Talk:Rosiglitazone

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Initial comments[edit]

It might be worthwhile to critique the Nissen study here for its questionable methodology, as well as include more recent study information re increased CV risk. Also, might be worth to mention of Rosiglitazone's effect of LDL metabolism (see Thiazolidinediones review by Hannele Yki-Järvineni, 2004; figure 4). --Xris0 (talk) 18:33, 13 March 2008 (UTC)

The statement in WIKI that "In February 2010, David Graham, the FDA's associate director of drug safety, recommended that rosiglitazone be taken off the market." is wholly inaccurate. David Graham, the reviewer of the FDA's office of surveillance and epidemiology estimated in a memo dated October 2008, 2008 mind you, stated it should be taken off the market".(First word) Graham has publicly been criticized by the FDA in the past for his opinions.(WIKI)----DM 08:28, 20 June 2006 —Preceding unsigned comment added by 202.80.63.2 (talkcontribs) [Bangalore, India]

Not sure whether it's worth mentioning[edit]

A generic version of this drug is available outside of the US. It is manufactured by Cipla Ltd. (India) and is called Senzia. InsultComicDog (talk) 00:54, 4 May 2010 (UTC)

July 9, 2010 article[edit]

Caleb Hellerman (July 9, 2010). "Key diabetes drug study was flawed, review charges". CNN. 

-- John Broughton (♫♫) 01:26, 10 July 2010 (UTC)

And here from the NYT:

http://www.nytimes.com/2010/07/10/health/10diabetes.html?src=me&ref=health Gandydancer (talk) 11:13, 11 July 2010 (UTC)

Nissen/Wolski[edit]

They've done an updated meta-analysis. OR was 1.3 for MI but no change in cardiovascular death - http://archinte.ama-assn.org/cgi/content/abstract/170/14/1191. Probably citable after the recent raft of additions. JFW | T@lk 10:39, 27 July 2010 (UTC)

US Federal restrictions on purchasing[edit]

I deleted the following unsourced sentence from the Controversy and response section: "In Nov 2011, in a unique case, all sales of rosiglitazone were directed by the U.S. Department of Health and Human Services to go through Liberty Medical in Port St. Lucie, Florida. As a result of this action, the price of the drug immediately more than doubled, and in some cases, increased 250%.[citation needed]."

It may be true that the Centers for Medicare and Medicaid Services, an agency with HHS, has restricted federal reimbursement for the drug and it's possible that the price increased as a result, but an unverified statement to that effect violates Wiki standards. Lahaun (talk) 02:37, 17 March 2013 (UTC)

Quoted statistics[edit]

I added an explanation of the 43% statistic reported by Nissen & Wolski, to follow good practice in interpreting effects on the original scale rather than just reporting them on the ratio scale. I also corrected the statement that said N&W found a higher risk of death from CV causes, compared to the risk of heart attack: it was the increase (on the ratio scale) that was higher (1.64 compared to 1.43), rather than the risk itself. Peterwlane (talk) 06:45, 4 June 2013 (UTC)

Re-evaluation of cardiovascular risk[edit]

Based on a very recent re-analysis of the rosiglitazone clinical trials, parts of this article needs to be modified, especially the statement "The drug ... is estimated to have caused 83,000 heart attacks in the United States alone".

The following meta analysis suggests an increased risk of myocardial infarction from rosiglitazone treatment:

  • Nissen SE, Wolski K (2007). "Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes". N. Engl. J. Med. 356 (24): 2457–71. PMID 17517853. doi:10.1056/NEJMoa072761.  Unknown parameter |month= ignored (help)

However by request from the FDA, the clinical data has been recently re-examined. This re-evaluation demonstrates that rosiglitazone treatment, in agreement with the original conclusions of RECORD clinical trial, is not associated with an increased cardiovascular risk:

  • Mahaffey KW, Hafley G, Dickerson S, Burns S, Tourt-Uhlig S, White J, Newby LK, Komajda M, McMurray J, Bigelow R, Home PD, Lopes RD (2013). "Results of a reevaluation of cardiovascular outcomes in the RECORD trial". Am. Heart J. 166 (2): 240–249.e1. PMID 23895806. doi:10.1016/j.ahj.2013.05.004.  Unknown parameter |month= ignored (help)
  • Lopes RD, Dickerson S, Hafley G, Burns S, Tourt-Uhlig S, White J, Newby LK, Komajda M, McMurray J, Bigelow R, Home PD, Mahaffey KW (2013). "Methodology of a reevaluation of cardiovascular outcomes in the RECORD trial: Study design and conduct". Am. Heart J. 166 (2): 208–216.e28. PMID 23895802. doi:10.1016/j.ahj.2013.05.005.  Unknown parameter |month= ignored (help)

Based on this re-evaluation, an FDA panel has voted to relax the Risk Evaluation and Mitigation Strategies (REMS) on rosiglitazone cardiovascular risks:

Boghog (talk) 20:05, 8 September 2013 (UTC)

As of 25-November-2013, the FDA removed the black box warning for the drug. "Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - Removal of Some Prescribing and Dispensing Restrictions". Wzrd1 (talk) 23:01, 25 November 2013 (UTC)
I actually made changes to the opening section earlier today to reflect that news. Please feel free to make changes to the body of the article to reflect the FDA's latest requirements, and perhaps the results of the RECORD trial.
In light of the RECORD trial's results, it might be time to revisit the fact that Dr. Nissen, author of the original 2007 meta-analysis that originally raised the idea of a link to heart attacks, has been accused of cherry picking the results that supported his hypothesis (he admitted to selective inclusion/exclusion of studies during congressional hearings, but stated that his decision was scientifically justified). Any thoughts/opinions on that? DoctorEric (talk) 20:45, 26 November 2013 (UTC)
That would be worthy, but a significant undertaking, as one would need loads of citations to make the point and avoid OR pitfalls. In light of the current FDA changes, perhaps a partial re-write of (scratch that, took another look at the article, it isn't a section re-write, it'd be much of the article). To tell the truth, I really don't know *what* to do with it and the newest from the FDA. Either we'd need a full re-write of the article or turn the article into a tome with the criticism, as I'm sure quite a few readers will come here for information. Any way you slice it, it'd be easy to turn the article into a cloistersmurf.Wzrd1 (talk) 00:47, 27 November 2013 (UTC)
The scope of the undertaking (rewriting much of the article to reflect the latest research and FDA guidelines surrounding Rosiglitazone) is the very reason I chose to stop after my edits to the opening section -- even that took a fair chunk of time -- and offer the rest of the task to another willing editor. As to the design flaws in the original 2007 meta-analysis: as I think about it more, I think that it should get brief mention at most; I may make some changes to the page on Dr. Nissen, as another editor suggested. DoctorEric (talk) 14:26, 27 November 2013 (UTC)

Treatment of obesity?[edit]

I lack the necessary skills to write up new information - perhaps someone more qualified can update the article?

A recent paper suggests that long term exposure to Rosiglitazone can induce "browning" of white adipose tissue, leading to weight loss.

The reference is: A. Loft, I. Forss, M. S. Siersbaek, S. F. Schmidt, A.-S. B. Larsen, J. G. S. Madsen, D. F. Pisani, R. Nielsen, M. M. Aagaard, A. Mathison, M. J. Neville, R. Urrutia, F. Karpe, E.-Z. Amri, S. Mandrup. Browning of human adipocytes requires KLF11 and reprogramming of PPAR superenhancers. Genes & Development, 2014; DOI: 10.1101/gad.250829.114

A link is: http://genesdev.cshlp.org/content/early/2014/12/10/gad.250829.114

The abstract says:

Long-term exposure to peroxisome proliferator-activated receptor γ (PPARγ) agonists such as rosiglitazone induces browning of rodent and human adipocytes; however, the transcriptional mechanisms governing this phenotypic switch in adipocytes are largely unknown. Here we show that rosiglitazone-induced browning of human adipocytes activates a comprehensive gene program that leads to increased mitochondrial oxidative capacity. Once induced, this gene program and oxidative capacity are maintained independently of rosiglitazone, suggesting that additional browning factors are activated. Browning triggers reprogramming of PPARγ binding, leading to the formation of PPARγ “superenhancers” that are selective for brown-in-white (brite) adipocytes. These are highly associated with key brite-selective genes. Based on such an association, we identified an evolutionarily conserved metabolic regulator, Kruppel-like factor 11 (KLF11), as a novel browning transcription factor in human adipocytes that is required for rosiglitazone-induced browning, including the increase in mitochondrial oxidative capacity. KLF11 is directly induced by PPARγ and appears to cooperate with PPARγ in a feed-forward manner to activate and maintain the brite-selective gene program. AncientBrit (talk) 05:48, 19 December 2014 (UTC)

Thanks for posting, but we don't add content about health based on animal or in vitro studies - please see WP:MEDRS. Jytdog (talk) 12:05, 19 December 2014 (UTC)

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Bad Pharma[edit]

The book Bad Pharma notes that a large percentage of trials were not published. www.alltrials.net has details. Should Wiki work with Alltrials to point out the suppression of trials and include data on how many trials were unpublished or terminated early if the results would not reflect well. People rely on Wiki for information and we CAN provide more information than the PDF, BNF and similar references used by doctors. It's a big step but if we take it, we will become the BEST source for doctors and patients. — Preceding unsigned comment added by 81.99.74.135 (talk) 22:55, 1 January 2017 (UTC)

Is this article only about the maleate form[edit]

I guess that the trials and approvals are all of Rosiglitazone maleate but it would be nice to have the article say for sure. - Rod57 (talk) 12:35, 18 August 2017 (UTC)

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