Evidence map›Paper›PMID 18398457›Full record

Trial reportPloS one2008

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 and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in PloS one, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00616187 (Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis), which is not on this map. Cited by 48 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 4 pooled it
11.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00616187 phase2completednot on this map

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

TypeinterventionalSponsorCharite University, Berlin, GermanyRan2003Enrolled41ConditionsRelapsing Remitting Multiple SclerosisArmsinterferon beta treatment to add-on atorvastatin treatment, untreated to atorvastatin treatment
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 4 syntheses or guidelines pooled it, 121 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Statins for multiple sclerosis.The Cochrane database of systematic reviews · 2011
    Pooled it
  4. The role of statins in neurosurgery.Neurosurgical review · 2010
    Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Review
  11. Review
  12. Review
  13. Evaluation of Rosuvastatin Therapy onCurrent therapeutic research, clinical and experimental · 2023
    Article
  14. Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Friedemann PaulCecilie Vogt Clinic for Neurology in the HELIOS Clinic Berlin-Buch, Charité-University Medicine Berlin and Max-Delbrueck Center for Molecular Medicine, Berlin, Germany.
Sonia Waiczies
Jens Wuerfel
Judith Bellmann-Strobl
Jan Dörr
Helmar Waiczies
Mareile Haertle
Klaus D Wernecke
Hans-Dieter Volk
Orhan Aktas
Frauke Zipp
Charité - Universitätsmedizin Berlin · DEHelios Hospital Berlin-Buch · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecent data from animal models of multiple sclerosis (MS) and from a pilot study indicated a possible beneficial impact of statins on MS. METHODOLOGY/PRINCIPAL

findingsSafety, tolerability and effects on disease activity of atorvastatin given alone or in combination with interferon-beta (IFN-beta) 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-beta comedication. The high dose of 80 mg atorvastatin was well tolerated in the majority of patients, regardless of IFN-beta 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-beta comedication (p = 0.060 and p = 0.062), in contrast to patients without IFN-beta 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-beta, 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.

trial registrationClinicalTrials.gov NCT00616187.

Indexed as

Administration, OralAdjuvants, ImmunologicAtorvastatinGadoliniumHeptanoic AcidsHumansHydroxymethylglutaryl-CoA Reductase InhibitorsInterferon-betaInterleukinsMagnetic Resonance ImagingModels, BiologicalMultiple Sclerosis, Relapsing-RemittingMultivariate AnalysisPyrrolesRecurrenceTreatment OutcomeAdjuvants, ImmunologicAtorvastatinGadoliniumHeptanoic AcidsHydroxymethylglutaryl-CoA Reductase InhibitorsInterferon-betainterleukin 20InterleukinsPyrroles

Identifiers

PMID18398457
PMCPMC2276246
OpenAlexW2053714231

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.