GLG News by Non-Electrophysiologist Cardiologists (US)

Ronald InnerfieldVice President of Clinical AffairsEvidence Based Medicine, Inc.

Metanalyses, Metapsychoses

September 30, 2009

Analysis of:Controls to blood sugar 'cuts stroke risk' | www.barchester.com

There have been many epidemiologic studies showing a very tight correlation between baseline A1c and cardiovascular mortalityDespite this, five major randomized prospective studies have failed to show any macrovascular benefit for tighter glucose controlThe logical conclusion is that glucose is, therefore, a marker for increased mortality but not a modifiable risk factor thereofThis is why FDA has mandated cardiovascular safety for new antidiabetic agentsData dredging persists, however

Joshua FeuerOwnerJOSHUA M FEUER

If it seems too good to be true...it probably is.

December 9, 2008

Analysis of:Generic Heart Drugs as Good as Brand-Name Counterparts | www.washingtonpost.com

This article implies that physician's have no justifiable reason for prescribing brand-name drugs. Unfortunately, it's not that simple.

Joshua FeuerOwnerJOSHUA M FEUER

“You've got to be very careful if you don't know where you are going, because you might not get there.” Yogi Berra

December 8, 2008

Analysis of:Patients Taking Lipitor Had a Significantly Reduced Risk of Cardiovascular Events Compared with Patients Taking Simvastatin, New Observational Study Shows | pharmalive.com

There is a question of bias in this study. It is not prospective, not randomized and not blinded and thus no valid conclusions can be made. The study should be ignored. It will have no impact on sales.

Dan StrejaClinical Professor of MedicineUNIVERSITY OF CALIFORNIA, LOS ANGELES

Outsourcing of compassionate use of drugs?

January 18, 2008

Analysis of: No right to experimental drugs for dying patients: Supreme Court | news.yahoo.com

The Supreme Court has rejected the use of experimental drugs by the dying patients on the grounds that "The framers (of the US constitution) understood that the pursuit of life is an inalienable right that should not be abridged without due process of law." Over the years our patients with terminal illness have traveled outside the US to purchase hope when our management was offering none. Although in the majority of cases the hope was unjustified, the current decision will encourage healthcare providers residing outside the US to advertise for their services through the internet. The issue should be addressed by the legislators sooner rather than later. Drugs who improve quality of life, awaiting approval for survival indication or drugs looking promising in early clinical trials could be made available to dying patients with informed consent addressing our limitations.  

Ramin EbrahimiDirector of Cardiac Catheterization LabWadsworth VA Medical Center

Risk Versus Benefit

November 23, 2007

Analysis of:Study Shows Weight-Loss Drug Rimonabant is Associated with Severe Adverse Psychiatric Events | pharmalive.com

The pooled analysis of Rimonabant trials point to a significant increase in psychiatric disorders. These studies also point to significant improvements in markers of cardiovascular risk. Risks versus benefits must be considered before the final decision is made on this class of medications.

Howard WeintraubClinical DirectorNEW YORK UNIVERSITY (INC)

Another piece of good news for a very good drug

November 8, 2007

Analysis of:Ranexa(R) Significantly Reduces Incidence Of CV Death, MI Or Recurrent Ischemia In MERLIN TIMI-36 Patients With Elevated BNP | www.medicalnewstoday.com

By restoring function in the late Na channel and hence improving diastolic function (amongst other things), Ranexa has worked terrifically in my patients with any evidence for diastolic dysfunction. This typically manifests with shortness of breath and can be associated with an elevated level of BNP. This has not been as successful in patients without myocardial ischemia, but in those with ischemia the shortness of breath and associated chest discomfort has been helped in many. Including the most recent patient with a severe ischemic cardiomyopathy who has responded very very well with a significant increase in his functional capacity. Hopefully this news along with the safety from MERLIN and the A1C data and reduction in arrhythmias in that study will awaken docs to the benefits of Ranexa.  

Howard WeintraubClinical DirectorNEW YORK UNIVERSITY (INC)

Even more benefit.

November 8, 2007

Analysis of:Ranexa(R) Significantly Reduces Incidence Of CV Death, MI Or Recurrent Ischemia In MERLIN TIMI-36 Patients With Elevated BNP | www.medicalnewstoday.com

The good news gets better as there is now data from MERLIN that corroborates the news from CARISA showing a reduction in HbGA1C that was significant.

Ramin EbrahimiDirector of Cardiac Catheterization LabWadsworth VA Medical Center

Good device but not much improvement.

August 31, 2007

Analysis of:St. Jude Medical Announces Japanese Approval Of The Angio-Seal STS Plus Vascular Closure Device | www.medicalnewstoday.com

The repositioning of the hole, also present with the VIP version is a mild improvement to decrease sheath manipulation. Otherwise the device has not changed much in the past few years. While a very good device in general, its primary limitaions listed below still remain. 1. not allowing re-access at the previous access site within 90 days of the index procedure  2. inability to promote means for primary healing of the arteriotomy site (primary healing results in much less scar formation and secondary healing that angioseal provides) and 3. relying on an intravascular component for deployment that stays within the vessel for weeks prior to its resolution  Newer devices such as the STARCLOSE that also are easy to deploy, rely on no intravascular components and potentially provide much better healing process may be the way of future.   

Michael DavidsonDirector, Preventive CardiologyTHE UNIVERSITY OF CHICAGO

What are the potential ramification for Avandia following the FDA Advisory Committee?

July 25, 2007

Analysis of:FDA Advisory Committee on The Cardiovascular Ischemic/thrombotic Risks of Rosiglitzone | www.ncbi.nlm.nih.gov

It appears from the breifing documents that the FDA has concerns about the CV safety of Avandia. They appear to be less concerned about the CV safety of Actos but both drugs are associated with an increase risk of heart failure. It is unknown how the Advisory Committee will vote but based on the available information there is likely to be some labeling change for Avandia (possibly a black box for more than CHF) than could put it at significant commercial disadvantage to Actos or Januvia.

Howard WeintraubClinical DirectorNEW YORK UNIVERSITY (INC)

This one may hurt.

June 15, 2007

Analysis of:FDA Advisory Committee Did Not Recommend Approval Of Rimonabant (ZIMULTI(R)) For Use In Obese And Overweight Patients With Associated Risks Factors | www.medicalnewstoday.com

It is clear that the panel felt that there was inadequate data on the psychiatric implications of rimonabant. It is a strong statement coming in the wake of the rosiglitazone mess (with strong recollections of cerivastatin and Vioxx) demonstrating that the FDA will be very finicky about approvals in the near and mid-term future. This does not bode well for Sanofi, who will not have to regroup and pray for success with son of Amiodarone.

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