Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Insulin glulisin

Klassificering: A

Preparat: Apidra, Apidra (OptiClik), Apidra (OptiSet), Apidra (SoloStar)

ATC kod: A10AB06

Substanser: insulin glulisin

Sammanfattning

Inga kliniskt viktiga könsrelaterade skillnader i effekt av insulin glulisin har beskrivits. Biverkningsprofilen har i en retrospektiv analys av data från randomiserade prövningar visat på en ökad risk för kvinnor att utveckla nattlig och symtomatisk hypoglykemi.
 

Additional information

Pharmacokinetics and dosing

Women have been included in published pharmacokinetic studies, but results have not been presented separately for men and women. The producer does not deem different doses according to patient sex to be necessary [5].

Effects

No studies with a clinically relevant sex analysis regarding the effect of insulin glulisine have been found.

Adverse effects

One study retrospectively analysed four large trials including 713 patients (378 men, 335 women) with type 2 diabetes. Insulin glulisine was added to a basal treatment with oral antidiabetic drugs (OAD) and insulin glargine. Female sex was identified as a predictor of nocturnal and symptomatic hypoglycemia (OR 1.82; 95 % CI 1.07-3.11 and OR 1.89; 95% CI 1.31-2.78) [1]. Furthermore, several meta analyses have shown similar data [2-4].

Reproductive health issues

Concurrent administration of insulin glulisine and oral contraceptives may decrease the effect of insulin glulisine [5]. Regarding drug-drug interactions aspects, please consult Janusmed Interactions (in Swedish, Janusmed interaktioner).

Insulin glulisine can be used in pregnant women. Insulin requirements may change during pregnancy, and quickly return to normal after delivery [5]. Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).

Other information

Two observational studies from the 1990’s with a total of 418 patients (43 men, 374 women) reported intentional insulin omission among 1/3 of women to control their weight [6,7].

In a retrospective study in 124 women, perimenstrual changes in selfreported glucose concentrations were found in 61%. Use of oral contraceptives did not diminish variability in blood glucosis [8]. In another study based on questionnaires (406 women) 67% of the participants reported changes in blood glucose levels or glycosuria premenstrually and 70% during the menstrual phase. Those with more cravings had larger elevations in blood glucosis levels suggesting that giving in to cravings might cause the changes [9].

Försäljning på recept

Fler män än kvinnor hämtade ut läkemedel innehållande insulin glulisin (ATC-kod A10AB06) på recept i Sverige år 2016, totalt 3 664 män och 2 552 kvinnor. Det motsvarar 0,7 respektive 0,5 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 70-79 år hos män och i åldersgruppen 75-84 år hos kvinnor. I genomsnitt var läkemedel innehållande insulin glulisin 1,4 gånger vanligare bland män [10].

Uppdaterat: 2018-01-07

Litteratursökningsdatum: 2017-09-20

Referenser

  1. Seufert J, Brath H, Pscherer S, Borck A, Bramlage P, Siegmund T. Composite efficacy parameters and predictors of hypoglycaemia in basal-plus insulin therapy--a combined analysis of 713 type 2 diabetic patients. Diabetes Obes Metab. 2014;16:248-54. PubMed
  2. Kautzky-Willer A, Kosi L, Lin J, Mihaljevic R. Gender-based differences in glycaemic control and hypoglycaemia prevalence in patients with type 2 diabetes: results from patient-level pooled data of six randomized controlled trials. Diabetes Obes Metab. 2015;17:533-40. PubMed
  3. McGill JB, Vlajnic A, Knutsen PG, Recklein C, Rimler M, Fisher SJ. Effect of gender on treatment outcomes in type 2 diabetes mellitus. Diabetes Res Clin Pract. 2013;102:167-74. PubMed
  4. Owens DR, Bolli GB, Charbonnel B, Haak T, Landgraf W, Porcellati F et al. Effects of age, gender, and body mass index on efficacy and hypoglycaemia outcomes across treat-to-target trials with insulin glargine 100 U/mL added to oral antidiabetes agents in type 2 diabetes. Diabetes Obes Metab. 2017;19:1546-1554. PubMed
  5. Apidra (insulin glulisine). Summary of Product Characteristics. European Medicines Agency (EMA); 2017.
  6. Polonsky WH, Anderson BJ, Lohrer PA, Aponte JE, Jacobson AM, Cole CF. Insulin omission in women with IDDM. Diabetes Care. 1994;17:1178-85. PubMed
  7. Bryden KS, Neil A, Mayou RA, Peveler RC, Fairburn CG, Dunger DB. Eating habits, body weight, and insulin misuse A longitudinal study of teenagers and young adults with type 1 diabetes. Diabetes Care. 1999;22:1956-60. PubMed
  8. Lunt H, Brown LJ. Self-reported changes in capillary glucose and insulin requirements during the menstrual cycle. Diabet Med. 1996;13:525-30. PubMed
  9. Cawood EH, Bancroft J, Steel JM. Perimenstrual symptoms in women with diabetes mellitus and the relationship to diabetic control. Diabet Med. 1993;10:444-8. PubMed
  10. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2016 [cited 2017-12-08.] länk

Författare: Anna Törring

Faktagranskat av: Mia von Euler

Godkänt av: Karin Schenck-Gustafsson