Evidence map›Paper›PMID 33259671›Full record

Observational studyJournal of internal medicine2021

Reported muscle symptoms during statin treatment amongst Italian dyslipidaemic patients in the real-life setting: the PROSISA Study.

M Casula, M Gazzotti, F Bonaiti, E OImastroni, M Arca, M Averna, A Zambon, A L Catapano, PROSISA Study Group

Open access · hybridFull text readMulticenter StudyObservational Study
In one paragraph

Observational study in Journal of internal medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
4.3field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Prevalence of statin intolerance: a meta-analysis.European heart journal · 2022 · on this map
    Pooled it
  3. Pooled it
  4. Association Between Statin Initiation and Myasthenia Gravis Crisis.Journal of clinical neurology (Seoul, Korea) · 2026
    Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Review
  11. Challenges in Improving Adherence to Diet and Drug Treatment in Hypercholesterolemia Patients.International journal of environmental research and public health · 2023
    Review
  12. Review
  13. Initial statin dose after myocardial infarction and long-term cardiovascular outcomes.European heart journal. Cardiovascular pharmacotherapy · 2023
    Article
  14. Review
  15. Review
  16. Review
  17. Statin-Associated Myopathy: Emphasis on Mechanisms and Targeted Therapy.International journal of molecular sciences · 2021
    Review
  18. Observational
  19. Observational
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

9 authors at 4 institutions in 1 country.

M CasulaEpidemiology and Preventive Pharmacology Service (SEFAP), Department of Pharmacological and Biomolecular Sciences, University of Milan, Milan, Italy.ORCID 0000-0002-5124-5361
M GazzottiEpidemiology and Preventive Pharmacology Service (SEFAP), Department of Pharmacological and Biomolecular Sciences, University of Milan, Milan, Italy.ORCID 0000-0001-5651-3161
F BonaitiEpidemiology and Preventive Pharmacology Service (SEFAP), Department of Pharmacological and Biomolecular Sciences, University of Milan, Milan, Italy.
E OImastroniEpidemiology and Preventive Pharmacology Service (SEFAP), Department of Pharmacological and Biomolecular Sciences, University of Milan, Milan, Italy.ORCID 0000-0001-7107-243X
M ArcaDepartment of Translational and Precision Medicine, Unit of Internal Medicine and Metabolic Diseases, Sapienza University, Rome, Italy.
M AvernaDepartment of Health Promotion Sciences Maternal and Infantile Care, Internal Medicine and Medical Specialities, University of Palermo, Palermo, Italy.ORCID 0000-0003-3558-9209
A ZambonIRCCS MultiMedica, Milan, Italy.ORCID 0000-0001-7096-5201
A L CatapanoEpidemiology and Preventive Pharmacology Service (SEFAP), Department of Pharmacological and Biomolecular Sciences, University of Milan, Milan, Italy.ORCID 0000-0002-7593-2094
PROSISA Study Group
University of Milan · ITSapienza University of Rome · ITUniversity of Padua · ITUniversity of Palermo · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimStatin-associated muscle symptoms (SAMS) are a major determinant of poor treatment adherence and/or discontinuation, but a definitive diagnosis of SAMS is challenging. The PROSISA study was an observational retrospective study aimed to assess the prevalence of reported SAMS in a cohort of dyslipidaemic patients.

methodsDemographic/anamnestic data, biochemical values and occurrence of SAMS were collected by 23 Italian Lipid Clinics. Adjusted logistic regression was performed to estimate odds ratio (OR) and 95% confidence intervals for association between probability of reporting SAMS and several factors.

resultsAnalyses were carried out on 16 717 statin-treated patients (mean ± SD, age 60.5 ± 12.0 years; 52.1% men). During statin therapy, 9.6% (N = 1599) of patients reported SAMS. Women and physically active subjects were more likely to report SAMS (OR 1.23 [1.10-1.37] and OR 1.35 [1.14-1.60], respectively), whist age ≥ 65 (OR 0.79 [0.70-0.89]), presence of type 2 diabetes mellitus (OR 0.62 [0.51-0.74]), use of concomitant nonstatin lipid-lowering drugs (OR 0.87 [0.76-0.99]), use of high-intensity statins (OR 0.79 [0.69-0.90]) and use of potential interacting drugs (OR 0.63 [0.48-0.84]) were associated with lower probability of reporting SAMS. Amongst patients reporting SAMS, 82.2% underwent dechallenge (treatment interruption) and/or rechallenge (change or restart of statin therapy), with reappearance of muscular symptoms in 38.4% (3.01% of the whole cohort).

conclusionsThe reported prevalence of SAMS was 9.6% of the whole PROSISA cohort, but only a third of patients still reported SAMS after dechallenge/rechallenge. These results emphasize the need for a better management of SAMS to implement a more accurate diagnosis and treatment re-evaluation.

Indexed as

Creatine KinaseDyslipidemiasFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsItalyMaleMedication AdherenceMiddle AgedMuscular DiseasesPrevalenceRetrospective StudiesCreatine KinaseHydroxymethylglutaryl-CoA Reductase Inhibitorsadverse effectsmyopathystatin-associated muscle symptomsstatins

Identifiers

PMID33259671
PMCPMC8359216
OpenAlexW3107173064

What OpenQuestion holds

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Registered trials

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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.