Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Empagliflozin

Klassificering: A

Preparat: Jardiance, Synjardy

ATC kod: A10BD20, A10BK03

Substanser: empagliflozin

Sammanfattning

Effekten av empagliflozin på kardiovaskulär död, sjukhusinläggning på grund av hjärtsvikt och nefropati är lika hos kvinnor och män med typ-2 diabetes. Incidensen av genital infektion ökar vid empagliflozinbehandling hos både kvinnor och män.
 
Vår bedömning är att nuvarande kunskapsunderlag inte motiverar skillnad i dosering eller behandling mellan kvinnor och män.

Additional information

Pharmacokinetics and dosing

A population pharmacokinetic analysis of empagliflozin was performed from phase I, II and III studies in 2761 persons with type 2 diabetes mellitus. Compared to men, women had 11% lower clearance and approximately 10-15% higher AUC of empagliflozin [1].

Pooled data from five randomized Phase I and II clinical trials (574 men, 400 women), four were  included in the population pharmacokinetic analysis mentioned above, and showed that women had a 5% smaller apparent central volume of distribution (V2/F) than men [2].

Effects

A secondary analysis of the placebo-controlled EMPA-REG OUTCOME trial (5016 men, 2004 women) showed that empagliflozin reduced cardiovascular death, non-fatal stroke and non-fatal myocardial infarction to a similar degree in men and women. No sex differences in cardiovascular death, hospitalization for heart failure, or incident or worsening nephropathy were observed [3].

A population exposure-response analysis of empagliflozin plasma concentrations from Phase I, II and III studies in persons with type 2 diabetes mellitus (2217 men, 1848 women) showed that the maximum reduction of fasting plasma glucose (Gmax) was 11% lower in women than in men [1]. Contrary to these findings, a covariate analysis of five randomized Phase I and II clinical trials in persons with type 2 diabetes (232 men, 63 women) showed that women had 12% higher Gmax than men. No clinically relevant difference between men and women was noted in urinary glucose excretion [4].

No differences in body weight, waist circumference, index of central obesity or visceral adiposity index between men and women with type 2 diabetes mellitus treated with empagliflozin were observed in analysis of data from five randomized placebo-controlled studies (1846 men, 1454 women). [5].

Adverse effects

Empagliflozin treatment have been associated with increased incidence of genital infections in both men and women, as compared to placebo [1, 3].

Reproductive health issues

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

Försäljning på recept

Fler män än kvinnor hämtade ut tabletter innehållande empagliflozin (ATC-kod A10BK03) på recept i Sverige år 2017, totalt 10 365 män och 5 498 kvinnor. Det motsvarar 2,1 respektive 1,1 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 65-69 år hos båda könen. I genomsnitt var tabletter innehållande empagliflozin 1,9 gånger vanligare hos män [6].

Fler män än kvinnor hämtade ut tabletter innehållande kombination av metformin och empagliflozin (ATC-kod A10BD20) på recept i Sverige år 2017, totalt 1 026 män och 471 kvinnor [6].

Uppdaterat: 2020-08-28

Litteratursökningsdatum: 2017-05-10

Referenser

  1. Baron KT, Macha S, Broedl UC, Nock V, Retlich S, Riggs M. Population Pharmacokinetics and Exposure-Response (Efficacy and Safety/Tolerability) of Empagliflozin in Patients with Type 2 Diabetes. Diabetes Ther 2016 Jun 16; PubMed
  2. Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR et al. Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes. J Clin Pharmacol. 2013;53(10):1028-38. PubMed
  3. Zinman B, Inzucchi SE, Wanner C, Hehnke U, George JT, Johansen OE et al. Empagliflozin in women with type 2 diabetes and cardiovascular disease - an analysis of EMPA-REG OUTCOME®. Diabetologia. 2018;61(7):1522-1527. PubMed
  4. Mondick J, Riggs M, Sasaki T, Sarashina A, Broedl UC, Retlich S. Mixed-effects modelling to quantify the effect of empagliflozin on renal glucose reabsorption in patients with type 2 diabetes. Diabetes Obes Metab. 2016;18(3):241-8. PubMed
  5. Neeland IJ, McGuire DK, Chilton R, Crowe S, Lund SS, Woerle HJ et al. Empagliflozin reduces body weight and indices of adipose distribution in patients with type 2 diabetes mellitus. Diab Vasc Dis Res. 2016;13(2):119-26. PubMed
  6. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2017 [cited 2018-07-24.] länk

Författare: Maria Enghag, Linnéa Karlsson Lind

Faktagranskat av: Mia von Euler

Godkänt av: Karin Schenck-Gustafsson