Dr. Carlos Dujovne MD

GLG News by Dr. Carlos Dujovne MD, Affiliate Professor of Medicine

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Crestor's results in the Jupiter Study likely to change medical-economic perspectives in statin choices.

November 13, 2008

Analysis of:CRESTOR Demonstrates Dramatic CV Risk Reduction in a Large Statin Outcomes Study | www.astrazeneca.com

1:Crestor is the most potent statin in the market,yet is 3d in sales behind Zocor and Lipitor.2:The efficacy supriority together with its capacity to lower CRP levels led to the highest rate of ASCVD prevention in the shortest period of time evr documented in statin trials.3:The trial in near 18,000 patients with otherwise lower risk of ASCVD offered $0% reduction y many ascvd endpoints.4:There were no statistical differences in side effect compared to placebo.5:The dosage was 20 mg /day (an intermediate dose below the approved max dose of 40 mg/day

Mutiple causes for no publications of many reports on FDA approved drugs.Some problems and solutions.

September 29, 2008

Analysis of:Many Trial Reports on FDA-Approved Drugs Go Unpublished | www.washingtonpost.com

This article is not news for clinical researchers like myself that have performed hundreds of clinical trials in collaboration with the Pharmaceutical Industry. Some of the most common reasons for that are: A)Negative studies are difficult to get published.B)Negative results for the dug of the sponsor company are of potentially damaging financial  for the sponsor.C)There is no FDA regulation that prohibits a sponsor to deny access to data and freedom of publication to Investigators of the trial not employed by them. Some of the possible solutions for these problems are:A)Complete freedom of access and publication of data by investigators.B)Sponsors of studies be obligated to submit result regardless of outcome,to FDA.C)Studies shall be easily searchable in a Google style manner at  FDA files,by naming a company ,a drug ,a condition,etc,etc.

Exenatide may provide practical and cost convenient efficacy in tratment of Metabolic Syndrome patients

June 23, 2008

Analysis of:After One Year, Type 2 Diabetes Patients Taking Exenatide Once Weekly Sustained Improvements in Glycemic Control and Weight; DURATION-1 Presented at ADA 2008 | newsroom.lilly.com

More than 50% of patients have the 3 ccomponents to qualify for diagnosis of Metabolic Syndrome.Twwo of the components,Diabetes and Obesity are present in 20-25% of them and are difficult to control.Exenatide seems to provide that benefit.

China is the largest exporter of drugs or drug's ingredients and FDA does not have resources to check the quality of the majority of the imported as well as the USA produced generic drugs.

February 19, 2008

Analysis of:China Plant Played Role | online.wsj.com

1:Most of our legislators are forcefully endorsing generic drug usage and importing cheaper drugs.2:As a physician specialist in Clinical Pharmacologist I am fully aware or the safety and efficacy pitfalls of poorly manufactured  drugs and have done clinical research documenting the risks of patients treated with them.3:For that reason I strongly advised my patients to buy branded drugs by reputable Pharmaceutical Companies who have much to loose if found to manufacture poorly made drugs.

Dying patient denied access to experimental drugs is contrary to common sense and discovery of new treatments.

January 23, 2008

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

One, twenty years ago I was the chairman of the government affairs committee of the American Society for Clinical Pharmacology and Therapeutics; under that role my committee was successful lobbying for approval new investigational drugs for possible treatment of AIDS. We were successful in getting the FDA to approve the testing of those drugs to dying AIDS patients. Such approval led to the discovery and successful drugs we have available today for the treatment of AIDS. Two, This scenario can be easily applied to patients that are dying from any other incurable diseases where drugs that have the potential for serious toxicity cannot be ethically tested in human volunteers or patients with the same disease but not yet at a terminal stage.

Merck Developement of Anacetrapib not as Risky as it may appear!

January 17, 2008

Analysis of:Merck & Co.: Engaging in Risky Business? | www.pharmaweek.com

My expertise in the clinical research of Torcetrapib and reports presented at the latest American College of Cardiology meetings made me conclude that the failure of  Torcetrapib in rendering clinical benefits were related to intrinsic problems of the drug which effected the nature of the HDL which levels in blood were extraordinarily elevated.     Other CETP inhibitors may eventually be proven save and effective and be approved by the FDA.

Merck Developement of Taranabant not as Risky as it may appear!

January 17, 2008

Analysis of:Merck & Co.: Engaging in Risky Business? | www.pharmaweek.com

Those like myself who have more extensive knowledge on the rational used by the FDA to reject the approval of Rimonabant and know the differences between Rimonabant and Taranabant do not believe that there is an error in judgment by Merck in developing their new cannabinoid receptor antagonist. This approach to control obesity is one of the most promising available today.

Liraglutide benefis in obesity not as greater as authors claim when compared to Orlistat

November 26, 2007

Analysis of:New Phase 2 Study Shows That Liraglutide Leads to Significant Weight Loss in Obese People | pharmalive.com

As past Principal Investigator in most clinical trials wit Orlistat I can offer a different interpretations of tthe resuls of the comparayive study just announced,as follows.1.The result on diabetes or glucose regulation were earlier with Liraglutide,possibly because it has specific antidiabetic(besides weight loss)effects.Howeber the overall benefit was not greater than that 0f Orlistat at 1 and 2 years.

Potential Benefit of Rimonabant on Fatty Liver.

March 22, 2007

Analysis of:Endocannabinoids as novel mediators of liver diseases. | www.ncbi.nlm.nih.gov

1.)  Excessive accumulation of fat in the liver is a common occurrence in obesity and obesity comorbidities, such as diabetes and dyslipidemia. 

2.) There has been no useful therapeutic intervention to remove fat from excessive deposits in the liver of these patients. 

3.) Excessive fat accumulation can lead to chronic liver disease.

Potential Additional Benefit from Rimonabant (Acomplia) Treatment

March 22, 2007

Analysis of:A therapeutic role for cannabinoid CB1 receptor antagonists in major depressive disorders. | www.ncbi.nlm.nih.gov

1.) Depression is very common among the obese population.

2.) Suppressors of cannabinoid receptors are suspect of causing depression because of the euphoric effect of cannibinoids.

3.) Rimonabant when tested in thousands of patients, in comparison to placebo caused a very small statistically insignificantly larger incidence of depression.

4.) There is a concern about whether that could be an undesirable side effect from treatment with this agent.

Drugs Effects on HDL Cholesterol Levels and Regression of Coronary Atherosclerosis

February 12, 2007

Analysis of:Effect of very high-intensity Statin therapy on regression of Coronary Atherosclerosis.Nissen S.E. etal | www.jama.com

1.This study's results are the first clinical confirmation of the benefits of a single drug to reverse coronary deposits of cholesterol in patients after just 2 years of treatment with Rosuvastatin (Crestor).

2. These results originated further clinical trials which will be presented at the forthcoming meetings of The American College of Cardiology (ACC).

Contents of newly published review article on pharmacological treatment of obesity.

October 10, 2006

Analysis of:Adiposopathy is a more rational treatment target for metabolic disease than obesity alone. | www.ncbi.nlm.nih.gov

In this extensive review, we discuss the current concepts on the mechanisms of obesity and rationale for the pharmacological interventions available.
 
In addition, we make an extensive review of the products currently under development and their mechanisms of action and potential therapeutic usefulness.

We also describe more extensively the mechanisms of action of cannabinoid receptor antagonists, in particular Rimonabant (Accomplia-Zimulti). 

Dr. Dujovne, one of the authors, was original consultant in the planning of Phase II Clinical Trials and was an investigator for all subsequent trials up to NDA submission.

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