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Statin‐Associated Adverse Cognitive Effects: Survey Results from 171 Patients
Marcella A. Evans, Beatrice Alexandra Golomb. Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy, 2009-06-26
Topic: Drug trials: efficacy and safety
Patients completed a survey assessing statin-associated, cognitive-specific adverse drug reaction (ADR) characteristics, relation of the ADR to specific statin and dose (or potency), and time course of symptom onset and recovery. Visual analog scales were used to assess the effect of the cognitive ADRs on seven quality-of-life domains. Demographic and clinical data were also collected. To target cognitive ADRs with a probable or definite causal relationship to statins, the Naranjo adverse drug reaction probability scale was used: 128 patients (75%) experienced cognitive ADRs determined to be probably or definitely related to statin therapy. Of 143 patients (84%) who reported stopping statin therapy, 128 (90%) reported improvement in cognitive problems, sometimes within days of statin discontinuation (median time to first-noted recovery 2.5 wks). Of interest, in some patients, a diagnosis of dementia or Alzheimer's disease reportedly was reversed. Nineteen patients whose symptoms improved or resolved after they discontinued statin therapy and who underwent rechallenge with a statin exhibited cognitive problems again (multiple times in some). Within this vulnerable group, a powerful relationship was observed between potency of the statin and fraction of trials with that agent resulting in cognitive ADRs (p<0.00001). Quality of life was significantly adversely affected for each of the seven assessed domains (all p<0.00000001). Findings from the survey suggest that cognitive problems associated with statin therapy have variable onset and recovery courses, a clear relation to statin potency, and significant negative impact on quality-of-life. Administration of a patient-targeted questionnaire is a feasible approach that provides a useful complement to other ADR surveillance approaches.
Key findings
- Patients completed a survey assessing statin-associated, cognitive-specific adverse drug reaction (ADR) characteristics, relation of the ADR to specific statin and dose (or potency), and time course of symptom onset and recovery.
- Visual analog scales were used to assess the effect of the cognitive ADRs on seven quality-of-life domains.
- Demographic and clinical data were also collected.
- To target cognitive ADRs with a probable or definite causal relationship to statins, the Naranjo adverse drug reaction probability scale was used: 128 patients (75%) experienced cognitive ADRs determined to be probably or definitely related to statin therapy.
- Of 143 patients (84%) who reported stopping statin therapy, 128 (90%) reported improvement in cognitive problems, sometimes within days of statin discontinuation (median time to first-noted recovery 2.5 wks).
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Study details
- Participants128
- Evidence strengthLow
How this study scored 45/100
Published in a peer-reviewed journal. Scored zero for study design, effect reported and randomised / blinded because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record and multi-centre collaboration, so those were left out: it earned 26 of the 58 points we could judge it on, which is 45 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 1 / 5 | 2009 — within 20 year(s) of the newest study here |
| Sample size | 2 / 4 | 128 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 19558254) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 26 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 26 of the 58 points we could judge it on is 45 out of 100. |
| Total | 45 / 100 | — |
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Cite this study APA, Vancouver, BibTeX · download .bib or .ris
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APA 7th
Evans, M. A., & Golomb, B. A. (2009). Statin‐Associated Adverse Cognitive Effects: Survey Results from 171 Patients. Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy. https://doi.org/10.1592/phco.29.7.800
Vancouver
Evans MA, Golomb BA. Statin‐Associated Adverse Cognitive Effects: Survey Results from 171 Patients. Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy. 2009. doi:10.1592/phco.29.7.800. PMID: 19558254.
BibTeX
@article{evans2009-19558254,
author = {Evans, Marcella A. and Golomb, Beatrice Alexandra},
title = {{Statin‐Associated Adverse Cognitive Effects: Survey Results from 171 Patients}},
journal = {Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy},
year = {2009},
doi = {10.1592/phco.29.7.800},
pmid = {19558254},
url = {https://doi.org/10.1592/phco.29.7.800}
}
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