Dabigatran (Pradaxa) Anatomy of Drug Disaster. Thomas J. Moore Senior Scien1st Ins1tute for Safe Medica1on Prac1ces
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1 Dabigatran (Pradaxa) Anatomy of Drug Disaster Thomas J. Moore Senior Scien1st Ins1tute for Safe Medica1on Prac1ces
2 Compe9ng Interests No compensa1on for any dabigatran work except for honoraria for QuarterWatch issues.
3 Acknowledgements Ned McWilliams, Levin- Papantonio, Pensacola, FL Deborah Cohen, BMJ inves1ga1ve editor, London/Oxford
4 Pharmaceu9cal Disasters A scien1fic drama with just one plot
5 Scene 1: New Molecular Target
6 Scene 2: Large Pa9ent Popula9on
7 Scene 3: A Marke9ng Advantage Greater Efficacy Ease of Use Safety Advantage End of Act 1
8 Act 2: A Lot Can Go Wrong! Pivotal trial fails. Cancer in animals. Poorly tolerated. Teratogen. Problem metabolites. Severe hypersensi1vity. Poor bioavailability. Liver toxicity. Kidney impairment. Prolongs QT Interval. Psychiatric side effects. Comparator is bewer. Fungal infec1ons. Tendon rupture. Photo- sensi1vity. Hemorrhage. Rhabdomyolysis. Diabetes. Tardive dyskinesia.
9 Act 3: The drama climax Now what do we do?
10 Sir, Your Management Op9ons Abandon the drug Cover up/discount/ignore/hide/minimize Proceed with full/fair disclosure Reposi1on drug learn more
11 The Dabigatran Disaster Pharmacodrama Drama in 3 Acts
12 Biology of Blood CloQng
13 Molecular Targets An1- platelet agents Aspirin Clopidogrel Thrombin inhibi1on Warfarin (oral) IV forms Heparin Lovenox
14 Pa9ent Popula9ons Hip/knee replacement surgery Atrial fibrilla1on (afib) Acute coronary syndrome (ACS) Heart value replacement
15 Atrial Fibrilla9on Popula9on
16 Razor s Edge of An9coagula9on
17 Afib Treatment: Warfarin Inexpensive ~ $300 yr (+ monitoring visits) Dangerous Most ER visits in elderly for any drug (33%) 15-20% yr with bleeds 3.6% yr severe, life- threatening Hard to use Requires monitoring every 2 weeks Inter and intra- pa1ent variability
18 The Afib Gold Rush AstraZenica Ximelagatran Boehringer Ingelheim Pradaxa Janssen Pharmaceu1cals Xarelto Bristol Myers Squib Equis Daiichi- Sankyo - Savaysa
19 Dabigatran Plan: Act 1 Direct thrombin inhibitor (target) Afib (large popula1on) No monitoring (ease of use) Choose just 1 or 2 doses Effec1ve as warfarin (maybe a liwle bewer) No worse on bleeds
20 The RE- LY Trial Older pa1ents with atrial fibrilla1on 18,000 pa1ents studied 2 years Warfarin dose individualized Dabigatran 2 fixed doses studied 110 mg 150 mg RESULTS: About the same as warfarin
21 The Road to Blockbuster First in class FDA approved 2010 Single therapeu1c dose No monitoring No dose adjustment No tests Successful launch But.serious bleeding events in the elderly
22 QuarterWatch: 2011 Q1
23 Act 2: A Lot Can Go Wrong! Pivotal trial fails. Cancer in animals. Poorly tolerated. Teratogen. Problem metabolites. Severe hypersensi1vity. Poor bioavailability. Liver toxicity. Kidney impairment. Prolongs QT Interval. Psychiatric side effects. Comparator is bewer. Fungal infec1ons. Tendon rupture. Photo- sensi1vity. Hemorrhage. Rhabdomyolysis. Diabetes. Tardive dyskinesia.
24 Act 2: A Lot Can Go Wrong! Pivotal trial fails. Cancer in animals. Poorly tolerated. Teratogen. Problem metabolites. Severe PK/PD hypersensi1vity. Disaster Poor bioavailability. Liver toxicity. Kidney impairment. Prolongs QT Interval. Psychiatric side effects. Comparator is bewer. Fungal infec1ons. Tendon rupture. Photo- sensi1vity. Hemorrhage. Rhabdomyolysis. Diabetes. Tardive dyskinesia.
25 PK: Pharmacokine1cs PD: Pharmacodynamics
26 The PK/PD Disaster 5- fold variability in most pa1ents Terrible choice for 1 dose- for- all 8% can t metabolize 17% don t get enough to work 20-30% get excessive coagula1on Cri1cal need for dose adjustment Major health consequences Disabling strokes Life threatening bleeds
27 Reason for Variability Requires metabolic ac1va1on Hydrolyzed to form ac1ve moiety Metabolized to 4 glucuronides Low biovailability (3-7%) Only 1 elimina1on route (kidneys) Kidney func1on declines With age Cardiac problems
28 Sir, Your Management Op9ons Abandon the drug Cover up/discount/ignore/hide/minimize Proceed with full/fair disclosure Reposi1on drug learn more Act 3 Begins
29 Sir, Your Management Op9ons Abandon the drug Cover up/discount/ignore/hide/minimize Proceed with full/fair disclosure Reposi1on drug learn more
30 Planned ~
31 PK/PD Substudy 9,183 pa1ents in RE- LY ( ~ 50%) Peak- trough 1 month Had outcome events Strokes Systemic embolic events Major and minor bleeds Withheld for 5 years
32 Substudy Results 5- fold varia1on (10 th - 90 th percen1les) Range: 2 ng/ml 1000 ng/ml Higher concentra1ons More bleeding No real benefit gain 17% had sub- therapeu1c dose Withheld for 5 years
33 Dose Adjustment Requirements Accurate and available test Clear therapeu1c range
34
35
36 Boehringer Ingelheim Sanc9oned US District Court MDL Fined $935,000 for egregious viola1ons Withholding or destroying informa1on Case 3:12- md DRH- SCW Document 320 Filed 12/09/13 Page 1 of 51 Page ID #6220
37 from Paul Reilly (Doc p 28)
38 from Andreas Clements to Thorsten Lehr Thorsten Lehr s custodial files were destroyed, despite a li1ga1on hold
39
40 The Dose Escala9on Could not scale up RE- LY formula1on Alterna1ve failed bio- equivalence test 10-13% dose increase (10%- 90 %CI) > 26% dose increase in 10% of pa1ents Regulators did not object
41 Dose Boost Illustrated
42 Without Monitoring 8% can t metabolize, need other drug 17% sub- therapeu1c levels High risk of stroke 20-30% get excessive dose High risk of bleeding 10% at extremely high risk of bleeding Should not be on this drug Actual doses 10-25% higher than data
43 Need Dose Adjustment BUT Familiar test (INR) not reliable for dabigatran No lower dose available No therapeu1c range revealed No approved blood- level test
44 Best Defenses RE- LY proves no monitoring needed FDA approved every step FDA got all the data promptly Revealed some PK/PD data early FDA insisted on 1 therapeu1c dose Benefits of plasma- level adjustment unproven
45 Without Monitoring 8% can t metabolize, need other drug 17% sub- therapeu1c levels High risk of stroke 20-30% get excessive dose Higher risk of bleeding 10% at extremely high risk of bleeding Should not be on this drug Actual doses 10-25% higher than data
46 FDA Made It Worse Approved only 1 therapeu1c dose (150 mg) Only regulator to do so Went into denial with bleed reports Contradictory studies jus1fying posi1on Didn t insist on therapeu1c range
47 Sales vs. Safety
Committee Approval Date: September 12, 2014 Next Review Date: September 2015
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