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Prasugrel

Classification: A

Drug products: Efient, Prasugrel Krka

ATC code: B01AC22

Substances: prasugrel, prasugrel hydrochloride

Summary

In the large randomized studies comparing prasugrel and clopidogrel in patients with acute coronary syndrome and PCI (TRITON) or not (TRIOLOGY), no difference between men and women in effect on primary outcomes or severe bleeding.

Additional information

Pharmacokinetics and dosing

Pharmacokinetics of prasugrel’s active metabolite is similar in healthy men and women [1-3]. No studies with a clinically relevant sex analysis regarding the pharmacokinetics or dosing of prasugrel have been found.

Effects

A large sex-specific meta-analysis of randomized phase III and IV trials compared the efficacy of P2Y12 inhibitors (prasugrel, ticagrelor, cangrelor) with clopidogrel or placebo in patients with coronary artery disease (63 346 men, 24 494 women). The potent P2Y12 inhibitors reduced the risk of major adverse cardiovascular events similarly in men and women [4]. This finding was confirmed in a recent sex-specific meta-analysis of P2Y12 inhibitors (ticagrelor, prasugrel, clopidogrel) in patients with acute coronary syndrome [5]. The meta-analyses included two clinical trials on prasugrel, which was compared to clopidogrel in patients with acute coronary syndromes who have undergone PCI (TRITON-TIMI 38) or not (TRILOGY-ACS). Maintenance doses in both studies were either prasugrel 10 mg daily or clopidogrel 75 mg daily. No significant sex differences were observed for the effect on primary events (cardiovascular death, nonfatal MI, or nonfatal stroke) [6, 7]. 

Adverse effects

A sex-specific meta-analysis (63 346 men, 24 494 women) examining the risk of major bleeding from treatment with P2Y12 inhibitors (prasugrel, ticagrelor, cangrelor) in coronary artery disease suggested no significant difference in major bleeding in men and women [4, 6, 7]. This finding has been confirmed in an observational study [8]. In a post-hoc analysis of predictors of bleeding events from prasugrel treatment (2922 men, 1111 women), female sex was one independent factor predicting major bleeding [9].

Reproductive health issues

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

Updated: 2019-02-26

Date of litterature search: 2018-12-21

References

  1. Efient (prasugrel). Summary of Product Chracteristics. European Medicines Agency (EMA) [updated 2018-12-10, cited 2018-12-21].
  2. Efient (prasugrel). DailyMed [www]. US National Library of Medicine. [updated 2018-03-09, cited 2018-12-21]. länk
  3. Wrishko RE, Ernest CS, Small DS, Li YG, Weerakkody GJ, Riesmeyer JR et al. Population pharmacokinetic analyses to evaluate the influence of intrinsic and extrinsic factors on exposure of prasugrel active metabolite in TRITON-TIMI 38. J Clin Pharmacol. 2009;49:984-98. PubMed
  4. Lau ES, Braunwald E, Murphy SA, Wiviott SD, Bonaca MP, Husted S et al. Potent P2Y12 Inhibitors in Men Versus Women: A Collaborative Meta-Analysis of Randomized Trials. J Am Coll Cardiol. 2017;69(12):1549-1559. PubMed
  5. Lee KK, Welton N, Shah AS, Adamson PD, Dias S, Anand A et al. Differences in relative and absolute effectiveness of oral P2Y12 inhibition in men and women: a meta-analysis and modelling study. Heart. 2018;104(8):657-664. PubMed
  6. Roe MT, Armstrong PW, Fox KA, White HD, Prabhakaran D, Goodman SG et al. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization. N Engl J Med. 2012;367:1297-309. PubMed
  7. Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007;357:2001-15. PubMed
  8. Almendro-Delia M, Blanco Ponce E, Gomez-Domínguez R, Gonzalez-Matos C, Lobo-Gonzalez M, Caballero-Garcia A et al. Safety and efficacy of in-hospital clopidogrel-to-prasugrel switching in patients with acute coronary syndrome An analysis from the 'real world'. J Thromb Thrombolysis. 2015;39(4):499-507. PubMed
  9. Widimsky P, Motovska Z, Bolognese L, Dudek D, Hamm C, Tanguay JF et al. Predictors of bleeding in patients with acute coronary syndromes treated with prasugrel. Heart. 2015;101(15):1219-24. PubMed
  10. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2017 [cited 2018-12-17.] länk

Authors: Linnéa Karlsson Lind

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson