Abstract
Purpose: We performed a pharmacovigilance study of 10 drugs used in patients with relapsing-remitting multiple sclerosis (RR-MS). Our aim was to provide an overview of the safety of these drugs by the evaluation of reported expected and unexpected adverse reactions. Patients and methods: We collected and analyzed adverse drug reactions from RR-MS patients belonging to four hospitals in three Italian regions, for a period of 24 months. Results: We received a total of 411 adverse reactions, of which 84.18% were expected and only 15.82% were unexpected. We found no correlation between the number of reported adverse reactions and the route of administration (injectable/intravenous drugs N=224, oral drugs N=187). However, oral agents have caused a greater number of unexpected moderate-to-severe adverse reactions while, in injectable and infusion therapies, they have been evaluated as mild–moderate adverse reactions. Conclusion: Our results underscore the importance of monitoring the safety profile of multiple sclerosis therapies, with particular attention to oral agents that have been introduced later in the clinical practice.
| Original language | English |
|---|---|
| Pages (from-to) | 1765-1788 |
| Number of pages | 24 |
| Journal | Therapeutics and Clinical Risk Management |
| Volume | 14 |
| DOIs | |
| Publication status | Published - Jan 1 2018 |
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Keywords
- Adverse drug reaction
- Disease-modifying therapy
- Pharmacovigilance
- Relapsing-remitting multiple sclerosis
- Safety
ASJC Scopus subject areas
- Safety Research
- Pharmacology, Toxicology and Pharmaceutics(all)
- Pharmacology (medical)
- Chemical Health and Safety
Cite this
A multicentric pharmacovigilance study : Collection and analysis of adverse drug reactions in relapsing-remitting multiple sclerosis patients. / Gugliandolo, Agnese; Longo, Federica; Marrosu, Maria Giovanna; Mancardi, Giovanni Luigi; Gandoglia, Ilaria; Melis, Maurizio; Giudice, Fabrizio Lo; Bramanti, Placido; Mazzon, Emanuela.
In: Therapeutics and Clinical Risk Management, Vol. 14, 01.01.2018, p. 1765-1788.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A multicentric pharmacovigilance study
T2 - Collection and analysis of adverse drug reactions in relapsing-remitting multiple sclerosis patients
AU - Gugliandolo, Agnese
AU - Longo, Federica
AU - Marrosu, Maria Giovanna
AU - Mancardi, Giovanni Luigi
AU - Gandoglia, Ilaria
AU - Melis, Maurizio
AU - Giudice, Fabrizio Lo
AU - Bramanti, Placido
AU - Mazzon, Emanuela
PY - 2018/1/1
Y1 - 2018/1/1
N2 - Purpose: We performed a pharmacovigilance study of 10 drugs used in patients with relapsing-remitting multiple sclerosis (RR-MS). Our aim was to provide an overview of the safety of these drugs by the evaluation of reported expected and unexpected adverse reactions. Patients and methods: We collected and analyzed adverse drug reactions from RR-MS patients belonging to four hospitals in three Italian regions, for a period of 24 months. Results: We received a total of 411 adverse reactions, of which 84.18% were expected and only 15.82% were unexpected. We found no correlation between the number of reported adverse reactions and the route of administration (injectable/intravenous drugs N=224, oral drugs N=187). However, oral agents have caused a greater number of unexpected moderate-to-severe adverse reactions while, in injectable and infusion therapies, they have been evaluated as mild–moderate adverse reactions. Conclusion: Our results underscore the importance of monitoring the safety profile of multiple sclerosis therapies, with particular attention to oral agents that have been introduced later in the clinical practice.
AB - Purpose: We performed a pharmacovigilance study of 10 drugs used in patients with relapsing-remitting multiple sclerosis (RR-MS). Our aim was to provide an overview of the safety of these drugs by the evaluation of reported expected and unexpected adverse reactions. Patients and methods: We collected and analyzed adverse drug reactions from RR-MS patients belonging to four hospitals in three Italian regions, for a period of 24 months. Results: We received a total of 411 adverse reactions, of which 84.18% were expected and only 15.82% were unexpected. We found no correlation between the number of reported adverse reactions and the route of administration (injectable/intravenous drugs N=224, oral drugs N=187). However, oral agents have caused a greater number of unexpected moderate-to-severe adverse reactions while, in injectable and infusion therapies, they have been evaluated as mild–moderate adverse reactions. Conclusion: Our results underscore the importance of monitoring the safety profile of multiple sclerosis therapies, with particular attention to oral agents that have been introduced later in the clinical practice.
KW - Adverse drug reaction
KW - Disease-modifying therapy
KW - Pharmacovigilance
KW - Relapsing-remitting multiple sclerosis
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=85058467448&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85058467448&partnerID=8YFLogxK
U2 - 10.2147/TCRM.S174864
DO - 10.2147/TCRM.S174864
M3 - Article
AN - SCOPUS:85058467448
VL - 14
SP - 1765
EP - 1788
JO - Therapeutics and Clinical Risk Management
JF - Therapeutics and Clinical Risk Management
SN - 1176-6336
ER -