Morphine interaction with prasugrel: a double-blind, cross-over trial in healthy volunteers
Background Morphine decreases the concentrations and effects of clopidogrel, which could lead to treatment failure in myocardial infarction. Objectives To clarify whether more potent P2Y 12 -inhibitors may provide an effective alternative, we examined drug–drug interactions between morphine and pras...
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| Veröffentlicht in: | Clinical research in cardiology Jg. 105; H. 4; S. 349 - 355 |
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| Format: | Journal Article |
| Sprache: | Englisch |
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Berlin/Heidelberg
Springer Berlin Heidelberg
01.04.2016
Springer Nature B.V |
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| ISSN: | 1861-0684, 1861-0692, 1861-0692 |
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| Abstract | Background
Morphine decreases the concentrations and effects of clopidogrel, which could lead to treatment failure in myocardial infarction.
Objectives
To clarify whether more potent P2Y
12
-inhibitors may provide an effective alternative, we examined drug–drug interactions between morphine and prasugrel.
Methods
Twelve healthy volunteers received 60 mg prasugrel with placebo or 5 mg morphine intravenously in a randomized, double-blind, placebo-controlled, cross-over trial. Pharmacokinetics were determined by liquid chromatography tandem mass spectrometry, and prasugrel effects were measured by platelet function tests.
Results
Morphine neither diminished total drug exposure (AUC), which was the primary endpoint, nor significantly delayed drug absorption of prasugrel. However, morphine reduced maximal plasma concentrations (
C
max
) of prasugrel active metabolite by 31 % (
p
= 0.019). Morphine slightly, but not significantly, delayed the onset of maximal inhibition of platelet plug formation under high shear rates (30 vs. 20 min). Whole blood aggregation was not influenced.
Conclusions
Although morphine significantly decreases the maximal plasma concentrations of prasugrel active metabolite, it does not diminish its effects on platelets to a clinically relevant degree in healthy volunteers. However, it should be considered that the observed decrease in
C
max
of prasugrel active metabolite caused by morphine co-administration may gain relevance in STEMI patients.
Clinical Trial Registration
: NCT01369186, EUDRA-CT#: 2010-023761-22. |
|---|---|
| AbstractList | Morphine decreases the concentrations and effects of clopidogrel, which could lead to treatment failure in myocardial infarction.
To clarify whether more potent P2Y12-inhibitors may provide an effective alternative, we examined drug-drug interactions between morphine and prasugrel.
Twelve healthy volunteers received 60 mg prasugrel with placebo or 5 mg morphine intravenously in a randomized, double-blind, placebo-controlled, cross-over trial. Pharmacokinetics were determined by liquid chromatography tandem mass spectrometry, and prasugrel effects were measured by platelet function tests.
Morphine neither diminished total drug exposure (AUC), which was the primary endpoint, nor significantly delayed drug absorption of prasugrel. However, morphine reduced maximal plasma concentrations (C max) of prasugrel active metabolite by 31 % (p = 0.019). Morphine slightly, but not significantly, delayed the onset of maximal inhibition of platelet plug formation under high shear rates (30 vs. 20 min). Whole blood aggregation was not influenced.
Although morphine significantly decreases the maximal plasma concentrations of prasugrel active metabolite, it does not diminish its effects on platelets to a clinically relevant degree in healthy volunteers. However, it should be considered that the observed decrease in C max of prasugrel active metabolite caused by morphine co-administration may gain relevance in STEMI patients.
NCT01369186, EUDRA-CT#: 2010-023761-22. Background Morphine decreases the concentrations and effects of clopidogrel, which could lead to treatment failure in myocardial infarction. Objectives To clarify whether more potent P2Y 12 -inhibitors may provide an effective alternative, we examined drug–drug interactions between morphine and prasugrel. Methods Twelve healthy volunteers received 60 mg prasugrel with placebo or 5 mg morphine intravenously in a randomized, double-blind, placebo-controlled, cross-over trial. Pharmacokinetics were determined by liquid chromatography tandem mass spectrometry, and prasugrel effects were measured by platelet function tests. Results Morphine neither diminished total drug exposure (AUC), which was the primary endpoint, nor significantly delayed drug absorption of prasugrel. However, morphine reduced maximal plasma concentrations ( C max ) of prasugrel active metabolite by 31 % ( p = 0.019). Morphine slightly, but not significantly, delayed the onset of maximal inhibition of platelet plug formation under high shear rates (30 vs. 20 min). Whole blood aggregation was not influenced. Conclusions Although morphine significantly decreases the maximal plasma concentrations of prasugrel active metabolite, it does not diminish its effects on platelets to a clinically relevant degree in healthy volunteers. However, it should be considered that the observed decrease in C max of prasugrel active metabolite caused by morphine co-administration may gain relevance in STEMI patients. Clinical Trial Registration : NCT01369186, EUDRA-CT#: 2010-023761-22. Morphine decreases the concentrations and effects of clopidogrel, which could lead to treatment failure in myocardial infarction.BACKGROUNDMorphine decreases the concentrations and effects of clopidogrel, which could lead to treatment failure in myocardial infarction.To clarify whether more potent P2Y12-inhibitors may provide an effective alternative, we examined drug-drug interactions between morphine and prasugrel.OBJECTIVESTo clarify whether more potent P2Y12-inhibitors may provide an effective alternative, we examined drug-drug interactions between morphine and prasugrel.Twelve healthy volunteers received 60 mg prasugrel with placebo or 5 mg morphine intravenously in a randomized, double-blind, placebo-controlled, cross-over trial. Pharmacokinetics were determined by liquid chromatography tandem mass spectrometry, and prasugrel effects were measured by platelet function tests.METHODSTwelve healthy volunteers received 60 mg prasugrel with placebo or 5 mg morphine intravenously in a randomized, double-blind, placebo-controlled, cross-over trial. Pharmacokinetics were determined by liquid chromatography tandem mass spectrometry, and prasugrel effects were measured by platelet function tests.Morphine neither diminished total drug exposure (AUC), which was the primary endpoint, nor significantly delayed drug absorption of prasugrel. However, morphine reduced maximal plasma concentrations (C max) of prasugrel active metabolite by 31 % (p = 0.019). Morphine slightly, but not significantly, delayed the onset of maximal inhibition of platelet plug formation under high shear rates (30 vs. 20 min). Whole blood aggregation was not influenced.RESULTSMorphine neither diminished total drug exposure (AUC), which was the primary endpoint, nor significantly delayed drug absorption of prasugrel. However, morphine reduced maximal plasma concentrations (C max) of prasugrel active metabolite by 31 % (p = 0.019). Morphine slightly, but not significantly, delayed the onset of maximal inhibition of platelet plug formation under high shear rates (30 vs. 20 min). Whole blood aggregation was not influenced.Although morphine significantly decreases the maximal plasma concentrations of prasugrel active metabolite, it does not diminish its effects on platelets to a clinically relevant degree in healthy volunteers. However, it should be considered that the observed decrease in C max of prasugrel active metabolite caused by morphine co-administration may gain relevance in STEMI patients.CONCLUSIONSAlthough morphine significantly decreases the maximal plasma concentrations of prasugrel active metabolite, it does not diminish its effects on platelets to a clinically relevant degree in healthy volunteers. However, it should be considered that the observed decrease in C max of prasugrel active metabolite caused by morphine co-administration may gain relevance in STEMI patients.NCT01369186, EUDRA-CT#: 2010-023761-22.CLINICAL TRIAL REGISTRATIONNCT01369186, EUDRA-CT#: 2010-023761-22. Background Morphine decreases the concentrations and effects of clopidogrel, which could lead to treatment failure in myocardial infarction. Objectives To clarify whether more potent P2Y^sub 12^-inhibitors may provide an effective alternative, we examined drug-drug interactions between morphine and prasugrel. Methods Twelve healthy volunteers received 60 mg prasugrel with placebo or 5 mg morphine intravenously in a randomized, double-blind, placebo-controlled, cross-over trial. Pharmacokinetics were determined by liquid chromatography tandem mass spectrometry, and prasugrel effects were measured by platelet function tests. Results Morphine neither diminished total drug exposure (AUC), which was the primary endpoint, nor significantly delayed drug absorption of prasugrel. However, morphine reduced maximal plasma concentrations (C ^sub max^) of prasugrel active metabolite by 31 % (p = 0.019). Morphine slightly, but not significantly, delayed the onset of maximal inhibition of platelet plug formation under high shear rates (30 vs. 20 min). Whole blood aggregation was not influenced. Conclusions Although morphine significantly decreases the maximal plasma concentrations of prasugrel active metabolite, it does not diminish its effects on platelets to a clinically relevant degree in healthy volunteers. However, it should be considered that the observed decrease in C ^sub max^ of prasugrel active metabolite caused by morphine co-administration may gain relevance in STEMI patients. Clinical Trial Registration: NCT01369186, EUDRA-CT#: 2010-023761-22. |
| Author | Hobl, Eva-Luise Schoergenhofer, Christian Reiter, Birgit Lang, Irene Marthe Schwameis, Michael Derhaschnig, Ulla Jilma, Bernd Stimpfl, Thomas |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/26493304$$D View this record in MEDLINE/PubMed |
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| Keywords | Prasugrel Morphine Platelet function tests Drug interactions Vasodilator-stimulated phosphoprotein |
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| SSID | ssj0051034 |
| Score | 2.345828 |
| Snippet | Background
Morphine decreases the concentrations and effects of clopidogrel, which could lead to treatment failure in myocardial infarction.
Objectives
To... Morphine decreases the concentrations and effects of clopidogrel, which could lead to treatment failure in myocardial infarction. To clarify whether more... Background Morphine decreases the concentrations and effects of clopidogrel, which could lead to treatment failure in myocardial infarction. Objectives To... Morphine decreases the concentrations and effects of clopidogrel, which could lead to treatment failure in myocardial infarction.BACKGROUNDMorphine decreases... |
| SourceID | pubmedcentral proquest pubmed crossref springer |
| SourceType | Open Access Repository Aggregation Database Index Database Enrichment Source Publisher |
| StartPage | 349 |
| SubjectTerms | Adult Analgesics, Opioid - administration & dosage Analgesics, Opioid - adverse effects Austria Biotransformation Cardiology Chromatography, Liquid Cross-Over Studies Double-Blind Method Drug Interactions Drug Monitoring - methods Female Healthy Volunteers Humans Male Medicine Medicine & Public Health Morphine - administration & dosage Morphine - adverse effects Original Paper Platelet Aggregation - drug effects Platelet Aggregation Inhibitors - administration & dosage Platelet Aggregation Inhibitors - adverse effects Platelet Aggregation Inhibitors - blood Platelet Aggregation Inhibitors - pharmacokinetics Platelet Function Tests Prasugrel Hydrochloride - administration & dosage Prasugrel Hydrochloride - adverse effects Prasugrel Hydrochloride - blood Prasugrel Hydrochloride - pharmacokinetics Purinergic P2Y Receptor Antagonists - administration & dosage Purinergic P2Y Receptor Antagonists - adverse effects Purinergic P2Y Receptor Antagonists - blood Purinergic P2Y Receptor Antagonists - pharmacokinetics Risk Assessment Tandem Mass Spectrometry Young Adult |
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| Title | Morphine interaction with prasugrel: a double-blind, cross-over trial in healthy volunteers |
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