NEW ORLEANS, April 5, 2011 /PRNewswire/ — Takeda
Pharmaceuticals North America, Inc. (Takeda) announced the
presentation of new study results, which evaluated the potential
inhibitory effects of certain proton pump inhibitors (PPIs) on
Plavix (clopidogrel bisulfate). The results showed that in healthy
subjects, clopidogrel’s active metabolite and inhibition of
platelet function were reduced less by the co-administration of
clopidogrel with dexlansoprazole or lansoprazole, rather than
esomeprazole. The randomized, open-label, two-period, crossover
study was designed to assess the effects of selected PPIs, a class
of drugs used to treat gastroesophageal reflux disease, on the
pharmacokinetics (PK) and pharmacodynamics (PD) of clopidogrel.
Clopidogrel is a platelet-inhibiting drug that is indicated for the
reduction of atherothrombotic events in patients with acute
coronary syndromes, recent myocardial infarction, recent stroke or
established peripheral arterial disease. The results were presented
at the American College of Cardiology (ACC) 2011 60th Annual
Scientific Session in New Orleans.
Studies have shown that PPIs may inhibit a liver enzyme
(CYP2C19) important for the metabolism of clopidogrel. With CYP2C19
inhibition, clopidogrel may have reduced antiplatelet effects,
potentially reducing its effectiveness. Because PPIs differ in
their degree of inhibition of CYP2C19, using omeprazole as a
positive control, this study evaluated the effect of several PPIs
(dexlansoprazole, lansoprazole and esomeprazole) on the
steady-state PK and PD of clopidogrel in healthy subjects.
“We conducted this study to look at the effect of select PPIs on
Plavix and add to the growing body of evidence on the potential
interaction between these drugs,” said lead investigator Alan D.
Michelson, M.D., Professor of Pediatrics at Harvard Medical School
and Director of the Center for Platelet Research Studies at
Children’s Hospital Boston. “We found that in healthy