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Indakaterol

Klassificering: A

Preparat: Onbrez® Breezhaler®

ATC kod: R03AC18

Substanser: indakaterol, indakaterolmaleat

Sammanfattning

Färre kvinnor än män har inkluderats i randomiserade kliniska studier av indak
a
terol vid kroniskt obstruktiv lungsjukdom. En stor poolad analys fann bättre prevention av KOL-exacerbation hos både män och kvinnor vid behandling med indak
a
terol/glycopyrronium jämfört med placebo eller annan behandling. Denna studie visade förbättring avseende symtom, allmänt hälsotillstånd, dyspné och behov av anfallsbehandling hos kvinnor. En post-hoc analys fann dock enbart signifikant bättre effekt av indak
a
terol/glycopyrronium jämfört med salmeterol/ flutikason hos män. Detta kan bero på att få kvinnor var med i studien. Ingen könsskillnad har påvisats avseende säkerhet.

Additional information

Indacaterol is a long-acting beta2-agonist (LABA) used for treating airflow obstruction in patients with COPD [1, 2].

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 [3]. Historically, more men than women had COPD and although the prevalence in most countries now is more equal trial participation has been slower to reflect this [3].

Pharmacokinetics and dosing

Cmax has been found to be 11% higher in women [4]. A population pharmacokinetic study found smoking, age, and patient's sex to affect apparent clearance of indacaterol (5). Neither of these differences are perceived to be clinically relevant and no dose adjustment according to patient’s sex is recommended [1, 2, 4, 5].

Effects

A pooled analysis of the IGNITE program (4719 men, 1389 women) comparing the effect by sex 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 (6). Improvements in health status, dyspnea, rescue medication use, and symptoms were generally larger in women than in men [6].

In a post-hoc analysis of sex differences in the randomized controlled FLAME trial in patients with moderate-to very severe COPD (2257 men, 805 women) the annualized rates of moderate/severe as well as all exacerbations were lower in men treated with indacaterol/glycopyrronium than those treated with salmeterol/ fluticasone [3]. The difference was not significant in women. Time-to-first moderate/severe COPD exacerbation was lower in both indacaterol/glycopyrronium treated men and women. If this reflects the lower number of women in the study or a true difference in efficacy is not clear [3].

Adverse effects

A pooled analysis of safety data from 14 randomized studies on fixed dose indacaterol/glycopyrronium, the monocomponents, or comparators in patients with COPD (in all 8 334 men, 3 064 women) found no difference in adverse events between men and women [7].

Reproductive health issues

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

Försäljning på recept

Något fler kvinnor än män hämtade ut inhalationspulver innehållande indakaterol (ATC-kod R03AC18) på recept i Sverige år 2018, totalt 2 746 kvinnor och 2 234 män. Det motsvarar 0,6 respektive 0,4 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 70-84 år hos kvinnor och i åldersgruppen 75 år och äldre hos män. I genomsnitt var inhalationspulver innehållande indakaterol 1,7 gånger vanligare hos kvinnor [8].

Uppdaterat: 2019-07-16

Litteratursökningsdatum: 2019-05-28

Referenser

  1. Arcapta (indacaterol). DailyMed [www]. US National Library of Medicine. [updated 2018-12-16, cited 2019-05-28]. länk
  2. Onbrez Breezhaler (indakaterol). Summary of Product Characteristics. European Medicines Agency [updated 2018-08-31, cited 2019-05-28].
  3. 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. PubMed
  4. Cazzola M, Calzetta L, Page CP, Matera MG. Use of indacaterol for the treatment of COPD: a pharmacokinetic evaluation. Expert Opin Drug Metab Toxicol. 2014;10(1):129-37. PubMed
  5. Demin I, Bartels C, Graham G, Bieth B, Gautier A, Tillmann HC et al. Population pharmacokinetics of IND/GLY (indacaterol/glycopyrronium) in COPD patients. Int J Clin Pharmacol Ther. 2016;54(6):405-15. PubMed
  6. 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. PubMed
  7. 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. PubMed
  8. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2018 [cited 2019-05-28.] länk

Författare: Mia von Euler, Linnéa Karlsson Lind

Faktagranskat av: Karin Schenck-Gustafsson

Godkänt av: Karin Schenck-Gustafsson