PARTNER: “fundamental breakthrough” for transcatheter aortic-valve implantation

Patients with aortic stenosis who are not candidates for aortic valve replacement surgery can benefit from transcatheter aortic-valve implantation (TAVI), according to results of the PARTNER (Placement of AoRTic TraNscathetER Valves) trial published in the New England Journal of Medicine. (The trial will also be presented at the TCT conference on Thursday.) Martin Leon and colleagues…

Click here to continue reading…

FDA panel unanimously recommends approval for dabigatran

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-0 in favor of approval of dabigatran (Pradaxa, Boehringer-Ingelheim) for the prevention of stroke in patients with AF. The panel was split on whether both doses (150 mg bid and 110 mg bid) used in the RE-LY trial should gain approval, though in an informal straw…

Click here to continue reading…

Soap opera star helps BI prepare the market for Pradaxa (dabigatran)

What can a soap opera star teach us about atrial fibrillation? Not much. But perhaps she can teach us a whole lot about pharmaceutical marketing in the 21st century. Her first lesson is about market preparation, or creating awareness and demand for a product before it’s available. In this case the product is Pradaxa, and BI…

Click here to continue reading…

Guest post: A rich OASIS for Your journal club

Editor’s note: This post by Harlan Krumholz is republished with permission from CardioExchange, a new website for cardiovascular healthcare professionals from the New England Journal of Medicine. CardioBrief readers who are healthcare professionals are invited to join the site. by Harlan Krumholz I’m always scouting for papers to discuss in journal club with my students. Earlier this…

Click here to continue reading…

Red light or green light for AAA screening?

Editor’s note: Last week I put up a post, Blue light special: AAA screening at Kmart in the disease-mongering aisle, that attracted some interesting and thoughtful comments. In particular, the exchange between Dan Hackam, an old online friend, and Joe Ross, a researcher who I quoted in the piece, is worthy of more attention than…

Click here to continue reading…

FDA announces safety review of pioglitazone (Actos) over cancer risk

The FDA announced today that it was undertaking a safety review of pioglitazone (Actos). The review was initiated after the FDA received data from Takeda, the drug’s manufacturer, suggesting a possible increase in bladder cancer in patients taking the drug for more than 2 years. The data is taken from a planned 5 year analysis…

Click here to continue reading…

FDA panel votes 9-5 against approval of lorcaserin

The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 9-5 against recommending marketing approval for lorcaserin (Lorqess, Arena). Panel members were underwhelmed by the modest weight-loss efficacy of the drug, and responded to concerns raised by FDA reviewers about the incidence of cancer in rats taking lorcaserin. Some panelists also thought the sponsor had not definitively…

Click here to continue reading…

Approval likely for dabigatran as FDA posts positive briefing documents for advisory panel

A positive recommendation for dabigatran appears likely based on the extremely benign briefing documents posted by the FDA in preparation for Monday’s meeting of the Cardiovascular and Renal Drugs Advisory Committee. The panel will discuss the NDA for dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The conclusions and recommendations of…

Click here to continue reading…

TREAT Analysis: Target Dosing is Tricky

A new analysis of TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) is raising questions about the use of target-based strategies for the treatment of anemia in people with chronic kidney disease. (Last year, the main TREAT results showed that treatment with darbepoetin alfa was not beneficial, and was associated with an increase in the risk…

Click here to continue reading…

FDA advisory panel refuses to put Meridia out of its misery

8 members of the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted in favor of withdrawing sibutramine (Meridia) from the US market. 8 members voted to keep it on the market, though all 8 agreed it needed a boxed warning and 6 thought it also should have its distribution limited to specially trained physicians. No panel…

Click here to continue reading…

Blue light special: AAA screening at Kmart in the disease-mongering aisle

Now, in addition to all the other stuff  there, you can go to Kmart and get screened for abdominal aortic aneurysm (AAA). Some people will even receive free ultrasound tests. The new program, from the Find the AAAnswers Coalition, was announced on Friday. It’s a perfect example of disease mongering, the selling of a sickness…

Click here to continue reading…

FDA extends review of ticagrelor (Brilinta) until December

AstraZeneca announced today that the FDA had extended the PDUFA date for its highly anticipated antiplatelet drug ticagrelor (Brilinta) for 3 months. The deadline  for a decision on the drug’s approval has therefore been moved from  September 16 to December 16. On July 28 the FDA Cardiovascular and Renal Advisory Committee voted 7-1 in favor…

Click here to continue reading…

FDA posts briefing documents for diet drug lorcaserin, investors get nervous

The FDA has posted the briefing documents for the September 16 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee that will consider the NDA for the diet drug lorcaserin (Lorqess, Arena). The FDA reviewers agree that the drug met the predetermined measure of efficacy, though only by a slim margin. After briefly skimming the…

Click here to continue reading…

FDA posts briefing material for Meridia death panel

The FDA has posted briefing material for the September 15 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee that will consider the fate of Meridia (sibutramine), Abbot’s embattled diet drug. Two weeks ago the publication of the controversial SCOUT trial in the New England Journal of Medicine was accompanied by a strongly worded editorial…

Click here to continue reading…

2 FDA rebels criticize inclusion of Avandia defenders on July advisory panel

Two FDA officials who have been highly vocal critics of Avandia (rosiglitazone) are now suggesting that the FDA stacked the deck in favor of rosiglitazone at the July advisory committee meeting by including panel members from the earlier 2007 meeting that recommended against removing the drug from the market. In a letter published in BMJ, David…

Click here to continue reading…

SYNTAX at 3 years: CABG still winning, but PCI acceptable in low-risk patients

Three-year outcomes from the SYNTAX trial continue to show the overall superiority of CABG over PCI in patients with complex disease but leave room for the use of PCI in patients with low-risk disease. The results of the trial were presented by A. Pieter Kappetein at the European Association of Cardio-Thoracic Surgery annual meeting in Geneva,…

Click here to continue reading…

Roche halts use of taspolgutide in clinical trials

Roche announced on Friday a major setback in its development of taspoglutide, a once-weekly GLP-1 analog. Roche had previously claimed that taspoglutide had successfully completed a series of phase 3 clinical trials, but the  drug had been viewed skeptically by many observers due to reports that the drug was poorly tolerated….

Click here to continue reading…

Lancet meta-analysis finds high risk for carotid stenting in older patients

Carotid stenting should not be performed in patients over 70, according to the results of a new meta-analysis appearing in the Lancet. Researchers in the Carotid Stenting Trialists’ Collaboration combined data from 3433 patients with symptomatic carotid stenosis who were randomized to either endarterectomy or stenting in the EVA-3S, SPACE, and ICSS trials. At 120…

Click here to continue reading…

Medical nonprofits starting to disclose revenue from industry

Medical nonprofit organizations are starting to disclose revenue they receive from medical companies, according to an article in the Chronicle of Philanthropy. The article by Suzanne Perry anticipates a full senate report that is expected to appear later this fall. Howard Brody, director of the Institute for the Medical Humanities at the University of Texas Medical Branch…

Click here to continue reading…

Protective Effect of Education Only Occurs in High-Income Countries

The well-known cardiovascular protective effect of education only occurs in high-income countries (HICs), according to a new report from the REACH registry appearing in Circulation. A striking finding was that highly educated women were more likely than their less educated counterparts to smoke in both affluent countries and less affluent countries. The authors point out that “studies…

Click here to continue reading…

Patients Still Overestimate Benefits of Elective PCI

Patients who undergo elective PCI continue to overestimate the benefits of the procedure, according to a small study published in the Annals of Internal Medicine. Michael Rothberg and colleagues surveyed 153 patients and 27 cardiologists at a single academic center and found that 88% of the patients thought PCI would reduce their risk of MI and…

Click here to continue reading…

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…