Evidence mapPaperPMID 12466341Full record

Trial reportThe Journal of clinical endocrinology and metabolism2002

Effect of fluvastatin slow-release on low density lipoprotein (LDL) subfractions in patients with type 2 diabetes mellitus: baseline LDL profile determines specific mode of action.

Karl Winkler, Claudia Abletshauser, Michael M Hoffmann, Isolde Friedrich, Manfred W Baumstark, Heinrich Wieland, Winfried März

Registry-linked trialOpen access · bronzeAbstract readClinical TrialMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2002. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01384058 (The Effect of Ezetimibe 10 mg, Simvastatin 20 mg and the Combination of Simvastatin 20 mg Plus 10 mg Ezetimibe on Low Density Lipoprotein), which is not on this map. Cited by 10 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 4 pooled it
6.1field-weighted citation impact, top 3% 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.

NCT01384058 phase4completedstarted 2007, after this paper: background citation

The Effect of Ezetimibe 10 mg, Simvastatin 20 mg and the Combination of Simvastatin 20 mg Plus 10 mg Ezetimibe on Low Density Lipoprotein (LDL)-Subfractions in Patients With Type 2 Diabetes

Ran2007Enrolled41Registered outcomes5Posted comparisons0ConditionsDiabetes Mellitus Type 2, HypercholesterolemiaArmsEzetimibe, Ezetimibe 10/Simvastatin 20, simvastatin
Open the trial in the graph
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 4 syntheses or guidelines pooled it, 55 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Fluvastatin for lowering lipids.The Cochrane database of systematic reviews · 2018
    Pooled it
  4. Pooled it
  5. Review
  6. Fluvastatin Sodium Ameliorates Obesity through Brown Fat Activation.International journal of molecular sciences · 2019
    Article
  7. Article
  8. Article
  9. Article
  10. 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

7 authors at 2 institutions in 1 country.

Karl WinklerDivision of Clinical Chemistry, Department of Medicine, Albert Ludwigs-University, D-79106 Freiburg, Germany. kwinkler@ukl.uni-freiburg.de
Claudia Abletshauser
Michael M Hoffmann
Isolde Friedrich
Manfred W Baumstark
Heinrich Wieland
Winfried März
University of Freiburg · DENovartis (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The objective of this study was to determine the effect of slow-release (XL) fluvastatin on low density lipoprotein (LDL) subfractions in type 2 diabetes. A multicenter, double-blind, randomized, parallel-group comparison of fluvastatin XL 80 mg (n = 42) and placebo (n = 47), each given once-daily for 8 wk, in 89 patients with type 2 diabetes (HbA1c: 7.2 +/- 1.0%, LDL cholesterol (LDL-C): 3.4 +/- 0.7 mmol/liter, high density lipoprotein cholesterol: 1.1 +/- 0.3 mmol/liter, and triglycerides (TG): 2.4 +/- 1.4 mmol/liter). At baseline and on treatment, plasma lipoproteins were isolated and quantified. Eight weeks of fluvastatin treatment decreased total cholesterol (-23.0%, P < 0.001), LDL-C (-29%, P < 0.001) and TG (-18%, P < 0.001), compared with placebo. At baseline, there was a preponderance of dense LDL (dLDL) (apolipoprotein B in LDL-5 plus LDL-6 > 25 mg/dl) in 79% of patients, among whom fluvastatin decreased all LDL subfractions, reductions in dLDL being greatest (-28%, P = 0.001; cholesterol in dLDL -29%). In patients with low baseline dLDL (apolipoprotein B in LDL-5 plus LDL-6 </= 25 mg/dl), but a preponderance of buoyant LDL (LDL-1 through LDL-3), fluvastatin significantly decreased only these subfractions. Fluvastatin 80 mg XL, once daily, decreased total cholesterol and total LDL-C. In patients with atherogenic dLDL, absolute changes of dLDL were most pronounced, emphasizing the value of fluvastatin treatment in type 2 diabetes. The antiatherogenic potential of fluvastatin in type 2 diabetes may thus be greater than that expected from its effects on LDL-C and TG alone.

Indexed as

AgedApolipoproteinsDelayed-Action PreparationsDiabetes Mellitus, Type 2Double-Blind MethodFatty Acids, MonounsaturatedFemaleFluvastatinHumansIndolesLipidsLipoproteinsLipoproteins, LDLMaleMiddle AgedSafetyApolipoproteinsDelayed-Action PreparationsFatty Acids, MonounsaturatedFluvastatinIndolesLipidsLipoproteinsLipoproteins, LDL

Identifiers

PMID12466341
OpenAlexW2075025181

What Socratic holds

Texttitle and abstract
Read underepoch 390

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 Socratic graph.