July 25th, 2013
Novel Pulmonary Hypertension Drug Shows Modest Promise in Phase 3 Trials
Larry Husten, PHD
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 […]
July 25th, 2013
The Changing Landscape of Pulmonary Hypertension
John Ryan, MD
Two multicenter clinical trials published in the New England Journal of Medicine explore the role of a new oral pulmonary vasodilator in pulmonary hypertension.
July 18th, 2013
BNP-Based Screening + Collaborative Care to Prevent Heart Failure?
John Ryan, MD and Kenneth McDonald, MD
Kenneth McDonald discusses findings from the STOP-HF randomized trial of BNP-based screening versus usual primary care for preventing new-onset heart failure.
June 27th, 2013
Novel Heart Failure Drug from Novartis Gains ‘Breakthrough Therapy’ Designation from FDA
Larry Husten, PHD
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 […]
May 28th, 2013
Interpretations Differ Over Study of Coenzyme Q10 in Heart Failure
Larry Husten, PHD
Coenzyme Q10 (CoQ10) may be beneficial in heart failure (HF), 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. A possible role for CoQ10 in the treatment of HF has long been proposed. A recent […]
May 20th, 2013
Similar Cardiovascular Risk Observed with COPD Drugs
Larry Husten, PHD
A large observational study has found no difference in the increased risk for cardiovascular disease between the two main classes of drugs used in the first-line treatment of chronic obstructive pulmonary disease (COPD). LABAs (long-acting inhaled beta-agonists) and LAMAs (long-acting muscarinic antagonists) have a variety of beneficial effects in COPD patients, but evidence has been […]
May 1st, 2013
FDA Warns That Tolvaptan Can Lead to Serious Liver Injury
Larry Husten, PHD
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 […]
April 26th, 2013
Conflicting Results from Two Trials of Cardiac Resynchronization Therapy
Larry Husten, PHD
Two new trials have ended up reporting conflicting results regarding the expansion of the indication for cardiac resynchronization therapy (CRT) for patients without a wide QRS interval. The positive results of the smaller trial seem likely to be undermined by the early stopping of the much larger trial. The first trial, NARROW-CRT, published in Circulation: Arrhythmia […]
April 24th, 2013
BLOCK HF: CRT Superior to Conventional Pacing in Heart Failure Patients with AV Block
Larry Husten, PHD
Patients with atrioventricular (AV) block generally receive right ventricular (RV) 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 […]
April 11th, 2013
Treatment of Heart Failure with Preserved Ejection Fraction: Why Have All the Clinical Trials Failed, and What Can We Do About It?
Sanjiv Shah, MD and John Ryan, MD
Laying out a road map for better trials and ultimately better outcomes for this confounding condition