Preventable statin adverse reactions and therapy discontinuation. What can we learn from the spontaneous reporting system?
BACKGROUND
Statin treatment is often associated with poor adherence, which may be due to the onset of adverse drug reactions (ADRs). We investigated on potential risk factors related to preventable cases of statin-induced ADRs and to the discontinuation of statin therapy.


METHODS
We performed a study using the database of Italian spontaneous reporting. The target population for the preventability assessment was all patients with suspected statin-induced ADRs deriving from Campania Region (a territory of Southern Italy) between 2012 and 2017. Additionally, a local sentinel surveillance site involving General Practitioners was selected to countercheck in routine clinical practice the role of ADRs for statin discontinuation.


RESULTS
In total, 34 of 655 (5.19%) regional cases were preventable and among detected risk factors 90.0% was related to healthcare professionals' practices and 10.0% to patient behaviour. In 81.4% (533/655) of cases, statin therapy was discontinued due to ADRs, mainly classified as not serious and associated with a positive prognosis. These results were also confirmed in the active sentinel site.


CONCLUSIONS
Our findings suggest an inappropriate use of statins among the identified preventable cases and a potential inappropriate statin discontinuation due to ADRs. These factors may be useful for targeting interventions to improve statin adherence.
['Sessa|Maurizio|M|', 'Rafaniello|Concetta|C|', 'Scavone|Cristina|C|', 'Mascolo|Annamaria|A|', 'di Mauro|Gabriella|G|', 'Fucile|Annamaria|A|', 'Rossi|Francesco|F|', 'Sportiello|Liberata|L|', 'Capuano|Annalisa|A|']
D016907:Adverse Drug Reaction Reporting Systems D000368:Aged D016208:Databases, Factual D005260:Female D006801:Humans D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors D007558:Italy D008297:Male D055118:Medication Adherence D008875:Middle Aged D012307:Risk Factors D018571:Sentinel Surveillance
preventability statins spontaneous reporting system Adverse drug reactions pharmacovigilance safety treatment discontinuation