New Company Bets Hundreds Of Millions Of Dollars On A Genetic Strategy To Resurrect A CETP Inhibitor
–But skeptics think CETP inhibitors are a dead end A new company is betting hundreds of millions of dollars that it can snatch victory from the jaws of defeat. Over the last decade no class of drugs has undergone a reversal of fortune as dramatic as the cholesterol ester transfer protein (CETP) inhibitors, the once...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - April 20, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Prevention, Epidemiology & Outcomes CETP dalcetrapib DalCor genetic Source Type: blogs

FDA Ends Niacin and Fenofibric Acid Combinations With Statins
–“In the absence of benefits, there remain only harms.” The FDA is putting an end to the combined use of statins with two once-popular lipid drugs, niacin and fenofibric acid. On Monday the FDA will announce in the Federal Register that it is withdrawing its approval for indications for coadministration of these drugs with statins...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - April 18, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes fabric acid FDA fibrates lipid drugs niacin statins Source Type: blogs

Orexigen Terminates Another Cardiovascular Outcomes Trial
Updated–In a further sign of the chaos surrounding its weight loss drug Contrave, Orexigen has again terminated an FDA-mandated cardiovascular outcomes trial with the drug. Following a year of controversy (see below) Orexigen last month assumed sole control of Contrave (the combination of naltrexone and bupropion) from its former partner, Takeda. The company has now terminated enrollment...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - April 13, 2016 Category: Cardiology Authors: Larry Husten Tags: Uncategorized Source Type: blogs

New Analysis Of Old Study Delivers Another Blow To Traditional Diet Advice
–Replacing saturated fat with vegetable oils lowered cholesterol but didn’t improve outcomes A new analysis from a long-forgotten study dating to the 1960s adds to mounting doubts over a cornerstone of dietary advice for more than 50 years: the demonization of saturated fat in the diet. Although in recent years the nutritional establishment has retreated...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - April 13, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes diet Linoleic acid nutrition Saturated fat trans fats vegetable oil Source Type: blogs

USPSTF Updates Aspirin for Primary Prevention Recommendation
–But many experts think the evidence base is slim at best. The U.S. Preventive Services Task Force (USPSTF) finalized the update to its guidelines regarding the use of aspirin for the primary prevention of cardiovascular disease and colorectal cancer. The USPSTF is now recommending that people between the ages of 50 and 59 who are at increased...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - April 11, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes aspirin colorectal cancer cv disease primary prevention USPSTF Source Type: blogs

FDA Expands Metformin Label
— The diabetes drug can now be used in more patients with reduced kidney function The FDA on Friday greatly expanded the indication for the type 2 diabetes drug metformin. Until now use of metformin in patients with reduced kidney function had not been recommended. The new label states that metformin “can be used safely...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - April 10, 2016 Category: Cardiology Authors: Larry Husten Tags: Diabetes People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes FDA guidelines metformin renal impairment Source Type: blogs

PNAS Paper By Prominent Cardiologist And Dean Retracted
A 2002 PNAS paper has been retracted by its authors, including senior author Pascal Goldschmidt, a prominent cardiologist and Dean of the University of Miami School of Medicine. News of the retraction was reported by Retraction Watch on Tuesday. The paper, “Deficient Smad7 expression: A putative molecular defect in scleroderma,”has been cited 198 times, Retraction Watch reported. Here is...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - April 6, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Goldschmidt Retraction Watch retractions scientific misconduct Source Type: blogs

FDA Adds Heart Failure Warning To Saxagliptin and Alogliptin Labels
The FDA said on Tuesday that it was adding new warning to the labels of diabetes drugs containing the  saxagliptin and alogliptin. The FDA said the drugs “may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.” The announcement comes two years after an FDA panel recommended that...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - April 6, 2016 Category: Cardiology Authors: Larry Husten Tags: Diabetes Heart Failure Policy & Ethics Prevention, Epidemiology & Outcomes Uncategorized Alogliptin EXAMINE FDA FDA warning glucose control SAVOR Saxagliptin Source Type: blogs

ATMOSPHERE: Heart Failure Trial Poisoned By Controversy
–Aliskiren raised regulatory pandemonium as it crashed in trials When it comes to interrupting the renin-angiotensin system, the third time was definitely not the charm. Following the enormous success of the ACE inhibitors and angiotensin-receptor blockers, there were early high expectations for a third class of drugs, the direct renin inhibitors. Those hopes were dashed...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - April 4, 2016 Category: Cardiology Authors: Larry Husten Tags: Heart Failure People, Places & Events Policy & Ethics aliskiren Novartis renin inhibitor Renin-angiotensin system Tekturna Source Type: blogs

After a Decade, CABG Pulls Ahead of Meds for HF
–Life-saving benefit of CABG now clear in long-term trial follow-up Finally, after 10 years of follow-up, the life-saving benefits of coronary artery bypass graft (CABG) surgery in heart failure patients with coronary artery disease are clear. More than 15 years ago, the NIH funded the original STICH trial to answer a question that was already...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - April 4, 2016 Category: Cardiology Authors: Larry Husten Tags: Heart Failure Interventional Cardiology & Surgery People, Places & Events CABG coronary artery disease STICH STICHES Source Type: blogs

Not So Rare, FH Is Truly Risky Lipid Disorder
–Not all elevated is LDL is equally dangerous CHICAGO — Familial hypercholesterolemia (FH), a condition that has long been overshadowed by more common cardiovascular diagnoses, has now found the spotlight in the big tent as a hot and even controversial topic. The new interest is driven by important advances in understanding the genetics of the...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - April 3, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes cholesterol familial hypercholesterolemia FH LDL PCSK9 Source Type: blogs

ACCELERATE Puts the Brake on CETP Inhibition
–No benefit with evacetrapib despite increase in HDL and decrease in LDL The fat lady hasn’t sung, the referee hasn’t counted up to 10, but it’s sure not looking good for the once highly promising class of drugs known as the CETP inhibitors. Bang the Drum Slowly, and Play the Fife Lowly Following the crash...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - April 3, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes CETP evacetrapib HDL LDL Source Type: blogs

How Does HOPE-3 Change Thinking About Primary Prevention?
–The study lends strong support for statins but delivers a mixed message for antihypertensives. The widely reported results of HOPE-3 may bolster the case for primary prevention with statins and blood pressure drugs. But the trial also makes clear that the benefits, though real, are also modest, and may not be evenly distributed between statins...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - April 2, 2016 Category: Cardiology Authors: Larry Husten Tags: Policy & Ethics Prevention, Epidemiology & Outcomes antihypertensives blood pressure HOPE-3 primary prevention Rosuvastatin SPRINT statins Source Type: blogs

US DOJ Expands Investigation Into Phony Novartis Speaking Events
— The government wants Novartis to turn over documents on 80,000 separate speaking events. The US Department of Justice is seeking to greatly expand its investigation of Novartis “for engaging in a nationwide kickback scheme, spanning 10 years, to induce doctors to write prescriptions for certain of its cardiovascular (‘CV’) drugs.” Last week the DOJ...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - March 29, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics DOJ false claims act kickbacks Novartis speaking programs Source Type: blogs

How Should SPRINT Influence High Blood Pressure In Children And Adolescents?
–Editorialists say pediatric hypertension in children is ready for a ‘paradigm shift’ Last year’s influential— and highly controversial— SPRINT trial should be used to better inform and influence our understanding and management of hypertension in children, write two influential physicians who have played a key role in the cardiovascular guidelines for children and adolescents. They...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - March 28, 2016 Category: Cardiology Authors: Larry Husten Tags: Policy & Ethics Prevention, Epidemiology & Outcomes guidelines hypertension pediatrics primordial prevention Source Type: blogs