Pharmacokinetics of extended-release dipyridamole following administration through a gastrostomy tube: an open-label, case-control, two-centre study

Clin Drug Investig. 2010;30(7):483-8. doi: 10.2165/11536220-000000000-00000.

Abstract

Background: Many stroke survivors have severe dysphagia and are unable to take antithrombotic medications orally.

Objective: To evaluate whether dipyridamole concentrations achieved in the plasma of patients taking an extended-release formulation of the medication through a gastrostomy tube (G-tube) are therapeutic and similar to those achieved in the plasma of patients who receive the drug orally.

Methods: This was an open-label, case-control, two-centre study conducted in two academic centres in a metropolitan area. Patients included were those admitted following an acute cerebral infarction, with an indication for antiplatelet therapy for secondary prevention. Twelve patients with severe dysphagia requiring G-tube placement were cases, and 12 patients who were able to swallow safely served as controls. The components of Aggrenox (extended-release dipyridamole/aspirin [acetylsalicylic acid]), suspended in water, were administered twice daily for 5 days through the G-tube. The 12 control patients without dysphagia took the medication orally. Dipyridamole plasma concentrations were compared between the groups at three different timepoints on the fifth day: 2, 6 and 12 hours after administration. The main outcome measure was dipyridamole plasma concentrations on day 5 at all three timepoints.

Results: No significant difference in dipyridamole plasma concentrations between the groups was found at 2 hours (p = 0.18), 6 hours (p = 0.92) or 12 hours (p = 0.69).

Conclusion: Dipyridamole plasma concentrations obtained following administration of extended-release dipyridamole through a G-tube in dysphagic patients achieved similar therapeutic levels to those obtained in patients taking the medication orally.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aggrecans / administration & dosage*
  • Case-Control Studies
  • Cerebral Infarction / complications*
  • Cerebral Infarction / drug therapy
  • Deglutition Disorders / complications
  • Deglutition Disorders / etiology
  • Delayed-Action Preparations
  • Dipyridamole / administration & dosage
  • Dipyridamole / pharmacokinetics*
  • Female
  • Gastrostomy*
  • Humans
  • Male
  • Middle Aged
  • Platelet Aggregation Inhibitors / administration & dosage
  • Platelet Aggregation Inhibitors / pharmacokinetics*
  • Severity of Illness Index
  • Stroke / prevention & control

Substances

  • Aggrecans
  • Delayed-Action Preparations
  • Platelet Aggregation Inhibitors
  • Dipyridamole