FDA safety concerns and menopausal-like symptoms in postmenopausal statin users.

OBJECTIVES

In light of US Food and Drug Administration (FDA) warnings about adverse effects of statin therapy, some of which resemble menopausal complaints, this study compared menopause-related manifestations [Menopause Rating Scale (MRS), cognitive, and musculoskeletal symptoms] between users and non-users of statins among postmenopausal women.

METHODS

This multinational, cross-sectional sub-analysis of the REDLINC XII study included 1,184 postmenopausal women from nine Latin American countries. Menopausal symptoms were assessed with the MRS, cognitive function with the Montreal Cognitive Assessment (MoCA), and sarcopenia risk with the SARC-F questionnaire. Multivariable logistic regression models evaluated associations between statin therapy and outcomes (menopausal symptoms, cognition, and sarcopenia risk) after adjustment for sociodemographic, lifestyle, and clinical factors.

RESULTS

Of the 1,184 women, 307 (25.9%) used statins. Compared with non-users, statin users had a higher prevalence of severe menopausal symptoms (47.2% vs. 30.6%), more intense musculoskeletal symptoms (53.1% vs. 33.9%), and higher sarcopenia risk (28.7% vs. 16.5%; all P=0.0001). In multivariable logistic regression analyses, statin therapy was not associated with mild cognitive impairment defined by the MoCA global score, although exploratory analyses suggested poorer performance in delayed recall memory and visuospatial function among users. Statin therapy remained independently associated with severe menopausal symptoms [odds ratio (OR): 1.56; 95% CI: 1.17-2.10] and sarcopenia risk (OR: 1.65; 95% CI: 1.19-2.29).

CONCLUSIONS

In postmenopausal women, statin therapy was not associated with mild cognitive impairment; however, statin use was linked to poorer delayed recall memory and visuospatial function and a higher burden of menopausal symptoms and sarcopenia risk. Statin-related cognitive and somatic effects may overlap with menopausal symptomatology and contribute to symptom burden during midlife.