Background: Signals of disproportionally high reporting of amyotrophic lateral sclerosis (ALS) with HMG-CoA-reductase inhibitors (statins) were detected in surveillance databases. A pooled analysis of clinical trials did not find an increased incidence of ALS in the statins arm. Case-control and cohort studies yield inconclusive results. Evidence that statins worsen disease course is also inconclusive.
Objectives: Preliminarily to an analytic study, we assessed statins use in a cohort of ALS patients and in the general population.
Methods: The cohort included all residents of the Friuli Venezia Giulia (FVG) region, Italy, with incident ALS from 2002 to 2009. Cases were identified through multiple sources including health databases; the diagnosis was validated through clinical documentation review. Statins prescriptions in the cohort and in the general FVG population from 2002 to 2009 were obtained from the regional outpatient prescription database, through the ATC classification code C10AA. We calculated the 2002–2009 annual age–sexstandardized prevalence of statins use, with 95%
confidence interval (95%CI). The 2006 census FVG population was the standard.
Results: The cohort included 262 subjects with ALS, 50.4% men, median age at diagnosis 67.4 years. Age–sex-standardized prevalence of statins use was 62.0‰ (95%CI [56.3, 67.6]) in the cohort and
65.2‰(95%CI [59.6, 70.9]) in the general population. Fifty-three (20.2%) patients had at least one prescription of a statin in the year before diagnosis, only 16 (6.1%) in the year thereafter.
Conclusions: Prevalence of statin use was similar in ALS cohort and general population. In ALS cohort, the frequency of use decreased after diagnosis. Conflicting study results may have influenced prescribing
physicians’ and/or patients’ decision of discontinue statins.
