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Putting TOPCAT in Perspective (9 Apr 2014)

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

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

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TOPCAT Fails to Find Advantage for Spironolactone in HFPEF (9 Apr 2014)

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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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NSAID Use Associated with Atrial Fibrillation in Older People (8 Apr 2014)

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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…

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Novartis Trial Was Stopped Early Because of a Significant Drop in Cardiovascular Mortality (31 Mar 2014)

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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…

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Early Success for Novel Novartis Heart Failure Drug (31 Mar 2014)

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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…

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Long-Term Follow-Up from MADIT-CRT: Guideline Implications (30 Mar 2014)

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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.

Avatar of Larry Husten, PHD

MADIT-CRT Long-Term Follow-Up Shows Survival Benefit with CRT-D (30 Mar 2014)

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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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FDA Advisory Panel Recommends Against Approval of Novartis Heart Failure Drug (27 Mar 2014)

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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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FDA Reviewers Recommend Against Approval for Novartis Heart Failure Drug (25 Mar 2014)

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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…

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ACC.14 Preview: Renal Denervation, TAVR Comparisons, and More (24 Mar 2014)

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The ACC begins this Saturday in Washington, DC. Here’s a preview of some of the most highly anticipated late-breaking clinical trials: On Saturday morning at the opening session the world will finally learn more about the failure of Symplicity HTN-3, the Medtronic trial of renal denervation. Until recently, renal denervation was thought to be an…

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