Dabigatran: how the drug company withheld important analyses

Dabigatran: how the drug company withheld important analyses
BMJ 2014; 349 doi: http://dx.doi.org/10.1136/bmj.g4670 (Published 23 July 2014)
Cite this as: BMJ 2014;349:g4670

“In an investigation by The BMJ Deborah Cohen finds that recommendations for use of new generation oral anticoagulants may be flawed because regulators did not see evidence showing that monitoring drug plasma levels could improve safety”

[Full text at Journal Web site]
[Full Text PDF at Journal Web site]

[EMLitOfNote Commentary]


Pearls From Wednesday Lecture (7/23/2014)

  • 10a Paolo, Program Director Rounds

    • Pharm, “Pt Assist Programs” Rx discount for brand names… “mab” is $$, Profits > Pts? perhaps.
    • Repeat Imaging c Transfers… might be reasonable in select circumstances such as q6 headCT, although clinical reassessment is better anyways. Try to get a formal report rather than repeat!
    • PE & Thrombolysis (update from 2002 study)… 25% Sudden Cardiac Death, previously shown better c anticoagulation?… “I don’t know if it works. Maybe if you’re dying I’ll give you tPa because I’ve got nothing else”. Systematic Review found mild total decreased mortality risk in mild to moderate size PE. …BUT NNT(59, All cause mortality) > NNH(18, major bleeding)
    • Head Trauma & Emesis in Peds… PECARN risks increase bleed risk in Observation vs CT pts, only ~15% truly “isolated vomiting”, lower risk, but still 2/815 had TBI CT abnormalities (SDH, EDH). Timing & # of emesis episodes didn’t matter much. NO WAKE UP @home.
    • Family Watching CPR… family presence started 1980s, was anecdotal, 2010 AHA recommended presence… 2013 study found short term improvement in psych parameters of witnessing family members, now PRESENCE trial (’09 to ’11) showing some long term benefits as well (lower long term grief problems & PTSD). Bottom line: LET FAMILY DECIDE.
    • US in PE (should have DVT study anyways) low sensitivity of Cardiac US alone… MultiOrgan US (lungs, heart, leg veins) compared v CTA. Sensitivity 90%, Specificity 86% (c Wells >orEq4, or pos Ddimer pts).
  • 1230p Research Design, Wojcik
  • 130p Maraffa (Tox)
    • Approach to Poisoned Patient – Clinical Hx!, EKG, pupils, bowel sounds, vitals, skin, APAP lv (4hrs if elevated for Nomogram), ASA lv, check GLUCOSE!
    • Tox as leading cause of heart attack in pts <40yo… Don’t forget Naloxone in ABCs (“B”) & Dextrose in ABCD…
    • Opioids common OD, don’t forget similarity to Clonidine. We have “dirt cheap” heroin epidemic in Onondaga County, especially c Rx narcotic crackdown…
    • EMS systems talking about Naloxone use in the field for reversal (competetive mu antagonist).  Single dose 0.4 to 2mg Naloxone. NYS can do IntraNasal Naloxone via BLS!
    • Neonates can have Sz from Naloxone! Orogastric Lavage NOTproven helpful for any drug to date.
  • 230p D.Cooney, EMS Overview
    • 911 calls routed to nearest Emergency Call Center.  Dispatcher uses dispatch card algorithms to assigned ALS/BLS/priority (lights & sirens?) resources.  EMS goal to start care <10min from call Single v 2 Tier Ambulance systems, here we are single tier NYS (ALS & BLS on rig)

Thrombolysis for Pulmonary Embolism and Risk of All-Cause Mortality, Major Bleeding, and Intracranial Hemorrhage

JAMA. 2014 Jun 18;311(23):2414-21. doi: 10.1001/jama.2014.5990.

Thrombolysis for Pulmonary Embolism and Risk of All-Cause Mortality, Major Bleeding, and Intracranial Hemorrhage: A Meta-analysis

From the abstract:

Conclusions and Relevance
Among patients with pulmonary embolism, including those who were hemodynamically stable with right ventricular dysfunction, thrombolytic therapy was associated with lower rates of all-cause mortality and increased risks of major bleeding and ICH. However, findings may not apply to patients with pulmonary embolism who are hemodynamically stable without right ventricular dysfunction.

[Full text at Journal Web site]
[Full text PDF at Journal Web site]

Providing Formal Reports for Outside Imaging and the Rate of Repeat Imaging

AJR Am J Roentgenol. 2014 Jul;203(1):107-10. doi: 10.2214/AJR.13.10617.

From the abstract:

CONCLUSION. Patients who received a formal report for their outside abdominal CT examinations were less likely to have repeat imaging. Institutions, payers, and policy makers should consider providing and supporting formal reports for outside imaging.

[Full text at Journal Web site]
[Full text PDF at Journal Web site]

Accuracy of point-of-care multiorgan ultrasonography for the diagnosis of pulmonary embolism.

Chest. 2014 May;145(5):950-7. doi: 10.1378/chest.13-1087.

From the abstract:

Conclusions: Multiorgan ultrasonography is more sensitive than single-organ ultrasonography, increases the accuracy of clinical pretest probability estimation in patients with suspected PE, and may safely reduce the MCTPA burden.

[Full text available at Journal Web site]
[Full text PDF at Journal Web site]

Offering the opportunity for family to be present during cardiopulmonary resuscitation: 1-year assessment

Intensive Care Med. 2014 Jul;40(7):981-7. doi: 10.1007/s00134-014-3337-1. Epub 2014 May 23.

From the abstract:

At 1 year after the event, psychological benefits persist for those family members offered the possibility to witness the CPR of a relative in cardiac arrest.

[Article at SpringerLink (Publisher)]
[Full text PDF]

Association of Traumatic Brain Injuries With Vomiting in Children With Blunt Head Trauma

Ann Emerg Med. 2014 Jun;63(6):657-65. doi: 10.1016/j.annemergmed.2014.01.009. Epub 2014 Feb 19.

From the abstract:

Traumatic brain injury on CT is uncommon and clinically important traumatic brain injury is very uncommon in children with minor blunt head trauma when vomiting is their only sign or symptom. Observation in the emergency department before determining the need for CT appears appropriate for many of these children.

[Abstract at Journal Web site]

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