BMJ papers increase pressure on Avandia

A trio of papers in BMJ are turning up the heat on rosiglitazone (Avandia), prompting the editor-in-chief of the journal, Fiona Godlee, to say that she believes rosiglitazone “should not have been licensed and should now be withdrawn.” The detailed investigative report by BMJ features editor Deborah Cohen reviews the long and troubled history of rosiglitazone, with a focus…

Click here to continue reading…

The rise of the ESC: is the ESC anti-American or pro-industry?

A prominent US cardiologist remarked to me in Stockholm that he was disturbed by the “anti-American” tone of some remarks made at the opening session of the ESC. I’m not entirely sure to what he was referring because I make a point of skipping official ceremonies, but I’m certain that at least part of his…

Click here to continue reading…

NEJM editors call for removal of sibutramine from the US market

Earlier this year, following the discovery of signals of potential danger in a large clinical trial, the weight loss drug sibutramine (Meridia) was withdrawn from the market in Europe while the FDA added a strongly-worded contraindiction to its use in people with cardiovascular disease. Now, two weeks before an FDA advisory panel will vote on…

Click here to continue reading…

NEJM & Lancet: Clopidogrel and aspirin dosages scrutinized in CURRENT-OASIS 7 papers and editorials

In the CURRENT-OASIS 7 trial more than 25,000 patients with ACS for whom an interventional strategy was planned were randomized to either double-dose clopdiogrel (a 600-mg loading dose on the first day followed by 150 mg daily for 6 days and 75 mg daily thereafter) or standard-dose clopidogrel (a 300-mg loading dose on the first day…

Click here to continue reading…

Study examines long-term effect of intensive BP control in blacks

The African-American Study of Kidney Disease and Hypertension (AASK) investigated the role of intensive blood-pressure control in slowing the progression of chronic kidney disease in black patients. In the previously reported results of the randomized portion of AASK, intensive BP control had no effect on the progression of CKD. Now the AASK Collaborative Research Group reports…

Click here to continue reading…

ESC: apixaban beats aspirin for stroke prevention in AF

The AVERROES (Apixaban Versus Acetylsalicylic acid (ASA) to Prevent Strokes) trial randomized 5600 AF patients who were unable to take warfarin to receive either aspirin or apixaban, a Factor Xa inhibitor. (Another trial still underway, ARISTOTLE, is a direct comparison of warfarin and apixaban in AF.) AVERROES was stopped early after the Data Monitoring Committee…

Click here to continue reading…

ESC: no benefits for low dose heparin over standard heparin in FUTURA OASIS 8

FUTURA (Fondaparinux Trial With Unfractionated Heparin During Revascularization in Acute Coronary Syndromes)/OASIS-8 is the first trial to compare low dose unfractionated heparin with conventional heparin dosing in PCI patients receiving fondaparinux. Sanjit Jolly and colleagues randomized 2026 non-STEMI  high-risk patients undergoing PCI within 72 hours to either low-dose unfractionated heparin or a standard dose of…

Click here to continue reading…

ESC: positive results for rivaroxaban in EINSTEIN-DVT

The EINSTEIN-DVT study tested the effect of the new oral anticoagulant rivaroxaban in the setting of DVT. The open-label, non-inferiority study randomized more than 3,400 patients with acute, symptomatic DVT to either oral rivaroxaban or conventional therapy with enoxaparin followed by warfarin or acenocoumarol for three, six or 12 months, based on the attending physician’s…

Click here to continue reading…

Circulation: African-Americans at higher risk for stent thrombosis

African-Americans are nearly three times more likely to develop stent thrombosis after receiving a drug-eluting stent, according to a new study appearing in Circulation. Ron Waksman and colleagues analyzed data from a large, single-center registry of 7,236 patients who received a DES and found that African-American race was the single strongest predictor for late stent thrombosis,…

Click here to continue reading…

Dronedarone and ticagrelor speed into ESC guidelines

Getting into the guidelines can be a slow and laborious process. Some critics complain that it takes too long for new therapies to receive the guideline seal of approval. But with the new guidelines released at the ESC it’s unlikely that anyone will complain about such dawdling. With unprecedented speed, dronedarone  and ticagrelor have achieved…

Click here to continue reading…

ESC: 4 year findings from the REACH registry

“Not all atherothrombosis is equal.” That’s the message from the latest findings of the international REACH (Reduction of Atherothrombosis for Continued Health) registry of more than 45000 patients with atherothrombosis. According to the REACH investigators, “easily demarcated subgroups of atherothrombotic patients had widely varying risks, ranging from 7% in nondiabetic patients with other risk factors…

Click here to continue reading…

ESC responds to controversy over previous publication of a Hot Line trial

The ESC has responded to the controversy surrounding the previous publication of data presented in Sunday’s Hot Line session of the STAR Heart Study of stem cell therapy. (See our earlier story here.) The ESC statement said “this clearly breaks ESC rules for Hot Line Sessions which state that information must be first presented at ESC Congress…

Click here to continue reading…

ESC: genetic substudies of large trials question value of clopidogrel genotyping

Genetic substudies across a broad range of large clinical trials that used clopidogrel  raise questions about the clinical utility of clopidogrel genotyping. The substudies come from large and important trials like PLATO, TRITON-TIMI 38, CURE, and ACTIVE A….

Click here to continue reading…

ESC: Superiority of dabigatran more evident in places where INR is not well controlled

At last year’s ESC the RE-LY trial heightened interest in the prospect of dabigatran as a potential replacement for warfarin. Now the RE-LY investigators have analyzed the trial in an attempt to see whether the local standard of care has an impact on the beneficial effects of switching to dabigatran. In a presentation at the…

Click here to continue reading…

ESC: downshifting heart rate in HF found beneficial

Update: The ESC has posted the presentation and discussion slides for SHIFT. In the SHIFT trial Karl Swedberg and colleagues tested the effects of ivabradine, a selective sinus-node inhibitor, on 6558 patients with heart failure who had a heart rate > 70 bpm. After a median 22 months of followup, the rate of cardiovascular death…

Click here to continue reading…

ESC hot line trial turns out to be ice cold

The thing about hot line sessions is that the trials are supposed to be hot, or at the very least lukewarm. Certainly they’re not supposed to be cold. But at the press conference for the first hot line session here in Stockholm today, reporters and other observers were caught off guard when they learned that…

Click here to continue reading…

ESC: Alpha Omega Trial Tests n-3 Fatty Acids in CV Disease

To test the effect of n-3 fatty acids in cardiovascular disease, Kromhout and colleagues in the Alpha Omega Trial group randomized 4,837 patients with a history of MI to treatment with  4 different margarine preparations containing n-3 fatty acids: (EPA and DHA; ALA; EPA, DHA, and ALA; or placebo). After 40 months, the rate of…

Click here to continue reading…

FDA approves combination of aliskiren and amlodipine for treatment of hypertension

Novartis announced that it had received FDA approval to market Tekamlo, a combination of aliskiren and amlodopine. The drug has been approved as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals, and as replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren…

Click here to continue reading…

The debate over CME and industry influence continues

Editor’s note: Back in June (Listening to industry: what’s the ROI of medical education?) I commented on some statements made by Bill Cooney, the President & CEO of Medpoint Communications, which is, in its own words, “a global leader in diversified communications services for leading pharmaceutical and biotechnology companies.” Cooney recently commented on my post, and this…

Click here to continue reading…

FDA sets September 20 date for dabigatran (Pradaxa) advisory panel

The FDA has announced that dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in atrial fibrillation will be the subject of a Cardiovascular and Renal Drugs ADvisory Committee on September 20. (h/t to Larry Biegelsen)…

Click here to continue reading…

I guess the ESC is really happening…

The ESC just tweeted this picture:…

Click here to continue reading…

AHA Late-Breakers: ASCEND-HF, ROCKET-AF, GRAVITAS, BASKET PROVE, DEFINE and more

The AHA has published the list of late-breaking clinical trials to be presented at scientific sessions in November. Some highly anticipated trials include: ASCEND-HF– the 7000 patient trial with nesiritide designed to resolve the long-standing controvery over the drug) ROCKET-AF– the pivotal trial for the factor Xa inhibitor rivaroxaban for stroke prevention in AF GRAVITAS–…

Click here to continue reading…

CardioBrief: AHA Science Advisory Calls for More Research on CVD in Asian-Americans

In a “Call to Action” contained in a new scientific statement, the American Heart Association says that more research is needed on cardiovascular disease in Asian-Americans. “Available research shows that subgroups of Asian-Americans are at increased risk of complications and death from cardiovascular disease; however, Asian-Americans are often studied as a group, which masks the differences…

Click here to continue reading…

GSK letter to TIDE investigators provokes Avandia critics

A letter describing the July FDA advisory panel on Avandia that was sent by GlaxoSmithKline to TIDE investigators has sparked criticism from some FDA officials and panel members, according to an article by Gardiner Harris in the New York Times….

Click here to continue reading…

Saving time and setting the clock back in STEMI

Efforts to speed delivery of PCI to STEMI patients have focused on shortening the door-to-balloon time. Now a group of Danish researchers propose that efforts to improve care must include assessment of treatment from the time of the patient’s first contact with the emergency medical system. Analyzing historical data from 6209 MI patients who received…

Click here to continue reading…