New Anticoagulant Found Safe And Effective In Acute Venous Thromboembolism 1

In a large clinical trial the new oral anticoagulant apixaban (Eliquis, Pfizer and Bristol-Myers Squibb) was at least as effective as standard therapy and caused fewer bleeding complications in patients with acute venous thromboembolism. The results of the AMPLIFY (Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy) trial are being presented on Monday at the annual meeting of the International Society on Thrombosis and Haemostasis in Amsterdam and are being published in the New England Journal of Medicine. (The embargo on the trial was lifted early by the Journal after being broken by Reuters.)

Click here to read the full story on Forbes.

 

 

Advertisements

More Bad News For HDL Therapies: ASSURE Trial Misses Primary Endpoint Reply

The string of bad news for HDL-related therapies continues. Resverlogix yesterday announced that the ASSURE clinical trial had failed to meet its primary endpoint. RVX-208, the drug being studied in the trial, is a novel small molecule that increases production of ApoA-1, which raises HDL levels and is thought to enhance reverse cholesterol transport.

Click here to read the full story on Forbes.

Steve Nissen

FDA Turns Back New Indication For Rivaroxaban To Prevent Stent Thrombosis In ACS Patients Reply

Johnson & Johnson said today that it had received a complete response letter from the FDA for the supplemental new drug application for rivaroxaban (Xarrelto) for the prevention of stent thrombosis in patients with acute coronary syndromes (ACS). Earlier this year the FDA turned down for the second time the sNDA for the  general use of rivaroxaban to treat ACS patients.

Click here to read the full story on Forbes.

 

English: Logo of the .

 

 

Novel Heart Failure Drug From Novartis Gains ‘Breakthrough Therapy’ Designation From FDA 1

Serelaxin, the novel therapy under development for the treatment of acute heart failure, has received a “breakthrough therapy” designation from the FDA, according to Novartis, the company developing the drug. The designation, the FDA explains, “is intended to expedite the development and review of drugs for serious or life-threatening conditions” and requires “preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.” In addition to getting a speedier review process, the sponsor of a drug with the designation receives “more intensive FDA guidance” on the development program.

Click here to read the full story on Forbes.

 

Some Patients With Minor Stroke Or TIA May Benefit From Early Clopidogrel And Aspirin Reply

Some people with minor ischemic stroke or transit ischemic attack (TIA) may benefit from dual antiplatelet therapy with aspirin and clopidogrel, according to a large new study from China published in the New England Journal of Medicine. In the immediate period following a TIA or minor stroke people are at high risk for having a major stroke. Aspirin is known to cause a modest reduction in recurrent events. More potent antiplatelet agents like clopidogrel may also be beneficial, but have not been well studied in the early phase and may increase the risk of bleeding complications, including the conversion of an ischemic stroke into a worse hemorrhagic stroke.

Investigators in the CHANCE (Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events) trial randomized 5,170 patients within 24 hours of a minor ischemic stroke or high-risk TIA to three months of treatment with either clopidogrel and aspirin or placebo and aspirin. At 90 days the rate of stroke was 8.2% in the combination group versus 11.7% in the aspirin-alone group (hazard ratio 0.68, CI 0.57-0.81, p<0.001). There were also significant reductions…

Click here to read the full story on Forbes.

 

Large NIH Trial Finds No Cardiovascular Benefits For Weight Loss And Exercise In Type 2 Diabetics 1

A large NIH-sponsored trial has found that an intensive lifestyle intervention was no better than standard care in reducing cardiovascular events in people with type 2 diabetes. The results of the Look AHEAD trial were presented today at the American Diabetes Association meeting and published simultaneously in the New England Journal of Medicine.

5,145 people with type 2 diabetes were randomized to either an intensive lifestyle intervention, focusing on weight loss through a low-calorie diet and increased exercise, or conventional diabetes care. Trial investigators had planned to run the study for as long as 13.5 years, in the hope of finding a significant difference in the rate of major cardiovascular events (death from cardiovascular causes, nonfatal MI, nonfatal stroke, or hospitalization for angina). However, after 9.6 years of followup the data and safety monitoring board performed an analysis and recommended that the trial be stopped for futility.

Click here to read the full story on Forbes.

Roller Coaster Path To Approval For Eliquis Uncovered By FDA Documents Reply

After the presentation and publication of the pivotal ARISTOTLE trial,  the novel anticoagulant apixaban (Eliquis, Pfizer and BristolMyers Squibb) was widely expected to be  a blockbuster. But then it got bogged down at the FDA where initial hopes for a speedy approval were dashed after highly critical reviews. Ultimately approval of the drug was delayed for 9 months past the original deadline as a result of both a PDUFA date extension and a complete response letter from the FDA. Now an article by Sue Sutter in  Pharmaceutical Approvals Monthlybased on documents posted by the FDA on its website, offers an inside look at the drug’s roller coaster ride through the FDA.

The article describes in detail the efforts of the FDA to investigate evidence of fraud and dispensing errors in ARISTOTLE. As Sutter writes: “To many looking in from the outside, the apixaban NDA filing seemed like a sure thing.” Initial results of ARISTOTLE suggested that it had “the potential to be best-in-class if the published ARISTOTLE data were to be believed.”

Click here to read the full story on Forbes.

Hypertension And Cholesterol Guidelines Delayed Again As NHLBI Gets Out Of The Guidelines Business Reply

The National Heart, Lung, and Blood Institute (NHLBI) will no longer issue guidelines, including the much-delayed and much-anticipated hypertension (JNC 8) and cholesterol (ATP IV) guidelines. Instead, the NHLBI will perform systematic evidence reviews that other organizations, including the American Heart Association and the American College of Cardiology, will use as a resource for their own guidelines.

The exact fate and form of the delayed hypertension and cholesterol guidelines has not yet been decided, though the NHLBI’s Michael Lauer said he was confident that these guidelines would appear in less than a year. But a lot of work remains before the documents can be published. ACC President John Harold said that  “the ACC has not formally agreed to or begun the process of updating” the NHLBI documents, “but we are open to this role and look forward to working out details with NHLBI and the American Heart Association.”

Click here to read the full story on Forbes.

 

NHLBI Director Dr. Gary Gibbons

NHLBI Director Dr. Gary Gibbons

Top Line Results: No Cardiovascular Benefits Found For Saxagliptin Reply

Top line results of a large phase 4 study with saxagliptin (Onglyza, Bristol-Myers Squibb and AstraZeneca) demonstrate that the drug is safe but has no cardiovascular benefits. AstraZeneca and Bristol-Myers Squibb today announced the top line results for the SAVOR-TIMI-53 Cardiovascular Outcomes Trial of Onglyza®. The full results are scheduled to presented at the  annual meeting of the European Society of Cardiology in Amsterdam on September 2 by Deepak Bhatt.

Click here to read the full story on Forbes.

 

FDA Raises Concerns About The Cybersecurity Of Medical Devices Reply

The FDA has raised concerns about the vulnerability of medical devices to cyberattack. In one dramatic instance, reported by the Wall Street Journal, a VA catheterization laboratory in New Jersey was temporarily closed after malware infected the lab’s computer devices.

 

Halamka offered some additional perspective on the problem to the Washington Post:

“There’s almost no medical device that doesn’t have a network jack on the back. To fight the evils of the Internet, not only do you have to have a moat, you have to have a drawbridge, burning oil to pour on attackers, and guys with arrows.”

Click here to read the full story on Forbes.

 

New European Hypertension Guidelines Released With Simplified Blood Pressure Target Reply

New hypertension guidelines from the European Society of Hypertension and the European Society of Cardiology were released in Milan today at the European Meeting on Hypertension & Cardiovascular Protection.

The authors of the guidelines write that “despite overwhelming evidence that hypertension is a major cardiovascular risk, studies show that many are still unaware of the condition, that target blood pressure levels are seldom achieved”. They report that hypertension affects 30-45% of people in Europe.

Perhaps the biggest single change in the new document is the adoption of a single systolic blood pressure target for almost all patients: 140 mmHg, This replaces the previous, more complicated target, which included both systolic and diastolic recommendations for different levels of risk (140/90 mmHg for moderate to low risk patients and 130/80 mmHg target for high risk patients).  One of the authors, Robert Fagard, commented: “there was not enough evidence to justify two targets.”

Click here to read the full story on Forbes.

 

 

New Trend? Free Tablet Computers For All Registrants At TCT Meeting Reply

Cardiologists and others who attend this year’s TCT meeting in San Francisco will receive a free tablet computer. TCT is the highly influential interventional cardiology meeting run by the Cardiovascular Research Foundation. This year it will take place in San Francisco from October 27 through November 1.

Heavily promoted in emails and on the site’s webpage, TCT is promising that paid registrants for the entire meeting “will receive a free tablet computer loaded with the official conference app and other interactive tools to optimize the TCT experience.” Attendees will get to keep their tablets. Here’s how TCT is saying the tablets can be used:

Another very important question: what sort of information about the user will the device send to TCT and/or sponsors? What sort of privacy controls will be available to the user, and will these controls be understood (see Facebook)? Concerns have been raised in the past about the presence of RFID tags embedded in conference badges. The potential for invasion of privacy is much greater with a tablet computer, I imagine.

Click here to read the full post on Forbes.

 

 

Too Much, Too Fast? Cross-Country Skiing And Heart Arrhythmias 1

When it comes to exercise it may be true that you can do too much or go too fast. It may seem counterintuitive but a new study finds that among cross-country skiers the risk of having a cardiac arrhythmia was highest in those who raced the fastest or most often.

In a paper published in the European Heart JournalSwedish researchers report on more than 50,000 participants in the Vasaloppetan enormously popular 90 kilometer cross-country skiing event that takes place each year in Sweden. Previous research has shown that Vasaloppet participants are, not surprisingly, healthier than other Swedes across a broad range of measures. The new research, however, shows that those participants who finished with the fastest times or who completed more races were more likely to develop an arrhythmia.

Click here to read the full post on Forbes.

 

 

 

 

 

People With Sleep Apnea At Increased Risk For Sudden Cardiac Death Reply

Although people with obstructive sleep apnea (OSA) have an increased risk for death and cardiovascular disease, the relationship between OSA and sudden cardiac death (SCD) has not been clear. Now a new study published in the Journal of the American College of Cardiology provides evidence that OSA is in fact associated with an increase in the risk for SCD.

Click here to read the full post in Forbes.

 

Dramatic Increase in Use of Radial Artery Access for PCI in the U.S. Reply

In the last six years interventional cardiologists have dramatically increased their use of radial access for PCI, according to a retrospective study published in Circulation. Using data from the CathPCI registry on more than 2.8 million procedures between January 2007 and September 2012, Dmitriy Feldman and colleagues found that radial access PCI increased 13-fold, from a negligible 1.2% at the beginning of the study to 16.1% at the end.

Click here to read the full story in Forbes.

 

Infographic from the American Heart Association

FDA Advisory Panel Backs Looser Restrictions On Avandia Reply

After two days of deliberation an FDA advisory panel today recommended that the severe restrictions (REMS) placed on rosiglitazone (Avandia, GlaxoSmithKline) be modified. The vote constitutes a modest revival in fortune for the embattled drug and its maker after many years of controversy and bad news.

Only 5 panel members voted to continue the current severe restrictions. One member (the consumer representative) voted for the withdrawal of rosiglitazone. By contrast, 20 members voted to either modify (13 votes) or remove (7 votes) the REMS. But the vote should not be interpreted as a broad statement by the panel that rosiglitazone is safe. Panel members made clear that they still had concerns about the safety of the drug. But their concerns were less pressing than in the past.

Click here to read the full story on Forbes.

 

 

Study Finds More Musculoskeletal Problems In People Who Take Statins Reply

An observational study published in JAMA Internal Medicine provides new evidence suggesting that people who take statins are more likely to develop musculoskeletal problems.

Ishak Mansi and colleagues analyzed data from 6,967 statin users and an equal number of propensity-matched nonusers who were active-duty soldiers, veterans and their families in the San Antonio Military Area. They found that the statin users were more likely to have musculoskeletal problems:

  • All musculoskeletal diseases: Odds Ratio 1.19, CI 1.08-1.3
  • Dislocation/strain/sprain: OR 1.13, CI 1.05-1.21
  • Musculoskeletal pain: OR 1.09, CI 1.02-1.18
  • Osteoarthritis/arthropathy: OR 1.07, CI 0.99-1.16

The authors calculated that between 37 and 58 people would need to be treated with statins to cause one additional person to develop musculoskeletal disease. However, increased exposure did not appear to raise the risk of statin use.

The results, according to the authors, “indicate that the full spectrum of statin AEs [adverse events] has not been fully explored.” They call for more studies on this topic: “the full spectrum of statin AEs will provide more complete data for cost-benefit and cost-effectiveness analyses of statin use.”

The study appears two weeks after a small study published in the Journal of the American College of Cardiology received considerable attention after it was covered in the New York Times. In that study the investigators found that statins appeared to blunt the beneficial effects of aerobic exercise.

 

 

With One Big Exception FDA Reviewers Back More Benign View Of Avandia Trial Reply

 

The FDA today released a 538-page briefing document for an advisory panel meeting on Wednesday and Thursday that will reassess a key clinical trial and reconsider the fate of the now-tarnished former blockbuster diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). (Click here for the FDA documents.) As reported last week, the re-adjudication of the RECORD safety trial performed by the Duke Clinical Research Institute (DCRI) confirmed the initial finding of the trial that rosiglitazone was not associated with an increased risk for cardiovascular events.

 

For the most part, the FDA documents released today express strong support for the DCRI re-adjudication. But one FDA official, Thomas Marciniak, remains highly critical of RECORD  and says the trial data and, therefore, the analysis of the data from GSK and DCRI are completely unreliable. All parties agree, however, that the fundamental underlying design flaws of RECORD–  in particular, it’s open-label design– mean that data from the trial will never provide definitive assurance about the safety of rosiglitazone.

 

One FDA reviewer said the DCRI review of the mortality results in RECORD was “well-conceived and comprehensive” and “no stone was left unturned.” But the same reviewer states:

 

There is no amount of analytical rigor that can compensate for a weak trial design that is exacerbated by elements of poor execution, both of which afflicted RECORD. Its open- label non-inferiority design was simply problematic, especially for ascertainment of non-mortality MACE during trial execution…. Thus, while we agree with the analytical findings of the DCRI mortality re-analysis, we would emphasize that RECORD’s design irreparably hampers its ability to characterize definitively the CV risk of rosiglitazone.

 

The panel may well accept the findings of the re-adjudication and the FDA analysis. In that case the terrifying specter looming over the FDA and the rest of the medical establishment– that not just rosiglitazone but the entire drug development and approval process was fundamentally flawed and unreliable– will be put to rest, at least for now.

 

A Bitter Feud

 

Buried in the massive document is a bitter feud between an FDA rebel, Thomas Marciniak, and his bosses and other senior officials in the FDA’s drug division….

Click here to read the full story on Forbes.

 

Fda

 

A CME Program Begs The Question: Promotion Or Education? Reply

In recent years defenders of commercially-supported continuing medical education (CME) have claimed that the industry has cleaned up its act and that CME programs today are largely free of the abuses that were so common not so long ago. Perhaps. But there are still plenty of examples of programs that violate the fundamental principle that medical education should be completely separate from commercial interests.

A striking example is a recent email I received from TCTMD, the online arm of the Cardiovascular Research Foundation (CRF), which is basically the equivalent of the Vatican for interventional cardiologists. The subject line of the email was nothing out of the ordinary:

Sponsored Message from Volcano: ADAPT-DES Webcast and Investigator Interview

I get lots of these sort of messages from different medical organizations. I’m not crazy about them but I understand that these groups have to pay their bills. But it’s vitally important that these groups maintain a clear separation between commercial messages like these and genuine educational content.

The text of the email makes some astonishing claims. It makes the case– not surprising in a promotional message– that interventional cardiologists should use IVUS more often during their procedures. But the text fails to mention that the numbers mentioned in the text come not from a randomized controlled trial but from an observational study. The findings thus should be considered hypothesis generating. In addition, as is so often the case when medical results are being hyped, the relative differences sound quite impressive– 50% reduction in stent thrombosis and 33% reduction in MI– but the absolute differences are much less impressive: at one year stent thrombosis was reduced from 1.04% to  0.52% and MI was reduced from 3.7% to 2.5%. And remember, since these differences are not the result of a randomized comparison they may be completely illusory.

Click here to read the full post on Forbes.