Quetiapine Case 1 Warfarin Jose de Leon, MD
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1 Quetiapine Case 1 Warfarin Jose de Leon, MD
2 1. Quetiapine Case 1 J Clin Psychopharm 1999;19:
3 Educational Objectives At the conclusion of this presentation, the participant should be able to: 1. Think about pharmacological principles in the context of polypharmacy. 2. Appreciate that for understanding quetiapine safety, one must consider: 2.1. Personal, environmental and genetic factors Pharmacodynamics and pharmacokinetics. 3. Be familiar with warfarin and phenytoin pharmacology.
4 Abbreviations ADR: adverse drug reaction AED: anti-epileptic drug C: concentration D: dose DDI: drug-drug interaction INR: international normalized ratio PM: poor metabolizer. They lack active CYP. For CYP2D6 and CYP2C19, PMs exist. For CYP2C9, PMs do not exist, but some individuals have very low activity. TDM: therapeutic drug monitoring UM: ultrarapid metabolizer
5 Quetiapine Case Case Description 1.1. Phenytoin Pharmacology 1.2. Warfarin Pharmacology 1.3. Olanzapine Pharmacology 1.4. Quetiapine Pharmacology 1.5. Phenytoin s Role in This Case 1.6. Relevance of This Case Report
6 Quetiapine Case Case Description 1.1. Phenytoin Pharmacology Pharmacokinetics Pharmacodynamics 1.2. Warfarin Pharmacology Pharmacodynamics Pharmacokinetics 1.3. Olanzapine Pharmacology Pharmacokinetics Pharmacodynamics 1.4. Quetiapine Pharmacology Pharmacokinetics Pharmacodynamics Quetiapine DI in This Case 1.5. Phenytoin s Role in This Case 1.6. Relevance of This Case Report Initial Recommendation at Time of Publication (1999) PubMed Search Review of Articles Generalization from a Case Report
7 1.0. Quetiapine Case 1: Case Description
8 1.0. Quetiapine Case 1: Introduction 71-year-old Caucasian Diagnosis of vascular dementia Medications: phenytoin for seizures warfarin for deep vein thrombosis Target INR values for this patient:
9 1.1. Phenytoin Pharmacology
10 1.1. Quetiapine Case 1: Phenytoin What do you know about phenytoin pharmacology?
11 1.1. Phenytoin Pharmacology Phenytoin Pharmacokinetics Phenytoin Pharmacodynamics
12 Phenytoin Pharmacokinetics
13 Quetiapine Case 1: Phenytoin Pharmacokinetics What do you know about phenytoin pharmacokinetics?
14 Quetiapine Case 1: Phenytoin Pharmacokinetics Very complex pharmacokinetics: complex metabolism narrow therapeutic window non-linear kinetics particularly during intoxication complex DDIs
15 Phenytoin Pharmacokinetics Metabolism Therapeutic Window Non-Linear Kinetics DDIs
16 Phenytoin Metabolism
17 Quetiapine Case 1: Phenytoin Metabolism Phenytoin metabolism: Main enzyme is: CYP2C9 Second enzyme: CYP2C19 Others: CYP2C18 and CYP3A4
18 Quetiapine Case 1: Phenytoin Metabolism Is CYP2C9 polymorphic?
19 Quetiapine Case 1: Phenytoin Metabolism Is CYP2C9 polymorphic? Yes.
20 Quetiapine Case 1: Phenytoin Metabolism CYP2C9 alleles: *2: minor in activity 11% of Caucasians (lower % in other races) *3: moderate in activity 7% of Caucasians (lower % in other races)
21 Quetiapine Case 1: Phenytoin Metabolism CYP2C9 polymorphism: Alleles Activity (up to 1.0) *1/*1 Normal (1.00) *1/*2 Minor (0.82) *2/*2 Moderate (0.70) *1/*3 Moderate (0.56) *2/*3 Moderate (0.39) *3/*3 Very low (0.13) It varies from drug to drug. The correction factor for phenytoin on CYP2C9 *3/*3 is
22 Quetiapine Case 1: Phenytoin Metabolism Is CYP2C19 polymorphic?
23 Quetiapine Case 1: Phenytoin Metabolism Is CYP2C19 polymorphic? Yes.
24 Quetiapine Case 1: Phenytoin Metabolism CYP2C19 PMs: East Asians: 25 % Other races: <5% CYP2C19 UMs: *17: associated with expression Its clinical relevance is not well established. The frequency is 1-5% for *17/*17. The frequency is higher with only one *17. See the presentation Pharmacogenetic Tests in Psychiatry for more details.
25 Phenytoin Therapeutic Window
26 Quetiapine Case 1: Phenytoin Therapeutic Window What do you know about phenytoin TDM?
27 Quetiapine Case 1: Phenytoin Therapeutic Window Typical therapeutic range: mcg/ml (mg/l) This is a narrow therapeutic index (or window). If you divide 20/10=2. This is <3 and indicates a narrow therapeutic window. For more details on therapeutic index, see the TDM section on the presentation Pharmacokinetics of Oral Second-Generation Antipsychotics.
28 Quetiapine Case 1: Phenytoin Therapeutic Window Should you worry about phenytoin intoxications?
29 Quetiapine Case 1: Phenytoin Therapeutic Window Should you worry about phenytoin intoxications? Yes, very much.
30 Quetiapine Case 1: Phenytoin Therapeutic Window Why do you need to worry so much?
31 Quetiapine Case 1: Phenytoin Therapeutic Window Why do you need to worry so much? Phenytoin follows non-linear kinetics during intoxications.
32 Non-Linear Kinetics
33 Quetiapine Case 1: Phenytoin Kinetics Phenytoin s non-linear kinetics is: dose-dependent, and capacity-limited. Dose-dependent kinetics: changes with dose, (more precisely is concentration-dependent). Capacity-limited: metabolism can easily reach saturation when you are close to the upper therapeutic range (20 mcg/ml).
34 Quetiapine Case 1: Phenytoin Kinetics What is the clinical relevance of this?
35 Quetiapine Case 1: Phenytoin Kinetics What is the clinical relevance of this? Be careful with high serum Cs.
36 Quetiapine Case 1: Phenytoin Kinetics With Cs around 20 mcg/ml, the CYPs (CYP2C9 and CYP2C19) can be saturated. Extraordinarily long phenytoin halflives have been described during Intoxication. This requires the complete discontinuation of phenytoin for 2-3 days until Cs < 20 mcg/ml and metabolism normalizes.
37 Quetiapine Case 1: Phenytoin Kinetics Non-linear kinetics should be considered for dosing. dose slowly to reach therapeutic C. Phenytoin C (mcg/ml) Recommended dose (mg/day) <7 by by 50 >12 by 30
38 Phenytoin DDIs
39 Quetiapine Case 1: Phenytoin DDIs Do you need to worry about phenytoin pharmacokinetic DDIs?
40 Quetiapine Case 1: Phenytoin DDIs Do you need to worry about phenytoin pharmacokinetic DDIs? Yes.
41 Quetiapine Case 1: Phenytoin DDIs Why?
42 Quetiapine Case 1: Phenytoin DDIs Why? Phenytoin is a major inducer.
43 Quetiapine Case 1: Phenytoin DDIs Potent inducers: CYPs: Massive effects: CYP2B6, CYP3A4 Moderate effects: CYP1A2, CYP2A6 Mild effects: CYP2C (CYP2C8, CYP2C9 & CYP2C19) UGTs: several
44 Quetiapine Case 1: Phenytoin DDIs Time required (not well-studied): Maximum: 1-2 weeks De-induction: 1-2 weeks Auto-induction: mild and not clinically relevant
45 Quetiapine Case 1: Phenytoin DDIs Are phenytoin s inductive effects important for psychiatric drugs?
46 Quetiapine Case 1: Phenytoin DDIs Are phenytoin s inductive effects important for psychiatric drugs? Yes, very important.
47 Quetiapine Case 1: Phenytoin DDIs Induces metabolism of: most antipsychotics many antidepressants many benzodiazepines carbamazepine & lamotrigine
48 Quetiapine Case 1: Phenytoin DDIs Correction factors (described if 1.5): 5 x: lurasidone, quetiapine 3 x: haloperidol, paliperidone 2-3 x: olanzapine 2 x: aripiprazole, carbamazepine, iloperidone, lamotrigine, mirtazapine, risperidone, TCAs, topiramate x: clozapine 1.5 x: felbamate
49 Phenytoin Pharmacodynamics
50 Quetiapine Case 1: Phenytoin Pharmacodynamics What do you know about phenytoin pharmacodynamics?
51 Quetiapine Case 1: Phenytoin Pharmacodynamics Efficacy as an AED: Phenytoin blocks voltage-dependent sodium channels in neurons.
52 1.2. Warfarin Pharmacology
53 1.2. Quetiapine Case 1: Warfarin What do you know about warfarin pharmacology?
54 1.2. Warfarin Pharmacology Warfarin Pharmacodynamics Warfarin Pharmacokinetics
55 Warfarin Pharmacodynamics
56 Quetiapine Case 1: Warfarin Pharmacodynamics Racemic mix: S-warfarin: most of the activity (5-6 times more active) R-warfarin: little of the activity Anticoagulant efficacy: Vitamin K antagonist
57 Warfarin Pharmacokinetics
58 Warfarin Pharmacokinetics Warfarin Metabolism Warfarin DDIs Warfarin Monitoring Warfarin Pharmacogenetics
59 Warfarin Metabolism
60 Quetiapine Case 1: Warfarin Metabolism S-warfarin metabolism: mainly by CYP2C9 R-warfarin metabolism: CYP3A CYP1A2 CYP2C19
61 Warfarin DDIs
62 Quetiapine Case 1: Warfarin DDIs Warfarin DDIs frequently have clinically relevant effects and are potentially lethal. Potent CYP2C9 inhibitors can warfarin metabolism. Potent CYP2C9 inducers can warfarin metabolism.
63 Quetiapine Case 1: Warfarin DDIs CYP2C9 inhibitors used in psychiatry: potent: fluvoxamine valproate moderate: fluoxetine
64 Quetiapine Case 1: Warfarin DDIs CYP2C9 inducers used in psychiatry: carbamazepine
65 Warfarin Monitoring
66 Quetiapine Case 1: Warfarin Monitoring What do you know about warfarin monitoring?
67 Quetiapine Case 1: Warfarin Monitoring Measured by the INR. INR values = patient prothrombin time mean normal prothrombin time INR recommended values: vary per indication usually recommended range
68 Quetiapine Case 1: Warfarin Monitoring Serum warfarin Cs are not measured. However, you may want to remember warfarin as: a narrow therapeutic window drug with potentially lethal DDIs
69 Warfarin Pharmacogenetics
70 Quetiapine Case 1: Warfarin Pharmacogenetics What do you know about warfarin pharmacogenetic testing?
71 Quetiapine Case 1: Warfarin Pharmacogenetics Clinical tests for polymorphic variations: CYP2C9 VKORC1 (vitamin K epoxide reductase complex subunit 1) There are dose calculators using: genetics: these 2 genes co-medications: inducers inhibitors personal factors: age race height and weight
72 1.3. Olanzapine Pharmacology
73 1.3. Quetiapine Case 1: Olanzapine Olanzapine Phenytoin Warfarin D D C D(mg/wk)INR (6 weeks) Taking benztropine 0.5 mg/day. Olanzapine discontinued: no changes in INR.
74 1.3. Olanzapine Pharmacology Olanzapine Pharmacokinetics Olanzapine Pharmacodynamics
75 Olanzapine Pharmacokinetics
76 Quetiapine Case 1: Olanzapine Pharmacokinetics What do you know about olanzapine pharmacokinetics?
77 Quetiapine Case 1: Olanzapine Pharmacokinetics Olanzapine metabolism: mainly by CYP1A2 secondarily by UGT1A4 As with most second-generation antipsychotics, olanzapine is: not an inducer, not a major inhibitor, but possibly a competitive inhibitor.
78 Olanzapine Pharmacodynamics
79 Quetiapine Case 1: Olanzapine Pharmacodynamics What do you know about olanzapine pharmacodynamics?
80 Quetiapine Case 1: Olanzapine Pharmacodynamics Olanzapine efficacy in psychosis (schizophrenia): D 2 antagonist No major effects on coagulation or platelet function are known. As with all antipsychotics, it has a black box warning for risk of death in elderly demented patients. Olanzapine use in dementia is an off-label indication.
81 1.4. Quetiapine Pharmacology
82 1.4. Quetiapine Case 1: Quetiapine Quetiapine Phenytoin Warfarin D D C D(mg/wk)INR * *After 2 weeks on quetiapine up to 200 mg/day.
83 1.4. Quetiapine Case 1: Quetiapine As INR from 2.7 to 9.2: quetiapine was discontinued warfarin was hold (not administered until INR normalized) 2 injections of vitamin K 1 10 mg was given injections produced a small amount of bleeding, along with bruising on the hand INR = 1.1 the next day The patient was stabilized on olanzapine.
84 1.4. Quetiapine Case 1: Quetiapine Olanzapine Phenytoin Warfarin D D C D(mg/wk) INR 15* *4 weeks on olanzapine and taking benztropine 0.5 mg/day.
85 1.4. Quetiapine Pharmacology Quetiapine Pharmacokinetics Quetiapine Pharmacodynamics Quetiapine DI in This Case
86 Quetiapine Pharmacokinetics
87 Quetiapine Case 1: Quetiapine Pharmacokinetics What do you know about quetiapine pharmacokinetics?
88 Quetiapine Case 1: Quetiapine Pharmacokinetics Quetiapine metabolism: mainly by CYP3A secondarily by CYP2D6 As with most second-generation antipsychotics, quetiapine is: not an inducer not a major inhibitor, but possibly a competitive inhibitor, particularly for CYP3A4
89 Quetiapine Pharmacodynamics
90 Quetiapine Case 1: Quetiapine Pharmacodynamics What do you know about quetiapine pharmacodynamics?
91 Quetiapine Case 1: Quetiapine Pharmacodynamics Quetiapine efficacy in psychosis: D 2 antagonist (with low affinity and loose binding). No known major effects on coagulation or platelet function. As with all antipsychotics, it has a black box warning for risk of death in elderly demented patients. Quetiapine use in dementia is an off-label indication.
92 Quetiapine DI in This Case
93 Quetiapine Case 1: Quetiapine DI in This Case Quetiapine: addition: INR discontinuation: back to normal INRs Quetiapine appears to have caused a DI with warfarin. Mechanism: pharmacodynamic mechanism: not known pharmacokinetic mechanism: possible
94 Quetiapine Case 1: Quetiapine DI in This Case Competitive inhibition was possible: At CYP3A4: quetiapine may inhibit R-warfarin metabolism.
95 1.5. Phenytoin s Role in This Case
96 1.5. Quetiapine Case 1: Phenytoin s Role The INR was stable before and after quetiapine treatment and the patient was on phenytoin.
97 1.5. Quetiapine Case 1: Phenytoin s Role Thus, we conclude that phenytoin played no role in this DDI.
98 1.5. Quetiapine Case 1: Phenytoin s Role Is this conclusion correct?
99 1.5. Quetiapine Case 1: Phenytoin s Role Is this conclusion correct? Certainly not.
100 1.5. Quetiapine Case 1: Phenytoin s Role What is phenytoin s role?
101 1.5. Quetiapine Case 1: Phenytoin s Role What is phenytoin s role? Dr. de Leon is not sure, but it can be hypothesized.
102 1.5. Quetiapine Case 1: Phenytoin s Role Phenytoin metabolism by CYP2C9 was probably important. Phenytoin competes with warfarin for CYP2C9 : warfarin D was in low range. Phenytoin is an inducer: but this was not evident: warfarin D was low which may change the balance of CYP2C9 and CYP3A4 for warfarin metabolism. By correcting warfarin D according to the INR, the doctor was correcting for phenytoin s effects.
103 1.5. Quetiapine Case 1: Phenytoin s Role We can only hypothesize phenytoin s role. It is probably relevant by: contributing to CYP2C9 inhibition and/or induction, which may modify the metabolism of: warfarin (and/or quetiapine) In situations of polypharmacotherapy, it is not easy to interpret DIs.
104 1.6. Relevance of This Case Report
105 1.6. Relevance Initial Recommendation at the Time of Publication (1999) PubMed Search Review of Articles Generalization from a Case Report
106 Initial Recommendation at the Time of Publication (1999)
107 Quetiapine Case 1: Initial Recommendation The initial recommendation in the article regarding warfarin patients: Consider whether adding quetiapine is really necessary; olanzapine did not the INR. If it is necessary, monitor the INR closely.
108 PubMed Search (2016)
109 Quetiapine Case 1: PubMed Search Go to PubMed. Type in the search box: quetiapine and warfarin On January 20, 2016, Dr. de Leon found 9 articles. Starting from the bottom, they are as follows.
110 Quetiapine Case 1: PubMed Search Number 9: This is a case report. Number 8: The abstract suggests it is not relevant. Number 7: The abstract suggests it is not relevant. Number 6: The abstract suggests it is not relevant. Number 5: The abstract suggests it is not relevant.
111 Quetiapine Case 1: PubMed Search Number 4: Title: Drug interaction as cause of spontaneously resolving epidural spinal hematoma on warfarin therapy. The abstract (and available pdf) suggest this was a case of polypharmacy and it is unclear whether quetiapine contributed or not.
112 Quetiapine Case 1: PubMed Search Number 3: Yang & Liang, 2011 Title: Multiple intracerebral hemorrhages in an elderly patient after adding quetiapine to a stable warfarin regimen. The abstract says, Here, we present an elderly male patient with dementia who developed multiple intracerebral hemorrhages (ICHs) 3 days after the addition of quetiapine to his stable warfarin regimen
113 Quetiapine Case 1: PubMed Search Number 2: Nadkarni et al., 2012 Title: Drug-drug interactions between warfarin and psychotropics: updated review of the literature The abstract states: Psychotropics that pose a particular risk of increasing the INR when used with warfarin include fluoxetine, fluvoxamine, quetiapine, and valproic acid.
114 Quetiapine Case 1: PubMed Search Number 1: Chen et al., 2013 Title: Enhanced bleeding risk in an elderly dementia patient treated with warfarin and quetiapine. There is no abstract.
115 Review of Articles
116 Review of Articles Number 3: Case by Yang & Liang, Number 1: Case by Chen et al., Number 2: Review by Nadkarni et al., Another Warfarin Review: Holdbrook et al., 2005
117 Number 3: Case by Yang & Liang,
118 Quetiapine Case 1: Case by Yang & Liang, year-old from Taiwan Diagnosis of dementia Medications: warfarin for atrial fibrillation: INR other co-medications: atenolol 50 mg/d lacidipine 4 mg/d donepezil 5 mg/d After 3 days on quetiapine 12.5 mg/d: an intracerebral hemorrhage developed INR to 3.2
119 Number 1: Case by Chen et al.,
120 Quetiapine Case 1: Case by Chen et al., year-old from Taiwan Diagnosis of vascular dementia Medication: quetiapine 400 mg/day for 3 years Developed peripheral vein thrombosis: warfarin 1.25 mg/day for 1 month Admitted due to psychotic exacerbation: INR was found to be 3.9 warfarin was stopped (and vitamin K added). quetiapine was switched to amisulpride. Restarted with warfarin 1.25 mg/day with normal INRs on amisulpride.
121 Number 2: Review by Nadkarni et al.,
122 Quetiapine Case 1: Review by Nadkarni et al., 2012 Based on 2 cases: this case, and case by Yang & Liang, 2011 They consider quetiapine to pose particular risk of increasing the INR. They group quetiapine with some other inhibitors with more definitive data: fluoxetine fluvoxamine valproic acid
123 Another Warfarin Review: Holdbrook et al.,
124 Quetiapine Case 1: Review by Holdbrook et al., 2005 Yang & Liang, 2011, quote a 2005 warfarin review article, by Holbrook et al. Holbrook et al. had a different opinion: Tables 2 and 3 describe as highly improbable the quetiapine-warfarin DDI case described in this presentation.
125 Quetiapine Case 1: Review by Holdbrook et al., 2005 There is a big difference between an evidence-based medicine approach used by Holbrook et al. versus a personalized medicine approach based on pharmacokinetic mechanisms used in this presentation.
126 Quetiapine Case 1: Review by Holdbrook et al., 2005 Using an evidence-based medicine approach to verify the DDI described in this case requires studying a group of patients taking phenytoin and warfarin, randomizing them to quetiapine versus placebo, and following them prospectively. Such a study won t happen for economic (lack of funding) and ethical reasons (serious risk).
127 Generalization from a Case Report
128 Quetiapine Case 1: Generalization from a Case Report There are no case reports with other antipsychotics INR. Interpreting this case report, with a personalized medicine approach (pharmacological mechanisms), in 1999, Dr. de Leon recommended monitoring INR closely if the decision is made to add quetiapine to warfarin.
129 Quetiapine Case 1: Generalization from a Case Report In 2005, interpreting this case report, with an evidence-based medicine approach, Holbrook et al. recommended ignoring it ( highly improbable ).
130 Quetiapine Case 1: Generalization from a Case Report When interpreting this case, what is best? To give value to a personalized medicine approach or to an evidence-based medicine approach?
131 Quetiapine Case 1: Generalization from a Case Report The best way is to frame the question as a risk-benefit analysis.
132 Quetiapine Case 1: Generalization from a Case Report Let s imagine Holbrook et al. s evidence-based approach is right, but you have followed Dr. de Leon s personalized medicine approach. What are the risks and benefits?
133 Quetiapine Case 1: Generalization from a Case Report No benefits: quetiapine does not INR. Risks: you have wasted a few INRs by closely monitoring INR after adding quetiapine. The INRs were normal and you were overconcerned.
134 Quetiapine Case 1: Generalization from a Case Report Let s imagine Dr. de Leon s personalized medicine approach is right, but you have followed Holbrook et al. s evidencebased approach. What are the risks and benefits?
135 Generalization from a Case Report The risks of adding quetiapine to warfarin are demonstrated in 2 published cases by clinicians who ignored the risks: Yang & Liang, 2011: the outcome was an intracerebral hemorrhage. Chen et al., 2013: INR was fortunately caught rapidly. Benefits: avoiding these risky outcomes.
136 Generalization from a Case Report Is this case report potentially relevant?
137 Generalization from a Case Report Is this case report potentially relevant? It depends on how you frame your thinking.
138 Generalization from a Case Report Dr. de Leon thinks the evidencebased medicine approach is very limited for identifying rare and potentially lethal ADRs. RCTs by pharmaceutical companies: are short-term (weeks), are small (hundreds of patients), exclude patients with relevant medical problems, or co-medications.
139 Generalization from a Case Report Dr. de Leon thinks that you should pay attention to case reports for preventing rare and potentially lethal ADRs.
140 1.6. Quetiapine Case 1: Relevance If you are interested in differences between evidence-based and personalized-medicine approaches, see the presentation titled Evidence- Based Medicine versus Personalized Medicine or the editorial on which it is based. pre-printed free copy
141 Questions Please review the 10 questions on the pdf entitled Questions on the Presentation Quetiapine Case 1 Warfarin. You will find the answers on the last slide after the Thank you slide. No peeking until you have answered all the questions. If you do not answer all the questions correctly, please review the PowerPoint presentation again to reinforce the pharmacological concepts.
142 Thank you
143 Answers 1. A 6. C 2. B 7. D 3. D 8. B 4. D 9. B 5. B 10. A
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