FDA Grants Fast Track Status To Amgen Heart Failure Drug Reply

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 umet medical need, will aid the development and speed the review of the drug.

Click here to read the full post on Forbes.

 

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Troubled NHLBI TOPCAT Trial Disappoints Reply

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 therapy for heart failure patients with reduced ejection fraction. But trial investigators and heart failure experts believe it is too early to dismiss hope that spironolactone and other aldosterone antagonists– including Pfizer’s Inspra (eplerenone)– may eventually be found to work in this population.

TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist), published in the New England Journal of Medicine, randomized 3,445 patients with heart failure with preserved ejection fraction (HFPEF) to either spironolactone or placebo.

Click here to read the full post on Forbes.

 

A New Novartis Heart Failure Drug Might Be A Blockbuster Reply

I try to avoid using words like “blockbuster” and “breakthrough” when writing about new drugs and treatments. I’ve been disappointed too many times. But, though they’ve been in short supply lately in cardiovascular medicine, sometimes there really are breakthroughs and blockbusters. In my career writing about cardiovascular medicine I’ve seen the introduction of the ACE inhibitors, statins, stents, ICDs, and clopidogrel, among others. All of these became multibillion-dollar products. Now there’s a new candidate that just might join this group. I’ll tell you why, but I can’t emphasize strongly enough that right now we only have extremely preliminary information. So be warned. And don’t be completely surprised if it does bomb out. We’ve been down this road before.

As I reported previously (here and here), early on Monday Novartis disclosed that the PARADIGM-HF trial testing LCZ696, a novel, first-in-class Angiotensin Receptor Neprilysin Inhibitor (ARNI), had been stopped early. As I later found out, the news was even better than Novartis had said in its press release. I spoke with the co-principal investigator of the trial, Milton Packer, who told me that the trial had been stopped because of a highly statistically significant reduction in cardiovascular mortality in patients taking LCZ696 instead of the current gold standard of treatment, an ACE inhibitor. Marc Pfeffer, a cardiologist at the Brigham and Women’s Hospital with long experience in heart failure, told me that he interprets “the stopping of a major clinical outcome trial for effectiveness by an experienced DSMB [Data and Safety Monitoring Board] as indicating that the final results will be both definitive and important.”

The first thing to know is that a reduction in cardiovascular mortality is a really big deal….

Click here to read the full post on Forbes.

 

 

Novartis Trial Was Stopped Early Because Of A Significant Drop In Cardiovascular Mortality 1

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 primary endpoint of cardiovascular death and heart failure hospitalization. This information was taken from a Novartis press release.

But it turns out that the press release wasn’t entirely accurate. For once, a company appears to have actually downplayed a positive finding in its trial….

Click here to read the full post on Forbes.

English: Mohawk Stop Sign

English: Mohawk Stop Sign (Photo credit: Wikipedia)

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

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 of CRT. Now, a second look at 854 patients who participated in a follow-up study, presented at the American College of Cardiology and published in the New England Journal of Medicine, suggests that over the long term, CRT may save lives in this population. MADIT-CRT was sponsored by Boston Scientific.

Click here to read the full post on Forbes.

 

 

 

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

FDA Advisory Panel Recommends Against Approval Of Novartis Heart Failure Drug Reply

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. The once highly-promising drug, which received a ”breakthrough therapy” designation from the FDA last year, was also turned down for approval in Europe earlier this year.

Click here to read the entire post on Forbes.

 

 

FDA Reviewers Recommend Against Approval For Novartis Heart Failure Drug 1

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) for serelaxin injection (proposed trade name Reasanz) from Novartis.

Click here to read the full post on Forbes.

 

 

Phase 4 Actelion Study Misses Primary Endpoint Reply

Actelion announced today that a phase 4 study with its blockbuster drug bosentan (Tracleer) had failed to meet its primary endpoint.

The COMPASS-2 trial was a prospective, randomized, double-blind, placebo-controlled trial evaluating the effect of bosentan on the time to first confirmed event in patients with symptomatic pulmonary arterial hypertension (PAH) already receiving treatment with sildenafil.

Click here to read the full post on Forbes.

 

4 Deaths Linked To Thoratec Heart System Reply

Thoratec Corporation today issued an urgent safety advisory about a serious problem with a key component of the HeartMate II LVAS system. The company said 4 patients had died and 5 patients had a loss of consciousness or other symptoms of hypoperfusion. The episodes occurred when patients and caregivers “experienced difficulties with the process of changing from a primary system controller to their backup system controller.”

The company said that 8 of the 9 events “occurred in patients who were converted to the Pocket Controller after being originally trained on an older model, the EPC System Controller….

Click here to read the full post on Forbes.

 

HeartMate II

 

 

FDA Investigating Heart Failure Risk Linked To Onglyza Reply

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 than 16,000 type 2 diabetics were randomized to the DPP-4 inhibitor saxagliptin or placebo.

Click here to read the full post on Forbes.

 

 

 

 

European Setback For Novartis Heart Failure Drug Reply

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 was published in the Lancet in 2012. Here is CHMP’s explanation for their decision:

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FDA Advisory Panel To Review New Heart Failure Drug From Novartis Reply

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 symptoms of acute heart failure through reduction of the rate of worsening of heart failure. (The meeting notice has been posted in the Federal Register but has not yet appeared on the FDA website.) Last year the drug received a “breakthrough therapy” designation from the FDA.

Click here to read the full post on Forbes.

 

Cardiology in 2013: Like A Wrecking Ball 1

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 cholesterol and hypertension guidelines. Then the new ACC/AHA guidelines came along, abandoning tradition and targets and adopting a whole new approach. But the controversy didn’t go away. One easy prediction for 2014: we’ll see more debate about guidelines.

Click here to read the full post on Forbes.

Wrecking Ball

The New Guidelines

Miley Cyrus- Note: Cropped from larger image

The Old Guidelines

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

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 company believes may predict a positive response to the drug. And the trial will be one of the first to utilize the much-discussed “adaptive” trial design, starting as a phase 2B study and then possibly expanding to a phase 3 study after an interim analysis of the trial data.

But if GENETIC-AF represents the very model of a modern drug, it also serves as a good example of the pitfalls of drug development. Because this drug has been around for a very long time and has had a very troubled history.

Click here to read the full story on Forbes.

 

Michael Bristow, Arca Biopharma President and CEO

 

No Support For Broad Screening Of Chronic Kidney Disease 1

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 do not have symptoms and are generally diagnosed with labarotory tests or imaging. People who progress to advanced kidney disease are at greatly increased risk for dialysis, end-stage renal disease, and death.

The authors of “Screening, Monitoring, and Treatment of Stage 1-3 Chronic Kidney Disease” discuss the paucity of evidence in the field and highlight the absence of randomized, controlled trials evaluating the risks and benefits of screening for CKD or evaluating the sensitivity and specificity of screening tests.

Click here to read the full post on Forbes.

 

 

CardioMEMS Heart Failure Device Gets Mixed Reception From FDA Advisory Panel Reply

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 the device had not been shown to be effective, and 6-4 that the benefits did not outweigh the risks. Now, two years, later, the vote wasn’t much different: the panel agreed unanimously (11-0) that the device was safe; 7-4 that it had not been shown  to be effective, and 6-4-1 that the benefits outweighed the risks.

Click here to read the full story on Forbes.

 

CardioMEMS wireless sensor with quarter

 

Study Raises Questions About Digoxin Use Today Reply

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 publication of the DIG trial in 1997. The trial found that digitalis reduced hospitalization for heart failure but did not have an impact on mortality. On the basis of the trial digitalis received recommendations in the US and European guidelines for use in patients with systolic heart failure who remain symptomatic despite optimal therapy. However, the epidemiology and treatment of heart failure have evolved considerably since then. Now the authors of a new study, supported by an accompanying editorial, say that these recommendations need to be reconsidered.

In a study published in Circulation: Cardiovascular Quality and Outcomes, James Freeman and colleagues followed 2,891 patients with newly diagnosed systolic heart failure, 18% of whom received digitalis. After 2.5 years the digoxin users had a higher rate of death and hospitalization for heart failure…

Click here to read the full post on Forbes.

 

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

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 simultaneously in the New England Journal of Medicine, once again has failed to find benefits for CRT in a broader patient population.

The EchoCRT Study Group randomized HF patients with a QRS duration < 130 msec and left ventricular dyssnchrony upon echocardiography. All patients received a CRT-D device; half the patients were randomized to have the CRT feature activated.

The study was stopped prematurely after 809 patients had been randomized and followed for nearly 20 months.

Click here to read the full story on Forbes.

Automatic Wireless Monitoring Shows Benefits in Chronic Heart Failure Reply

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 the trial, said that In-Time was designed to test whether automatic remote home monitoring can detect events that precede clinical events and thereby spark interventions to help reduce hospitalizations for HF. In the trial, 664 chronic HF patients with an indication for an ICD were randomized to home monitoring plus standard care or standard care alone.

Click here to read the full story on Forbes.

 

 

 

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

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 Receptor Antagonist in Pulmonary Arterial Hypertension to Improve Clinical Outcome), have now been published in the New England Journal of Medicine.

In the trial, 742 patients with PAH were randomized to one of three groups: a daily dose of 3 mg of macitentan, a daily dose of 10 mg of macitentan, or placebo. The primary endpoint (the time to the first occurrence of a composite endpoint of death, atrial septostomy, lung transplantation, initiation of treatment with intravenous or subcutaneous prostanoids, or worsening of pulmonary arterial hypertension) was significantly reduced in the two treatment arms:

Click here to read the full post on Forbes.

Actelion

American Heart Association Announces Late-Breaking Clinical Trials Reply

AHA 2013 logoThere 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 – 5:19 PM

Moderators:

  • Lance Becker, Philadelphia, PA
  • Stephen Bernard, Melbourne, Australia

4:00 PM: Nitrites in Acute Myocardial Infarction

  • Nishat Siddiqi, Univ of Aberdeen, Aberdeen, United Kingdom
  • Discussant: Kenneth Bloch, Boston, MA

4:13 PM: Blood Pressure Reduction Among Acute Ischemic Stroke Patients: A Randomized Controlled Clinical Trial

  • Jiang He, Tulane Univ, New Orleans, LA
  • Discussant: Cathy A Sila, Cleveland, OH

4:35 PM: Randomized Clinical Trial of Pre-hospital Induction of Mild Hypothermia in Out-of-Hospital Cardiac Arrest Patients Using a Rapid Infusion of 4oC Normal Saline

  • Francis Kim, Univ of Washington, Seattle, WA
  •  Discussant: Maaret Castrén, Stockholm, Sweden

4:57 PM: Target Temperature Management 33°C versus 36°C after Out-of-hospital Cardiac Arrest, a Randomized, Parallel Group, Assessor Blinded Clinical Trial

  • Niklas Nielsen, Helsingborg Hosp, Lund Univ, Helsingborg, Sweden
  •  Discussant: Benjamin S Abella, Philadelphia, PA

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Late-Breaking Clinical Trials 2: Prevention: From Schools to Countries

  • Monday, Nov 18, 2013, 9:00 AM -10:28 AM

Moderators:

  • Donna K Arnett, Birmingham, AL
  • Lynne Braun, Chicago, IL

9:00 AM: Promotion of Cardiovascular Health in Preschool Children: 36-month Cohort Follow-up

  • Jaime Céspedes, Fundación CardioInfantil Insto de Cardiología, Bogotá, Colombia
  • Discussant: Gerard R Martin, Washington, DC

9:22 AM: Randomized Trial of Social Network Lifestyle Intervention for Obesity: MICROCLINIC Intervention Results and 16-Month Followup

  • Eric L Ding, Harvard Sch of Public Health, Boston, MA
  • Discussant: Lawrence J Appel, Baltimore, MD

9:44 AM:  Multifaceted Intervention to Improve Medication Adherence and Secondary Prevention Measures (Medication Study) After Acute Coronary Syndrome Hospital Discharge

Michael Ho, VA Eastern Colorado Health Care System, Denver, CO

Discussant: Nancy Albert, Cleveland, OH

10:06 AM: China Rural Health Initiative – Sodium Reduction Study: the Effects of a Community-Based Sodium Reduction Program on 24hr Urinary Sodium and Blood Pressure in Rural China

  • Nicole Li, The George Inst for Global Health, Sydney, Australia

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Late-Breaking Clinical Trials 3: Medical and Surgical Approaches to Improving Heart Failure Outcomes

  • Monday, Nov 18, 2013, 10:45 AM -12:13 PM

Moderators:

  • Frederick A Masoudi, Aurora, CO
  • Adrian F Hernandez, Durham, NC

10:45 AM: Atrial Antitachycardia Pacing and Managed Ventricular Pacing Reduce the Endpoint Composed by Death, Cardiovascular Hospitalizations and Permanent Atrial Fibrillation Compared to Conventional Dual Chamber Pacing in Bradycardia Patients: Results of the Minerva Randomized Study

  • Giuseppe Boriani, Univ of Bologna, Policlinico S.Orsola-Malpighi, Bologna, Bologna, Italy
  • Discussant: Anthony Tang, Victoria, BC, Canada

11:07 AM: Renal Optimization Strategies Evaluation in Acute Heart Failure (ROSE AHF) Trial

  • Horng H Chen, MAYO Clinic, Rochester, MN
  • Discussant: Marco Metra, Brescia, Italy

11:29 AM: Severe Ischemic Mitral Regurgitation: Is it Better to Repair or Replace the Valve?

  • Michael A Acker, Hosp of the Univ of Pennsylvania, Philadelphia, PA
  • Discussant: Timothy J Gardner, Newark, DE

11:51 AM: Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT)

  • Marc A. Pfeffer, Brigham & Women’s Hosp, Harvard, Boston, MA
  • Discussant: Margaret M Redfield, Rochester, MN

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Late-Breaking Clinical Trials 4: Therapeutic Advances in Coronary and Peripheral Vascular Disease.

  • Monday, Nov 18, 2013, 3:45 PM – 5:13 PM

Moderators:

  • John G Harold, Washington, DC
  • Mark A Creager, Boston, MA

3:45 PM: One Year Mortality in STEMI Patients Randomized to Primary PCI or a Pharmaco-invasive Strategy. The Stream 1 Year Follow-up

  • Peter Sinnaeve, Univ of Leuven, Leuven, Belgium
  • Discussant: Harold Dauerman, Burlington, VT

4:07 PM: Secretory Phospholipase A2 Inhibition with Varespladib and Cardiovascular Events in Patients with an Acute Coronary Syndrome: Results of the VISTA-16 Study

  • Stephen Nicholls, South Australian Health and Medical Res Inst, Adelaide, Australia
  • Discussant: Philippe Gabriel Steg, Paris, France

4:29 PM: Randomized Comparison of Endovascular Revascularization Plus Supervised Exercise Therapy Versus Supervised Exercise Therapy Only in Patients With Peripheral Artery Disease and Intermittent Claudication: Results of the Endovascular Revascularization and Supervised Exercise (ERASE) Trial

  • Farzin Fakhry, Erasmus MC, Rotterdam, Netherlands
  • Discussant: Mary McDermott, Chicago, IL

4:51 PM: A Randomized Multicenter Clinical Trial of Renal Artery Stenting in Preventing Cardiovascular and Renal Events: Results of the CORAL Study

  • Christopher J Cooper, Univ of Toledo, Toledo, OH
  • Discussant: Thomas Zeller, Bad Krozingen, Germany
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Late-Breaking Clinical Trials 5: New Strategies for Atrial Fibrillation Patients: Rhythm and Thrombosis

  • Tuesday, Nov 19, 2013, 10:45 AM -12:03 PM

Moderators:

  • Augustus O Grant, Durham, NC
  • Keith A Fox, Edinburgh, United Kingdom

10:45 AM: RADAR-AF Trial. A Randomized Multicenter Comparison of Radiofrequency Catheter Ablation of Drivers versus Circumferential Pulmonary Vein Isolation in Patients with Atrial Fibrillation

  • Felipe Atienza, Hosp Gregorio Maranon, Madrid, Spain
  • Discussant: Mark Link, Boston, MA

11:07 AM: A Randomized Trial Comparing Genotype-Guided Dosing of Warfarin to Standard Dosing: The EU Pharmacogenetics of Anticoagulant Therapy (EU-PACT) Warfarin Study

  • Munir Pirmohamed, Univ of Liverpool, Liverpool, United Kingdom

11:17 AM: The Clarification of Optimal Anticoagulation through Genetics (COAG) Trial

  • Stephen E. Kimmel, Univ PA Sch of Med, Philadelphia, PA

11:27 AM: Discussant of EU-PACT Warfarin Study and COAG Trial: Patrick T. Ellinor, Boston, MA

11:41 AM: ENGAGE AF-TIMI 48 Primary Results

  • Robert P Giugliano, Brigham and Women’s Hosp, Boston, MA
  • Discussant: Elaine Hylek, Boston, MA

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FDA Panel Recommends Approval For Pulmonary Hypertension Drug From Bayer Reply

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.

 

 

 

 

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

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 issue of the delay or complete absence of publication of many clinical trials.

An accompanying editorial, by Marc Pfeffer and Hicham Skali, is highly critical of the delay:

Although standards for conduct and reporting of clinical trials have improved since 2000, the failure to fully vet the results of a clinical trial of human volunteers in a peer-reviewed journal was and remains unacceptable.

PRAISE-2 had its origins in the first PRAISE trial, which was first presented in 1995 and subsequently published in the New England Journal of Medicine in 1996. In that trial there was no difference between amlodipine (Norvasc, Pfizer) and placebo in the rate of mortality or cardiovascular hospitalization in patients with heart failure. However, a prespecified subgroup analysis turned up the highly surprising result that heart failure patients with a nonischemic etiology who received amlodipine had a highly significant 46% reduction in the risk of death compared with placebo patients.

Click here to read the full post on Forbes.

Milton Packer

Milton Packer

Novel Pulmonary Hypertension Drug From Bayer Shows Modest Promise In Phase 3 Trials 1

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 of riociguat in 262 patients with chronic thromboembolic pulmonary hypertension; PATENT-1 studied the the drug in 443 patients with pulmonary arterial hypertension.

Click here to read the full story on Forbes, including a comment from pulmonary hypertension expert John Ryan.

 

Ball-and-stick model of the riociguat molecule...

 

Novel Heart Failure Drug From Novartis Gains ‘Breakthrough Therapy’ Designation From FDA 1

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 drug may have substantial improvement on at least one clinically significant endpoint over available therapy.” In addition to getting a speedier review process, the sponsor of a drug with the designation receives “more intensive FDA guidance” on the development program.

Click here to read the full story on Forbes.