Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Formoterol

Klassificering: A

Preparat: Assieme forte Turbuhaler, Assieme mite Turbuhaler, Assieme Turbuhaler, Bufomix Easyhaler, DuoResp Spiromax, Flutiform, Flutiform K-haler, Foradil HFA, Foradil®, Formatris Novolizer, Oxez Turbuhaler, Oxis Turbuhaler, Oxis® 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 kod: R03AC13, R03AK07, R03AK11

Substanser: formoterol, formoterolfumaratdihydrat

Sammanfattning

En studie på patienter med KOL som behandlats med formoterol/budesonid visade att kvinnor hade en ökad risk för exacerbationer. Inga könsskillnader i effekt eller farmakokinetik har observerats.

En mindre studie fann generellt sämre inhalationsteknik hos kvinnor vilket gav lägre effektiv dos.

Additional information

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 [5, 6].

Pharmacokinetics and dosing

According to studies conducted by the manufacturer, no sex differences in pharmacokinetics have been identified for inhalation of either formoterol or budesonide [7, 8].

Effects

A randomized, open-label, crossover trial compared efficacy of formoterol and ipratropium/salbutamol in patients with chronic obstructive pulmonary disease (COPD) (49 men, 50 women). Post-hoc subgroup analyses showed that pre-dose FEV1 after two weeks was improved with formoterol when compared to ipratropium/salbutamol in men but not in women. Transition Dyspnea Index after two weeks was similar between treatments and in men and women [9].

A post hoc analysis of data from a randomized double-blind study in COPD patients (169 men, 86 women) showed that combination therapy of tiotropium and formoterol was more efficacious on FEV1 than tiotropium monotherapy in both men and women [10].

Adverse effects

Except for events such as exacerbations in COPD no studies with a clinically relevant sex-analysis of adverse effects of formoterol have been found.

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].Predictors for exacerbations in COPD patients was identified by analyzing data from clinical trials of formoterol/budesonide in patients with a history of exacerbations (2017 men, 1124 women). Multivariate analyses showed that female sex was one of the predictors of increased risk of exacerbations (HR 1.32). When data was analyzed separately for men and women, identified predictors in men were the same as for to the whole study population. In women, the same predictors were identified with the exceptions; ‘number of COPD exacerbations during the previous year’ was not one of the predictors while total score on the St George’s Respiratory Questionnaire was one [11].

Försäljning på recept

Fler kvinnor än män hämtade ut inhalationspulver innehållande formoterol (ATC-kod R03AC13) på recept i Sverige år 2016, totalt 30 810 kvinnor och 19 235 män. Det motsvarar 6,3 respektive 3,9 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 70–79 år hos kvinnor och i åldersgruppen 80–84 år hos män. I åldersgruppen 0-14 år var inhalationspulver innehållande formoterol i genomsnitt 1,5 gånger vanligare hos pojkar, i åldersgruppen 15-84 år i genomsnitt 1,6 gånger vanligare hos kvinnor och i åldersgruppen 85 år och äldre 1,1 gånger vanligare hos män [12].

Kombinationsprodukter,,Fler kvinnor än män hämtade ut läkemedel innehållande kombination av formoterol och budesonid (ATC-kod R03AK07) på recept i Sverige år 2016, totalt 111 392 kvinnor och 84 573 män. Det motsvarar 23 respektive 17 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 70–79 år hos kvinnor och i åldersgruppen 80 år och äldre hos män. I åldersgruppen 0–19 år var läkemedel innehållande kombination av formoterol och budesonid i genomsnitt 1,4 gånger vanligare hos pojkar, i åldersgruppen 20–84 år i genomsnitt 1,3 gånger vanligare hos kvinnor och i åldersgruppen 85 år och äldre 1,2 gånger vanligare hos män [12].

Fler kvinnor än män hämtade ut inhalationsspray innehållande kombination av formoterol och flutikason (ATC-kod R03AK11) på recept i Sverige år 2016, totalt 2 242 kvinnor och 1 443 män. Det motsvarar 0,5 respektive 0,3 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 85 år och äldre hos båda könen. I åldersgruppen 0–14 år var inhalationsspray innehållande kombination av formoterol och flutikason i genomsnitt 3,2 gånger vanligare hos pojkar, i åldersgruppen 15 år och äldre i genomsnitt 1,6 gånger vanligare hos kvinnor [12].

Uppdaterat: 2019-04-08

Litteratursökningsdatum: 2017-05-27

Referenser

  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. Symbicort (budesonide/formoterol). DailyMed [www]. [updated 2017-01-27, cited 2017-05-27]. länk
  8. Food and Drug Aministration (FDA) . Clinical Pharmacology and Biopharmaceutics Review - SYMBICORT (budesonide/formoterol). Food and Drug Aministration [www]. [updated 2006-07-21, cited 2017-05-27]. länk
  9. Sutherland ER, Brazinsky S, Feldman G, McGinty J, Tomlinson L, Denis-Mize K. Nebulized formoterol effect on bronchodilation and satisfaction in COPD patients compared to QID ipratropium/albuterol MDI. Curr Med Res Opin. 2009;25:653-61. PubMed
  10. Tashkin DP, Varghese ST. Combined treatment with formoterol and tiotropium is more efficacious than treatment with tiotropium alone in patients with chronic obstructive pulmonary disease, regardless of smoking status, inhaled corticosteroid use, baseline severity, or gender. Pulm Pharmacol Ther. 2011;24:147-52. PubMed
  11. Make BJ, Eriksson G, Calverley PM, Jenkins CR, Postma DS, Peterson S et al. A score to predict short-term risk of COPD exacerbations (SCOPEX). Int J Chron Obstruct Pulmon Dis. 2015;10:201-9. PubMed

Författare: Linnéa Karlsson Lind

Faktagranskat av: Mia von Euler

Godkänt av: Karin Schenck-Gustafsson