Meta-Analysis Gives More Support To Aggressive Blood Pressure Treatment

A large new meta-analysis offers fresh support to the growing movement in favor of more aggressive treatment to lower high blood pressure. The findings are consistent with and extend the results of the recently reported NIH SPRINT trial, which found substantial clinical benefits for a systolic blood pressure target of 120 mm Hg instead of 140…

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First Outcomes Trial Results For PCSK9 Drugs Will Come In 2016

In less than a year we may know a whole lot more about the PCSK9 inhibitors than we do now. Since the approval earlier this year of Repatha (evolocumab, Amgen) and Praluent (alirocumab, Regeneron and Sanofi) critics and benefit managers have recommended strict limitations on use of the drugs because of the absence of evidence showing clinical benefit….

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Amgen Denies Rumors About PCSK9 Inhibitors (Updated)

(Updated) Amgen says there is no truth to the rumor that the FDA is investigating post-marketing reports of serious brain infections in patients taking PCSK9 inhibitors. The Amgen statement was in response to this anonymous post on CafePharma: “The FDA informed Amgen and Regeneron today that there have been a number of post marketing reports…

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Prepublish or Perish? Making a Case for Medicine to Take a Cue from Basic Science

  It’s time for clinical research to join other scientific fields like physics and computer science and encourage preprint publication of manuscripts on the internet, according to three top cardiologists writing in a Lancet comment. Since 1969 researchers have labored under the constraints of the Ingelfinger rule, in which “posting a paper, data, or key findings on the internet represented presubmission…

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FDA Panel Turns Down Expanded Indication For Ezetimibe

An FDA advisory panel on Monday voted 10-5 against an expanded indication for Merck’s ezetimibe (Vytorin, Zetia). The current label states that the drugs have not been shown to improve cardiovascular morbidity or mortality. The proposed expanded indication was based on findings from the IMPROVE-IT trial. The panel spent most of the day trying to interpret…

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Live Blog: The FDA Advisory Panel On IMPROVE-IT

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ROCKET-AF Investigators Seek To Calm Concerns About Trial Reliability

(Updated) In response to disturbing questions about the integrity and reliability of crucial data in the ROCKET AF trial, the executive committee of the trial has released a statement saying that they have “conducted a secondary analysis of the trial findings” and that “the findings from the analysis are consistent with the results from the original trial and do not…

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Pioneering Cardiologist George Diamond Dead At 74

George Diamond, a pioneering cardiologist at the Cedars-Sinai Medical Center in Los Angeles, died on Saturday at the age of 74 from complications related to colon cancer. Here are some reactions to news of his death from several of his long-time friends and colleagues at Cedars-Sinai. Sanjay Kaul: “I am deeply saddened at the loss…

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Expect Intellectual Fireworks At FDA Advisory Panel On Ezetimibe

You can expect a lot of high-powered intellectual fireworks at next Monday’s FDA advisory panel considering Merck’s application to upgrade the indications for Vytorin and Zetia. Both brands contain the  cholesterol-lowering drug ezetimibe, which was studied exhaustively– in many senses of the word– in the IMPROVE-IT trial. The discussion will likely focus on what to do about missing data and how to…

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More Concerns Raised About Possible Risks Of New Heart Failure Drug

(Updated with an additional comment from Milton Packer) More safety concerns are being voiced about Entresto, the new, ballyhooed heart failure drug from Novartis.  Fueling these concerns is a mix of speculation, worry about the FDA’s rapid approval of the drug, and a long-running feud between two leading heart failure researchers. The concerns, raised in a JAMA Viewpoint by heart failure…

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Survey: Docs Think Cardiologists Are Rude, Dismissive, And Aggressive

Nearly a third of English doctors report that they are subject to rude, dismissive and aggressive (RDA) behavior more than once a week. Cardiologists are among the specialists who are most likely to be responsible for this “workplace incivility.” These are some of the chief findings of a survey  published in Clinical Medicine of 606 British doctors at three…

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Prominent European Cardiologists Decry Curbs On Industry Support For Docs Attending Medical Meetings

(Updated) Starting in 2018 European device companies will no longer be allowed to directly sponsor physician attendance at medical meetings. In response, three prominent European interventional cardiologists warn that the change could have dire consequences, stifling education and potentially reducing attendance at European medical meetings by 30-50%. In the US physicians can still enjoy free meals….

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PARADIGM Investigators Estimate Entresto Prolongs Life by 1-2 Years

Treatment with Entresto (the combination of sacubitril and valsartan, formerly known as LCZ 696) instead of an ACE inhibitor will add approximately one to two years of life for most people taking the drug, according to new estimates published in the New England Journal of Medicine. Because of the time and population limitations of clinical trials it…

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New Questions Raised About ROCKET AF, Pivotal Xarelto Trial Chaired By Califf

(Updated) Disturbing questions are being raised about the integrity and reliability of crucial data in the ROCKET AF trial. The investigation could have important implications on several fronts. First, the trial serves as the basis for the use of the blockbuster drug rivaroxaban (Xarelto, Johnson & Johnson) for stroke prevention in atrial fibrillation. Second, the…

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Encouraging Results Found In Long Term TAVR Registry

Since it’s first FDA approval in late 2011 the use of transcatheter aortic valve replacement therapy (TAVR) has grown dramatically– but not dangerously or explosively– in the US. Now accumulating data from a central national registry provides the best picture yet of the evolution and current status of TAVR. The TVT Registry, which is run by the Society of Thoracic Surgeons (STS)…

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Novartis Heart Failure Drug Gains Approval In Europe

Entresto, the novel heart failure drug from Novartis, has now been approved in Europe. The company said the drug, a twice-a-day combination of sacubitril and valsartan (formerly known as LCZ 696), had been approved by the European Commission for the treatment of people with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). The news follows previous approval of the drug by…

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Amgen’s Repatha Beats Out Competitor For Spot On CVS/Caremark Formulary

CVS Health announced today that Amgen’s Repatha will be the only PCSK9 inhibitor on the CVS/Caremark formulary. This gives Amgen its first big win among the pharmacy benefits managers against Sanofi’s Praluent in the battle over the market for the powerful but expensive new cholesterol-lowering drugs. Previously Express Scripts had announced that both drugs would be placed…

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Experts Question Role For At-Home Statin Intolerance Test

A small laboratory company, Boston Heart Diagnostics, has introduced and is promoting “the first and only at-home saliva laboratory developed test” that it says will help identify people who are likely to experience side effects from taking a statin. The company claims the genetic test “helps patients understand how their bodies will process a statin…

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Amgen Takes The Pledge To Respect Patient Privacy

In response to criticism Amgen appears to have greatly tightened its corporate privacy policy regarding patient information. The company has published a “privacy pledge” to US patients” and says that it will  soon modify the authorization agreements that required patients participating in the company’s drug copay programs to surrender rights to their personal and health information. The move…

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A Few Observations About Rob Califf’s Picnic With The US Senate

I’m no expert on Washington politics but judging from the senate committee hearing today Rob Califf is going to be the next FDA commissioner. With the exception of Bernie Sanders, who had already announced his opposition, the committee members treated Califf with kid gloves. [Click here to read my live blog of the hearing.] Lamar…

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Live Blog: Senate Hearing On Rob Califf’s Nomination For FDA Commissioner

12:00 Hearing adjourned. It sure looks like Rob Califf will be our next FDA commissioner.  11:58 Scott asks about the high rate of heart disease and diabetes in South Carolina. The high cost of trials is preventing cures for these diseases. Califf asks how many hours he has to answer the question. Califf notes we have…

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Report Finds Problems With FDA Mandated Postapproval Device Studies

As a condition of approval FDA often requires manufacturers of medical devices to perform postapproval studies. Now a General Accounting Office (GAO) audit [PDF] finds that, among other problems, many studies remain unfinished for a great many years. In addition, digging on its own into the FDA database of postapproval studies, The Gray Sheet, a device industry newsletter, focused…

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Merck Reveals That Its 30,000 Patient CETP Trial Will Continue

Despite rumors to the contrary the story of the CETP inhibitors isn’t quite over. Merck today announced that the REVEAL trial will continue. After a series of disappointing and often spectacular failures, REVEAL is the last remaining phase 3 trial of a CETP inhibitor still underway. REVEAL is a 30,000 patient trial studying Merck’s anacetrapib. In the announcement Merck said the…

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Retiring Editor Says Its Times For Journals To Be Retired

Harlan Krumholz is not going gentle into the good night. Near the end of his tenure as the founding editor of Circulation:Cardiovascular Quality and Outcomes Krumholz has delivered a fiery editorial [PDF] arguing that the current model of printed peer-reviewed journals may not, and probably should not, survive in “a new world that is flat, digital, and…

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CMS Proposal Would Plug Up Watchman Reimbursement

Medicare is proposing to put severe constraints on reimbursement for percutaneous left atrial appendage closure using the Boston Scientific Watchman device to prevent stroke in patients with nonvalvular atrial fibrillation. On Tuesday afternoon the Centers for Medicare & Medicaid Services (CMS) issued the draft of a restrictive national coverage determination (NCD) for Watchman that would almost certainly apply the…

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