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FDA investigating the safety of Benicar
 Moderated by: Prof Trevor Marshall Page:  First Page Previous Page  ...  6  7  8  9  10  11  12  13  14  Next Page Last Page  
 

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Bane
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 Posted: Tue Jan 29th, 2013 15:40

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Effects of angiotensin receptor blockade (ARB) on mortality and cardiovascular outcomes in patients with long-term haemodialysis: a randomized controlled trial.

http://www.ncbi.nlm.nih.gov/pubmed/23355629

Hypertension is a major risk factor for death and cardiovascular disease (CVD) in patients undergoing chronic haemodialysis (HD), but there is uncertainty surrounding the effects of blood pressure (BP) lowering on this high-risk patient group.MethodsIn a multicenter, prospective, randomized, open-label, blinded-endpoint trial, 469 patients with chronic HD and elevated BP (140-199/90-99 mmHg) were assigned to receive the angiotensin receptor blockade (ARB) olmesartan (at a dose of 10-40 mg daily; n = 235) or another treatment that does not include angiotensin receptor blockers and angiotensin-converting enzyme (ACE) inhibitors (n = 234). The primary outcomes were the following: (i) composite of death, nonfatal stroke, nonfatal myocardial infarction and coronary revascularization and (ii) all-cause death. Results: During a mean follow-up of 3.5 years, the mean BP was 0.9/0.0 mmHg lower in the olmesartan group than in the control group (not significant). A total of 68 patients (28.9%) in the olmesartan group and 67 patients (28.6%) in the control group had subsequent primary composite endpoints [hazard ratio (HR) in the olmesartan group 1.00, 95% confidence interval (CI) 0.71-1.40, P = 0.99]. All-cause deaths occurred in 38 patients (16.2%) in the olmesartan group and 39 (16.7%) in the control group (HR, 0.97; 95% CI, 0.62-1.52, P = 0.91). Olmesartan did not alter the risks of serious adverse events. Conclusions: BP-lowering treatment with an ARB did not significantly lower the risks of major cardiovascular events or death among patients with hypertension on chronic HD.

Prof Trevor Marshall
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 Posted: Tue Jan 29th, 2013 15:52

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So it is a pretty good placebo, then?

Pretty amazing that none of these researchers stumble upon the immune modulating effects of the drug.

I doubt anybody here would agree that the drug does nothing :) :) :)
 

Seth
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 Posted: Wed Jan 30th, 2013 15:12

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I was about to make a suggestion, then realised how wrong it would be (use 4x or 5x the dose and redo the study).
Obviously, then they would be well-advised to prevent vitD consumption, sun exposure and various foods, as well as management of IP, that is, IF that particular drug did have any effect..  ;)

It kind of exposes the limited/faulty thinking behind a lot of trials - the ignorance of other factors and existing knowledge and the expectation that one factor alone might produce significant results.

Actually, just doing simple addition, and since I commented on another statistic of sorts recently - another 77 deaths occured while limited thinking is happening.. it's kind of shocking.

Last edited on Wed Jan 30th, 2013 15:15 by Seth



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 Posted: Wed Jan 30th, 2013 20:48

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Hm...

How about: high bloodpressure alone is nothing, that makes people die early?

Or the other way around: artificially lowering high bloodpressure does not solve the underlying problem?

I mean, if you are old, your veins are narrow and you have put on to much weight, your body might need higher bloodpressure to make sure, that enough blood arrives in the outer areas of the body?

I would bet, that after "cleaning" the veins and reopening some stuffed pathways the bloodpressure would go down without any medicamentation.



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Jigsaw
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 Posted: Thu Jan 31st, 2013 16:05

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Bane wrote: Effects of angiotensin receptor blockade (ARB) on mortality and cardiovascular outcomes in patients with long-term haemodialysis: a randomized controlled trial.
http://www.ncbi.nlm.nih.gov/pubmed/23355629
  469 patients with chronic HD and elevated BP (140-199/90-99 mmHg) were assigned to receive the angiotensin receptor blockade (ARB) olmesartan (at a dose of 10-40 mg daily; n = 235) or another treatment that does not include angiotensin receptor blockers and angiotensin-converting enzyme (ACE) inhibitors (n = 234). All-cause deaths occurred in 38 patients (16.2%) in the olmesartan group and 39 (16.7%) in the control group (HR, 0.97; 95% CI, 0.62-1.52, P = 0.91). Olmesartan did not alter the risks of serious adverse events. Conclusions: BP-lowering treatment with an ARB did not significantly lower the risks of major cardiovascular events or death among patients with hypertension on chronic HD.

olmesartan (at a dose of 10-40 mg daily)  would be insufficient to sustain ongoing activation of the VDR. While it would be providing significant blockage of the ATR1, this action would be countered by feedback to increase the level of RAAS components which would maintain the damaging action of these mediated by signalling through ATR1 and the (pro)renin receptor. 
  Higher levels of olmesartan, such as the 4 x 40mg or 6 x 40 mg used in the MP, would provide activation of the VDR to inhibit production of the RAAS components: angiotensinogen, prorenin and renin, ATR1 and the (pro)renin receptor. This would help prevent the levels of these rising through feedback and so limit the damaging action of the RAAS.

Last edited on Thu Jan 31st, 2013 16:36 by Jigsaw



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Bane
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 Posted: Tue May 21st, 2013 10:27

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Angiotensin Receptor Blockers and Risk of Prostate Cancer Among United States Veterans.

http://www.ncbi.nlm.nih.gov/pubmed/23686462

"There was no significant difference in Gleason scores between the two groups. We found a small, but statistically significant, reduction in the incidence of clinically detected PrCA among patients assigned to receive ARB with no countervailing effect on degree of differentiation"

Hogan
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 Posted: Fri May 31st, 2013 04:24

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Even the passionate scientists don't understand:(

http://online.wsj.com/article/SB10001424127887324682204578515172395384146.html?mod=djemalertNEWS

Dr. Marciniak's analysis didn't include data from trials on some ARB drugs, including Benicar, but he concluded "that the increased incidence of lung cancers with ARB use is likely a class effect of ARBs" and that it would be "inappropriate" to classify specific ARBs as safe due to a "lack of adequate studies."



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Russ
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 Posted: Fri May 31st, 2013 06:38

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Thanks Hogan.  Amazing how he is able to talk back to his boss like that and ignore his orders without getting fired.  I guess firing someone because they insisted on looking into a safety concern would be a bad PR situation.

It's weird being on the side of the big bureaucratic government agency and the drug companies and against the rougue scientist emphasizing safety of drugs, but in this case I guess we are.  Although we wouldn't have to be, if he would just look at the ARBs individually instead of as a class.



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 Posted: Fri May 31st, 2013 12:18

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I wonder if this is a factor in the FDA's stonewalling of Dr Marshall's request to approve pure olmesartan for study in ONE patient!!!  :X:X:X:X:X:X:X:X:X:X



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 Posted: Fri May 31st, 2013 14:14

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It really is infuriating.  With so many wacky "therapies" being approved (of course they're usually very profitable...), it's just awful what an uphill climb this is Chris.  It is so not fair.  Whatever happened to the patient's well-being truly being the goal of everyone involved in health care???  I used to work for one of the early health maintenance organizations and that really was the goal, despite all the well-financed pressure toward other goals.

Love you Chris.

Dody



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ChrisMavo
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 Posted: Fri May 31st, 2013 17:37

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Thanks Dody!!

I agree that the FDA has lost the focus on the patients and what is best for them.  I don't know if pure olmesartan would stop and turnaround this horrible disease.  But I feel I have the right to find out!!  There should be different guidelines and procedures for terminally ill patients.  It is utterly ridiculous that the FDA is treating the application for pure olmesartan as any old new drug for a lesser disease ... meanwhile ignoring the fact real people are suffering and dying with ALS!!!  There is no sense of urgency at all.  Everything has to go through the same frustrating bureaucratic mill!!!

Love you too!!
Chris




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Cairo123
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 Posted: Fri May 31st, 2013 18:03

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Money talks.



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 Posted: Fri May 31st, 2013 18:17

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"Money doesn't talk, it screams." Bob Dylan

I consider myself well read on the topic of Benicar or olmesartan as a treatment for chronic illness. I have studied the science for more than 8 years, and observed the documented changes for the better in my own health. And others on the MP.

The study in question is rubbish, IMHO.

Sherry



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Bane
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 Posted: Fri Jul 5th, 2013 02:34

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Angiotensin receptor blockers: are they related to lung cancer?

http://www.ncbi.nlm.nih.gov/pubmed/23822929

"In this large nationwide cohort of United States Veterans, we found no evidence to support any concern of increased risk of lung cancer among new users of ARBs compared with nonusers. Our findings were consistent with a protective effect of ARBs"

Bane
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 Posted: Tue Jul 9th, 2013 04:09

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Comparative effectiveness of angiotensin-receptor blockers for preventing macrovascular disease in patients with diabetes: a population-based cohort study

http://www.cmaj.ca/content/early/2013/07/08/cmaj.121771

"Compared with other angiotensin-receptor blockers, telmisartan and valsartan were both associated with a lower risk of admission to hospital for acute myocardial infarction, stroke or heart failure among older adults with diabetes and hypertension"

Jigsaw
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 Posted: Tue Jul 9th, 2013 05:30

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Bane wrote: Compared with other angiotensin-receptor blockers, telmisartan and valsartan were both associated with a lower risk of admission to hospital for acute myocardial infarction, stroke or heart failure among older adults with diabetes and hypertension"
Olmesartan was not assessed.



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Trudy.Heil_NP
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 Posted: Tue Jul 9th, 2013 07:41

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Ignore the prior link, it is old news....LOL.

This is the link for the skinny....

http://www.medscape.com/viewarticle/807289?src=wnl_edit_medn_wir&uac=43453BN&spon=34

Too bad they haven't been following the MP science or they would understand why this is happening. I think someone needs to post a reply to the 14 providers that haven't a clue.

Happily Healing,
Trudy



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Verena
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 Posted: Sat Jul 13th, 2013 06:11

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Trudy, the linked site is asking for a password.



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Bane
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 Posted: Sun Jul 14th, 2013 00:53

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Verena wrote: Trudy, the linked site is asking for a password.

http://www.fda.gov/downloads/Drugs/DrugSafety/UCM359496.pdf

Pamela H-F
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 Posted: Thu Jul 18th, 2013 10:08

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Does this mean that it "seems" (to them) like benicar is causing intestinal problems, but really it's helping to heal existing problems?
Pam



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