CardioExchange Archive

April 17th, 2014

FDA Grants Fast Track Status to Ivabradine

Larry Husten, PHD

Amgen announced yesterday that its new chronic heart failure drug ivabradine had been granted fast track status by the FDA. The company said the fast track designation, which is for drugs that treat serious conditions and fill an unmet medical need, will aid the development and speed the review of the drug. The company said it planned to file […]

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April 9th, 2014

Putting TOPCAT in Perspective

Bertram Pitt, MD, Marc A. Pfeffer, MD and Clyde Yancy, MD

TOPCAT investigators Bertram Pitt and Marc Pfeffer discuss the trial, and Clyde Yancy offers his analysis.

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April 9th, 2014

TOPCAT Fails to Find Advantage for Spironolactone in HFPEF

Larry Husten, PHD

Although a significant portion of people with heart failure have preserved ejection fraction, none of the proven heart failure therapies has been shown to be beneficial in this important and growing heart failure subpopulation. Now a new NHLBI-funded study has failed to find a benefit in this group for spironolactone, which is a cornerstone of […]

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April 8th, 2014

NSAID Use Associated with Atrial Fibrillation in Older People

Use of nonsteroidal anti-inflammatory drugs (NSAIDs) in the elderly is associated with an increased risk for atrial fibrillation (AF), according to a prospective study in BMJ Open. Using a Dutch cohort designed to investigate risk factors of disease onset in the aged, researchers followed some 8400 people for 13 years. None had AF at baseline (when […]

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March 31st, 2014

Novartis Trial Was Stopped Early Because of a Significant Drop in Cardiovascular Mortality

Larry Husten, PHD

The largest-ever trial in heart failure was stopped early because of a highly statistically significant reduction in cardiovascular mortality, according to one of the trial’s two primary investigators. Earlier today I reported that the PARADIGM-HF trial testing LCZ696, a novel, first-in-class Angiotensin Receptor Neprilysin Inhibitor (ARNI), had been stopped early because the trial had demonstrated a significant reduction in the combined […]

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March 31st, 2014

Early Success for Novel Novartis Heart Failure Drug

Larry Husten, PHD

A large clinical trial testing a novel compound from Novartis for chronic heart failure has been stopped early for efficacy. In a press release Novartis said the Data Monitoring Committee had recommended early closure of the PARADIGM-HF trial because the trial had demonstrated a significant reduction in the combined primary endpoint of cardiovascular death and heart failure hospitalization. PARADIGM-HF randomized patients with heart failure […]

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March 30th, 2014

Long-Term Follow-Up from MADIT-CRT: Guideline Implications

Arthur J. Moss, MD

Arthur J. Moss discusses his research group’s study of long-term survival for patients who received cardiac resynchronization therapy with a defibrillator in the MADIT-CRT trial.

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March 30th, 2014

MADIT-CRT Long-Term Follow-Up Shows Survival Benefit with CRT-D

Larry Husten, PHD

MADIT-CRT was an influential trial that showed a reduction in heart failure complications — but not mortality — when cardiac resynchronization therapy (CRT) was added to an implantable defibrillator in patients with mild heart failure who also had left bundle-branch block (LBBB). Patients in the trial were followed for 2.4 years, raising questions about the long-term effects […]

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March 27th, 2014

FDA Advisory Panel Recommends Against Approval of Novartis Heart Failure Drug

Larry Husten, PHD

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted unanimously (11-0) against approval of the biologics license application (BLA) for serelaxin (proposed trade name, Reasanz). The novel drug from Novartis was intended to be used in patients with acute heart failure (HF). The once highly promising drug, which received a ”breakthrough therapy” designation from the FDA last year, was also turned down for approval […]

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March 25th, 2014

FDA Reviewers Recommend Against Approval for Novartis Heart Failure Drug

Larry Husten, PHD

Ahead of an important advisory panel FDA reviewers have recommended against approval of a novel drug for acute heart failure from Novartis. The once highly promising drug, which received a “breakthrough therapy” designation from the FDA last year, was turned down for approval in Europe earlier this year. On Thursday, the FDA’s Cardiovascular and Renal Drugs Advisory Committee will discuss the biologics license application (BLA) […]

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