Colvin R, Tonascia J, Strunk RC, Weiss ST, Fuhlbrigge AL et al. Airway responsiveness in mild to moderate childhood asthma: sex influences on the natural history. Am J Respir Crit Care Med. 2008;178:325-31. PubMed
  5. QVAR REDIHALER (beclomethasone). DailyMed [www]. [updated 2020-10-14, cited 2020-12-02]. länk
  6. U.S. Food and Drug Administration. Medical Review - QNASL (beclometahosone). Drugs@FDA [www]. [updated 2013-06-10, cited 2020-12-02]. länk
  7. van Staa TP, Bishop N, Leufkens HG, Cooper C. Are inhaled corticosteroids associated with an increased risk of fracture in children?. Osteoporos Int. 2004;15(10):785-91. PubMed
  8. Ferrajolo C, Sultana J, Ientile V, Scavone C, Scondotto G, Tari M et al. Gender Differences in Outpatient Pediatric Drug Utilization: A Cohort Study From Southern Italy. Front Pharmacol. 2019;10:11. PubMed
  9. Goodman DE, Israel E, Rosenberg M, Johnston R, Weiss ST, Drazen JM. The influence of age, diagnosis, and gender on proper use of metered-dose inhalers. Am J Respir Crit Care Med. 1994;150:1256-61. PubMed
  10. Osborne ML, Vollmer WM, Linton KL, Buist AS. Characteristics of patients with asthma within a large HMO: a comparison by age and gender. Am J Respir Crit Care Med. 1998;157:123-8. PubMed
  11. Prescott E, Lange P, Vestbo J. Effect of gender on hospital admissions for asthma and prevalence of self-reported asthma: a prospective study based on a sample of the general population Copenhagen City Heart Study Group. Thorax. 1997;52:287-9. PubMed
  12. Ng TP, Niti M, Tan WC. Trends and ethnic differences in asthma hospitalization rates in Singapore, 1991 to 1998. Ann Allergy Asthma Immunol. 2003;90:51-5. PubMed
  13. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2019 [cited 2020-03-10.] länk

Authors: Ishita Huq

Reviewed by: Diana Rydberg

Approved by: Karin Schenck-Gustafsson