Logical Fallacies in Defense of the PARADIGM - HF Trial of Valsartan - Sacubitril, Suppsedly the "Game Changer" for Heart Failure
We frequently discuss how commercial sponsors manipulate clinical research to serve their interests. There have been many cases of commercially sponsored controlled trials ostensibly designed to assess their sponsors' products manipulated to make these products look better.Unfortunately, often such manipulation seems to escape public notice. What skepticism they may generate often gets little notice, an example of the anechoic effect. Very rarely do the people responsible for the trial deign to address skeptical criticism. However, we recently noted that cogent criticism of a very recently published ...
Source: Health Care Renewal - September 5, 2014 Category: Health Management Tags: anechoic effect conflicts of interest logical fallacies manipulating clinical research Novartis sacubitril Source Type: blogs
Sacubitril - Valsartan, a "New Threshold of Hope" or Hype for Heart Failure?
Summer must be over, because the next new blockbuster drug appears to be here. At the end of August, the media heralded the results of a study of a new product for congestive heart failure (CHF) from Novartis.Novartis' New "Game Changer" The New York Times article was fairly restrained, simply saying ithas shown a striking efficacy in prolonging the lives of people with heart failureThe Reuters article's headline saidNew Novartis drug may upend heart failure treatmentIn Forbes, Matthew Herper called it aGame ChangerThe accompanying editorial in the New England Journal of Medicine (1) suggested the drugmay well repres...
Source: Health Care Renewal - September 3, 2014 Category: Health Management Tags: CHF clinical trials evidence-based medicine manipulating clinical research Novartis sacubitril Source Type: blogs
ACE Inhibitors and anemia
: Angiotensin converting enzyme (ACE) inhibitors have been implicated in the worsening of anemia in patients with chronic kidney disease (CKD) on dialysis and renal transplant recipients. Both ACE inhibitors and angiotensin receptor blockers (ARB) have some effect on erythropoietin synthesis and can cause suppression of erythropoiesis in those with CKD. This can sometimes be overcome by escalating the dose of exogenously administered erythropoietin. It is known that activation of renin-angiotensin system enhances the production of erythropoietin in peritubular fibroblasts of the kidney. Some studies also suggest that ACE i...
Source: Cardiophile MD - August 23, 2014 Category: Cardiology Authors: Prof. Dr. Johnson Francis MD, DM, FACC, FRCP Edin, FRCP London Tags: General Cardiology Source Type: blogs
A New Novartis Heart Failure Drug Might Be A Blockbuster
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 c...
Source: CardioBrief - April 1, 2014 Category: Cardiology Authors: Larry Husten Tags: Heart Failure People, Places & Events Policy & Ethics ACE inhibitors Angiotensin Receptor Neprilysin Inhibitor enalapril LCZ696 Novartis Source Type: blogs
Early Success For Novel Novartis Heart Failure Drug
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 and reduced left ventricular ejection fraction to either the ACE inhibitor enalapril or LCZ696, an Angiotensin Receptor Neprilysin Inhibitor (ARNI) that is the first in its class. ̷...
Source: CardioBrief - March 31, 2014 Category: Cardiology Authors: Larry Husten Tags: Uncategorized Angiotensin Receptor Neprilysin Inhibitor clinical trials heart failure Novartis Source Type: blogs
Drug for dilutional hyponatremia
Drug useful in management of dilutional hyponatremia:
a) Tolvaptan
b) Enalapril
c) Omapatrilat
d) Ambrisentan
Correct Answer: a) Tolvaptan
Tolvaptan is a vasopressin antagonist useful in the management of dilutional hyponatremia. It should not be used in hypovolemic hyponatremia. It is orally active and a selective V2 antagonist. Tolvaptan is an aquaretic causing free water excretion without loss of electrolytes.
Schrier RW. Tolvaptan, a Selective Oral Vasopressin V2-Receptor Antagonist, for Hyponatremia. N Engl J Med 2006; 355:2099-2112 (Source: Cardiophile MD)
Source: Cardiophile MD - July 22, 2013 Category: Cardiology Authors: Prof. Dr. Johnson Francis MD, DM, FACC, FRCP Edin, FRCP London Tags: Cardiology MCQ DM / DNB Cardiology Entrance Source Type: blogs
Cardiology MCQ Test 6
Cardiology MCQ Online 6
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Source: Cardiophile MD - July 16, 2013 Category: Cardiology Authors: Prof. Dr. Johnson Francis MD, DM, FACC, FRCP Edin Tags: Cardiology MCQ DM / DNB Cardiology Entrance Source Type: blogs
Congestive Heart Failure
Pathophysiology of Congestive Heart Failure
Congestive heart failure is:
1) inability of heart to deliver sufficient cardiac output to meet physiologic needs
2) both diastolic and systolic phases are abnormal
3) initially, compensatory mechanisms occur(increased catecholamines, increased atrial natriuretic factor, myocardial hypertrophy), but eventual failure of these ensues causing congestive heart failure
4) result is increase in venous pressure with congestion of liver, spleen, and kidney (“backward failure”) and sodium retention, peripheral edema, and pulmonary sequelae (“forward” failure”...
Source: Inside Surgery - March 20, 2013 Category: Surgeons Authors: Editor Tags: Cardiology backward failure enlarged heart foward failure myocardial hypertrophy nutmeg liver peripheral edema Source Type: blogs
FDA: Enrichment Strategies to Improve Efficiency of Drug Development
Conclusion
Temple noted that there are some issues with predictive enrichment. One is that you always believe the characteristic you use to enrich predicts the good responders; it may not do this as well as you hope. So it’s very important to characterize the test that leads you to select those patients; then see whether it’s true that patients with the characteristic always (or most of the time) respond, and that patients without the characteristic don’t respond very much.
An issue to consider in any enrichment design is how much you need to study the people who don’t have the enrichment characteristic...
Source: Policy and Medicine - February 12, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
