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…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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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,…

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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….

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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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,…

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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…

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