Meta-analysis: increased mortality in cancer patients treated with epoetin and darbepoetin 1

Cancer patients who take erythropoiesis-stimulating agents (ESAs) have a higher risk of death, according to a new meta-analysis published in the Lancet. European researchers analyzed 53 cancer trials including nearly 14,000 patients and found that those taking epoetin or darbepoetin had a 17% increase in mortality compared to control patients. There were no differences in outcome based on patient group or trial type. Although it has been speculated that ESAs might be safer in patients who receive chemotherapy, the analysis found a 10% mortality increase among ESA-treated patients in the chemotherapy group, which was consistent with the rest of the study.

The authors concluded that in “clinical practice, the increased risks of death and thromboembolic events should be balanced against the benefits of treatment with erythropoiesis-stimulating agents, taking into account each patient’s clinical circumstances and preferences. More data are needed for the effect of these drugs on quality of life and tumour progression, and meta-analyses similar to this one will address these questions. Further research is needed to clarify cellular and molecular mechanisms and pathways of the effects of erythropoiesis-stimulating agents on thrombogenesis and their potential effects on tumour growth.”

Harlan Krumholz offered the following comment to CardioBrief:
Click here to continue reading, and for the Lancet press release…

On the radar: BARI 2D could be the next COURAGE 3

The BARI 2D trial, which will be presented on June 7th at the scientific sessions of the American Diabetes Association, may have an outcome similar to the COURAGE trial, but its impact probably won’t be as big, according to one knowledgeable Wall Street analyst.

The BARI 2D trial is comparing revascularization with either CABG or PCI to medical therapy in diabetic patients with stable angina. In his research note, Larry Biegelsen, medical devices analyst for Wachovia, points out a number of similarities between BARI 2D and COURAGE, and predicts that BARI 2D will have a similar outcome, showing a reduction in angina with the revascularization arm, but no difference in mortality or hard clinical endpoints.
Click to continue reading…

Dronedarone debut: will it be successful? 6

In the wake of dronedarone’s successful but controversial advisory panel meeting in March, a perspective in the New England Journal of Medicine by Peter Zimetbaum reviews the complicated history of the drug and makes a cautious forecast that the drug may be accepted into clinical practice when and if it gains FDA approval:

“So where does dronedarone fit into the antiarrhythmic armamentarium? In terms of efficacy, it does not represent a step forward. In terms of safety, in a population without decompensated heart failure, it confers no apparent risk of ventricular tachyarrhythmia, and there is no obvious evidence of clinically significant, chronic toxic effects. Clinicians and patients will have to determine whether safety is enough to drive the use of a new antiarrhythmic drug; I, for one, suspect it will be.”

CardioBrief asked advisory panel members Darren McGuire and Sanjay Kaul to comment.
Click to continue reading…

New imaging technique may help monitor vulnerable plaque Reply

A new imaging technique may be helpful in assessing the efficacy of anti-inflammatory therapy in vulnerable plaque, according to a new study published online in the Journal of the American College of Cardiology. The ATHEROMA (Atorvastatin Therapy: Effects on Reduction of Macrophage Activity) Study used ultrasmall superparamagnetic iron oxide-enhanced magnetic resonance imaging to compare the effect of low-dose and high-dose atorvastatin on carotid plaque inflammation in 40 patients with carotid stenosis. USPIO-enhanced MRI showed  a significant reduction in inflammation in the high dose group.
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Pfizer reports drop in Lipitor sales Reply

Sales of atorvastatin (Lipitor) dropped 13% in the first quarter to (only) $2.72 billion, according to Pfizer’s quarterly report. Jacob Goldstein, writing in the Wall Street Journal Health Blog, notes, with perhaps only slight hyperbole, that Lipitor is “the biggest blockbuster in the history of the universe.” Although the drug has more than two years of patent protection, it has suffered competition from generic simvastatin and other generic statins.

Conflicts of interest threaten public’s trust in medicine: IOM report 2

“Conflicts of interest threaten the integrity of scientific investigations, the objectivity of medical education, the quality of patient care, and the public’s trust in medicine,” according to a new report issued today by the Institute of Medicine. [Here is a link to a free PDF of the Executive Summary.]

The report calls for “all academic medical centers, journals, professional societies, and other entities engaged in health research, education, clinical care, and development of practice guidelines” to “establish or strengthen conflict-of-interest policies.” Furthermore, “disclosure by physicians and researchers not only to their employers but also to other medical organizations of their financial links to pharmaceutical, biotechnology, and medical device firms is an essential first step in identifying and managing conflicts of interest and needs to be improved.”
Click to continue reading, and to read the IOM press release…

Dual antiplatelet therapy linked to more post-CABG infections Reply

The increased bleeding risk in CABG patients who are on dual antiplatelet therapy  is well known. Now a raised risk of post-surgical infection may be an additional concern, according to a new study appearing in the Archives of Internal Medicine.

Researchers at Johns Hopkins retrospecitvely 1677 CABG patients. At 30 days the rate of infection was 23.1% in the dual antiplatelet group receiving clopidogrel and aspirin and 16.1% in the aspirin monotherapy group. The risk in the dual antiplatelet group remained elevated even after adjusting for known confounding factors. As expected, transfusion rates were also higher in the dual antiplatelet group, but this did not appear to play an important role in the infection rate.
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Good kitty ROMICAT: CT to rule out MI Reply

CT angiography (CTA) may help rule out MI in the emergency department in chest pain patients at low to intermediate risk, according to results of the ROMICAT study published in the Journal of the American College of Cardiology.

Study investigators observed 368 patients admitted for rule out MI and found that half of these patients had no coronary disease upon CTA. An editorial by Mark Hlatky concludes that CTA is a “promising development” in this context.

“A finding of normal coronary arteries will likely obviate additional tests and speed patient discharge to home and appears to be associated with a good short-term prognosis. A finding of some degree of coronary atherosclerosis might not, however, “clear the air,” as further investigations are likely with either stress testing or invasive coronary angiography (or both). Whether patient outcomes are ultimately improved by adopting a strategy of coronary CTA in the ED will require further investigation…”

Statins linked to reduced incidence of prostate cancer 1

The use of statins has been linked to a reduced incidence of prostate cancer, according to the findings of a large observational study of 2,447 men from Olmstead County. Researchers from the Mayo Clinic presented the results on Sunday at the annual meeting of the American Urological Association meeting in Chicago.

After more than 15 years of followup, 6% of men on statins were diagnosed with prostate cancer. By contrast, among the men who did not take statins the incidence of prostate cancer was increased threefold.
Click to continue reading, and for a Mayo Clinic press release…

Football moms go red Reply

mcnabb-momIt seems unlikely but this is our second football-related post in less than a week. Last week we enjoyed reporting that the Stanford cardiology fellows had challenged the San Francisco 49ers to a push-up contest. Now we are pleased to report that the Professional Football Players Mothers’ Association (PFPMA) has joined the American Heart Associations’s Go Red for Women program.
Click to read the AHA press release…

Is the party over? PhRMA publishes new guidelines on clinical trials Reply

No more meetings at fancy resorts and no more ghost writers. The life of clinical trialists will be a bit more drab and constrained, as the pharmaceutical industry’s revised  Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results take effect later this year.

The document is a reflection of the ongoing efforts of the pharmaceutical industry’s trade group, PhRMA, to restore public confidence in the industry. The revised principles include “increased transparency by committing companies to the timely registration of all interventional clinical trials involving patients – including some early Phase 1 studies…”

However, as noted in an article in PharmaTimes, “the specification that these are clinical trials involving “patients” indicates that industry is still reluctant to make most Phase I information public.”
Click to continue reading, including the PhRMA press release…

FDA panel gives cautious nod to the Watchman 3

The FDA’s Circulatory System Devices Panel voted 7-5 in favor of the Watchman, an implantable device that blocks the left atrial appendage with a fabric-covered expandable nitinol cage. It is designed to help patients with nonvalvular AF avoid warfarin therapy.

You can read a Heartwire story, a MedPage story, or a Reuters story.

You can read links to additonal coverage about the device in our previous story.

Two radically different approaches to financial incentives Reply

We stumbled across two entirely different approaches to financial incentives today:

The first approach was discussed in an intriguing story by Andrew Pollack in today’s New York Times. In this story, drug makers change “what they charge for their drugs, based on how well the medicines improve patients’ health.” The article discusses a new agreement between Merck and Cigna, in which reimbursement for Januvia and Janumet will hinge on the ability of the drugs to control blood sugar. The deal is actually quite complex, though, since Merck will actually charge less for the drugs if they work as hoped: “In effect, though, Merck is betting not only that its drugs prove superior but that Cigna’s incentives to reap the benefits of the deeper Januvia and Janumet discounts will prompt the insurer to try to keep patients on those drugs,” writes Pollack. Merck’s advantageous pricing for the drugs will also help it get a better place on Cigna’s formulary.

The second approach, published in a commentary in Circulation: Cardiovascular Quality and Outcomes, proposes that physician reimbursement should be “evidence-based.”
Click to continue reading, including additional commentary from George Diamond…

FDA: is it time for the Watchman? 2

Following its promising debut in the PROTECT-AF trial a few weeks ago at the ACC, the Watchman device appears likely to receive a somewhat less ecstatic response when it appears before the FDA’s Circulatory System Devices Panel on Thursday. The Watchman is an implantable device that blocks the left atrial appendage with a fabric-covered expandable nitinol cage. It is designed to help patients with nonvalvular AF avoid warfarin therapy.

The FDA briefing documents suggest that  difficult questions will be raised at the hearing about the patient population that has been studied with the device, the duration of treatment they received, and the use of concomitant warfarin by some patients.

You can read Reuters, MedPage Today, and Heartwire news reports about the briefing documents.

You can read the FDA briefing documents here.

ACC defends partnership with industry group to separate clinical and cost effectiveness studies 1

The ACC has taken a firm position against yoking clinical effectiveness studies and cost effectiveness studies, and has joined an industry-supported group that supports a similar agenda. The issue has bubbled to the surface lately in response to a proposed Obama administration initiative that would support cost effectiveness measures based on comparative efficacy studies.

A Bloomberg news story, Drugmakers Boost Lobbying to Police Drug Comparisons, by Jonathan Salant and Aliza Marcu, linked the ACC to the Partnership to Improve Patient Care (PIPC), an organization funded by pharmaceutical, device, and biotech industries. The story has been heavily criticized by ACC CEO Jack Lewin in an interview with CardioBrief, in a post in Lewin’s blog (Clinical and Cost Effectiveness: The Bloomberg Boo Boo), and in a statement from the ACC (printed below).

According to the Bloomberg story: “Makers of drugs and other health-care products say they support side-by-side studies of medical products as a tool for doctors and patients, not as a way to stop medical professionals from prescribing a more expensive drug if they’re convinced it will work better.”

Lewin, in his interview, said that the ACC joined PIPC because it has a “noble purpose to proceed aggressively with comparative effectiveness research, but to do so by keeping the clinical side separate from cost effectiveness.”

Lewin acknowledges that industry “may have a different interest: Click to continue reading…

Electricians do it better 1

Electrophysiologists do it better— at least when it comes to implanting ICDs, according to a large registry report published in JAMA.

71% of implantations were performed by electrophysiologists, according to the study of more than 111,000 procedures reported to the ICD Registry. There were more complications and lower likelihood of receiving a CRT-D device when indicated when the procedure was performed by non-EPs.

In an accompanying editorial, James Coromilas writes that “a compelling argument can be made” that “whenever possible, a board-certified electrophysiologist should be implanting ICDs.”
Click to continue reading…

Bring it on! Stanford cardiology fellows challenge 49ers to push-up contest 1

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We couldn’t overlook a recent Stanford University Medical Center press release. In what may be the ultimate geek versus jock competition, the Stanford cardiology fellows have challenged the San Francisco 49ers to a push-up contest to help raise money for hypertrophic cardiomyopathy. We have been unable to confirm rumors that television executives are already planning a reality TV show spinoff…

Click to read the Stanford press release…

STEMI networks key to rapid reperfusion Reply

The best way to consistently deliver rapid primary PCI is through organized regional networks combining paramedics, emergency departments and cardiology teams, according to a new study published in the Journal of the American College of Cardiology: Cardiovascular Interventions.

“Whether it was big cities like Los Angeles or smaller towns like Medford, Oregon, the creation of these networks was feasible,” said Ivan Rokos, in a press release. “Common to each region was a spirit of multi-disciplinary collaboration, often initiated by a small group of visionary healthcare providers, who saw new opportunities to improve STEMI heart attack care in their communities.”
Click to read the JACC:Cardiovascular Interventions press release…

JACC white paper clarifies role of cardiovascular MR in myocarditis Reply

Cardiovascular magnetic resonance (CMR) may have an important role to play in the diagnosis of myocarditis, according to a white paper published in the Journal of the American College of Cardiology.

The  International Consensus Group on Cardiovascular Magnetic Resonance in Myocarditis writes in their conclusion: “The use of CMR appears suitable to identify patients with significant ongoing inflammation, which may be especially important for patients with recurrent or persisting symptoms and in patients with new onset heart failure.”
Click to continue reading…

JAMA imbroglio: the shrink strikes back 1

Robert Robinson is the psychiatrist who failed to disclose a conflict of interest in a JAMA article and thereby sparked an imbroglio that quickly expanded beyond the initial subject. The story’s focus soon shifted to the JAMA editors for their ham-fisted handling of the episode, especially after they had a series of contentious conversations with their critics and a Wall Street Journal reporter. (See our previous coverage herehere, and here.) Now Robinson has presented his own perspective on the controversy in a letter in BMJ.

Robinson apologizes for the failure to disclose but makes a reasonable case that it was an honest error:
Click to continue reading…

COURAGE & OAT: persistent doubts among interventionalists Reply

It will come as little surprise to readers of this blog that the COURAGE and OAT trials were not exactly welcomed with open arms by the interventional community. An innovative study published in the American Heart Journal helps quantify and characterize this dissent by analyzing articles that cited the studies. The details of their methods are complex, but I imagine their finding will not provoke much disagreement: 19% of articles citing COURAGE and 15% of articles citing OAT “had an overall reserved stance,” according to the authors. Most of the criticism was written— again, this should not be a surprise— by interventional cardiologists.

It’s unclear whether this level of resistance is too high or too low. As John French and Jennifer Shearer write in an accompanying editorial:

Click to continue reading…

MR angiography continues to advance, but still limited Reply

Coronary magnetic resonance angiography (CMRA) continues to make broad advances but is still not ready for routine clinical usage, according to a new study published online in the Journal of the American College of Cardiology.

The new study reports on the single-center experience with a new 3.0 tesla contrast MRA in 96 patients scheduled for conventional angiography. The procedure was successfully performed in 62 patients. CMRA correctly identified CAD in 32 patients and ruled it out in 23 patients. Here are the results on a per-patient basis:
Click to continue reading, and for commentary from PK Shah…

GISSI-AF: valsartan fails to prevent AF recurrence Reply

The angiotensin II-receptor blocker (ARB) valsartan failed to prevent the recurrence of atrial fibrillation in 1,442 patients enrolled in the GISSI-AF study. “Our findings do not support the original hypothesis of a beneficial role of blockers of the renin–angiotensin–aldosterone system in the prevention of recurrent atrial fibrillation,” wrote the GISSI investigators. The results of GISSI-AF were published in the New England Journal of Medicine.

But ARBs may still prove valuable in the primary prevention of AF, according to Anne Gillis in an accompanying editorial.
Click to continue reading…