Although there is broad consensus in the medical community that primary PCI is the best treatment for heart attack patients when it can be delivered promptly, there is no agreement about the best accompanying drug regimen, which usually entails a combination of antiplatelet and antithrombotic drugs. The role of one antithrombotic, bivalirudin (Angiomax, The Medicines Company) has…
ESC Hot Lines: First Real Data On Promising Novartis Heart Failure Drug
July 1, 2014 by Leave a Comment
The first real details about the much-anticipated novel new heart failure drug from Novartis will kick off this year’s Hot Line sessions at the annual meeting of the European Society of Cardiology in Barcelona, Spain. The meeting runs from August 30 until September 3. As I have previously reported, the PARADIGM-HF trial was stopped because of a highly statistically significant reduction…
Study Offers Reassurance About Newer Drug-Eluting Stents
July 1, 2014 by Leave a Comment
Drug-eluting stents (DES) have been viewed as a great advance over earlier stents and balloon angioplasty because they result in many fewer cases of restenosis. But enthusiasm for the first generation of DES was somewhat curbed due to reports of late stent thrombosis (ST), a rare but very dangerous complication. Now findings from a large ongoing…
In Emerging China Heart Attacks Skyrocket But Treatment Lags
June 24, 2014 by Leave a Comment
Accompanying all the other changes in China over the past decade, admission to the hospital for heart attacks ST-elevation myocardial infarction, or STEMI) has soared, according to a paper published in the Lancet. Although the study finds that there have been some genuine improvements in treatment, the Chinese healthcare system still has a long way to go in…
Strike 2 For Once Promising GSK ‘Stinkbomb’ Heart Drug
May 13, 2014 by Leave a Comment
GSK said today that a large phase 3 trial of a once highly-promising drug had failed to meet its primary endpoint. Last year the company announced that another phase 3 trial with the same drug had failed. GSK said it would “further analyse the data and better understand the findings” but that, for now at least, it…
Intensive Insulin Therapy Saves Lives– But Is The Finding Still Relevant?
May 12, 2014 by 1 Comment
A trial that started back in 1990 continues to demonstrate a significant mortality advantage for intensive insulin therapy in heart attack (MI) patients. But experts say the trial design is so outdated that the findings should have no influence on clinical practice today. During the years 1990 through 1993 the Swedish DIGAMI I (Diabetes Mellitus…
FDA Approves Novel Merck Drug To Prevent Heart Attacks And Strokes
May 8, 2014 by Leave a Comment
The FDA today approved vorapaxar (Zontivity), Merck’s once-troubled platelet receptor antagonist, to reduce the risk of myocardial infarction (heart attack), stroke, cardiovascular death, and revascularization procedures. The drug is approved for use in people with a history of MI or peripheral arterial disease. The approval represents an amazing turnaround for a drug that had experienced nearly…
FDA Comes Out Against Aspirin To Prevent First Heart Attacks
May 5, 2014 by 1 Comment
In the latest development in a long-simmering debate, the FDA has announced that aspirin should not be marketed for the prevention of a first heart attack or stroke in people with no history of cardiovascular disease. The announcement follows FDA’s rejection on Friday of Bayer Healthcare’s decade-old petition requesting approval of a primary prevention indication. [PDF of FDA rejection letter]…
Another Failed HDL Therapy Trial
April 30, 2014 by Leave a Comment
Despite robust epidemiological evidence suggesting that HDL has a strong protective effect against cardiovascular disease, there has been no good evidence showing that HDL-based therapies are beneficial. Large trials of drugs that raise HDL levels, including niacin and CETP-inhibitors, have failed to demonstrate improvements in outcome. Some observers gleaned hope from several small studies of…
Stem Cell Therapy To Fix The Heart: A House Of Cards About To Fall?
April 28, 2014 by 1 Comment
For more than a decade cardiac stem cell therapy has attracted an enormous amount of attention, promise, and research dollars. Now an original and important new study published in BMJ finds that many of the most promising results in the field are illusory and that the potential benefits of stem cells to treat heart disease are probably far…
New Study Lends Support For Alternative Heart Attack Treatment Strategy
April 22, 2014 by 2 Comments
It is generally agreed that the best treatment for heart attack patients is to immediately reperfuse the blocked artery with a stent. But many people live in areas where this strategy, known as primary PCI, is not available within the time frame when it produces the greatest benefit. Previous studies have found good short term…
High-Sensitivity Troponin Test Could Identify Low Risk Chest Pain Patients In The ED
March 30, 2014 by Leave a Comment
Approximately 15-20 million people in Europe and the United States go to the emergency department every year with chest pain. Many can be discharged early if they are not having an acute coronary syndrome. A large new single-center observational study, presented at the American College of Cardiology meeting in Washington, DC and published simultaneously in the Journal…
FDA Once Again Rejects New Indication For Rivaroxaban
February 14, 2014 by Leave a Comment
The third time wasn’t the charm. The FDA today turned turned down– for the third time– the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke or death. In addition, the FDA– for the second time– turned down the sNDA for rivaroxaban in…
Surviving A Heart Attack: Location And Time Make A Big Difference
January 22, 2014 by Leave a Comment
Two studies published this week offer fresh evidence that your life may depend on where and when you have a heart attack. 1. Heart attack patients in the United Kingdom are more likely to die than heart attack patients in Sweden, according to a study published in the Lancet. … 2. Heart attack patients are more likely to die…
FDA Panel Once Again Rejects New Indication For Rivaroxaban
January 16, 2014 by Leave a Comment
The FDA’s Cardiovascular and Renal Drugs Advisory Committee once again turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto (rivaroxaban). The nearly unanimous vote (10-0, with 1 abstention) was in line with a highly negative review from FDA staff members. … Click here to read the full post on Forbes….
FDA Advisory Panel Votes In Favor Of Approval For Merck’s Vorapaxar
January 15, 2014 by Leave a Comment
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 in favor of approval for vorapaxar, Merck’s novel thrombin receptor antagonist. The “roller coaster ride” cliché might have been invented for this drug, which was the subject of tremendous early hopes followed by major disappointments and, finally, a subsequent revival. … Click here to read the entire…
Rivaroxaban Faces Uphill Battle At FDA Advisory Panel
January 14, 2014 by Leave a Comment
The third time may not be the charm. Twice before the FDA has turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto (rivaroxaban). On Thursday the Cardiovascular and Renal Drugs Advisory Committee will take up the sNDA yet again, but FDA review documents posted today suggest that the company will again…
Merck’s Vorapaxar Gets Positive FDA Review
January 13, 2014 by Leave a Comment
A few years ago a novel antiplatelet agent from Merck seemed all but dead. Vorapaxar, a thrombin receptor antagonist, was widely thought to have no future after unacceptably high serious bleeding rates were found in two large clinical trials studying the drug in a wide variety of acute and chronic cardiovascular patients. But hopes for the drug resurfaced with…
Massive Heart Attack Or Massive Journalistic Irresponsibility?
January 5, 2014 by 2 Comments
A great lesson in how not to report about heart attacks in the general media, from Gary Schwitzer, health journalism watchdog: Journalists: don’t use the term “massive” heart attack if you don’t know what you’re talking about … Very quickly, the term “massive heart attack” started going viral among Minnesota news organizations and on Twitter and…
Cardiology in 2013: Like A Wrecking Ball
December 26, 2013 by 1 Comment
Perhaps I’m being overdramatic but I think the best metaphor for the year in cardiology is Miley Cyrus on the wrecking ball. The Guidelines Wrecking Ball: Like Hannah Montana guidelines are supposed to be boring and reliable. But in 2013 the guidelines were more like Miley Cyrus. Like a wrecking ball, the NIH abandoned its long-entrenched and highly influential role in producing…
Possible New Lease On Life For Two Cardiology Drugs From Merck And J&J
December 16, 2013 by Leave a Comment
Early next year an FDA panel will review a new drug from Merck and a new indication for Xarelto (rivaroxaban), Johnson & Johnson’s highly successful new oral anticoagulant. Both drugs have had a rocky road getting to this stage and their success is by no means assured, but the announcement of the meeting of the FDA’s Cardiovascular and Renal…
Little Difference In Chest Pain Between Men And Women
November 26, 2013 by 1 Comment
In recent years the medical community has grown increasingly concerned that women with heart attacks may be less likely to receive prompt and effective treatment. The difference between the sexes in the presentation of symptoms is thought to be a major barrier to better treatment for women. But now a new study published in JAMA Internal Medicine finds…
FDA Removes Restrictions On Avandia
November 25, 2013 by Leave a Comment
In a remarkable climax to a long-running drama, the FDA today lifted major restrictions on rosiglitazone (Avandia, GlaxoSmithKline). The drug has been the subject of intense criticism and controversy since the 2007 publication of the famous Nissen meta-analsysis that first raised the possibility that the blockbuster diabetes drug might increase the risk of heart attack and cardiovascular death. The FDA said…
TACT Substudy Suggests Possible Strong Benefit for Chelation in Diabetics
November 19, 2013 by Leave a Comment
One year ago the results of the TACT trial were published in JAMA, sparking an enormous controversy over the propriety of publishing a trial suggesting that chelation therapy might be beneficial in people with cardiovascular disease. Chelation therapy has long been a staple of alternative medicine, but until the publication of TACT it had received no credit whatsoever in…
EUROMAX Meets Primary Endpoint But Editorialist Raises Questions
October 30, 2013 by Leave a Comment
When started during transport to the hospital during a heart attack, bivalirudin (Angiox, Medicines Company) improves clinical outcomes and reduces major bleeding, though at the cost of a small but significant risk in stent thrombosis. The results of the European Ambulance Acute Coronary Syndrome (ACS) Angiography) Trial (EUROMAX) were presented today by Phillippe Gabriel Steg…
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