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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Monthly Archives: September 2010
Lancet meta-analysis finds high risk for carotid stenting in older patients Reply
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 days after randomization, the rate of stroke or death was higher in the stenting group than in the endarterectomy group (8.9% versus 5.8%, RR 1.53, p=0.0006). However, there was no difference between the groups among patients younger than 70, while in patients over 70 stenting was associated with double the risk associated with endarterectomy:
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Medical nonprofits starting to disclose revenue from industry Reply
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 in Galveston, is quoted as saying that some pharmaceutical companies treat nonprofits like “an extension of the marketing department.” Brody says that these financial relationships have not been the subject of much scrutiny because organizations such as the American Cancer Society seem like “God, mother, and apple pie.”
Here are details from the Chronicle list of disclosures of particular interest to cardiovascular medicine:
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Protective Effect of Education Only Occurs in High-Income Countries 1
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 linking socioeconomic status to cardiovascular outcomes in HICs cannot be extrapolated to LMICs (low- or middle-income countries), particularly for women.” Overall, educational attainment was protective in HICs, but not in LMICs, against obesity, smoking, and hypertension.
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Patients Still Overestimate Benefits of Elective PCI 1
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 82% thought it would reduce their risk for fatal MI. By contrast, their cardiologists believed that the benefits of PCI in stable patients like these would be limited to symptom relief.
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BMJ papers increase pressure on Avandia Reply
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 on the deficiencies of the European and British regulatory process. Cohen writes that “we still have no clear picture of why, after initial rejection in October 1999, the EMA gave market authorization to rosiglitazone in July 2000 in the absence of new evidence.” She also reports for the first time that in July of this year the UK’s Commission on Human Medicines unanimously recommended that the Medicines and Healthcare products Regulatory Agency (MHRA) withdraw rosiglitazone from the market but “a ‘dear doctor’ letter sent to UK doctors in July advised doctors to ‘consider alternative treatments where appropriate’.”
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The rise of the ESC: is the ESC anti-American or pro-industry? 4
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 concern was grounded in the repeated assertions made during the meeting that the ESC was now the largest cardiology meeting in the world, having surpassed the AHA and the ACC some years ago. Of course, being cardiologists, the ESC officers weren’t going to taunt “nyah nyah nyah we’re bigger than you now” to every American they could find, but I did detect at least a faint odor of childish triumph. And, to be fair, it would be hard to blame the Europeans entirely, since for many years the European meeting– and European cardiology as a whole, for that matter– was routinely disregarded or condescended to by many Americans.
But what is behind the remarkable rise of the European meeting? There were many theories discussed in Stockholm. Most agreed that one common explanation– the economic impact of the great recession– failed to explain the phenomenon, as the effects of the recession appear to be at least as great in Europe as in the US.
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NEJM editors call for removal of sibutramine from the US market 4
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 whether the drug should remain on the market in the US, the results of the clinical trial that sparked the concerns have been published in the New England Journal of Medicine.
The Sibutramine Cardiovascular Outcomes (SCOUT) trial randomized 9804 overweight subjects with preexisting cardiovascular disease and/or diabetes to either sibutramine or placebo for 3.4 years. The combined rate of nonfatal MI, nonfatal stroke, resuscitation after cardiac arrest, or cardiovascular death was 11.4% in the sibutramine group versus 10.0% in the placebo group (HR 1.16; 95% CI 1.03 to 1.31; P=0.02). The differences in nonfatal MI (4.1% versus 2.6%) and nonfatal stroke (3.2% and 1.9%) were significant by themself.
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NEJM & Lancet: Clopidogrel and aspirin dosages scrutinized in CURRENT-OASIS 7 papers and editorials Reply
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 followed by 75 mg daily thereafter) and either high-dose aspirin (300 to 325 mg daily) or low-dose aspirin (75 to 100 mg daily).
In the main result of the trial, published in the New England Journal of Medicine, there were no significant differences in the composite outcome of CV death, MI, or stroke at 30 days in either randomization, but more major bleeding occurred in the double-dose clopidogrel group compared to the standard-dose clopidogrel group (2.5% versus 2%, p=0.01).
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Study examines long-term effect of intensive BP control in blacks Reply
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 the results in the New England Journal of Medicine of the cohort phase of the study, in which patients who completed the trial phase of the study were treated with a blood-presssure target of less than 130/80 mm Hg.
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