6/10/2023

Janusmed kön och genus

Janusmed kön och genus – Bevespi Aerosphere

Janusmed kön och genus är ett kunskapsstöd som tillhandahåller information om köns- och genusaspekter på läkemedelsbehandling. Kunskapsstödet är avsedd främst för hälso- och sjukvårdspersonal. Texterna är generella och ska inte ses som behandlingsriktlinjer. Det är alltid behandlande läkare som ansvarar för patientens medicinering.

För att komma till startsidan för Janusmed kön och genus och för att göra sökningar klicka här.

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A A
A A

Formoterol

Formoterol

Klass: A

Produkter

Assieme Turbuhaler, Assieme forte Turbuhaler, Assieme m......

Assieme Turbuhaler, Assieme forte Turbuhaler, Assieme mite Turbuhaler, Bevespi Aerosphere, Bufomix Easyhaler, Duaklir Genuair, Dulera, DuoResp Spiromax, Flutiform, Flutiform K-haler, Foradil, Foradil HFA, Formatris Novolizer, Innovair, Innovair nexthaler, Oxez Turbuhaler, Oxis Turbuhaler, Rilast Turbuhaler, Rilast forte Turbuhaler, Sinestic Turbuhaler, Sinestic forte Turbuhaler, Symbicort, Symbicort Turbuhaler, Symbicort Turbuhaler, Symbicort forte Turbuhaler, Symbicort mite Turbuhaler, Trimbow, Trixeo Aerosphere
ATC-koder

R03AC13, R03AK07, R03AK08, R03AK09, R03AK11, R03AL05......

R03AC13, R03AK07, R03AK08, R03AK09, R03AK11, R03AL05, R03AL07, R03AL09, R03AL11
Substanser

formoterol, formoterolfumaratdihydrat

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.

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.
Background

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 ef......

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 Janusmed Drugs and Birth Defects (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].
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.
  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.
  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.
  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.
  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.
  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.
  7. Symbicort (budesonide/formoterol). DailyMed [www]. [updated 2017-01-27, cited 2017-05-27].
  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].
  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.
  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.
  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.
Uppdaterat

Litteratursökningsdatum 5/27/2017

Litteratursökningsdatum 5/27/2017
Se även
A A
A A

Glykopyrronium

Glykopyrronium

Klass: A

Produkter

Bevespi Aerosphere, Enerzair Breezhaler, Seebri Breezha......

Bevespi Aerosphere, Enerzair Breezhaler, Seebri Breezhaler, Trimbow, Trixeo Aerosphere, Ultibro Breezhaler
ATC-koder

R03AL04, R03AL07, R03AL09, R03AL11, R03AL12, R03BB06

R03AL04, R03AL07, R03AL09, R03AL11, R03AL12, R03BB06
Substanser

glykopyrronium, glykopyrroniumbromid, glykopyrroniumtos......

glykopyrronium, glykopyrroniumbromid, glykopyrroniumtosilatmonohydrat
Sammanfattning

Kön har ingen uppenbar påverkan på den systemiska exponeringen av glykopyrronium och dosjustering baserat på kön behövs därför inte. Avseende könsskillnader i effekt och biverkningar är resultaten inte konklusiva. Generellt har de flesta studier inkluderat fler män än kvinnor och man ser signifikanta skillnader i baslinjekarakteristika mellan könen vid studiestart.

Kön har ingen uppenbar påverkan på den systemiska exponeringen av glykopyrronium och dosjustering baserat på kön behövs därför inte. Avseende könsskillnader i effekt och biverkningar är resultaten inte konklusiva. Generellt har de flesta studier inkluderat fler män än kvinnor och man ser signifikanta skillnader i baslinjekarakteristika mellan könen vid studiestart.
Background

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].
Data from various studies indicate that women have increased dyspnea for a given level of airflow limitation and greater airway hyper-responsiveness, as well as greater frequency of exacerbations [5].

Pharmacokinetics and dosing
There were no sex-differences in the systemic exposure of glycopyrronium [6]. Therefore, pharmacokinetic parameters of glycopyrronium showed that no dosing adjustment was necessary based on the patient´s sex [7]. Neither did the patient´s sex affect the pharmacokinetics of the fixed dose combi......

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]. Data from various studies indicate that women have increased dyspnea for a given level of airflow limitation and greater airway hyper-responsiveness, as well as greater frequency of exacerbations [5]. # Pharmacokinetics and dosing There were no sex-differences in the systemic exposure of glycopyrronium [6]. Therefore, pharmacokinetic parameters of glycopyrronium showed that no dosing adjustment was necessary based on the patient´s sex [7]. Neither did the patient´s sex affect the pharmacokinetics of the fixed dose combination indacaterol/glycopyrronium bromide in a clinically relevant way in another study [8]. # Effects A pooled analysis of the IGNITE program (4719 men, 1389 women) comparing sex differences of indacaterol/glycopyrronium on moderate to very severe COPD versus other commonly used COPD treatments and placebo found indacaterol/glycopyrronium to improve lung function more than placebo and other active comparators in both men and women. Improvements in health status, dyspnea, rescue medication use, and symptoms were generally larger in women than in men [9].   The treatment effects of the fixed combination of indacaterol maleate and glycopyrronium bromide were consistent irrespective of the patient´s sex [8]. However, in a post hoc analysis of pooled data from two randomized, double-blind, placebo-controlled studies (724 men, 569 women), treatment with nebulized glycopyrronium 50 mcg, significantly decreased the risk of clinically important deterioration of COPD symptoms in men but not in women [10].  # Adverse effects In clinical trials of the fixed combination of indacaterol and glycopyrronium bromide, female patients, in both active and placebo groups, reported more adverse events than male patients. This is a known phenomenon in clinical trials. Thus, it is difficult to determine if and to what extent glycopyrronium bromide influenced the differences in reported adverse events between the sexes [8]. A pooled analysis of safety data from 14 randomized studies on fixed dose indacaterol/glycopyrronium, the monocomponents, or comparators in patients with COPD (in total 8 334 men, 3 064 women) found no difference in adverse events between men and women [11]. No evidence is found that patient's sex affects the risk of adverse event in studies using other formulations of glycopyrronium apart from oral solutions, as well as the pharmacokinetic study conducted with Sialanar [12]. # Reproductive health issues Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan). # Other information In many studies there were significant differences between the sexes regarding baseline characteristics [9, 13]. In a pooled analysis (4719 men, 1389 women), comparing the effect of indacaterol/glycopyrronoium by sex versus other commonly used COPD treatments and placebo, sex differences were observed in several baseline characteristics. Women were younger, had a higher BMI and more likely to be current smokers albeit having a shorter smoking history [9]. A post-hoc analysis (2557 men, 805 women) compared treatment response to indacaterol/glycopyrronium versus, salmeterol/fluticasone in COPD patients. Women at baseline were younger, more often current smokers and had poorer health status. Women also experienced exacerbations more frequently despite having better lung function and were treated more often with inhaled corticosteroids than men [13].
Försäljning på recept

Fler kvinnor än män hämtade ut inhalationspulver, hård kapsel, innehållande glykopyrroniumbromid (ATC-kod R03BB06) på recept i Sverige år 2020, totalt 1 083 kvinnor och 800 män. Det motsvarar 2,1 respektive 1,5 personer per tiotusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 75-84 år hos båda könen. Totalt sett var läkemedel innehållande glykopyrroniumbromid 1,4 gånger vanligare hos kvinnor [14]. Fler kvinnor än män hämtade ut inhalationspulver, hård kapsel, innehållande kombination av indakaterol och glykopyrroniumbromid (ATC-kod R03AL04) på recept i Sverige år 2020, totalt 5 448 kvinnor och 4 520 män. Det motsvarar 1,1 respektive 0,9 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 75-84 år hos båda könen. Totalt sett var inhalationspulver, hård kapsel, innehållande kombination av indakaterol och glykopyrroniumbromid 1,2 gånger vanligare hos kvinnor [14]. Fler kvinnor än män hämtade ut inhalationsspray, lösning, innehållande kombination av glykopyrroniumbromid, formoterol och beklometason (ATC-kod R03AL09) på recept år 2020, totalt 5 218 kvinnor och 3 653 män. Det motsvarar 1,0 respektive 0,7 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 75 år och äldre hos båda könen. Totalt sett var inhalationsspray, lösning, innehållande kombination av glykopyrroniumbromid, formoterol och beklometason 1,5 gånger vanligare hos kvinnor [14]. Fler kvinnor än män hämtade ut oral lösning innehållande glykopyrronium (ATC-kod A03AB02) på recept i Sverige år 2020, totalt 658 kvinnor och 578 män [14].
Referenser
  1. Nationella riktlinjer för vård vid astma och kroniskt obstruktiv lungsjukdom (KOL). Socialstyrelsen. [updated 2018-01-29, cited 2020-09-14].
  2. Dharmage SC, Perret JL, Custovic A. Epidemiology of Asthma in Children and Adults. Front Pediatr. 2019;7:246.
  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.
  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.
  5. Wedzicha JA, Singh D, Tsiligianni I, Jenkins C, Fucile S, Fogel R et al. Treatment response to indacaterol/glycopyrronium versus salmeterol/fluticasone in exacerbating COPD patients by gender: a post-hoc analysis in the FLAME study. Respir Res. 2019;20(1):4.
  6. Seebri Breezhaler (glycopyrronium). Summary of Product Characteristics. European Medicines Agency [updated 2020-02-13, cited 2020-12-29)
  7. Bevespi Aerosphere (glycopyrronium/formoterol). Summary of Product Characteristics. European Medicines Agency [updated 2020-09-17, cited 2020-12-29]
  8. European Medicines Agency (EMA). Xoterna Breezhaler (indacterol/ glycopyrronium bromide) - CHMP assessment report [updated 2013-07-25, cited 2020-12-29].
  9. Tsiligianni I, Mezzi K, Fucile S, Kostikas K, Shen S, Banerji D et al. Response to Indacaterol/Glycopyrronium (IND/GLY) by Sex in Patients with COPD: A Pooled Analysis from the IGNITE Program. COPD. 2017;14(4):375-381.
  10. Kerwin EM, Murray L, Niu X, Dembek C. Clinically Important Deterioration Among Patients with Chronic Obstructive Pulmonary Disease (COPD) Treated with Nebulized Glycopyrrolate: A Post Hoc Analysis of Pooled Data from Two Randomized, Double-Blind, Placebo-Controlled Studies. Int J Chron Obstruct Pulmon Dis. 2020;15:2309-2318.
  11. Wedzicha JA, Dahl R, Buhl R, Schubert-Tennigkeit A, Chen H, D'Andrea P et al. Pooled safety analysis of the fixed-dose combination of indacaterol and glycopyrronium (QVA149), its monocomponents, and tiotropium versus placebo in COPD patients. Respir Med. 2014;108(10):1498-507.
  12. European Medicines Agency (EMA). Sialanar (glycopyrronium) - Public assessment report [updated 2016-07-21, cited 2020-12-29].
  13. Wedzicha JA, Singh D, Tsiligianni I, Jenkins C, Fucile S, Fogel R et al. Treatment response to indacaterol/glycopyrronium versus salmeterol/fluticasone in exacerbating COPD patients by gender: a post-hoc analysis in the FLAME study. Respir Res. 2019;20(1):4.
  14. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.]
Uppdaterat

Litteratursökningsdatum 12/29/2020

Litteratursökningsdatum 12/29/2020