2018
DOI: 10.1007/s00228-018-2589-z
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Statin-associated immune-mediated necrotizing myopathy: a retrospective analysis of individual case safety reports from VigiBase

Abstract: use French regional pharmacovigilance network and the Surveillance Division from the ANSM The source of the information is the WHO database "VigiBase". The information comes from a variety of sources and the likelihood that the suspected adverse reaction is drug-related is not the same in all cases. This information does not represent the opinion of the World Health Organization.

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Cited by 12 publications
(12 citation statements)
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“…There are currently no randomised control trials to guide treatment protocols; thus recommendations are based on expert opinion from specialists experience, retrospective studies or case series. Initial treatment is usually with high-dose corticosteroids and majority of the patients require aggressive treatment with two or more immunotherapeutic agents including IVIG, methotrexate, mycophenolate mofetil, rituximab, azathioprine and occasionally plasmapheresis 1 9 11. Of note, our patient developed more severe symptoms after starting prednisone, requiring more aggressive immunosuppression.…”
Section: Discussionmentioning
confidence: 79%
See 1 more Smart Citation
“…There are currently no randomised control trials to guide treatment protocols; thus recommendations are based on expert opinion from specialists experience, retrospective studies or case series. Initial treatment is usually with high-dose corticosteroids and majority of the patients require aggressive treatment with two or more immunotherapeutic agents including IVIG, methotrexate, mycophenolate mofetil, rituximab, azathioprine and occasionally plasmapheresis 1 9 11. Of note, our patient developed more severe symptoms after starting prednisone, requiring more aggressive immunosuppression.…”
Section: Discussionmentioning
confidence: 79%
“…MRI when done, shows widespread muscle oedema, with focal or diffuse abnormal signal in the trunk and limb muscles. Characteristic features on histology are myocyte necrosis and regeneration without significant inflammation 1 5 9 10. While histology is required to confirm diagnosis in the autoantibody negative NAM, specific histological features are not required to classify patients with autoantibody positive NAM 4…”
Section: Discussionmentioning
confidence: 99%
“…A review of recent literature yielded only two reported cases with death as a complication of statininduced IMNM. 13 Of these two cases, one described dysphagia as a presenting symptom. Interestingly, this case was also complicated by respiratory distress requiring ventilator support, and ultimately death from ventilator-acquired pneumonia.…”
Section: Discussionmentioning
confidence: 99%
“… 7 With commercially available antibody testing now more readily available, biopsy is no longer required for a diagnosis of seropositive IMNM. 13 However, seronegative IMNM accounts for 25-40% of IMNM, and presents with elevated CPK, muscle weakness, and a biopsy demonstrating necrotizing myopathy despite no antibody detection. Hence, muscle biopsy remains necessary for a diagnosis of seronegative IMNM, and for this reason is still often employed as part of the diagnostic work up.…”
Section: Discussionmentioning
confidence: 99%
“…Its onset can be days to years after continuous exposure to statins 4. Most of the cases have been reported with atorvastatin, but no data on certain statins or dose dependency have been found 5. Pathogenesis of SINAM is still not completely understood, but an association has been observed between statin exposure and autoantibodies against HMGCR.…”
Section: Discussionmentioning
confidence: 99%