TY - JOUR
T1 - Reported muscle symptoms during statin treatment amongst Italian dyslipidaemic patients in the real-life setting
T2 - the PROSISA Study
AU - the PROSISA Study Group
AU - Casula, M.
AU - Gazzotti, M.
AU - Bonaiti, F.
AU - OImastroni, E.
AU - Arca, M.
AU - Averna, M.
AU - Zambon, A.
AU - Catapano, A. L.
AU - Arca, Marcello
AU - Montali, Anna
AU - Averna, Maurizio
AU - Giammanco, Antonina
AU - Biolo, Gianni
AU - Vinci, Pierandrea
AU - Borghi, Claudio
AU - D’Addato, Sergio
AU - Bossi, Antonio Carlo
AU - Meregalli, Giancarla
AU - Branchi, Adriana
AU - Squiccimarro, Giovanna
AU - Cavalot, Franco
AU - Ramadori, Linda
AU - Cipollone, Francesco
AU - Bucci, Marco
AU - Del Ben, Maria
AU - Angelico, Francesco
AU - Fiorenza, Anna Maria
AU - Colombo, Emanuela
AU - Grigore, Liliana
AU - Zampoleri, Veronica
AU - Lupattelli, Graziana
AU - Gandolfo, Vito
AU - Mandraffino, Giuseppe
AU - Savarino, Francesca
AU - Mombelli, Giuliana
AU - Pavanello, Chiara
AU - Pisciotta, Livia
AU - Pasta, Andrea
AU - Purrello, Francesco
AU - Scicali, Roberto
AU - Rubba, Paolo
AU - Fortunato, Giuliana
AU - Sabbà, Carlo
AU - Suppressa, Patrizia
AU - Sarzani, Riccardo
AU - Di Pentima, Chiara
AU - Vigna, Giovanni Battista
AU - Colangiulo, Angela
AU - Werba, Josè Pablo
AU - Vigo, Lorenzo Maria
N1 - Funding Information:
The PROSISA study is an initiative of the SISA Foundation supported by an unconditional research grant from Amgen Inc. The authors received no financial support for the research, authorship and/or publication of this article. The work of M Casula is supported by Ministry of Health‐IRCCS MultiMedica GR‐2016‐02361198 and Fondazione SISA. The work of M Arca is supported by Telethon GGP14066; Fondazione Roma Grant 2018‐H2217; National Institute of Health (USA), NIH R01‐HL 131961; Progetti Ricerca Ateneo, RM11715C683968E; and Grandi Progetti Unversità C26H15ZWC9, Fondazione SISA. The work of A Zambon is supported by Fondazione SISA. The work of AL Catapano has been supported by Ministry of Health ‐ Ricerca Corrente ‐ IRCCS MultiMedica, PRIN 2017H5F943 and ERANET ER‐2017‐2364981.
Funding Information:
M Casula, M Gazzotti, F Bonaiti and E Olmastroni report no disclosures. M Arca has received research funding and/or honoraria for advisory boards or speaker bureau from Alfasigma, Amryt, Amgen, Akcea/Ionis, Boehringer, Daichi‐Sankio, Novartis, Pfizer, Regeneron and Sanofi. M Averna received research funding and/or honoraria for advisory boards, consultancy or speaker bureau from Aegerion, Akcea, Amgen, Merck or MSD, Pfizer and Sanofi‐Regeneron. A Zambon received honoraria/expenses from Amgen, Eli Lilly, Abbott‐Mylan, Servier, Sanofi‐Regeneron, Amryt, Amarin and Daiichi Sankyo. AL Catapano reports grants from Amgen, Sanofi, Regeneron, personal fees from Merck, Sanofi, Regeneron, AstraZeneca, Amgen, Novartis, outside the submitted work.
Publisher Copyright:
© 2020 The Authors. Journal of Internal Medicine published by John Wiley & Sons Ltd on behalf of Association for Publication of The Journal of Internal Medicine
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020
Y1 - 2020
N2 - Aim: Statin-associated muscle symptoms (SAMS) are a major determinant of poor treatment adherence and/or discontinuation, but a definitive diagnosis of SAMS is challenging. The PROSISA study was an observational retrospective study aimed to assess the prevalence of reported SAMS in a cohort of dyslipidaemic patients. Methods: Demographic/anamnestic data, biochemical values and occurrence of SAMS were collected by 23 Italian Lipid Clinics. Adjusted logistic regression was performed to estimate odds ratio (OR) and 95% confidence intervals for association between probability of reporting SAMS and several factors. Results: Analyses were carried out on 16 717 statin-treated patients (mean ± SD, age 60.5 ± 12.0 years; 52.1% men). During statin therapy, 9.6% (N = 1599) of patients reported SAMS. Women and physically active subjects were more likely to report SAMS (OR 1.23 [1.10–1.37] and OR 1.35 [1.14–1.60], respectively), whist age ≥ 65 (OR 0.79 [0.70–0.89]), presence of type 2 diabetes mellitus (OR 0.62 [0.51–0.74]), use of concomitant nonstatin lipid-lowering drugs (OR 0.87 [0.76–0.99]), use of high-intensity statins (OR 0.79 [0.69–0.90]) and use of potential interacting drugs (OR 0.63 [0.48–0.84]) were associated with lower probability of reporting SAMS. Amongst patients reporting SAMS, 82.2% underwent dechallenge (treatment interruption) and/or rechallenge (change or restart of statin therapy), with reappearance of muscular symptoms in 38.4% (3.01% of the whole cohort). Conclusions: The reported prevalence of SAMS was 9.6% of the whole PROSISA cohort, but only a third of patients still reported SAMS after dechallenge/rechallenge. These results emphasize the need for a better management of SAMS to implement a more accurate diagnosis and treatment re-evaluation.
AB - Aim: Statin-associated muscle symptoms (SAMS) are a major determinant of poor treatment adherence and/or discontinuation, but a definitive diagnosis of SAMS is challenging. The PROSISA study was an observational retrospective study aimed to assess the prevalence of reported SAMS in a cohort of dyslipidaemic patients. Methods: Demographic/anamnestic data, biochemical values and occurrence of SAMS were collected by 23 Italian Lipid Clinics. Adjusted logistic regression was performed to estimate odds ratio (OR) and 95% confidence intervals for association between probability of reporting SAMS and several factors. Results: Analyses were carried out on 16 717 statin-treated patients (mean ± SD, age 60.5 ± 12.0 years; 52.1% men). During statin therapy, 9.6% (N = 1599) of patients reported SAMS. Women and physically active subjects were more likely to report SAMS (OR 1.23 [1.10–1.37] and OR 1.35 [1.14–1.60], respectively), whist age ≥ 65 (OR 0.79 [0.70–0.89]), presence of type 2 diabetes mellitus (OR 0.62 [0.51–0.74]), use of concomitant nonstatin lipid-lowering drugs (OR 0.87 [0.76–0.99]), use of high-intensity statins (OR 0.79 [0.69–0.90]) and use of potential interacting drugs (OR 0.63 [0.48–0.84]) were associated with lower probability of reporting SAMS. Amongst patients reporting SAMS, 82.2% underwent dechallenge (treatment interruption) and/or rechallenge (change or restart of statin therapy), with reappearance of muscular symptoms in 38.4% (3.01% of the whole cohort). Conclusions: The reported prevalence of SAMS was 9.6% of the whole PROSISA cohort, but only a third of patients still reported SAMS after dechallenge/rechallenge. These results emphasize the need for a better management of SAMS to implement a more accurate diagnosis and treatment re-evaluation.
KW - adverse effects
KW - myopathy
KW - statin-associated muscle symptoms
KW - statins
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U2 - 10.1111/joim.13219
DO - 10.1111/joim.13219
M3 - Article
C2 - 33259671
AN - SCOPUS:85098168978
JO - Journal of Internal Medicine
JF - Journal of Internal Medicine
SN - 0954-6820
ER -