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Finding
Finding
adverse
Fenofibrate added to simvastatin caused significantly more frequent serum creatinine elevations compared with simvastatin alone, in women (27.9% vs 18.7%, p<0.001) and men (36.7% vs 18.5%, p<0.001), though the effect is considered reversible.
| Effect size | Women: 27.9% vs 18.7%; Men: 36.7% vs 18.5% |
| Follow-up | 4.7 years |
| Comparator | Placebo added to simvastatin (20-40 mg/day) |
| Effect summary | adverse; Women: 27.9% vs 18.7%; Men: 36.7% vs 18.5% |
| Adverse events | serum creatinine elevation 27.9% in women, 36.7% in men |
| Effect modifiers | [{"modifier": "sex", "interaction_p": "", "direction": "null", "stratum_details": "Women: 27.9% vs 18.7% (p<0.001); Men: 36.7% vs 18.5% (p<0.001). Both sexes had significantly more creatinine elevation with fenofibrate, with similar relative increases.", "plain_language": "Both men and women had more creatinine elevation with fenofibrate, though men had slightly higher absolute rates.", "annotation_notes": "Reported stratified by sex in Table 1 with different thresholds (>1.3 mg/dl for women, >1.5 mg/dl for men). No formal interaction test reported."}] |
Connected entities
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Source
PMC4509601
The ACCORD-Lipid study: implications for treatment of dyslipidemia in Type 2 diabetes mellitus