Preventable statin adverse reactions and therapy discontinuation. What can we learn from the spontaneous reporting system?

ABSTRACT

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.

KEYWORDS:

• Adverse drug reactions
• preventability
• treatment discontinuation
• statins
• spontaneous reporting system
• safety
• pharmacovigilance

Acknowledgments

The authors would like to thank all the General Practitioners who provided patient data of the local health unit of Caserta: Dr. Bove RM, Dr. Coppola C, Dr. Coppola P, Dr. Coviello C, Dr. Diana T, Dr. Ferraiuolo C, Dr. Greco A, Dr. Letizia G, Dr. Lombardi I, Dr. Lonardo AC, Dr. Natale A, Dr. Santonastaso S, Dr. Stranges MP. Moreover, the authors thank all the monitors (Francesca Futura Bernardi, Alessandra Maccariello) who supported the above cited General Practitioners in the data entry in an ad-hoc database.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

Developed the concept and designed the study: CR, AF, FR, LS, AC. Analysis, or interpretation of data: MS, AM, CS, Gd, LS. Drafting the paper and revising it for important intellectual content: MS, CR, FR, LS, AC. Wrote the paper: MS, CR, LS. Final approval of the version to be published: MS, CR, CS, AM, Gd, AF, FR, LS, AC.

Supplemental data for this article can be accessed here.

Additional information

Funding

This paper has not been funded.