Patients with coronary artery disease who have very low LDL levels and normal blood pressure have slower progression of atherosclerosis, as measured by IVUS, according to an analysis of more than 3,400 patients published in the Journal of the American College of Cardiology.
But in an accompanying editorial, Jonathan Tobis and Alice Perlowski warn against overinterpreting the trial:
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In an editorial posted online in JAMA, the editors Catherine DeAngelis and Phil Fontanarosa have taken a strong stance against both conflict of interest and free speech. According to the editorial, it’s ok to accuse JAMA authors of conflict of interest, but you can’t tell anyone except the journal editors until the editors themselves report their final determination of guilt or innocence. We can’t go into all the details here, but you can read Wall Street Journal reporter David Armstrong’s account in a story in Monday’s edition.
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In response to a CardioBrief editorial posted earlier this week that was highly critical of SHAPE, I received a letter from a lawyer who is a member of SHAPE’s board of directors. Although I disagree with her views, her position is worthy of respect. With her permission I have posted her letter, followed by my own response.
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The FDA’s Circulatory System Devices Advisory Panel has voted 9-5 against the TherO Aqueous Oxygen System (AO System), intended for use in acuteMI patients who have undergone successful revascularization less than or equal to 6 hours from symptom onset.
You can read a report of the panel on TCTMD by Brian Vastag.
The FDA’s Cardiovascular and Renal Advisory committee voted 15-2 in favor of rivaroxaban. At least two Wall Street analysts have suggested, however, that the FDA may delay approval until it receives more data, pushing final approval into next year.
CardioBrief received detailed comments on the meeting from two panel members, Darren McGuire and Sanjay Kaul.
Click here to read comments from Darren McGuire, Sanjay Kaul, as well as the J&J press release…
Overall, CABG and PCI have similar death rates in patients with multivessel disease, but the results heavily favor CABG when it comes to diabetics and elderly patients, according to a new meta-analysis led by Mark Hlatky published in the Lancet.
The reasons for CABG’s better outcome are unclear, but “intuitively such mechanisms are most likely to reflect more advanced coronary disease,” notes David Taggart in an accompanying editorial. Extrapolating from the analysis as well as the recent COURAGE and SYNTAX trials, Taggart concludes:
For less severe coronary disease (mainly one-vessel or two-vessel disease and normal left ventricular function), there is little prognostic benefit from any intervention over optimum medical therapy. In such patients who do require intervention, perhaps for symptomatic reasons, there is no obvious survival advantage for either PCI or CABG (at least in patients who are not diabetic), but there is a significantly higher risk of repeat revascularisation with PCI. In patients with more severe coronary artery disease, and especially those with diabetes, CABG is superior in terms of survival and freedom from reintervention.
The FDA’s Cardiovascular and Renal Advisory Committee voted 10 to 3 in favor of approval for Sanofi’s dronedarone. By all accounts it was a difficult decision for the committee.
CardioBrief has received statements from panel members Sanjay Kaul (yes, he did make it to the meeting) and Darren McGuire.
Click here to read comments from Darren McGuire and Sanjay Kaul, as well as Sanofi’s press release…
Pfizer’s decision to abandon research in cardiovascular drugs is the occasion for a perspective by Alan Garber in the New England Journal of Medicine. Garber asks: “Did the decision reflect only the strengths and weaknesses of Pfizer’s pipeline, or have the commercial prospects soured so much that we can expect an industrywide decline in innovation in cardiovascular drugs?”
Generics and safety concerns with new drugs are big obstacles to successful research, he notes. “Pfizer’s decision is a reminder that pharmaceutical innovation is vulnerable to market forces, changes in medical practice, and regulatory requirements.”
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Blacks younger than 30 years old are 20 times more likely to develop heart failure over the next 20 years than whites, according to a new study published in the New England Journal of Medicine. Hypertension, obesity, and systolic dysfunction were significant predictors of heart failure.
The study, write Clyde Yancy and Eric Peterson in an accompanying perspective, “raises the possibility that a proactive approach to diet, lifestyle, and weight management might avert the development of hypertension; and more complete control of hypertension, once it is present, might reduce the downstream disparity in the incidence of heart failure. Such an opportunity should not be missed.” They concluded:
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Although the AURORA study, which is comparing rosuvastatin to placebo in hemodialysis patients, is not scheduled to be presented until March 30 at the ACC scientific sessions in Orlando, at least one analyst is claiming he “understands” that the results are negative, according to a Reuters story by Ben Hirschler.
Here is what Hirschler writes:
“Our understanding is that Aurora may have failed to show a benefit,” Tim Anderson of Sanford Bernstein said in a research note.
It’s hard to argue with a concept like heart attack prevention. So when an organization like SHAPE (The Society for Heart Attack Prevention and Eradication) comes along, it’s easy to overlook some of the troubling details of the group in the interest of the greater common good. When SHAPE published its own guidelines independent of the AHA, ACC, or NHLBI, and when SHAPE endorsed legislation to mandate insurance reimbursement for MI screening, my initial impulse was to overlook the nagging sense that something was wrong (why is a small, self-selected group publishing guidelines? do we really want legislators to decide what medical procedures should be reimbursed?). It was hard not to feel that at least the group’s heart was in the right place.
But the nagging questions have never gone away.
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The bleeding risk of rivaroxaban may be a significant focus of the FDA’s Cardiovascular and Renal Advisory Committee when it meets on Thursday. Briefing documents for the meeting posted this morning on the FDA website indicate that the FDA has significant safety concerns about the bleeding risk of rivaroxaban.
Almost 4 years after its specatacular crash and burn in the ACTIVATE trial, pactimibe has once again failed to live up to its much earlier promise. In the CAPTIVATE trial, published today in JAMA, pactimibe not only failed to prevent atherosclerotic progression in patients with familial hypercholesterolemia, as assessed by CIMT, but also caused an increase in cardiovascular events. Don’t go looking for any ACAT inhibitors on your pharmacy shelves any time in the near future.
Patients who have borderline or low normal ankle-brachial index (ABI) ratios are nevertheless at elevated risk for functional decline and disability, according to a new study appearing online in JACC. The 5 year, prospective, observational study found that patients with ABI values between 0.90 and 1.09 “appear to be at significantly greater risk of functional declines, including losing the ability to walk up a flight of stairs or walk a quarter of a mile without assistance, compared to people who have no evidence of PAD based on ABI values between 1.10 and 1.30,” said study author Mary McDermott, in a JACC press release.
A new study published online in Circulation provides further evidence that exercise after MI is benefical, improving endothelial function as measured by flow mediated dilation, but also shows that the benefits drop rapidly after exercise is stopped. The results were the same whether patients took up aerobic training, resistance training , or a combination regimen.
“This should be an additional reason to encourage patients to carry out several types of physical activity to avoid exercise boredom and promote better long-term adherence to exercise programs,” said Margherita Vona, lead author of the study and a cardiologist and director of the Cardiac Rehabilitation Center, Clinique Valmont-Genolier in Glion sur Montreux, Switzerland, in an AHA press release.
Click here to read the AHA press release…
Ahead of Wednesday’s meeting of the Cardiovascular and Renal Advisory Committee meeting, FDA reviewers have recommended approval of Sanofi’s dronedarone to delay recurrence of and hospitalization for atrial fibrillation.
FDA observers will be pleased to learn that Sanjay Kaul is listed on the roster as a committee member. CardioBrief is willing to bet that Sanjay Kaul will in fact appear as scheduled at this meeting…
(Also on Wednesday, the Circulatory System Devices Panel will meet to discuss the PMA for the TherOx Aqueous Oxygen System for use in acute myocardial infarction (AMI) patients, who have undergone successful revascularization. Click here for the FDA brieifng documents etc.)
A retrospective analysis of more than 12 million people in an insurance database has provided evidence that the anti-inflammatory effects of statins may help reduce the severity of asthma attacks, according to a new study presented at the 2009 Annual Meeting of the American Academy of Asthma, Allergy and Immunology (AAAAI). (You can find the abstract by going to the AAAAI meeting website, clicking on “Itinerary Planner” and searching for “statins.”)
Late on Friday the 13th Medtronic sent a letter to physicians saying that the number of deaths in which its Sprint Fidelis leads may have played a role has climbed to 13. Earlier this week we reported that the judge who had dismissed the lawsuits against the company would not step down from the case despite conflict of interest allegations.
It’s not a cardiology issue, but we can’t help being amazed at some of the “frank” talk and raw emotions on display in a new post by David Armstrong in the Wall Street Journal health blog. Armstrong recounts what happens when he spoke to JAMA editors about a letter that appeared on the British Medical Journal website criticizing a JAMA study on the antidepressant Lexapro. We won’t go into details here, but strongly recommend you read Armstrong’s account in which JAMA editor Catherine DeAngelis tells Armstrong that the BMJ letter writer is a “nobody and a nothing.” This demolition derby is far from being over, we predict.
Cardiac surgeon Eric Rose can hold his head up high: at $2.75 million his salary is the same as Mt Sinai’s top interventional cardiologist, Samin Sharma. By moving from Columbia to Mt Sinai last fall, Rose apparently increased his compensation from a mere $2.2 million at Columbia. According to an article in Crain‘s, Rose brought $50 million in federal grants with him, so Mt Sinai may have found a bargain.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will review BMS’s saxagliptin tablet and Novo Nordisk’s liraglutide injection on April 1-2. Saxagliptin is a DPP-4 inhibitor, liraglutide is a long-acting form of GLP-1. Click here for the FDA webpage for the advisory committee meeting.
Noticeably absent from the advisory committee meeting is Takeda’s alogliptin, another DPP-4 inhibitor. According to Takeda, the company was informed by the FDA that alogliptin will be subject to guidelines issued after Takeda had already filed its NDA, and that the drug’s existing clinical data will not be sufficient for approval.
Click here to read the Takeda press release…
Europe is losing the battle against heart disease, according to the latest report from EUROSPIRE III published in the Lancet. Among patients with heart disease, there has been no improvement in rates of smoking, hypertension, obesity, and diabetes, although patients are receiving more drugs. Real progress will require lifestyle programs and comprehensive, multidisciplinary approaches, write the authors.
In an accompanying editorial, Mette Brekke and Bjørn Gjelsvik write that the study has 3 messages:
First, to help patients with coronary heart disease achieve a healthy lifestyle should be mandatory and have high priority for doctors and health authorities. Second, therapeutic targets in guidelines need to be continually discussed. Blood pressure and lipid targets that are too ambitious might take focus away from important lifestyle issues. Finally, secondary risk prevention is not enough. Political action is needed to reverse the negative trends of obesity and sedentary habits, ranging from fighting against the fast food and sugar industries to safe bicycle paths and healthy school meals.
Two year results from the ABSORB trial continue to show promising results for bioabsorbable polymer drug-eluting stents (BVS), according to a new paper published in the Lancet. Results are hard to interpret given that only 30 patients were enrolled in the trial, but the researchers, led by Patrick Serruys, were encouraged by the fact that only one patient had a non-Q wave MI at two years. In an accompanying editorial, Antonio Colombo and Andrew Sharp say that “we could indeed be looking at a major step forward in coronary stenting. However, three “mores” are needed: more patients, more follow-up, and more experience in complex lesions.”
To no one’s surprise except all the patients who are convinced that their cardiologists saved their lives, elective PCI over the last 20 years has had no discernible effect on mortlaity or MI when compared to medical therapy, according to a new network meta-analysis by Thomas Trikalinos and colleagues in the Lancet. (The beneficial effects of PCI in the setting of ACS are commonly accepted.) In an accompanying editorial, Debabrata Mukherjee and David Moliterno write:
“We need to think of PCI not as an alternative to optimum medical therapy, but rather as an effective adjunct. Future studies of PCI as an adjunct will need to consider further assessment of endpoints related to quality of life.
Two years after its initial presentation at the ACC in 2007, the promising phase 2 results on Schering’s novel thrombin receptor antagonist (TRA) in the setting of elective PCI have been published in the Lancet. (You can see the slide set from the initial presentation at clinicaltrialresults.com.) The results were promising enough– good efficacy and low rate of bleeding events– to generate a lot of buzz in 2007. In an accompany editorial in the Lancet, Alessandro Colombo and Piera Merlini write:
Is the dream of an effective antithrombotic drug with a low bleeding risk becoming reality? Will this approach be effective in the acute setting (eg, primary percutaneous coronary intervention) and even in secondary prevention? Phase III trials will determine whether we are entering a new antithrombotic era.
Two large phase 3 trials are now underway. Initial results are expected in 2010 or 2011.
