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An evaluation of a data mining signal for amyotrophic lateral sclerosis and statins detected in FDA's spontaneous adverse event reporting system.
Pharmacoepidemiol Drug Saf. 2008 Nov; 17(11):1068-76.PD

Abstract

BACKGROUND

We detected disproportionate reporting of amyotrophic lateral sclerosis (ALS) with HMG-CoA-reductase inhibitors (statins) in the Food and Drug Administration's (FDA) spontaneous adverse event (AE) reporting system (AERS).

PURPOSE

To describe the original ALS signal and to provide additional context for interpreting the signal by conducting retrospective analyses of data from long-term, placebo-controlled clinical trials of statins.

METHODS

The ALS signal was detected using the multi-item gamma Poisson shrinker (MGPS) algorithm. All AERS cases of ALS reported in association with use of a statin were individually reviewed by two FDA neurologists. Manufacturers of lovastatin, pravastatin, simvastatin, fluvastatin, atorvastatin, cerivastatin, and rosuvastatin were requested to provide the number of cases of ALS diagnosed during all of their placebo-controlled statin trials that were at least 6 months in duration.

RESULTS

There were 91 US and foreign reports of ALS with statins in AERS. The data mining signal scores for ALS and statins ranged from 8.5 to 1.6. Data were obtained from 41 statin clinical trials ranging in duration from 6 months to 5 years and representing approximately 200,000 patient-years of exposure to statin and approximately 200,000 patient-years of exposure to placebo. Nine cases of ALS were reported in statin-treated patients and 10 cases in placebo-treated patients.

CONCLUSIONS

Although we observed a data mining signal for ALS with statins in FDA's AERS, retrospective analyses of 41 statin clinical trials did not reveal an increased incidence of ALS in subjects treated with a statin compared with placebo.

Authors+Show Affiliations

Division of Metabolism and Endocrinology Products, United States Food and Drug Administration, Silver Spring, MD 20993, USA. eric.colman@fda.hhs.govNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article

Language

eng

PubMed ID

18821724

Citation

Colman, Eric, et al. "An Evaluation of a Data Mining Signal for Amyotrophic Lateral Sclerosis and Statins Detected in FDA's Spontaneous Adverse Event Reporting System." Pharmacoepidemiology and Drug Safety, vol. 17, no. 11, 2008, pp. 1068-76.
Colman E, Szarfman A, Wyeth J, et al. An evaluation of a data mining signal for amyotrophic lateral sclerosis and statins detected in FDA's spontaneous adverse event reporting system. Pharmacoepidemiol Drug Saf. 2008;17(11):1068-76.
Colman, E., Szarfman, A., Wyeth, J., Mosholder, A., Jillapalli, D., Levine, J., & Avigan, M. (2008). An evaluation of a data mining signal for amyotrophic lateral sclerosis and statins detected in FDA's spontaneous adverse event reporting system. Pharmacoepidemiology and Drug Safety, 17(11), 1068-76. https://doi.org/10.1002/pds.1643
Colman E, et al. An Evaluation of a Data Mining Signal for Amyotrophic Lateral Sclerosis and Statins Detected in FDA's Spontaneous Adverse Event Reporting System. Pharmacoepidemiol Drug Saf. 2008;17(11):1068-76. PubMed PMID: 18821724.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An evaluation of a data mining signal for amyotrophic lateral sclerosis and statins detected in FDA's spontaneous adverse event reporting system. AU - Colman,Eric, AU - Szarfman,Ana, AU - Wyeth,Jo, AU - Mosholder,Andrew, AU - Jillapalli,Devanand, AU - Levine,Jonathan, AU - Avigan,Mark, PY - 2008/9/30/pubmed PY - 2008/12/17/medline PY - 2008/9/30/entrez SP - 1068 EP - 76 JF - Pharmacoepidemiology and drug safety JO - Pharmacoepidemiol Drug Saf VL - 17 IS - 11 N2 - BACKGROUND: We detected disproportionate reporting of amyotrophic lateral sclerosis (ALS) with HMG-CoA-reductase inhibitors (statins) in the Food and Drug Administration's (FDA) spontaneous adverse event (AE) reporting system (AERS). PURPOSE: To describe the original ALS signal and to provide additional context for interpreting the signal by conducting retrospective analyses of data from long-term, placebo-controlled clinical trials of statins. METHODS: The ALS signal was detected using the multi-item gamma Poisson shrinker (MGPS) algorithm. All AERS cases of ALS reported in association with use of a statin were individually reviewed by two FDA neurologists. Manufacturers of lovastatin, pravastatin, simvastatin, fluvastatin, atorvastatin, cerivastatin, and rosuvastatin were requested to provide the number of cases of ALS diagnosed during all of their placebo-controlled statin trials that were at least 6 months in duration. RESULTS: There were 91 US and foreign reports of ALS with statins in AERS. The data mining signal scores for ALS and statins ranged from 8.5 to 1.6. Data were obtained from 41 statin clinical trials ranging in duration from 6 months to 5 years and representing approximately 200,000 patient-years of exposure to statin and approximately 200,000 patient-years of exposure to placebo. Nine cases of ALS were reported in statin-treated patients and 10 cases in placebo-treated patients. CONCLUSIONS: Although we observed a data mining signal for ALS with statins in FDA's AERS, retrospective analyses of 41 statin clinical trials did not reveal an increased incidence of ALS in subjects treated with a statin compared with placebo. SN - 1099-1557 UR - https://www.unboundmedicine.com/medline/citation/18821724/An_evaluation_of_a_data_mining_signal_for_amyotrophic_lateral_sclerosis_and_statins_detected_in_FDA's_spontaneous_adverse_event_reporting_system_ L2 - https://doi.org/10.1002/pds.1643 DB - PRIME DP - Unbound Medicine ER -