Takeda announced today that the product labeling for DEXILANT (dexlansoprazole) now contains data from an investigation in healthy individuals. The information shows that DEXILANT had no clinically significant effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition.
According to the report, it is not necessary to adjust the dose of clopidogrel when taken with an approved dose of DEXILANT. DEXILANT is a proton pump inhibitor (PPI) designed to treat individuals with gastroesophageal reflux disease (GERD). In the United States approximately 19 million individuals are affected by the disease.
Clopidogrel is an antiplatelet medication designed to reduce atherothrombotic events in individuals with acute coronary syndromes, established peripheral arterial disease, recent stroke, or recent myocardial infarction. Investigations have indicated that to varying degrees, PPIs restrict the enzyme (CYP2C19), which metabolizes clopidogrel to its active form. Multiple communications claiming that the combined use of omeprazole and clopidogrel have been issued by the U.S. Food and Drug Administration since 2009.
David A. Johnson, M.D., FACG, FASGE, professor of Medicine, chief of Gastroenterology, Eastern Virginia School of Medicine, Norfolk, VA. Explained:
“An estimated 25 million prescriptions were dispensed for clopidogrel last year, and given the high prevalence of gastroesophageal reflux disease, it is likely that some of these same patients may also be taking a PPI for their GERD.
The study findings are important because as health care providers we have a responsibility to find appropriate treatment regimens for these patients without potentially reducing the intended anti-platelet effects of Plavix.”
Takeda carried out a randomized, open-label, two-period, crossover investigation in order to assess the effect of DEXILANT on the pharmacodynamics and pharmacokinetics of clopidogrel in healthy participants. Results from the investigation revealed that the area under the curve (AUC) of the active metabolite of clopidogrel was reduced by around 9% (mean AUC ratio was 91%, with 90% CI of 86% – 97%) when taken together with DEXILANT in comparison to clopidogrel administered alone.
Researchers also measured pharmacodynamic parameters and results showed that the change in inhibition of platelet aggregation (induced by 5 mcM ADP) was linked to the alteration in the exposure to clopidogrel active metabolite, although how clinically significant this finding is remains unclear. Results of the study were presented at the American College of Cardiology (ACC) 2011 60th Annual Scientific Session in April 2011.
Takeda collaborated with the FDA in order to find out suitable information to be included in the revised DEXILANT product labeling. This information can be found in the labeling’s Drug Interactions and Clinical Pharmacology sections. A section in the Drug Interactions specifically explains that it is not necessary to adjust the dose of Plavic when taken with an approved dose of DEXILANT.
Gilles Delecoeuillerie, M.D., Ph.D., executive medical director, Medical & Scientific Affairs, Gastroenterology and Internal Medicine, Takeda, explains:
“We are pleased to add this information into the DEXILANT labeling enabling us to provide a clearer understanding for health care prescribers about the co-administration of DEXILANT and Plavix.
Takeda conducted this study to further understand how DEXILANT may interact with clopidogrel and to ensure that patients with GERD, who are treated with both medications, have the most up to date co-administration information.”
About DEXILANT (dexlansoprazole) 30 mg and 60 mg delayed release capsules
DEXILANT is a PPI, which reduced the production of acid by switching off several acid pumps within the stomach, thereby helping to protect the esophagus from acidic reflux giving the esophageal inflammation time to heal.
DEXILANT combines a Duel Delayed Release (DDR) formulation together with an enantimer of lansoprazole designed to provide two independent releases of medication. DEXILANT is indicated for:
- Healing all grades of erosive esophagitis (EE) for up to eight weeks.
- Treating heartburn connected with symptomatic non-erosive GERD for up to four weeks
- and to maintain healing of EE and heartburn for up to six months.
Written by Grace Rattue