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GLG News by BiDil Prescribers (US)

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May 19, 2008
Obvious answer - wrong question - NO IMPACT on prescribing
Analysis of: New data show Tekturna HCT® is twice as effective at reducing blood pressure than the diuretic HCT alone | www.novartis.com
Author: GLG Expert Contributor
It is well known that the addition of thiazide diuretic to ACEI or ARB treatment adds about 10 mm Hg reduction on top of the 10 mm Hg reduction provided by the ACEI or ARB agent.  It is expected that blocking renin in the renin angiotensin system with Tekturna would provide a similar result.
January 25, 2008
Questions about bleeding, proper dose and appropriate patient subsets will limit use
Analysis of: Daiichi Sankyo, Lilly Submit New Drug Application for Investigational Antiplatelet Drug, Prasugrel, with U.S. Food and Drug Administration | www.pipelinereview.com
Author: GLG Expert Contributor
TRITON-TIMI 38 study of 13,608 patients with ACS compared prasugrel against clopidogrel, combined with aspirin.  Prasugrel reduced the combined rate of CV death, MI or stroke (12.1% for clopidogrel vs. 9.9% for prasugrel). The benefit came at a cost of increased serious bleeding (1.4%, vs....
January 14, 2008
The impact on Vytorin and zetia sales will be modest reduction after the release of ENHANCE data
Analysis of: Schering releases ENHANCE data today | www.tradingmarkets.com
Author: GLG Expert Contributor
Physicians have several possible conclusions that can be taken; These include: - the trial is flawed - the selection of patients with much less CIMT than previous trials such as ASAP and ARBITER flaws the study -  the failure to meet the trial endpoint is only a surrogate and clinical trial data...
December 17, 2007
A new and significant drug for acute heart failure is now available in Canada
Analysis of: NATRECOR Authorized In Canada For Treatment Of Acute Decompensated Heart Failure | www.medicalnewstoday.com
Author: GLG Expert Contributor
This is great news for Canada.  This is the first new drug approved for the treatment of acute heart failure since 1989, when milrinone was approved.  Nesiritide was approved in the United States in 2001.  Since then, it has proven to be of great benefit in patients with acute heart failure,...
November 8, 2007
Another piece of good news for a very good drug
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
Author: Howard Weintraub, Clinical Director, NYU Medical Center
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...
November 8, 2007
Even more benefit.
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
Author: Howard Weintraub, Clinical Director, NYU Medical Center
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.
October 31, 2007
Undue Pessimism
Analysis of: Phase 2 Prasugrel Studies Suspended Prior to Release of Major Phase 3 Trial | www.medscape.com
Author: GLG Expert Contributor
The devil is in the details! Far from disappointing, the protocol ammendments (dosing) based on pharmacokinetic analysis that have been effected are both prudent and reassuring. Prasugrel dosing is likely being adjusted to reflect its metabolism in various patient populations including the elderly and...
June 15, 2007
This one may hurt.
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
Author: Howard Weintraub, Clinical Director, NYU Medical Center
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...
June 15, 2007
This one may hurt.
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
Author: Howard Weintraub, Clinical Director, NYU Medical Center
It is clear that the advisory panel is more concerned with safety in a limited population that the broader impact of obesity and its metabolic problems and acceleration of diabetes and atherosclerosis. This demonstrates the likelihood that the FDA will likely be posturing to reflect the rosiglitazone...
Joseph FranciosaMay 30, 2007
Altace plus hydrochlorothiazide – ho hum or tip of the iceberg?
Analysis of: King Pharmaceuticals Reports Efficacy of Altace 20mg And Efficacy of a Combination of Altace 20mg And Hydrochlorothiazide 25mg For 24-hour Blood Pressure Control | pharmalive.com
Author: Joseph Franciosa, Owner, Joseph A. Franciosa, MD, Consultant
Implications: • The clinical trial experience with combination Altace plus hydrochlorothiazide (HCT) indicates safety and efficacy satisfactory for FDA approval. • The combination of ACE inhibitor and thiazide is old and ho-hum, and not as novel as newer combinations like Exforge (Novartis)....

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