Increasing adherence to statins would save twice the number of lives as expanding eligibility Reply

Although the beneficial effects of statins have been widely recognized, there is no agreement over the exact composition of the population who should receive statins. Now a new study from the UK makes the important point that extending the statin-eligible patient population would be far less effective than improving adherence in patients who are already prescribed the drugs.
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FDA’s Cardiorenal panel unanimously rejects nebivolol for HF Reply

The FDA’s Cardiovascular and Renal Drugs advisory committee has unanimously voted to reject a heart failure indication for Forest Laboratories’ Bystolic (nebivolol). The vote follows an extremely negative FDA staff review posted last week, as reported by CardioBrief at the time.

Click here to read a Dow Jones news report on the panel meeting.

Click here to read a Heartwire story by Steve Stiles.

Reevaluating ESAs: too little, too late? Reply

The NEJM Perspective by 4 top FDA officials raises several questions: what was the FDA’s role in creating the current situation? And is the “reevaluation” mentioned by the FDA officials a good example of “too little, too late”?

Anyone reading the article would be hard-pressed to know that the FDA played a key role in allowing the current situation to develop. Clearly, the FDA could have played a much more pro-active role in the past and have helped prevent the current crisis. Further, the “reevaluation” mentioned by the FDA authors may not address the root cause of the problem, says at least one well-placed expert.

TREAT lead investigator Marc Pfeffer spoke with CardioBrief about the NEJM Perspective. Although Pfeffer expressed broad agreement with the need for a reevaluation, he is also troubled that not enough will be done to address the problem.
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COMPARE investigators in the Lancet: “paclitaxel-eluting stents should no longer be used in everyday clinical practice” Reply

Everolimus-eluting stents are superior to paclitaxel-eluting stents, and the latter should no longer be used in everyday clinical practice. That’s the conclusion of the COMPARE investigators in a report published online in the Lancet. But at least one expert in the field, David Kandzari, thinks the conclusion, though justified by the data, goes beyond the simple binary choice of choosing one stent over another. (See below for his perspective.)
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FDA staff recommends against heart failure indication for Bystolic (nebivolol) 2

FDA staff reviewers have strongly recommended that Bystolic (nebivolol) not receive a new indication for heart failure. The scathing review was published on the FDA’s website in advance of next Monday’s meeting of the Cardiovascular and Renal Advisory Drugs committee.

The recommendation of the clinical reviewer was about as clear and concise as you will ever find in an FDA document:

“Approval is not recommended for nebivolol for the treatment of heart failure.”

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NEJM: FDA to reevaluate ESAs in treatment of anemia 1

The FDA plans to convene an advisory panel in 2010 “to reevaluate the use of ESAs in the treatment of anemia due to chronic kidney disease,” according to a “Perspective” written by four FDA officials in the New England Journal of Medicine.

In response to the failure of 3 large clinical trials to establish any clinical benefits for the drugs, Ellis Unger, Aliza Thompson, Melanie Blank, and Robert Temple write that although ESAs “have been widely accepted” to maintain or increase RBC levels and to avoid transfusions, “optimal hemoglobin targets have never been established.” Several trials “endeavored to show that using ESAs to raise hemoglobin concentration to higher targets improves clinical outcomes. Unfortunately, and unexpectedly, all results have suggested the opposite.”
Click to continue reading, including a comment from Sanjay Kaul…

Braunwald: “In all fairness, what was OK three years ago is not OK now.” Reply

A new policy from Partners Healthcare that limits compensation to doctors from industry is provoking lots of discussion (see below), at least in part because of a story in the New York Times by Duff Wilson. (Click here to read the press release Partners issued last April. Click here to read the full report.) One reason, of course, is that Partners is a major teaching affiliate of Harvard Medical School and includes top-rated Brigham and Women’s Hospital and Massachusetts General Hospital. Another reason is that the chairman of the policy-writing group was Eugene Braunwald.
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Leading Israeli cardiologists blocking their country’s participation in planned NIH-funded ISCHEMIA trial Reply

A group of prominent Israeli cardiologists is blocking their country’s participation in the ISCHEMIA trial, the planned NIH-funded follow-up to COURAGE. At a recent meeting of Israeli hospital cardiology department directors, according to an article in the Israeli newspaper Haaretz by Dan Even, the directors recommended that Israel not take part in the trial.
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ICTUS at 5 years still fails to find benefit for early invasive strategy in ACS Reply

The 5-year clinical results of ICTUS (Invasive versus Conservative Treatment in Unstable coronary Syndromes) confirm and extend the one-year results of the trial, which found no evidence of an advantage for an early invasive strategy in the treatment of ACS. The 5-year paper is published online in the Journal of the American College of Cardiology.

ICTUS randomized 1,200 patients with ACS to an early invasive or selective invasive strategy. Here are the major results at 5 years:
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Second study on approval of CV devices largely confirms FDA deficiencies Reply

On the heels of a JAMA study (which we reported earlier today), researchers from the FDA and Beth Israel Deaconess hospital released a similar paper appearing in the American Journal of Therapeutics. The report reaches many of the same conclusions as the JAMA paper, though, naturally, with a somewhat more sympathetic understanding of the FDA’s constraints.

A team led by William Maisel evaluated all 88 CV PMAs undertaken by the FDA between January 1, 2000 and December 31, 2007, including 132 clinical studies involving more than 37,000 study subjects. They found that safety and efficacy end points were “often not defined with precision” and concluded that their “study findings demonstrate that submitted studies frequently lack important details, including information about study subjects and study end point definitions.”
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JAMA review finds multiple flaws in FDA approval of CV devices 1

The FDA approval process for cardiovascular devices contains multiple flaws and weaknesses, according to a new article appearing in JAMA. Sanket Dhuva, Lisa Bero, and Rita Redberg performed a systematic review of 123 FDA summary of safety and effectiveness data (SSED) released by the FDA following premarket approval (PMA) of 78 CV devices. Although the PMA is reserved for class III devices, which is the highest risk category, the UCSF researchers found that PMA approval “is often based on studies that lack adequate strength and may be prone to bias.”

Among the findings:
Click to continue reading, including comments from William Maisel, Sanjay Kaul, and David Kandzari…

ACC files lawsuit against HHS Secretary Sebelius over Medicare cuts 1

The ACC has filed a lawsuit against HHS Secretary Kathleen Sebelius over the 2010 Medicare Physician Fee Schedule. The deep cuts for cardiology services in the new fee schedule are the result of using invalid data “in a manner that threatens access to care for patients and precipitously increases medical care costs,” according to a press release from the ACC.

Click here to read a USA Today story by Steve Sternberg.
Click here to read the ACC press release…

AHJ editorial calls for “something equivalent to fluoride in the drinking water” to fight SCD 1

“We believe that the epidemiologic prevention of sudden cardiac death will require something equivalent to fluoride in the drinking water that inhibited dental erosion, that is, a chemical additive to food or water that will stabilize the fibrous cap of the plaque, thereby reducing the probability of plaque erosion, plaque rupture, and sudden cardiac death,” write Arthur Moss MD and Ilan Goldenberg, in a provocative editorial in the January American Heart Journal.
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Study finds Sprint Fidelis lead fractures “increasing exponentially” Reply

A large single-center study finds that the rate of Spring Fidelis lead fracture “is increasing exponentially with time and… occurring at a higher rate than the latest manufacturer’s performance update.” The study from the University of Rochester appears in the January 1 issue of the American Journal of Cardiology.
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NEJM: 1 in 6 persons have Lp(a) variant associated with increased CAD risk Reply

Researchers from the Precocious Coronary Artery Disease (PROCARDIS) study have identified commonly occurring SNPs in the LPA gene for Lp(a) that may have an important future role in the diagnosis and treatment of coronary disease. According to the authors of the study in the New England Journal of Medicine, “one in six persons carries a variant LPA allele and thus has a risk of coronary disease that is increased by a factor of 1.5.”
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Medicines Company buys ApoA-1 Milano from Pfizer Reply

The Medicines Company announced earlier today that it had acquired the worldwide rights to ApoA-1 Milano from Pfizer.

ApoA-1 Milano became the subject of intense interest in 2003 when a study in JAMA by Nissen et al found that the naturally occurring variant of the important HDL apolipoprotein caused a significant regression of atherosclerosis as measured by IVUS. The company that was developing ApoA-1 Milano, Esperion Therapeutics, was subsequently acquired by Pfizer. Over the years many knowledgeable observers were baffled by the lack of further development of the compound, particularly as Pfizer appeared to place most of its HDL-related efforts on torcetrapib, Pfizer’s CETP inhibitor.  Following the failure of torcetrapib, Pfizer sharply curtailed its cardiovascular research.

Steve Nissen sent the following comment to CardioBrief:
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FDA says cancer risk of Vytorin and Zetia is “unlikely” 1

The FDA “believes it is unlikely that Vytorin or Zetia increase the risk of cancer or cancer-related death.” The FDA statement is a follow-up to its August 2008 early communication about a safety review of the drugs following cancer concerns initially raised by the SEAS trial in August 2008. Despite the reassurance the FDA said it was unable to definitively rule out an association “at this time.”
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Lancet: Huge metaanalysis finds no causative role for CRP Reply

CRP is a strong and consistent marker for CV disease and other non-vascular diseases, like cancer and lung disease, but does not appear to be a cause of disease, according to a new meta-analysis in the Lancet. The new study is the largest effort yet to to sort out the controversial role of CRP. The study, by John Danesh and colleagues in the Emerging Risk Factors Collaboration (ERFC), combined information from 54 studies including 160,000 people in 18 countries. “The relevance of CRP to such a range of disorders is unclear,” the authors write. “Associations with ischaemic vascular disease depend considerably on conventional risk factors and other markers of inflammation.”
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Niacin helps restore protective effects of HDL in diabetics 1

HDL in diabetics is less protective than HDL in nondiabetics, but niacin can help restore some of its protective effects, according to a new study appearing in Circulation.

Investigators from Switzerland and Germany studied HDL from 10 healthy subjects and 33 patients with type 2 diabetes. Sajoscha Sorrentino and colleagues found that HDL from the healthy subjects, but not from the diabetics, stimulated endothelial nitric oxide production, reduced endothelial oxidant stress, and improved endothelium-dependent vasodilation and early endothelial progenitor cell–mediated endothelial repair, suggesting, “markedly impaired endothelial-protective properties of HDL.”
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Primary PCI without surgical backup deemed safe in NYS study Reply

STEMI patients who receive primary PCI in hospitals without surgical backup have no significant differences in rates of death and the need for emergency surgery as similar patients treated at hospitals with surgical backup, according to a new study from the New York State PCI registry appearing in Circulation: Cardiovascular Interventions. However, patients at the PCI-only hospitals had higher rates of repeat target  vessel PCI, and patients who did not receive PCI had higher mortality rates.
Click to continue reading, including a comment from Melissa Walton-Shirley…