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...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - November 24, 2015 Category: Cardiology Authors: Larry Husten Tags: Heart Failure People, Places & Events Entresto LCZ 696 Novartis Source Type: blogs
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...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - November 23, 2015 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes Uncategorized Amgen Caremark CVS formulary PCSK9 reimbursement Repatha Source Type: blogs
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...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - November 23, 2015 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes Boston Heart Diagnostics myopathy SLCO1B1 statin intolerance statins StatinSmart Source Type: blogs
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...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - November 19, 2015 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Amgen PCSK9 privacy Source Type: blogs
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. Lamar Alexander, the Chairman of the Health, Education, Labor and Pension Committee,...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - November 17, 2015 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Califf FDA Senate Source Type: blogs
Live Blog: Senate Hearing On Rob Califf’s Nomination For FDA Commissioner
10:23:Alexander says that each senator will have 5 minutes to ask questions or talk. Alexander starts to ask questions but then is reminded that Califf hasn’t had a chance to give his opening statement. 10:21 Senator Scott (SC) points out that though Califf is well known as a North Carolinian he was actually born in...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - November 17, 2015 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Califf FDA Senate Source Type: blogs
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...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - November 16, 2015 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes devices FDA postapproval Source Type: blogs
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...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - November 13, 2015 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes anacetrapib CETP cholesterol Merck REVEAL Source Type: blogs
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...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - November 13, 2015 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics impact factor journals Krumholz publications Source Type: blogs
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...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - November 11, 2015 Category: Cardiology Authors: Larry Husten Tags: Heart Rhythms Interventional Cardiology & Surgery People, Places & Events Policy & Ethics AF Boston Scientific CMS left atrial appendage closure NCD Watchman Source Type: blogs
Reality Check: After Starting Warfarin One In Five Older Vets Hospitalized For Bleeding
A new study presented at the American Heart Association meeting in Orlando finds that more than one in five elderly US veterans are hospitalized for bleeding after starting warfarin. This high rate of serious bleeding complications in a real world setting surprised and even disturbed the study authors. Anticoagulants are the proverbial double-edged sword. Striking the right balance between benefit...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - November 10, 2015 Category: Cardiology Authors: Larry Husten Tags: Heart Rhythms People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes anticoagulants atrial fibrillation bleeding NOAC VA warfarin Source Type: blogs
SPRINT Will Change But Not Revolutionize Blood Pressure Treatment
After all the hype and hoopla it turns out that the SPRINT trial will in all likelihood really have a significant impact on clinical practice and future guidelines, but it also also seems clear that it will not bring about a revolution, as some have recently speculated, in the treatment of high blood pressure. That’s the broad consensus emerging from hypertension...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - November 9, 2015 Category: Cardiology Authors: Larry Husten Tags: Policy & Ethics Prevention, Epidemiology & Outcomes ACCORD high blood pressure hypertension SPRINT Source Type: blogs
Waiting For ISCHEMIA: Why Won’t Cardiologists Enroll Patients?
One of the most important unanswered questions in medicine today– the best treatment for stable ischemic heart disease– may never get a satisfactory answer because cardiologists are unwilling to enter their patients in a clinical trial. One major reason why the question is urgent: about a third of the 1 million PCI procedures performed each year in the...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - November 8, 2015 Category: Cardiology Authors: Larry Husten Tags: Uncategorized catheterization COURAGE ischemia NIH optimal medical therapy PCI Source Type: blogs
Lancet Sprints To The Front With A Blood Pressure Meta-Analysis
A new meta-analysis published in the Lancet on Friday lends fresh support to calls for more intensive blood pressure treatments. The publication comes only days before the highly anticipated presentation of the NIH’s SPRINT trial at the American Heart Association, which is also expected to offer support for stricter blood pressure control. Blood pressure goals were relaxed after the ACCORD...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - November 6, 2015 Category: Cardiology Authors: Larry Husten Tags: Diabetes Policy & Ethics Prevention, Epidemiology & Outcomes blood pressure guidelines hypertension SPRINT Source Type: blogs
You Don’t Know It But The Debate About SPRINT Is Already Over
On Monday you’re going to hear a lot– an awful lot– about SPRINT. That’s the big NIH blood pressure trial which was stopped early. On September 11 an NIH press release trumpeted the positive results without revealing most of the important details. This Monday, finally, the results are scheduled to be presented at the American Heart...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - November 5, 2015 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics blood pressure embargo guidelines SPRINT Source Type: blogs
