lipitor

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lipitor

Postby dignan » Sun Mar 16, 2008 12:19 pm

Here's another link to an AAN abstract. This one is a study of lipitor (atorvastatin). It looks promising. Still looks to me like it's not beneficial to combine a statin with an interferon.

http://www.abstracts2view.com/aan2008ch ... 8L_P02.145
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Postby dignan » Thu Apr 10, 2008 6:52 am

Pretty good results from a very small phase 2 trial...


Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis

Friedemann Paul, Sonia Waiczies, Jens Wuerfel, Judith Bellmann-Strobl, Jan Dörr,, Helmar Waiczies, Mareile Haertle, Klaus D. Wernecke, Hans-Dieter Volk, Orhan Aktas, Frauke Zipp

Recent data from animal models of multiple sclerosis (MS) and from a pilot study indicated a possible beneficial impact of statins on MS.
Methodology/Principal Findings

Safety, tolerability and effects on disease activity of atorvastatin given alone or in combination with interferon-beta (IFN-β) were assessed in a phase II open-label baseline-to-treatment trial in relapsing-remitting MS (RRMS). Patients with at least one gadolinium-enhancing lesion (CEL) at screening by magnetic resonance imaging (MRI) were eligible for the study. After a baseline period of 3 monthly MRI scans (months −2 to 0), patients followed a 9-month treatment period on 80 mg atorvastatin daily. The number of CEL in treatment months 6 to 9 compared to baseline served as the primary endpoint. Other MRI-based parameters as well as changes in clinical scores and immune responses served as secondary endpoints.

Of 80 RRMS patients screened, 41 were included, among them 16 with IFN-β comedication. The high dose of 80 mg atorvastatin was well tolerated in the majority of patients, regardless of IFN-β comedication. Atorvastatin treatment led to a substantial reduction in the number and volume of CEL in two-sided multivariate analysis (p = 0.003 and p = 0.008). A trend towards a significant decrease in number and volume of CEL was also detected in patients with IFN-β comedication (p = 0.060 and p = 0.062), in contrast to patients without IFN-β comedication (p = 0.170 and p = 0.140). Immunological investigations showed no suppression in T cell response but a significant increase in IL-10 production.

Conclusions/Significance
Our data suggest that high-dose atorvastatin treatment in RRMS is safe and well tolerated. Moreover, MRI analysis indicates a possible beneficial effect of atorvastatin, alone or in combination with IFN-β, on the development of new CEL. Thus, our findings provide a rationale for phase II/III trials, including combination of atorvastatin with already approved immunomodulatory therapy regimens.

To read the full study document:
http://www.plosone.org/article/info%3Ad ... ne.0001928
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Postby carolew » Thu Apr 10, 2008 7:01 pm

you all know that I have been on lipitor for long time .. 80mg OD and normal enzymes. I am convinced it is the reason why my MRI was so 'good' in the past and I could not enter other studies 'for lack of activity' on the MRI.
I am still taking it now whilst completing the FTY720 study (I am allowed) and I bet it will skew the results. They will think it is the new drug..
I am stable on this now and would never want to stop it.
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Postby Lyon » Thu Apr 10, 2008 8:30 pm

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Postby carolew » Sat Apr 12, 2008 10:21 am

thanks Lyon, you always know what to say.... Carole
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Postby rainer » Sat Apr 12, 2008 1:01 pm

yeah, you have such a way with words Bpb. :)
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Postby Lyon » Sat Apr 12, 2008 4:13 pm

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Re: lipitor

Postby NHE » Sat Apr 12, 2008 8:31 pm

Our data suggest that high-dose atorvastatin treatment in RRMS is safe and well tolerated. Moreover, MRI analysis indicates a possible beneficial effect of atorvastatin, alone or in combination with IFN-β, on the development of new CEL. Thus, our findings provide a rationale for phase II/III trials, including combination of atorvastatin with already approved immunomodulatory therapy regimens.

This is interesting. I don't have a link right now, but I remember reading a study which showed that statins shouldn't be taken in combination with Ifn-B since the statin was inhibiting a biochemical signalling pathway which was ativated by Ifn-B. Thus the two drugs were essentially cancelling eachother out and the people on the combination therapy actually did worse than people on either statins or Ifn-B alone.

OK. I found it. Here's the link to the post with the abstract.

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