FDA Investigating Heart Failure Risk Linked To Onglyza

The FDA said today that it was conducting an investigation of a possible increased risk for heart failure associated with the diabetes drug saxagliptin. Saxagliptin is marketed by AstraZeneca as Onglyza and Kombiglyze XR. (AstraZeneca recently completed the purchase of all rights to the drug from its manufacturer, BristolMyers-Squibb.) The investigation stems from findings from the cardiovascular outcomes trial SAVOR-TIMI 53 trial  in which more…

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European Setback For Novartis Heart Failure Drug

European regulators have dealt a setback to a novel heart failure drug under development by Novartis. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended against giving market approval to serelaxin (Reasanz) for the treatment of acute heart failure. The recommendation is based largely on the committee’s analysis of the RELAX-AHF trial, which…

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FDA Advisory Panel To Review New Heart Failure Drug From Novartis

A novel acute heart failure drug from Novartis will be evaluated next month by an FDA advisory committee, perhaps countering a long string of crash-and-burn cardiology drugs. On February 13 the FDA’s Cardiovascular and Renal Drugs Advisory Committee will discuss the biologics license application (BLA) for serelaxin injection from Novartis. The indication is for the improvement of the…

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Cardiology in 2013: Like A Wrecking Ball

Perhaps I’m being overdramatic but I think  the best metaphor for the year in cardiology is Miley Cyrus on the wrecking ball. The Guidelines Wrecking Ball: Like Hannah Montana guidelines are supposed to be boring and reliable.  But in 2013 the guidelines were more like Miley Cyrus. Like a wrecking ball, the NIH abandoned its long-entrenched and highly influential role in producing…

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Can Personalized Medicine And An Adaptive Trial Design Salvage This Hard Luck Drug?

Arca Biopharma today announced that it had received FDA clearance to start a phase 2B/3 trial of its novel beta-blocker, Gencaro (bucindolol) for the prevention of atrial fibrillation in patients with heart failure. The GENETIC-AF trial has all the hallmarks of the modern era: the drug will only be tested in patients with a genetic variation that the…

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No Support For Broad Screening Of Chronic Kidney Disease

Although taught in  medical school and widely used in clinical practice, broad screening of otherwise healthy people for chronic kidney disease (CKD) is unwarranted, according to new recommendations from the American College of Physicians published in the Annals of Internal Medicine. People with early kidney disease, who are classified as having stages 1 to 3 CKD, usually…

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CardioMEMS Heart Failure Device Gets Mixed Reception From FDA Advisory Panel

The FDA’s Circulatory System Devices Panel sent a mixed message to the FDA today about CardioMEMS Champion HF Pressure Measurement System.  The small implantable device provides provides daily pulmonary artery pressure measurements to guide physicians in their treatment of patients with congestive heart failure. In December 2011 the same panel voted 9-1 that the device was safe, 7-3 that…

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Study Raises Questions About Digoxin Use Today

Digitalis is one of the oldest medicines in the cardiovascular arsenal. When William Withering identified digitalis as the active ingredient in the foxglove plant more than 200 years ago he was only codifying a longstanding folk remedy for heart failure, or “dropsy” as it was known then. Digitalis fully entered the modern era with the…

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Study Fails To Support Broader Patient Population For Cardiac-Resynchronization Therapy

Cardiac-resynchronization therapy (CRT) has been shown to be beneficial in heart failure (HF) patients with a wide QRS interval. These benefits have not been reproduced so far in patients with narrow QRS intervals, though many such patients have ventricular dyssynchrony. Now a new study, presented at the European Society of Cardiology in Amsterdam and published…

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Automatic Wireless Monitoring Shows Benefits in Chronic Heart Failure

Following in the wake of studies that failed to find benefits associated with remote wireless monitoring of heart failure (HF) patients, the In-Time trial, presented at the European Society of Cardiology meeting in Amsterdam, is the first trial to show that home monitoring of HF patients may be beneficial. Gerhard Hindricks, the coordinating investigator of…

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New Actelion Drug Found Safe And Effective In Pulmonary Arterial Hypertension– But Does It Save Lives?

Macitentan, a new drug for pulmonary arterial hypertension (PAH), appears to be safe and effective, but it is unclear whether it offers any significant advantages over currently available drugs.  The drug, a dual endothelin-receptor antagonist, is under development from Actelion as an enhanced version of bosentan (Tracleer). The results of a phase 3 trial, SERAPHIN (Study with an Endothelin…

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American Heart Association Announces Late-Breaking Clinical Trials

There are still a few days left in August and the European Society of Cardiology meeting doesn’t start until this weekend in Amsterdam. Nevertheless, the American Heart Association has released the list of late-breaking clinical trials for the annual meeting in November. Late-Breaking Clinical Trials 1: Acute Cardiovascular and Cerebrovascular Care Sunday, Nov 17, 2013, 4:00 PM –…

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FDA Panel Recommends Approval For Pulmonary Hypertension Drug From Bayer

The FDA’s Cardiovascular and Renal Drugs Advisory Committee recommended approval for Bayer’s new pulmonary hypertension drug, riociguat. The committee voted 11-0 in favor of approving the drug for two forms of pulmonary hypertension: pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTPH). Click here to read the full story on Forbes.        …

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Faint PRAISE: 13 Year Delay In Publication Of A Major Clinical Trial Sparks Criticism

13 years after first being presented the results of the PRAISE-2 trial finally have been published in JACC: Heart Failure. The trial itself is now largely irrelevant to current clinical practice, as the hypothesis it tested has long been abandoned, but the long delay in publication may serve to bring even more awareness to the…

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Novel Pulmonary Hypertension Drug From Bayer Shows Modest Promise In Phase 3 Trials

A new drug appears to have promising– but not game-changing– effects in people with two forms of pulmonary hypertension. Riociguat, a soluble guanylate cyclase stimulator under development by Bayer, is thought to have vasodilating, antiproliferative and antifibrotic effects. Results of two phase 3 placebo-controlled trials were published today in the New England Journal of Medicine. CHEST-1 studied the clinical impact…

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

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…

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Interpretations Differ Over Study Of Coenzyme Q10 In Heart Failure

Coenzyme Q10 (CoQ10) may be beneficial in heart failure, according to the results of the Q-SYMBIO study presented this past weekend at the Heart Failure 2013 meeting in Lisbon, Portugal. But the results should be viewed with a critical eye, say experts. … Click here to read the full post on Forbes, including a comment from Milton…

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European Medicines Agency Starts Review of Combined Use Of Drugs That Block The Renin-Angiotensin System

The European Medicines Agency said last week that it was initiating a review of the combined use of agents that block the renin-angiotensin system (RAS). The three classes of RAS-blocking drugs (ACE inhibitors, ARBs, and direct renin inhibitors) are used to treat hypertension and congestive heart failure. The EMA said that the review was being performed to…

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Another Disappointing Study For Fish Oil Supplements

Another large study has failed to find any benefits  for  fish oil supplements. The Italian Risk and Prevention Study, published in the New England Journal of Medicine, enrolled 12,513 people who had not had a myocardial infarction but had evidence of atherosclerosis or had multiple cardiovascular risk factors. The patients were randomized to either a fish oil supplement…

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FDA Warns That Tolvaptan Can Lead To Serious Liver Injury

The FDA has issued a drug safety communication concerning tolvaptan (Samsca, Otsuka), a selective vasopression V2-receptor antagonist used in heart failure patients to treat clinically significant hypervolemic and euvolemic hyponatremia. The FDA said tolvaptan “should not be used for longer than 30 days and should not be used in patients with underlying liver disease because…

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BLOCK HF: CRT Superior To Conventional Pacing In Heart Failure Patients With AV Block

  Patients with atrioventricular (AV) block generally receive right ventricular pacing; cardiac resynchronization therapy (CRT) has been restricted to patients with a low ejection fraction and a wide QRS duration. However, RV pacing may worsen LV dysfunction in AV block patients with low ejection fractions. Previous studies have raised the possibility that these patients may…

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Another Negative Trial With Darbepoetin Alfa

Once again a trial testing the erythropoiesis-stimulating agent darbepoetin alfa (Aranesp, Amgen) has produced a negative result. Results of the RED-HF (Reduction of Events by Darbepoetin Alfa in Heart Failure) trial were presented at the ACC in San Francisco and published simultaneously in the New England Journal of Medicine. A total of 2278 patients with systolic heart failure…

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Eplerenone May Help Prevent Heart Failure In Acute STEMI Patients

A new trial presented at the ACC in San Francisco suggests that the mineralocorticoid receptor antagonist eplerenone Pfizer, Inspra) may help prevent the development of heart failure when given acutely in STEMI patients without preexisting heart failure. In the REMINDER trial 1,012 STEMI patients were randomized to eplerenone or placebo. After 10.5 months of followup, the primary endpoint–…

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Study Warns Against Dual Blockade of Renin-Angiotensin System In Heart Failure And Hypertension

The enormous success of ACE inhibitors in hypertension and heart failure spurred hope that adding a second drug to block the renin-angiotensin system would yield improved outcomes. Although definitive evidence supporting dual blockade of the renin-angiotensin system has never been found, more than 200,000 patients in the US currently receive  this therapy. Now a large…

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Trials Of Niacin And Atrial Fibrillation Device Will Headline American College Of Cardiology Program

Two big trials will highlight this year’s American College of Cardiology meeting in March in San Francisco. First is the PREVAIL trial testing Boston Scientific‘s long-anticipated Watchman left atrial appendage closure device for stroke prevention in patients with atrial fibrillation. Second is  the detailed presentation of the controversial failed HPS2-THRIVE trial of extended-release niacin and laropiprant. Read my…

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