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Budesonid – oral inhalation

Classification: A

Drug products: Assieme forte Turbuhaler, Assieme mite Turbuhaler, Assieme Turbuhaler, Budesonid 2care4, Budesonid Arrow, Budesonid Orifarm, Budesonid Teva, Budesonide STADA, Budesonide Teva Pharma, Bufomix Easyhaler, DuoResp Spiromax, Giona Easyhaler®, Novopulmon® Novolizer®, Pulmicort, Pulmicort Turbuhaler, Pulmicort®, Pulmicort® Turbuhaler®, Rilast forte Turbuhaler, Rilast Turbuhaler, Sinestic forte Turbuhaler, Sinestic Turbuhaler, Symbicort, Symbicort forte Turbuhaler, Symbicort mite Turbuhaler, Symbicort Turbuhaler, Symbicort® forte Turbuhaler®, Symbicort® mite Turbuhaler®, Symbicort® Turbuhaler®

ATC code: R03AK07, R03BA02

Summary

A large cohort study found no sex-difference in effect of different asthma therapies. Individuals above the age of 30 were more likely to have treatment failure but it was similar for men and women.

A smaller study found women to have a poorer inhalation technique, thus risking lower effective dose.

Despite the described findings we do not recommend to generally differentiate the use for men and women but emphasize the importance of ensuring a good inhalation technique.

Additional information

Some studies suggest that there are sex differences in expression and diagnosing of asthma, and it has been discussed whether women are under-treated for respiratory diseases or not [5, 6].

Pharmacokinetics and dosing

According to population pharmacokinetic studies conducted by the manufacturer, no differences in pharmacokinetics have been identified due to sex or age for inhalation of budesonide [7]. Persons with lower body weight may have higher bioavailability of budesonide [8].

Effects

A large cohort study (520 men, 680 women) investigated the impact of sex and age on response to asthma therapy (including salbutamol, salmeterol, inhaled budesonide, zafirlukast, montelukast, beclomethasone and inhaled corticosteroids). There was no difference between men and women in treatment failure for any individual therapy. Individuals aged 30 years and older were more likely to have treatment failure but the risk was similar for men and women [9].

Results from controlled clinical trials conducted by the manufacturer showed similar symptom reduction to budesonide suspension in both boys and girls aged 1-8 years [7].

Adverse effects

In a study of patients with asthma on inhaled budesonide and beclomethasone (12 men, 18 women), a significant decrease in BMD at the hip and lumbar spine was seen in premenopausal women but not in men, when compared to healthy subjects [10].

Reproductive health issues

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

Other information

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 [1].

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 [2]. 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 [3]. 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) [4]. In a Japanese survey of adult patients receiving inhaled fluticasone, budesonide or beclomethasone (in total 1017 men, 1118 women), budesonide was more frequently prescribed to young women (59%) than men [11].

Updated: 2019-04-08

Date of litterature search: 2017-03-02

References

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. Budesonid inhalation (budesonide) suspension. DailyMed [www]. US National Library of Medicine. [updated 2016-12-07, cited 2017-03-02]. länk
  8. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - Symbicort (budesonide/formoterol) Inhalation Aerosol. Food and Drug Administration [www]. [updated 2008-10-30, cited 2017-03-02]. länk
  9. Dunn RM, Lehman E, Chinchilli VM, Martin RJ, Boushey HA, Israel E et al. Impact of Age and Sex on Response to Asthma Therapy. Am J Respir Crit Care Med. 2015;192:551-8. PubMed
  10. Ip M, Lam K, Yam L, Kung A, Ng M. Decreased bone mineral density in premenopausal asthma patients receiving long-term inhaled steroids. Chest. 1994;105:1722-7. PubMed
  11. Ota K, Hasegawa T, Koya T, Sakagami T, Sekikawa T, Toyabe S et al. Analysis of inhaled corticosteroid selection in patients with bronchial asthma using a questionnaire survey--effects of age, gender, and disease severity. Allergol Int. 2009;58:365-71. PubMed
  12. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2016 [cited 2017-03-23.] länk

Authors: Linnéa Karlsson Lind

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson