New Trial Confirms Role For Pradaxa In Venous Thromboembolism
A new study helps support a role for  the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) in patients with venous thrombosis (VTE).  The RE-COVER II trial, published online in Circulation, confirms the finding of the earlier and highly similar RE-COVER trial, published in the New England Journal of Medicine in 2009, that dabigatran is as safe and effective as warfarin for the treatment of  deep vein thrombosis (DVT) and pulmonary embolism (PE). Dabigatran is currently approved only for the treatment of stroke prevention in patients with non-valvular atrial fibrillation. In RE-COVER II 2,589 pati...
Source: CardioBrief - December 18, 2013 Category: Cardiology Authors: Larry Husten Tags: Heart Rhythms People, Places & Events Prevention, Epidemiology & Outcomes apixaban boehringer ingelheim dabigatran deep vein thrombosis rivaroxaban VTE Source Type: blogs

A Second Order Cover Up? - Judge Finds Boehringer Ingelheim Allowed Destruction of Records Bearing on Allegations of Cover Up of Drug Adverse Effects
This case generated little coverage, a story in Bloomberg, and a post on PharmaLot, but perhaps should have received more attention.Background - the Pradaxa Case The background, per Bloomberg, is thatBoehringer [Ingelheim BmbH] is preparing to face the first federal court trial of claims that it hid Pradaxa’s bleeding risks. Pradaxa is dabigatran, a new anti-coagulant drug that can be used without frequent monitoring of blood tests, as is required when using the older drug warfarin.  However, unlike warfarin, the effects of dabigatran cannot be quickly reversed should a patient on the drug start to bleed. The r...
Source: Health Care Renewal - December 16, 2013 Category: Health Medicine and Bioethics Commentators Tags: Boehringer Ingelheim deception Pradaxa warfarin Source Type: blogs

Are doctors being duped through medical education? Could social media help?
I made a discovery this week about the novel anticoagulant medications, dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis) and edoxaban (Lixiana). I was looking into the often-asked question of how these new drugs compare to the old standard, warfarin. The discovery felt like a Eureka moment. I ran it by my stats guy–my son–and a couple of colleagues, and they confirmed, that my discovery was truth. I’m working on a post now that discusses the details of how the medical world has been misled about these drugs. Stay tuned. Medical Education: For now, though, this revelation got me thinking abo...
Source: Dr John M - December 14, 2013 Category: Cardiology Authors: Dr John Source Type: blogs

Diatbet Successful in Promoting Weight Loss Based on Wagering
There are a number of effective ways to provide incentives for patients to improve their health. One way, frowned upon by some, is to reward patients in a way that they value for compliance or good health outcomes (see: A Lottery to Improve Patient Adherence to Warfarin Therapy; Financial Incentives for the Pursuit of Wellness; Possible Impact on the Clinical Labs). Spurred on by the idea of competitive dieting highlighted by the TV show Biggest Looser, similar programs have succeeded at the state level (see: Statewide Weight-Loss Competitions Achieve Record of Success). Dietbetting is the general name for social die...
Source: Lab Soft News - December 13, 2013 Category: Pathologists Authors: Bruce Friedman Tags: Healthcare Business Medical Consumerism Medical Research Public Health Informatics Source Type: blogs

Boehringer's "gross inadequacy"
Boehringer Fined $931,000 Over Lost Pradaxa FilesBoehringer Ingelheim GmbH, which markets and manufactures Pradaxa, has been charged with a nearly $1 million fine, according to a recent ruling. The fine was levied for the drug maker’s withholding or failing to preserve files sought in Pradaxa litigation, according to the judge’s ruling.The “countless” files were sought by patients who have brought lawsuits over the blood thinner, Pradaxa, Bloomberg News reports. U.S. District Judge David Herndon, located in East St. Louis, Illinois, is overseeing more than 1,700 consolidated lawsuits that have been f...
Source: PharmaGossip - December 13, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Another novel anticoagulant scores against warfarin
(Source: Notes from Dr. RW)
Source: Notes from Dr. RW - December 8, 2013 Category: Internists and Doctors of Medicine Tags: cardiovascular hematology Source Type: blogs

Large Study Finds Favorable Risk-Benefit Profile For The New Anticoagulants
A very large new meta-analysis finds a favorable risk-benefit for the new oral anticoagulant drugs in the setting of atrial fibrillation. The findings, published online in the Lancet, were remarkably consistent for all four of the new agents which have been fighting to replace warfarin, which was the only oral anticoagulant available for decades until the arrival of the new agents. Although warfarin is inexpensive, it has numerous interactions with other drugs and foods and requires regular monitoring and dose adjustments. The new agents can be taken once or twice a day and do not require dose changes. More… (Source: CardioBrief)
Source: CardioBrief - December 5, 2013 Category: Cardiology Authors: Larry Husten Tags: Heart Rhythms Policy & Ethics Prevention, Epidemiology & Outcomes Anticoagulant anticoagulants apixaban atrial fibrillation boehringer ingelheim dabigatran Daiichi Sankyo Pfizer rivaroxaban stroke Source Type: blogs

Tough calls in cardiology :Dengue fever in a patient with prosthetic valve and warfarin !
Oral anticoagulant usage has been steadily increasing for variety of  indications.Dengue fever is also  appearing in different avatars with  low platelet counts  and bleeding being a primary risk. I was recently contacted by a physician , regarding a therapeutic dilemma .A young lady with mitral prosthetic valve and a febrile illness diagnosed as dengue . She has a platelet  count of 100,000 .She is on regular warfarin and aspirin .The physician  wanted to know , should he stop the OAC and aspirin ? What are the options ? Confirm if it is really dengue. Look for clinical bleeding.INR, platelet function tests are not...
Source: Dr.S.Venkatesan MD - December 5, 2013 Category: Cardiology Authors: dr s venkatesan Tags: Cardiology -guidelines Cardiology -Mechnisms of disease Cardiology -Therapeutic dilemma cardiology -Therapeutics Cardiology -unresolved questions Cardiology-Statistics dengue and coronary stent des and dengue falling platlets and coroanry Source Type: blogs

Tough calls in cardiology :Dengue fever in a patient with prosthetic valve and warfarin !
Oral anticoagulant usage has been steadily increasing for variety of  indications.Dengue fever is also  appearing in different avatars with  low platelet counts  and bleeding being a primary risk. I was recently contacted by a physician , regarding a therapeutic dilemma .A young lady with mitral prosthetic valve and a febrile illness diagnosed as dengue . She has a platelet  count of 100,000 .She is on regular warfarin and aspirin .The physician  wanted to know , should he stop the OAC and aspirin ? What are the options ? Confirm if it is really dengue. Look for clinical bleeding.INR, platelet function tests are not...
Source: Dr.S.Venkatesan MD - December 5, 2013 Category: Cardiology Authors: dr s venkatesan Tags: Cardiology -guidelines Cardiology -Mechnisms of disease Cardiology -Therapeutic dilemma cardiology -Therapeutics Cardiology -unresolved questions Cardiology-Statistics dengue and coronary stent des and dengue falling platlets and coroanry Source Type: blogs

The vaccine debate — Could compassion and nuance be an antidote?
I’ve been thinking a lot about vaccines. As a learner, an observer of humans and our nature, a worshiper of the scientific method, a doctor, a new grandfather, and a member of society, few debates could be more compelling. The kerfuffle over vaccines has it all. It’s the Lance Armstrong story on steroids. (Grin.) The spark for writing on this matter came from reading a mother’s impassioned call for reason. (Link at the end.) The author is a young lawyer who writes (skillfully) about being married to a young doctor. Her vaccine post went viral, garnering 483 comments—which, for a blogger, is akin to nirvana. In ...
Source: Dr John M - December 4, 2013 Category: Cardiology Authors: Dr John Source Type: blogs

Reports of therapeutic hypothermia’s death are greatly exaggerated
I expect you’re completely #FOAMed out by the post-publication frenzy stirred up by the TTM Trial. If not, you’ve come to the right place! Mike collated the explosion of initial FOAM responses in All in a lather over TTM and there have since been notable additions such as Scott Aberegg’s Chill Out: Homeopathic Hypothermia after Cardiac Arrest… and ICN’s interview with TTM investigators Niklas Nielsen and Anders Aneman one week after TTM. Soon after, Charles Bruen came with his fascinating blogpost/podcast putting the latest studies in historical perspective: Therapeutic hypothermia: The h...
Source: Life in the Fast Lane - December 1, 2013 Category: Emergency Medicine Doctors Authors: Chris Nickson Tags: Emergency Medicine Evidence Based Medicine Featured Health Intensive Care Resuscitation Bernard critical appraisal HACA Nielsen Targeted Temperature Management Therapeutic Hypothermia TTM Source Type: blogs

Reports of therapeutic hypothermia’s death are greatly exaggerated
I expect you’re completely #FOAMed out by the post-publication frenzy stirred up by the TTM Trial. If not, you’ve come to the right place! Mike collated the explosion of initial FOAM responses in All in a lather over TTM and there have since been notable additions such as Scott Aberegg’s Chill Out: Homeopathic Hypothermia after Cardiac Arrest… and ICN’s interview with TTM investigators Niklas Nielsen and Anders Aneman one week after TTM. Soon after, Charles Bruen came with his fascinating blogpost/podcast putting the latest studies in historical perspective: Therapeutic hypothermia: The h...
Source: Life in the Fast Lane - December 1, 2013 Category: Emergency Medicine Doctors Authors: Chris Nickson Tags: Emergency Medicine Evidence Based Medicine Featured Health Intensive Care Resuscitation Bernard critical appraisal HACA Nielsen OOHCA Targeted Temperature Management Therapeutic Hypothermia TTM Source Type: blogs

FDA Spanks 23andMe, Grants Breakthrough Status To Factor Xa Inhibitor, and Approves Promus Premier Stent
It was a busy morning at the FDA. Three new FDA actions may be of considerable interest in the cardiology universe: FDA Halts 23andMe Personal Genome Test– The FDA sent a scathing letter to 23andMe ordering the company to stop selling its Personal Genome Service (PGS) test.   The FDA highlighted two cardiology-related uses of PGS as “particularly concerning,” including drug responses involving warfarin sensitivity and clopidogrel response. … FDA Grants Breakthrough Status To Factor Xa Inhibitor Antidote–  … FDA Approves Promus Premier Everolimus-Eluting Platinum Chromium Coronary S...
Source: CardioBrief - November 25, 2013 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery People, Places & Events Policy & Ethics 23andMe anticoagulants DNA FDA food and drug administration PGS stents Source Type: blogs

MKSAP: 35-year-old pregnant woman with a history of pulmonary embolism
Test your medicine knowledge with the MKSAP challenge, in partnership with the American College of Physicians. A 35-year-old woman undergoes evaluation after home pregnancy testing indicated that she is pregnant. Her medical history includes a previous idiopathic pulmonary embolism. Her only medication is a daily prenatal vitamin. On physical examination, temperature is 36.2 °C (97.1 °F), blood pressure is 110/65 mm Hg, pulse rate is 70/min, and respiration rate is 20/min. BMI is 25. Results of a pregnancy test are positive. Which of the following is the most appropriate venous thromboembolism prophylaxis for this pati...
Source: Kevin, M.D. - Medical Weblog - November 23, 2013 Category: Family Physicians Tags: Conditions OB/GYN Source Type: blogs

Top stories in health and medicine, November 21, 2013
From MedPage Today: New Method Gives Better Guess on LDL Cholesterol. A new way of estimating LDL cholesterol levels may be more accurate than the widely used Friedewald equation. Novel Anticoagulant Bests Warfarin in Afib. The novel oral factor Xa inhibitor edoxaban prevented stroke as well as warfarin but did so with lower risk in nonvalvular atrial fibrillation. Mixed Data for Warfarin Dosing By Genotype. For patients requiring anticoagulation for atrial fibrillation, venous thromboembolism, or some other indication, genotype-guided dosing of warfarin and similar drugs might have some benefit. Procedure Plus Exercise ...
Source: Kevin, M.D. - Medical Weblog - November 21, 2013 Category: Family Physicians Tags: News Heart Source Type: blogs