The Expertise Imperative and Compliance Technology
Access to a diverse array of specialized expert inputs drives superior decisions in every organizational context: within corporations, by investors and consultancies, and within nonprofits. When decision makers are confident of their decision inputs, they can respond more quickly and creatively to challenges and opportunities.Learn more about GLG's Compliance Framework
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The Endeavour stent appears to have a higher restenosis rate than currently marketed Drug Eluting Stents without the improved safety profile claimed by the company. This finding is at odds with the companies marketing message to cardiologists. These studies, along with the introduction of...
Mechanical thrombectomy of the coronary arteries has becoming increasingly more common with the advent of simpler aspiration catheters. Although its use in the setting of acute myocardial infarction is even more common, it is not routine. Randomized data indicating its effect on clinical...
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.
Statin therapy in lower risk populations will not have as profound an effect as in high risk subsets but still very likely has overall positive benefits.
Bariatric surgery is a major operative procedure that caries significant morbidity and mortality risks due to the comorbid diseases seen in this patient population.
This procedure is increasing in frequency as more patients are willing to have it and more surgeons are becoming proficient.
The...
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....
The reality that the actual details of the ENHANCE have not been circulated and that alternate explanations or caveats may be raised is probably unimportant. The bottom line carries the day and the bottom line is that the trial's title, ENHANCE, was not achieved by the addition of VYTORIN when...
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...
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.
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...