The effect of dipyridamole on the pharmacokinetics of metformin: a randomized crossover study in healthy volunteers

Eur J Clin Pharmacol. 2016 Jun;72(6):725-30. doi: 10.1007/s00228-016-2039-8. Epub 2016 Mar 15.

Abstract

Purpose: Concomitant treatment with the glucose-lowering drug metformin and the platelet aggregation inhibitor dipyridamole often occurs in patients with type 2 diabetes mellitus who have suffered a cerebrovascular event. The gastrointestinal uptake of metformin is mediated by the human equilibrative nucleoside transporter 4 (ENT4), which is inhibited by dipyridamole in preclinical studies. We hypothesized that dipyridamole lowers the plasma exposure to metformin.

Methods: Eighteen healthy volunteers (mean age 23 years; 9 male) were randomized in an open-label crossover study. Subjects were allocated to treatment with metformin 500 mg twice daily in combination with dipyridamole slow-release 200 mg twice daily or to metformin alone for 4 days. After a washout period of 10 days, the volunteers were crossed over to the alternative treatment arm. Blood samples were collected during a 10-h period after intake of the last metformin dose. The primary endpoint was the area under the plasma concentration-time curve (AUC0-12h) and the maximum plasma metformin concentration (C max).

Results: In healthy subjects, dipyridamole did not significantly affect Cmax nor AUC0-12h of metformin under steady-state conditions.

Conclusions: Previous in vitro studies report that dipyridamole inhibits the ENT4 transporter that mediates gastrointestinal uptake of metformin. In contrast, co-administration of dipyridamole at therapeutic dosages to healthy volunteers does not have a clinically relevant effect on metformin plasma steady-state exposure. This observation is reassuring for patients who are treated with this combination of drugs.

Keywords: Dipyridamole; Drug interaction; ENT4; Metformin; PMAT; Pharmacokinetics.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Cross-Over Studies
  • Dipyridamole / adverse effects
  • Dipyridamole / pharmacology*
  • Equilibrative Nucleoside Transport Proteins / antagonists & inhibitors
  • Equilibrative Nucleoside Transport Proteins / metabolism
  • Female
  • Healthy Volunteers
  • Humans
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / blood
  • Hypoglycemic Agents / pharmacokinetics*
  • Male
  • Metformin / adverse effects
  • Metformin / blood
  • Metformin / pharmacokinetics*
  • Platelet Aggregation Inhibitors / adverse effects
  • Platelet Aggregation Inhibitors / pharmacology*
  • Young Adult

Substances

  • Equilibrative Nucleoside Transport Proteins
  • Hypoglycemic Agents
  • Platelet Aggregation Inhibitors
  • SLC29A4 protein, human
  • Dipyridamole
  • Metformin