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.

Reported muscle symptoms during statin treatment amongst Italian dyslipidaemic patients in the real-life setting : the PROSISA Study / M. Casula, M. Gazzotti, F. Bonaiti, E. Olmastroni, M. Arca, M. Averna, A. Zambon, A.L. Catapano, M. Arca, A. Montali, M. Averna, A. Giammanco, G. Biolo, P. Vinci, C. Borghi, S. D'Addato, A.C. Bossi, G. Meregalli, A. Branchi, G. Squiccimarro, F. Cavalot, L. Ramadori, F. Cipollone, M. Bucci, M. Del Ben, F. Angelico, A.M. Fiorenza, E. Colombo, L. Grigore, V. Zampoleri, G. Lupattelli, V. Gandolfo, G. Mandraffino, F. Savarino, G. Mombelli, C. Pavanello, L. Pisciotta, A. Pasta, F. Purrello, R. Scicali, P. Rubba, G. Fortunato, C. Sabba, P. Suppressa, R. Sarzani, C. Di Pentima, G.B. Vigna, A. Colangiulo, J.P. Werba, L.M. Vigo, S. Zambon, L. Previato, M.G. Zenti, C. Maneschi. - In: JOURNAL OF INTERNAL MEDICINE. - ISSN 0954-6820. - (2020 Dec 01). [Epub ahead of print] [10.1111/joim.13219]

Reported muscle symptoms during statin treatment amongst Italian dyslipidaemic patients in the real-life setting : the PROSISA Study

Casula M.;Gazzotti M.;Bonaiti F.;Olmastroni E.;Catapano A. L.;Branchi A.;Squiccimarro G.;Zampoleri V.;Mombelli G.;Pavanello C.;
2020-12-01

Abstract

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.
adverse effects; myopathy; statin-associated muscle symptoms; statins
Settore BIO/14 - Farmacologia
JOURNAL OF INTERNAL MEDICINE
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/809339
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