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FDA investigating the safety of Benicar
 Moderated by: Prof Trevor Marshall Page:  First Page Previous Page  1  2  3  4  5  6  7  8  9  10  11  ...  Next Page Last Page  
 

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Ute
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 Posted: Wed Aug 4th, 2010 03:49

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Yesterday the Drug Commission of the German Medical Profession (AkdÄ) commented on the side of sartanes:
 
http://tinyurl.com/3y9fvon
Drug commission takes position to Sartanen and cancer risk
Berlin – the drug commission of the German medical profession (AkdÄ) sees no necessity to change at this moment the recommendations for the regulation from Sartanen. The drug commission reacted in a current statement to an US-American Metanalyse for the occurrence of tumors in connection with the gift of Sartanen. This study appeared in June in the magazine Lancet Oncology (2010; 11:627 - 636) and resulted in a small, but statistically significantly increased risk of cancer conditions in the case of gift of a Sartans. From view of the AkdÄ the US-Metaanalyse has however some clear methodical weaknesses. Beyond that the biological plausibility is not given a tumor-promoting effect of Sartanen. „The results of the study should be taken to the cause to accomplish further investigations to the cancer risk with use of Sartanen “, so the AkdÄ. © hil/aerzteblatt.de



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Prof Trevor Marshall
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 Posted: Wed Aug 4th, 2010 04:11

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I would like to be encouraged by this pronouncement, but sadly the phrase "the biological plausibility is not given a tumor-promoting effect of Sartanen" indicates that we have the blind leading the blind here.

Even AkdÄ has no concept of how drugs work, beyond what has been clinically observed and published. It is sad, really.
 

Bane
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 Posted: Thu Sep 23rd, 2010 07:31

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Angiotensin receptor blockers and cancer - Relationship dismissed by VALUE data while waiting for EMA and FDA reports.

http://www.ncbi.nlm.nih.gov/pubmed/20858047

Bane
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 Posted: Wed Oct 6th, 2010 06:14

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Editorial: Meta-Analysis Concludes Angiotensin Receptor Blocker Use Increases the Risk of Developing Cancer: Concerns About the Science and the Message

http://onlinelibrary.wiley.com/doi/10.1111/j.1751-7176.2010.00369.x/full

"In conclusion, we think that this situation highlights the need for us to better educate the mass media about levels of evidence. The fact that the publication of this finding from a study with a low weight of evidence was given such widespread national attention is troubling. According to well-established rules of evidence-based medicine, studies such as this should never dictate clinical care and should remain hypothesis-generating. Perhaps the American Society of Hypertension (ASH) should develop a panel of experts that could be available to help the media appropriately evaluate the strength and significance of publications related to hypertension.


We feel that based on the evidence presented to date, there is no need for physicians to change their prescribing of ARBs or for any regulatory change to occur at this time. We do recommend the following steps be taken to clarify the issue of a potential link between ARBs and incident cancer: (1) a better-designed patient level meta-analysis of all relevant ARB studies, including VALUE, be performed; (2) administrative claims databases such as those available from the Veterans Administration (VA) should be examined to determine whether there is an association between ARB use and incident cancer; (3) any clinical investigators with cancer-related data and ARB use should contact the authors of the present study so they can perform an updated meta-analysis (submitted as a Letter to the Editor of Lancet Oncology); and (4) future trials using ARBs should collect cancer data as a pre-specified end point of interest. Societies such as ASH need to work with the media to properly position and explain the results"

rbcolo12
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 Posted: Tue Nov 2nd, 2010 10:27

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Is there any concern about the use of titanium dioxide in manufacturer of Benicar. I have found no Manufacturer that does not use Titanium Dioxide and it is raising concerns of being a carcinogenic,



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Prof Trevor Marshall
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 Posted: Tue Nov 2nd, 2010 10:30

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Titanium Dioxide is used in a wide variety of drugs. Where did you read it might be a carcinogen?

rbcolo12
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 Posted: Tue Nov 2nd, 2010 18:19

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I read this Article on AOL and then did some research these are some sites ,

http://www.aolnews.com/nanotech/article/amid-nanotechs-dazzling-promise-health-riskgrow/19401235

http://www.ccohs.ca/headlines/text186.html

It made me look for Benicar that was not made with Titanium Dioxide, But there is not one,It is used in all most every drug made. 

 



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Joyful
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 Posted: Tue Nov 2nd, 2010 18:34

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Hi Bob.
I am thinking that your reading was about nano-technology?

Typically the titanium dioxide used in drugs is not "nano" sized particles. :cool:



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Prof Trevor Marshall
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 Posted: Tue Nov 2nd, 2010 18:37

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Thanks for that article :) Interesting :)
I have previously raised questions about nano-particles in sunscreens :) It is important though to notice that it is the nano-particles which are known to cause the most trouble, not the powdered titanium dioxide in the GI tract which results from digesting tablets.

With that being said, I have been working on a solution to the excipients in Benicar tablets. It is still too early to discuss our results. Keep an eye open for press announcements over the next six months. I think you will find that we have figured out how to deal with the problem of excipients, at least in the long term...

rbcolo12
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 Posted: Wed Nov 3rd, 2010 10:50

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Thanks Dr Marshall



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mabluhm
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 Posted: Fri Nov 5th, 2010 00:40

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Yes--thanks Dr. Marshall!



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jlunn247
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 Posted: Tue Nov 9th, 2010 03:14

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i think using nano as a advertisement gimmick is a good way to get the public interest in new tech i hope it keeps going till we have the real deal adjusting our metabiome.



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Bane
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 Posted: Wed Dec 1st, 2010 11:20

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Antihypertensive drugs and risk of cancer: network meta-analyses and trial sequential analyses of 324 168 participants from randomised trials

http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(10)70260-6/fulltext

Our analysis refutes a 5·0—10·0% relative increase in the risk of cancer or cancer-related death with the use of ARBs, ACEi, β blockers, diuretics, and CCBs. However, increased risk of cancer with the combination of ACEi and ARBs cannot be ruled out.

 

Last edited on Wed Dec 1st, 2010 11:41 by Bane

Bane
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 Posted: Fri Jan 21st, 2011 02:38

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Effect of RAAS Inhibition on the Incidence of Cancer and Cancer Mortality in Patients with Glomerulonephritis

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3012851/?tool=pubmed

In conclusion, patients with GN show a higher incidence of cancer and cancer mortality compared with the general population. Prescription of ACEI or ARB in patients with GN does not increase cancer incidence and recipients of ARB show rather to be lower rates of all-cause mortality and cancer mortality.

eClaire
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 Posted: Fri Jan 21st, 2011 05:41

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Yet another reason to stay on olmesartan.



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Bane
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 Posted: Tue Jan 25th, 2011 06:49

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Angiotensin II Receptor Blockers and Risk of Cancer in Patients With Systemic Hypertension.

http://www.ncbi.nlm.nih.gov/pubmed/21256465

In conclusion, long-term use of ARBs is associated with a lower incidence of cancer occurrence, thereby suggesting that ARBs may prevent cancer development.

Joyful
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 Posted: Tue Jan 25th, 2011 18:02

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Interesting study because it was nationwide population study.

What they did:
    1. looked at data from 1 million members of national insurance database (1998-2006)
    2. identified 109,002 members with newly diagnosed hypertension
    3. identified 40,124 that had ARBs prescribed for the new diagnosis (and 68,878 that did not)
    4. identified any that reported a new cancer diagnosis during the study period (3,082 in ARB group-my calc: 7.7%; 5,985 in no-ARB group-my calc: 8.6%)
    5. statistically messed with the results to smooth out the variables in a scientifically approved manner
    6. published their finding that those on ARBs have a decreased risk for cancer occurance

What is good: those on any type of ARB had a gross reduction in cancer risk of about 1%.
What would be better: refining search to get results by ARB type. We believe some are better than others. :)

What else to improve the study: go longer. We know that cancer pathologies are best understood over decades. We suspect ARB benefits are similar.

My opinions only. :cool:



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Verena
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 Posted: Thu Jan 27th, 2011 02:56

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Related to the Study, Ute quoted on top of this side:

I quote and translate from the book: Ursel Siebner, Gesunder Zweifel (Healthy doubts), Berlin Verlag 2010, page 128:

"In einer Metaanalyse (...) zeigt sich, dass die Zahl der Krebsfälle in der mit Sartanen behandelten Patientengruppe erhöht war - signifikant bei Lungenkrebs und leicht erhöht bei Prostatakrebs. (...) Die meisten einbezogenen Teilstudien wurden mit Telmisartan durchgeführt, zu einer Zuordnung des erhöhten Krebsrisikos zu einem bestimmten Sartan sehen sich die Autoren der Metastudie allerdings nicht in der Lage.

In English:
It was shown by Metaanalysis, that the number of cancer cases in the group of people, who had been treated with Sartans, was elevated - significantly for lungcancer and slightly elevated for cancer of the prostate. Most of the included Studies used Telmisartan, however, the authors of the studie consider themselves unable, to relate the elevated cancerous risk to a specific Sartan".

Well. Please correct me, if I am wrong, but isn't  Telmisartan on of the the Sartans, that nearly completely knocks out the VDR?

Verena


Last edited on Thu Jan 27th, 2011 03:00 by Verena



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Prof Trevor Marshall
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 Posted: Thu Jan 27th, 2011 03:43

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Yes, Telmisartan completely reverses the action of Olmesartan. My in-silico work alerted me to this, and then I confirmed it by taking the dreadful stuff, just to be sure :)

..Trevor...

Ron
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 Posted: Thu Jan 27th, 2011 23:23

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LOL! Is Liz always aware of your experiments..? ;)

Anyway, thanks for being the guinea pig (again). :):D:)


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