Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Dapagliflozin

Klassificering: A

Preparat: Forxiga, Xigduo

ATC kod: A10BD15, A10BK01

Substanser: dapagliflozin, dapagliflozinpropandiolmonohydrat

Sammanfattning

Dapagliflozin som monoterapi eller i kombinationsbehandling reducerar HbA1c-nivåer på ett likvärdigt sätt hos kvinnor och män. Kliniska studier har visat att förekomsten av urinvägsinfektion och genital infektion är vanligare vid dapagliflozinbehandling hos kvinnor än hos män.
En randomiserad placebokontrollerad studie har visat att män minskar mer i vikt än kvinnor som behandlas.
 
Kunskapsunderlaget avseende skillnader mellan kvinnor och män är begränsat och motiverar inte olika dosering eller behandling.

Additional information

Pharmacokinetics and dosing

Pooled data from clinical pharmacology studies (349 men, 89 women) showed that women had a greater mean dapagliflozin AUC of 23%, even though Cmax was not increased [1]. In a population pharmacokinetic model (634 men, 619 women), mean dapagliflozin AUC at steady state was 22% higher in women than in men [1]. Despite differences described in AUC between men and women, this does not have any substantially clinically relevant impact and no dose adjustment has been considered necessary according to sex [2].

Effects

According to clinical studies done by the original manufacturer, treatment with dapagliflozin as monotherapy and in combination with metformin, glimepiride, pioglitazone, sitagliptin, or insulin reduced HbA1c at week 24 compared to control in both men and women [2]. Pooled data from several phase III studies show minimal differences in efficacy between men and women (data not shown) [1].

Adverse effects

Data from randomized placebo-controlled clinical trials [3-7] report a higher frequency of genital infections and urinary tract infections in women than men treated with dapagliflozin. Genital infections incidence rates vary from 4.3-4.5% in women and 2.0-2.1% in men. Urinary tract infections incidence rates vary from 2.8-11.9% in women and 2.0-3.5% in men. The incidence of infections was not dose-related [3-7].

Reproductive health issues

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

Other information

An international randomized, double-blind, placebo-controlled Phase III study (100 men, 80 women) showed a greater decrease in total body weight in men (-2.8 kg) at 24 weeks with dapagliflozin compared to women (-1.2 kg) [4].

Försäljning på recept

Fler män än kvinnor hämtade ut tabletter innehållande dapagliflozin (ATC-kod A10BK01) på recept i Sverige år 2015, totalt 4 121 män och 2 543 kvinnor. Det motsvarar 0,9 respektive 0,5 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 55-74 år hos båda könen. I genomsnitt var tabletter innehållande dapagliflozin 1,6 gånger vanligare hos män.

Något fler män än kvinnor hämtade ut tabletter innehållande kombination av metformin och dapagliflozin (ATC-kod A10BD15) på recept i Sverige år 2015, totalt 106 män och 54 kvinnor [8].

Uppdaterat: 2019-02-26

Litteratursökningsdatum: 2014-08-29

Referenser

  1. Kasichayanula S, Liu X, Lacreta F, Griffen SC, Boulton DW. Clinical Pharmacokinetics and Pharmacodynamics of Dapagliflozin, a Selective Inhibitor of Sodium-Glucose Co-transporter Type 2. Clin Pharmacokinet 2013 Oct 9; PubMed
  2. FARXIGA (dapagliflozin). DailyMed [www]. US National Library of Medicine. [cited 2014-08-01]. länk
  3. Bailey CJ, Iqbal N, T'joen C, List JF. Dapagliflozin monotherapy in drug-naïve patients with diabetes: a randomized-controlled trial of low-dose range. Diabetes Obes Metab. 2012;14:951-9. PubMed
  4. Bolinder J, Ljunggren Ö, Kullberg J, Johansson L, Wilding J, Langkilde AM et al. Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin. J Clin Endocrinol Metab. 2012;97:1020-31. PubMed
  5. Wilding JP, Woo V, Soler NG, Pahor A, Sugg J, Rohwedder K et al. Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin: a randomized trial. Ann Intern Med. 2012;156:405-15. PubMed
  6. Johnsson KM, Ptaszynska A, Schmitz B, Sugg J, Parikh SJ, List JF. Urinary tract infections in patients with diabetes treated with dapagliflozin. J Diabetes Complications. 2013;27:473-8. PubMed
  7. Johnsson KM, Ptaszynska A, Schmitz B, Sugg J, Parikh SJ, List JF. Vulvovaginitis and balanitis in patients with diabetes treated with dapagliflozin. J Diabetes Complications. 2013;27:479-84. PubMed
  8. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-05.] länk

Författare: Linnéa Karlsson Lind, Desirée Loikas

Faktagranskat av: Mia von Euler

Godkänt av: Karin Schenck-Gustafsson