Enrollment has resumed in the Trial to Assess Chelation Therapy (TACT), a large and controversial $30-million NIH study, according to an AP story by Marilynn Marchione. Last year in August the trial was suspended when the Office for Human Research Protections received complaints about consent forms and safety issues. The suspension was originally reported in detail by Michael O’Riordan in Heartwire.
Monthly Archives: June 2009
BMC therapy: still alive after 5 years Reply
Long term analysis of autologous bone marrow mononuclear cell (BMC) infusion after MI is safe and effective, according to 5 year results of the BALANCE study published in the Journal of the American College of Cardiology.
The publication of 5 year results of the procedure represents a significant but modest achievement for stem cell therapy. In an accompanying editorial, Forrester, Makkar, and Marbán note that the “publication of the first long-term results of BMC therapy in AMI serves as both a significant milestone and a pivot point in cardiovascular research. The therapy can now be considered safe and modestly efficacious. Conversely, there is little evidence that it has achieved either the biologic goal of regenerating new myocardium or the clinical goal of efficacy sufficient to justify widespread use.”
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Study in JAMA explores cutting radiation exposure in CT angiography Reply
Although CT angiography is viewed by many as an attractive imaging modality in an increasingly broad array of clinical situations, its chief drawback has been concerns about widespread radiation exposure. Now a new study published earlier this week in JAMA demonstrates that radiation exposure can be greatly reduced by applying various techniques, including minimized scan range, heart rate reduction, electrocardiographic-gated tube current modulation, and reduced tube voltage in suitable patients.
Click for more, including a JAMA press release…
Lipoprotein(a) associated with MI 3
(from WikiDoc–by Brian Blank) – Researchers in Denmark have shown genetically elevated levels of lipoprotein(a) are associated with increased risk of heart attack, according to a study in JAMA. The authors are quick to note their analysis does not necessarily prove the LDL-associated lipoprotein causes MI, but that the association between the two warrants further research.
Click for more, including a JAMA press release…
UK’s NICE favors restricted approval for prasugrel 2
Prasugrel should be made available in the UK, but only to a limited number of patients, according to preliminary guidance from the National Institute for Health and Clinical Excellence (NICE).
The document recommends that prasugrel, in combination with aspirin, should be “an option for preventing atherothrombotic events in people with acute coronary syndromes having percutaneous coronary intervention” only when immediate PCI for STEMI is “necessary” or when “stent thrombosis has occurred during clopidogrel treatment.” In addition, patients already receiving prasugrel for other indications “should have the option to continue therapy until they and their clinicians consider it appropriate to stop.”
Study shows it may be possible to diagnose diabetes sooner Reply
(from WikiDoc–by Brian Blank) –Certain metabolic changes start years before the onset of type 2 diabetes, according to research published online in the Lancet. The results from the WHITEHALL II study demonstrate it may be possible to identify people who are essentially “pre-prediabetes.” Researchers looked at 6,538 UK civil servants without diabetes and followed up with them 10 years later. In patients who eventually developed the disease, scientists noticed sharp increases in pre- and post-meal glucose levels starting a full three years before diagnosis.
Click to continue, including a Lancet press release…
Research suggests sleep-blood pressure link Reply
(from WikiDoc–by Brian Blank) – Middle-aged adults who sleep longer at night are less likely to have high blood pressure according to a study in the Archives of Internal Medicine. Researchers examined the blood pressure and sleep duration of 578 adults over the course of about five years. Subjects were on average 40.1 years old and slept six hours per night. After controlling for age, race, and sex, scientists found those who slept the least were more likely to have higher systolic and diastolic blood pressure. The researchers also found a 37 percent increase in the odds of developing high blood pressure for every less hour participants slept.
Click for more, including an Archives press release…
Lancet/ADA: Promising early studies with liraglutide and aleglitazar 2
Liraglutide and aleglitazar appear promising in type 2 diabetes, according to studies presented today at the American Diabetes Meeting and published online in the Lancet.
In the first study, the LEAD-6 trial, liraglutide once daily was superior to exenatide twice daily in controlling blood glucose in type 2 diabetics. Liraglutide and exenatide both work by increasing insulin production. John Buse and colleagues compared the two drugs in 464 patients with inadequately controlled diabetes.
Click for more, including Lancet press releases on the two studies…
Bring it on: the battle over BARI 2D Reply
The publication and presentation of the BARI 2D trial has triggered a battle that will surprise no one who observed the reception of COURAGE a few years ago.
On the one hand, the interventional cardiology community is doing its best to interpret the trial in a way that will dampen the impact of the trial on real world usage of PCI. On the other hand, more conservative cardiologists argue that the trial reinforces the major lesson from COURAGE that PCI is greatly overused in the US.
Click for more, including statements from SCAI, William Boden, Sanjay Kaul, and a Wall Street analyst…
BARI 2D: will it fortify COURAGE? 2
Will the BARI 2D trial reinforce the message of COURAGE, or will it prove just another speedbump all but ignored on the PCI autobahn?
The much anticipated BARI 2D trial was presented this afternoon at the American Diabetes Association meeting in New Orleans and published simultaneously in the New England Journal of Medicine, where there was also an accompanying editorial by William Boden and David Taggart.
Rosiglitazone goes on the RECORD, but is it a hit? 2
A big new rosiglitazone trial, RECORD, found no increase in overall cardiovascular morbidity and mortality, the primary endpoint of the trial, but is unlikely to quiet the drug’s critics or end the controversy over the drug. The trial is being presented at the American Diabetes Association (ADA) meeting in New Orleans and simultaneously published online in the Lancet.
The multicenter, open-label trial randomized 4,447 type 2 diabetics on metformin or sulfonylurea monotherapy to receive either rosiglitazone in addition or an active control consisting of a combination of metformin and sulfonylurea. After 5.5 years of followup there were 321 events in the rosiglitazone group and 323 in the control group. Consistent with previous trials, rosiglitazone caused an increase in heart failure and fractures. In addition, a nonsignificant increase in MI was observed.
Click for more, including commentary from Steve Nissen and press releases from the Lancet and GSK…
Cardiologists in the news: 1 sentenced to jail, 1 buys ICDs from girlfriend Reply
Mehmood M. Patel, 64, a cardiologist in Lafayette, Louisiana, was sentenced to 10 years in prison for health-care fraud.
Patel, according to a report in TheAdvertiser.Com, “falsified patient symptoms in medical records and on medical tests, and… performed unnecessary procedures such as using angioplasty balloons and stents…. Between 1992 and 2003, Patel was the top biller in cardiology services in Louisiana.”
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RECORD and BARI 2D to be presented this weekend at ADA Reply
Two much anticipated trials will be presented this weekend in New Orleans at the annual meeting of the American Diabetes Association.
Late Friday afternoon (5:15 PM ET) the RECORD trial with the highly controversial drug rosiglitazone (Avandia) will be presented at a symposium. The multicenter, open-label trial randomized nearly 4,500 patients with type 2 diabetes who were taking either metformin or sulfonylurea monotherapy to receive either rosiglitazone in addition or an active control consisting of a combination of metformin and sulfonylurea. The primary endpoint of the trial was overall cardiovascular morbidity and mortality.
On Sunday afternoon (5:15 PM ET) the BARI 2D trial will be presented.
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High healthcare costs: more bankruptcies and unfilled prescriptions Reply
Two new items today emphasize the sorry state of American medicine.
In the first item, healthcare costs played a contributing role in 62% of all bankruptcies in the United States in 2007, according to a study published online in the American Journal of Medicine. The Harvard researchers found that the “share of bankruptcies attributable to medical problems” increased by 50% from 2001. The authors conclude:
“The US health care financing system is broken, and not only for the poor and uninsured. Middle-class families frequently collapse under the strain of a health care system that treats physical wounds, but often inflicts fiscal ones.”
In the second item, Kevin Sack reports on the front page story of the New York Times that a great many people affected by the economic slump are unable to pay for their prescriptions. The news will come as little surprise to readers here, but the details are chilling nevertheless (see the highlighted paragraph below).
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Serebruany and Wolfe ask FDA to halt review of prasugrel 1
A frequent critic of prasugrel and the TRITON-TIMI 38 trial, Victor Serebruany, has joined with Sidney Wolfe’s Public Citizen Group and asked the FDA to halt its review of prasugrel.
Wolfe and Serebruany say that the 10 mg dose of prasugrel used in TRITON-TIMI 38 is unsafe, causing a “dramatic increase in the risk of hemorrhage and an unexpected increase in new cancers among patients on prasugrel when compared to those on clopidogrel,” according to a Public Citizen press release.
An AP story by Matthew Perrone quoted a Lilly spokesman’s response, who noted that Serebruany’s concerns are not new, and indeed were raised at the FDA hearing in February: “His concerns were heard by the committee at that time, and the committee voted unanimously that prasugrel should be approved by the FDA.”
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Dallas Heart Study: calcium screening adds little to traditional risk factors 2
Calcium screening provides very little additional prognostic information beyond traditional risk factors, according to a study by Mahesh Patel et al in the American Heart Journal. As part of the Dallas Heart Study, 2,610 patients between 30 and 65 years underwent calcium screening in addition to traditional Framingham risk scoring.
In moderately high risk patients, for whom calcium screening has most often been proposed, the investigators found no additional benefit in women and found only a “minor impact” in men. These findings were not substantially altered by either changing the age cut-offs or moving to a lower calcium threshold.
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Taubman new CEO in Rochester after spinal injury to predecessor Berk Reply
Following a serious spinal injury to University of Rochester Medical Center (URMC) CEO Bradford Berk, the chair of the Department of Medicine, Mark Taubman, will take over as acting CEO of URMC. Both Berk and Taubman are cardiologists.
Berk was injured over the weekend in a biking accident. Berk had recruited Taubman to URMC in 2003 from Mount Sinai, where Taubman had been the director of cardiovascular research.
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FDA rejects bucindolol and questions trial integrity Reply
Bucindolol, the beta blocker for heart failure that has been struggling to gain approval for well over a decade, has been rejected by the FDA, according to a press release from ARCA biopharma.
In its complete response letter, the FDA, in addition to requiring additional clinical studies, questioned the integrity of trial data. According to the company’s press release:
The letter raises concerns regarding the integrity of the BEST data based on its audit of certain clinical sites involved in the BEST trial, which may require an independent audit of additional clinical sites and other actions to verify the integrity of the data.
Hecht editorial: CT angiography is ready for prime time 1
CT angiography should replace stress testing in many clinical situations, according to an in press editorial by Harvey Hecht which is available at the American Journal of Cardiology website.
Hecht says that the shift to CT angiography represents a “paradigm shift,” and that CT angiography should be the test of choice “for whatever information is sought other than exercise capacity.” Stress tests should be used only “to establish the functional significance of intermediate stenoses demonstrated by CTA and for those patients with arrhythmias, very high coronary calcified plaque burdens, or renal dysfunction that prohibits CTA.”
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Krumholz: “Systematic and continuous measuring of performance is not part of the culture of medicine” Reply
It’s time for a medical version of Consumer Reports, Harlan Krumholz argues in an opinion piece in Sunday’s Washington Post, “Which Docs Measure Up?”
Krumholz tells readers that “you’re out of luck if you want to look at a doctor’s track record or an institution’s success rates. Results vary by surgeon and by hospital; you just have no way of knowing which one is best. And often, neither do they.”
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