1/23/2025

Janusmed kön och genus

Janusmed kön och genus – Relanio

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.

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A A
A A

Flutikason – inhalation

Flutikason – inhalation

Klass : A

Produkter

Aerivio Spiromax, Airflusal Forspiro, Atemur Diskus, Axotide 125 Dosie......

Aerivio Spiromax, Airflusal Forspiro, Atemur Diskus, Axotide 125 Dosier-Aerosol, Axotide 50 Dosier-Aerosol, Brisomax Diskus, Brisomax Diskus forte, Flixotide 125 Inhalator CFK-vrij, Flixotide 125 micrograms Evohaler, Flixotide 50 Inhalator CFK-vrij, Flixotide 50 micrograms Evohaler, Flixotide Diskus, Flixotide Evohaler, Flixotide Evohaler 250 micrograms, Flixotide junior, Fluticason Cipla, Fluticasone Cipla, Fluticasone Doc, Fluticasone Propionate/Salmeterol DISKUS, Flutide Diskus, Flutide Evohaler, Flutide mite 50 mikrogram Dosier-Aerosol, Flutiform, Flutiform K-haler, Icsori, Novucaeli, RELVAR ELLIPTA, Relanio, Salflumix Easyhaler, Salmeterol/Fluticasone Abacus Medicine, Salmeterol/Fluticasone Cipla, Salmeterol/Fluticasone Neutec, Salmeterol/Fluticasonpropionat AL, Salmeterol/Flutikason 2care4, Salmeterol/Flutikason Ebb, Salmex, Seretaide Diskus, Seretide Diskus, Seretide Diskus Mite, Seretide Diskus forte, Seretide Diskus mite, Seretide Evohaler, Seretide Evohaler forte, Seretide Evohaler mite, Trelegy Ellipta, Veraspir Diskus
ATC-koder

R03AK06, R03AK10, R03AK11, R03AL08, R03BA05

R03AK06, R03AK10, R03AK11, R03AL08, R03BA05
Substanser

flutikason, flutikasonfuroat, flutikasonpropionat

flutikason, flutikasonfuroat, flutikasonpropionat
Sammanfattning

Det finns enstaka studier med analys av könsskillnader vad gäller effekt och säkerhet av flutikason men resultaten är motstridiga och den kliniska relevansen oklar.
Sämre inhalationsteknik har visats hos kvinnor vid användning av vissa inhalatorer, vilket kan ha betydelse för god effekt av läkemedlet, men detta har inte studerats i tillräcklig utsträckning.

Det finns enstaka studier med analys av könsskillnader vad gäller effekt och säkerhet av flutikason men resultaten är motstridiga och den kliniska relevansen oklar. Sämre inhalationsteknik har visats hos kvinnor vid användning av vissa inhalatorer, vilket kan ha betydelse för god effekt av läkemedlet, men detta har inte studerats i tillräcklig utsträckning.
Background

COPD (chronic obstructive pulmonary disease) affects more women than men, and women often get a more serious and rapidly progressive disease [1]. 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 [2].
Childhood asthma is more common in boys while adult asthma is more common in women. 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 [3]. However, some studies suggest that there are sex differences in expression and diagnosing of asthma, and whether women are under-treated for respiratory diseases or not has been discussed [4,5].
A systematic review of 32 studies on sex differences in adult asthma and COPD therapy concludes inconsistent evidence concerning sex-related response to treatment [6].

Pharmacokinetics and dosing
Most of the pharmacokinetic studies included both men and women. However, no analysis of sex differences was found and sex-d......

COPD (chronic obstructive pulmonary disease) affects more women than men, and women often get a more serious and rapidly progressive disease [1]. 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 [2]. Childhood asthma is more common in boys while adult asthma is more common in women. 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 [3]. However, some studies suggest that there are sex differences in expression and diagnosing of asthma, and whether women are under-treated for respiratory diseases or not has been discussed [4,5]. A systematic review of 32 studies on sex differences in adult asthma and COPD therapy concludes inconsistent evidence concerning sex-related response to treatment [6]. # Pharmacokinetics and dosing Most of the pharmacokinetic studies included both men and women. However, no analysis of sex differences was found and sex-divided data is lacking [11]. # Effects Difference between men and women in the efficacy of fluticasone propionate was investigated in a post-hoc analysis of a large 1-year double-blind trial, TRISTAN where COPD patients (539 men, 180 women) were randomized to salmeterol/fluticasone or placebo [12, 13]. No differences between men and women were found for any study outcome. A post hoc-analysis to The Toward a Revolution in COPD Health (TORCH) study, a trial investigated the effect of fluticasone propionate and/or salmeterol therapy (4631 men, 1481 women ) over 3 years showed that women were 16% less likely to die over the period of the study compared to men [14]. However, correcting for important covariates, such as degree of airflow obstruction, body mass index, region of the world, and previous myocardial infarction, this difference was not statistically significant (hazard ratio 1.16 [95%CI, 0.98–1.39]). The causes of death were similar in men and women [15]. # Adverse effects A study investigated hoarseness/dysphonia in patients with bronchial asthma using the fluticasone propionate dry powder inhalers (128 men, 185 women), showed that women complain of hoarseness and dysphonia twice as likely as men. The authors highlight the necessity of further studies to evaluate the influence of different drug delivery devices on local adverse effects and adherence of fluticasone treatment [16]. # Reproductive health issues Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan). # Other information Women with asthma or COPD were more likely to have incorrect inhalation technique when using either dry-powder inhaler or soft mist inhaler, according to a systematic review and meta-analysis. No sex difference was found for metered-dose inhaler [7]. Several studies show worse prognosis for women with asthma. In an observational registry study (416 men, 498 women), women had more asthmatic symptoms, worse quality of life and require more health care due to their asthma [8]. 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 (95%CI 1.2-2.4) [9]. An observational study in Singapore found hospitalization due to asthma to be 1.69 times more common in boys than girls aged 0-4 years. In adults aged 35-64 years, women were more hospitalized (male/female ratio 0.81) [10]. The ISOLDE (Inhaled Steroids in Obstructive Lung Disease) study was a trial that randomized 752 patients with moderate to severe COPD to fluticasone propionate or placebo for three years [17]. In a longer follow-up of >13 years of the subjects with moderate- to severe COPD (280 men, 95 women), male sex was one of the factors, associated with higher mortality (p <0.05) among other factors such as older age and more severe COPD [18].
Försäljning på recept

Fler män än kvinnor hämtade ut inhalationsspray- eller pulver innehållande flutikason (ATC-kod R03BA05) på recept i Sverige år 2023, totalt 59 560 män och 46 569 kvinnor. Det motsvarar 11 respektive 9 personer per tusen invånare. Andelen som hämtade ut läkemedel var högst i åldersgruppen 0-9 år hos båda könen. I åldersgruppen 0-19 år var inhalationsspray eller -pulver innehållande flutikason i genomsnitt 1,3 gånger vanligare hos pojkar/män och i åldersgruppen 20 år och äldre i genomsnitt 1,8 gånger vanligare hos kvinnor [19].
Referenser
  1. Nationella riktlinjer för vård vid astma och kroniskt obstruktiv lungsjukdom (KOL). Socialstyrelsen. [updated 2018-01-29, cited 2020-09-14].
  2. 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.
  3. Dharmage SC, Perret JL, Custovic A. Epidemiology of Asthma in Children and Adults. Front Pediatr. 2019;7:246.
  4. 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.
  5. 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.
  6. Rogliani P, Cavalli F, Ritondo BL, Cazzola M, Calzetta L. Sex differences in adult asthma and COPD therapy: a systematic review. Respir Res. 2022;23(1):222.
  7. Calzetta L, Aiello M, Frizzelli A, Ritondo BL, Pistocchini E, Rogliani P et al. Impact of Sex on Proper Use of Inhaler Devices in Asthma and COPD: A Systematic Review and Meta-Analysis. Pharmaceutics. 2022;14(8):.
  8. 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.
  9. 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.
  10. 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.
  11. Mehta R, Riddell K, Gupta A, Louey MD, Chan RH. Comparison of the Pharmacokinetics of Salmeterol and Fluticasone Propionate 50/100 µg Delivered in Combination as a Dry Powder Via a Capsule-Based Inhaler and a Multi-Dose Inhaler. Clin Drug Investig. 2015;35:319-26.
  12. Vestbo J, Soriano JB, Anderson JA, Calverley P, Pauwels R, Jones P et al. Gender does not influence the response to the combination of salmeterol and fluticasone propionate in COPD. Respir Med. 2004;98:1045-50.
  13. Calverley P, Pauwels R, Vestbo J, Jones P, Pride N, Gulsvik A et al. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet. 2003;361:449-56.
  14. Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007;356:775-89.
  15. Celli B, Vestbo J, Jenkins CR, Jones PW, Ferguson GT, Calverley PM et al. Sex differences in mortality and clinical expressions of patients with chronic obstructive pulmonary disease The TORCH experience. Am J Respir Crit Care Med. 2011;183:317-22.
  16. Ishizuka T, Hisada T, Aoki H, Yanagitani N, Kaira K, Utsugi M et al. Gender and age risks for hoarseness and dysphonia with use of a dry powder fluticasone propionate inhaler in asthma. Allergy Asthma Proc. 2007;28:550-6.
  17. Bale G, Martínez-Camblor P, Burge PS, Soriano JB. Long-term mortality follow-up of the ISOLDE participants: causes of death during 13 years after trial completion. Respir Med. 2008;102:1468-72.
  18. Burge PS, Calverley PM, Jones PW, Spencer S, Anderson JA, Maslen TK. Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial. BMJ. 2000;320:1297-303.
  19. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2023 [cited 2024-03-06.]
Uppdaterat

Litteratursökningsdatum: 3/27/2024

Litteratursökningsdatum: 3/27/2024
Fasstexter
A A
A A

Salmeterol

Salmeterol

Klass : A

Produkter

Aerivio Spiromax, Airflusal Forspiro, Brisomax Diskus, Brisomax Diskus......

Aerivio Spiromax, Airflusal Forspiro, Brisomax Diskus, Brisomax Diskus forte, Fluticasone Propionate/Salmeterol DISKUS, Novucaeli, Relanio, Salflumix Easyhaler, Salmeterol Orifarm, Salmeterol/Fluticasone Abacus Medicine, Salmeterol/Fluticasone Cipla, Salmeterol/Fluticasone Neutec, Salmeterol/Fluticasonpropionat AL, Salmeterol/Flutikason 2care4, Salmeterol/Flutikason Ebb, Salmex, Seretaide Diskus, Seretide Diskus, Seretide Diskus Mite, Seretide Diskus forte, Seretide Diskus mite, Seretide Evohaler, Seretide Evohaler forte, Seretide Evohaler mite, Serevent Diskus, Serevent Evohaler, Veraspir Diskus
ATC-koder

R03AC12, R03AK06

R03AC12, R03AK06
Substanser

salmeterol, salmeterolxinafoat

salmeterol, salmeterolxinafoat
Sammanfattning

Salmeterol i kombination med flutikason har likvärdig effekt hos kvinnor och män med KOL. Inga könsskillnader i rapporterade biverkningar har setts.
Sämre inhalationsteknik har visats hos kvinnor vid användning av vissa inhalatorer, vilket kan ha betydelse för god effekt av läkemedlet, men detta har inte studerats i tillräcklig utsträckning.

Salmeterol i kombination med flutikason har likvärdig effekt hos kvinnor och män med KOL. Inga könsskillnader i rapporterade biverkningar har setts. Sämre inhalationsteknik har visats hos kvinnor vid användning av vissa inhalatorer, vilket kan ha betydelse för god effekt av läkemedlet, men detta har inte studerats i tillräcklig utsträckning.
Background

COPD (chronic obstructive pulmonary disease) affects more women than men, and women often get a more serious and rapidly progressive disease [1]. 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 [2].
Childhood asthma is more common in boys while adult asthma is more common in women. 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 [3]. However, some studies suggest that there are sex differences in expression and diagnosing of asthma, and whether women are under-treated for respiratory diseases or not has been discussed [4,5].
A systematic review of 32 studies on sex differences in adult asthma and COPD therapy concludes inconsistent evidence concerning sex-related response to treatment [6].

Pharmacokinetics and dosing
In a population pharmacokinetic analysis in healthy individuals (n=57) were given single dose of fluticasone/salmeterol 500/......

COPD (chronic obstructive pulmonary disease) affects more women than men, and women often get a more serious and rapidly progressive disease [1]. 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 [2]. Childhood asthma is more common in boys while adult asthma is more common in women. 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 [3]. However, some studies suggest that there are sex differences in expression and diagnosing of asthma, and whether women are under-treated for respiratory diseases or not has been discussed [4,5]. A systematic review of 32 studies on sex differences in adult asthma and COPD therapy concludes inconsistent evidence concerning sex-related response to treatment [6]. # Pharmacokinetics and dosing In a population pharmacokinetic analysis in healthy individuals (n=57) were given single dose of fluticasone/salmeterol 500/50 µg. Men had higher clearance than women [11]. The clinical relevance of this difference is unclear. # Effects Difference between men and women in effects in the efficacy of salmeterol has been investigated in a post-hoc analysis of a large 1-year double-blind trial, TRISTAN, where COPD patients (539 men, 180 women) were randomized to salmeterol/fluticasone or placebo [12, 13]. No differences between men and women were found for any study outcome. A post hoc-analysis to the TORCH study, a trial investigated the effect of fluticasone and/or salmeterol therapy (4631 men, 1481 women) over 3 years showed that women were 16% less likely to die over the period of the study compared to men [14]. The causes of death were similar in men and women [15]. However, the analysis did not adjust for important covariates [15], which makes the results inconclusive. # Adverse effects The frequency of adverse events from salmeterol/fluticasone combination treatment for COPD was similar in men and women [12]. # Reproductive health issues Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan). # Other information Women with asthma or COPD were more likely to have incorrect inhalation technique when using either dry-powder inhaler or soft mist inhaler, according to a systematic review and meta-analysis. No sex difference was found for metered-dose inhaler [7]. Several studies show worse prognosis for women with asthma. In an observational registry study (416 men, 498 women), women had more asthmatic symptoms, worse quality of life and require more health care due to their asthma [8]. 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 (95%CI 1.2-2.4) [9]. An observational study in Singapore found hospitalization due to asthma to be 1.69 times more common in boys than girls aged 0-4 years. In adults aged 35-64 years, women were more hospitalized (male/female ratio 0.81) [10].
Försäljning på recept

Fler kvinnor än män hämtade ut inhalationsspray eller -pulver innehållande salmeterol (ATC-kod R03AC12) på recept i Sverige år 2023, totalt 3 929 kvinnor och 2 101 män. Det motsvarar 0,8 respektive 0,4 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 80 år och äldre hos båda könen. I genomsnitt var läkemedel innehållande salmeterol 1,7 gånger vanligare hos kvinnor [16].
Referenser
  1. Nationella riktlinjer för vård vid astma och kroniskt obstruktiv lungsjukdom (KOL). Socialstyrelsen. [updated 2018-01-29, cited 2020-09-14].
  2. 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.
  3. Dharmage SC, Perret JL, Custovic A. Epidemiology of Asthma in Children and Adults. Front Pediatr. 2019;7:246.
  4. 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.
  5. 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.
  6. Rogliani P, Cavalli F, Ritondo BL, Cazzola M, Calzetta L. Sex differences in adult asthma and COPD therapy: a systematic review. Respir Res. 2022;23(1):222.
  7. Soulele K, Macheras P, Silvestro L, Rizea Savu S, Karalis V. Population pharmacokinetics of fluticasone propionate/salmeterol using two different dry powder inhalers. Eur J Pharm Sci. 2015;80(1):33-42.
  8. Vestbo J, Soriano JB, Anderson JA, Calverley P, Pauwels R, Jones P et al. Gender does not influence the response to the combination of salmeterol and fluticasone propionate in COPD. Respir Med. 2004;98:1045-50.
  9. Calverley P, Pauwels R, Vestbo J, Jones P, Pride N, Gulsvik A et al. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet. 2003;361:449-56.
  10. Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007;356:775-89.
  11. Celli B, Vestbo J, Jenkins CR, Jones PW, Ferguson GT, Calverley PM et al. Sex differences in mortality and clinical expressions of patients with chronic obstructive pulmonary disease The TORCH experience. Am J Respir Crit Care Med. 2011;183:317-22.
  12. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2023 [cited 2024-03-06.]
  13. Calzetta L, Aiello M, Frizzelli A, Ritondo BL, Pistocchini E, Rogliani P et al. Impact of Sex on Proper Use of Inhaler Devices in Asthma and COPD: A Systematic Review and Meta-Analysis. Pharmaceutics. 2022;14(8):.
  14. 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.
  15. 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.
  16. 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.
Uppdaterat

Litteratursökningsdatum: 3/26/2024

Litteratursökningsdatum: 3/26/2024
Fasstexter
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