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

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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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New Subcutaneous ICD Said To Pose ‘Existential Crisis’ For Older ICDs Reply

Last year the FDA approved Boston Scientific’s subcutaneous ICD, the first ICD that can defibrillate the heart without using leads threaded to the heart through the blood vessels. Those leads are the source of many sophisticated pacing features in today’s ICDs, but they are also the main source of ICD-related complications, and, in several well-publicized incidents, have forced the FDA and ICD companies to initiate recalls. Now a prominent cardiologist writes that the S-ICD poses an “existential crisis” for previous generations of ICDs.

FDA approval of the S-ICD was based on a pivotal trial designed to assess the device’s safety and effectiveness. Results of the trial have now been published in Circulation. In this nonrandomized trial, the S-ICD was successfully implanted in 314 patients out of 321 in whom the implnantation was attempted.

The S-ICD easily met the prespecified primary safety and efficacy endpoints:

Click here to read the full post on Forbes.

S-ICD+device+image_hires

Kaiser Program Yields Big Improvements In Hypertension Control Reply

A large percentage of the 65 million people with high blood pressure in the United States do not know they have hypertension or have not succeeded in controlling their hypertension. Although many programs have been proposed, there is little evidence that any method can produce long term improvement in hypertension control.

In a paper published in JAMA, researchers at Kaiser Permanente report the outcomes achieved with a large-scale multi-pronged approach to hypertension control. The program included a comprehensive hypertension registry and the development and sharing of performance metrics. Electronic medical records were used to encourage optimal treatment, while patients were offered free medical assistant follow-up visits and simplified medication regimens, including the use of single-pill combination therapy. Physicians were encouraged to use algorithms derived from evolving evidence.

Click here to read the full post on Forbes.

 

Can Inflating A Blood Pressure Cuff Improve Outcomes Following Bypass Surgery? Reply

http://www.forbes.com/sites/larryhusten/2013/08/15/can-inflating-a-blood-pressure-cuff-improve-outcomes-following-bypass-surgery/

 

For several decades cardiologists have been intrigued by the concept of ischemic preconditioning. A small body of research has consistently found that brief episodes of ischemia (in which reduced blood flow results in damage to tissue) appeared to somehow prepare the body to better handle a major episode of ischemia. Now a new study from Germany published in the Lancet holds out the promise that deliberate ischemic preconditioning prior to bypass surgery might prevent ischemic injury caused by the surgery and may even improve long-term survival. But the investigators themselves say that the results need to be confirmed in a larger study.

Click here to read the full post on Forbes.

 

Fuster To Succeed DeMaria As Editor Of JACC Reply

The American College of Cardiology has announced that Valentin Fuster will be the next editor-in-chief of the Journal of the American College of Cardiology. Fuster will succeed the current editor, Anthony DeMaria, beginning in 2014.

Click here to read the full post on Forbes.

 

Observational Study Lends Support to CRT Guidelines Reply

A large observational study published in JAMA suggests that patients with left bundle-branch block (LBBB) and longer QRS duration derive the most benefit from a cardiac resynchronization therapy defibrillator (CRT-D). The findings appear to support current, but often criticized, guidelines from the American College of Cardiology, American Heart Association, and the Heart Rhythm Society, in which a class I recommendation is restricted to patients with LBBB and QRS duration of 150 ms or greater.

Click here to read the full post on Forbes.

 

 

 

The Guidelines Are Dead. Long Live The Guidelines. Reply

Following last month’s surprising announcement that the National Heart, Lung, and Blood Institute would no longer issue guidelines, leaders of the American Heart Association and the American College of Cardiology have now announced that are “officially assuming the joint governance, management and public distribution” of the enormously influential cardiovascular prevention guidelines, including the much-delayed and much-anticipated hypertension and cholesterol guidelines (formerly known as JNC 8 and ATP IV). The ACC and AHA will also assume responsibility for guidelines on cardiovascular risk assessment, cardiovascular lifestyle interventions and obesity.

In an editorial published in Circulation and the Journal of the American College of Cardiology, leaders of the NHLBI, AHA, and ACC provide a little more information on how the new model will work. One important announcement, that “all chairs and members of the current writing panels have been invited to continue to work together with the ACC and AHA to finalize the guidelines,” might indicate that the hypertension and cholesterol guidelines could see the light of day in the not-too-far-distant future. In June the NHLBI’s Michael Lauer expressed confidence that these guidelines would appear in less than a year, but the AHA said that no timeline had yet been established.

Click here to read the full story on Forbes.

English: sm team guidelines logo

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.

 

 

 

 

A PR Pitch For The Worst Diet In The World Reply

I get all sorts of PR pitches. Most of them are uninteresting or ridiculous and I just ignore them. Here is one that is so stupifyingly wrong that I can’t resist sharing it. It should win some sort of award for combining the most amount of fraudulent claims in a single pitch. I don’t see the point of refuting all the claims here, but anyone reading this should know that there is absolutely no scientific evidence for any of it.

Hi Larry,

Always been curious about what a detox is, but never fully sure about the right way to do one? Featured on the cover of this week’s issue of Woman’s World, the Martha’s Vineyard Diet Detox, is a simple, yet effective soup and shake cleanse that is an easy-to-follow lose-a-pound-a-day regime that can help people lose 5 lbs in 2 days, to not only get thinner, but feel better!

Detoxing is not just about losing weight – it has many other benefits people are not always aware of such as helping to improve memory, ease chronic conditions such as allergies and arthritis, clear up one’s skin, as well as help people sleep throughout the night. Often referred to as the “pioneer of detoxing,” Dr. Roni DeLuz, RN, ND is the founder and director of the Martha’s Vineyard Detox Retreat and co-author of 1 Pound a Day.

We’d love for you to share Roni’s tips and information with your readers on how to detox safely, yet effectively using green, plant-based juices and soups, as well as clear up any misconceptions they may have about a cleanse, to help them get healthy and lose a few pounds, such as:

  • How to take a detox bath
  • How to use probiotics to enhance the detox process
  • The products and ingredients for one’s shopping list to get started on a detox
  • The steps to transition back to eating regular, healthy, solid food after completing a 21-day detox

Please let me know if you would like more information on 1 Pound a Day, the topics listed above, and how green, plant-based juicing can not only help you lose weight, but also help relieve chronic conditions such as arthritis and insomnia.

Thank you,

Rachel Albert

About Dr. Roni Deluz

Dr. Roni DeLuz, RN, ND, founded the Martha’s Vineyard Holistic Retreat in Vineyard Haven in 1997 to help others discover the optimal health she herself achieved after years of debilitating chronic illness. She has a PhD in natural health and a certificate as a naturopathic doctor from Clayton College of Natural Health/ American Holistic College of Nutrition. She is also a registered nurse and a colonic therapist recognized as a leading expert in the field of holistic health.

Rachel Albert

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Questions About President George W. Bush’s Stent Reply

Former President George W. Bush received a stent today at Texas Health Presbyterian Hospital. Here is the statement from Bush’s office:

During President George W. Bush’s annual physical examination at the Cooper Clinic in Dallas yesterday, a blockage was discovered in an artery in his heart. At the recommendation of his doctors, President Bush agreed to have a stent placed to open the blockage. The procedure was performed successfully this morning, without complication, at Texas Health Presbyterian Hospital. President Bush is in high spirits, eager to return home tomorrow and resume his normal schedule on Thursday. He is grateful to the skilled medical professionals who have cared for him. He thanks his family, friends, and fellow citizens for their prayers and well wishes. And he encourages us all to get our regular check-ups.

As someone who has followed the intense debate and discussion that has occurred in the cardiology community in the last few years about precisely this sort of case, I’m wondering about a number of issues raised here:

Read the full post on Forbes.

 

G.W. Bush on a bike

 

 

Deja Vu All Over Again: Study Links Calcium-Channel Blockers To Breast Cancer Reply

A new observational study raises the possibility that calcium-channel blockers (CCBs) may be associated with a higher risk for breast cancer. Although previous studies examining this relationship have failed to turn up convincing evidence of a link, the authors of a paper published in JAMA Internal Medicine state that their study is the first to look at long-term use of CCBs in a contemporary population.`

Christopher Li and colleagues analyzed data from women in the Seattle area, including 880 women with invasive ductal breast cancer, 1,027 with invasive lobular breast cancer, and 1,027 controls with no cancer. They found that women taking other antihypertensive drugs, including diuretics, beta-blockers, and angiotensin II antagonists, had no increased risk for breast cancer. But women taking CCBs had significantly elevated risk for ductal breast cancer (OR 2.4, CI 1.2-4.9, p=0.04) and lobular breast cancer (OR 2.6, CI 1.3-5.3, p=0.01). The results were consistent for different types of CCBs.

In an accompanying editorial, Patricia Coogan writes that the study “provides valid evidence supporting the hypothesis that long-term CCB use increases the risk of breast cancer.”

Click here to read the full post 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