Blog entry by Meguid El Nahas

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by Meguid El Nahas - Friday, 15 August 2014, 8:23 AM
Anyone in the world
J Am Soc Nephrol. 2014 Aug;25(8):1825-33. doi: 10.1681/ASN.2013090965. Epub 2014 May 1.
 
This publication from the SHARP study group showed NO EFFECT of STATINS on the PROGRESSION OF CKD.

COMMENTS:

So the SHARP study is also negative as far as the impact of STATINS ON CKD PROGRESSION...as it is on other major outcomes such as hospitalisations and mortality in CKD.

YET...IT IS OVERALL SPAN AS A STUDY THAT SHOWED THAT STATINS REDUCED MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) IN CKD PATIENTS....

THIS IS TOTALLY MISLEADING...AS:

SHARP FAILED TO SHOW ANY IMPACT OF STATINS ON:

1. All cause mortality

2. Vacsular/CVD Mortality

3. Non Vascular mortality

4. Hospitalisations

5. CAD and its complications

6. Strokes of unknown causes

AND NOW...as previously suggested CKD AND ITS PROGRESSION.

SO WHY IS SHARP SPUN TO NEPHROLOGISTS AS A POSITIVE STUDY THAT REDUCES CVD? 

AND WHY DO NEPHROLOGISTS BELEIVE SUCH SPIN?

1. Clearly many Nephrologists are gullible...

2. Many Nephrologists dont know how to read a publication/report critically...

3. Most Nephrologists know little about statistical analyses...

4. Those with a vested interest in a study positive outcomes, including BIG PHARMA, are smart...and take advantage of our shortcomings and fool us to beleive in what is in their interest...

Based upon the fact that SHARP showed BY THE INAPPROPRIATE USE OF SOFT ENDPOINTS AND COMPOSITE ENDPOINTS:

a. A reduction in THE SOFT ENDPOINT OF vascular revascularisation; a procedure freely and subjectively undertaken in many countries, including the USA, by interventionists with little justification, indications or lasting beneficial outcome. In favour of such assumption is the absence of any IMPACT of statins on harder CAD endpoints such as myocardial infarction or coronary related mortality...!!!???

b. A Reduction in ischemic/non-hemorragic strokes; whilst other strokes were not affected AND more significanlty the hard endpoint of death from ischemic strokes is NOT affeceted...!!!!

Also to bare in mind, STATINS INCREASE THE INCIDENCE OF HEMORRHAGIC STROKES  as shown in numerous studies including AURORA but also in the recent analysis of the Framingham Heart Study (FRS) where statins increased the risk of cerebral bleeds...

http://www.ncbi.nlm.nih.gov/pubmed/24713533

c. SHARP innapropriately used COMPOSITE ENDPOINTS, mixing meaningful and irrelevant outcomes in order to rely on the meaningless (revascularisation procedures) to give the impression that the meaningful MACE are improved on Statins...WRONG AND MISLEADING and a poor and ill informed use of composite endpoint in clinical trials:

http://www.bmj.com/content/334/7597/786

http://www.bmj.com/content/330/7491/594

In fact, there is a complete disconnect in SHARP between the chosen soft endpoints coronoray revascularisations and ischemic stroke events and the HARD ENDPOINTS related to these such as hospitalisations or MORTALITY....?!

ALTOGETHER SHARP IS A NEGATIVE STUDY SHOWING NO MEANINGFUL EFFECT OF STATINS ON HOSPITALISATIONS OR ANY TYPE OF MORTALITY IN CKD PATIENTS....IT IS BEING SPUN TO CONVINCE US OTHERWISE...SO BEWARE...AS SUCH SPIN HAS ALREADY FOOLED MANY INCLUDING THE KEY OPINION LEADERS WHO DRAFT NATIONAL AND INTERNATIONAL GUIDELINES...BUT IT SHOULDNT FOOL YOU!

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