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Finding
Finding
null
Addition of fenofibrate to simvastatin did not significantly reduce major cardiovascular events compared with simvastatin alone in the overall ACCORD-Lipid cohort of patients with Type 2 diabetes (2.24% vs 2.41% per year, HR 0.92, 95% CI 0.79-1.08, p=0.32).
| Effect size | HR 0.92 |
| CI | 95% CI 0.79-1.08 |
| Follow-up | 4.7 years |
| Comparator | Placebo added to simvastatin (20-40 mg/day) |
| Effect summary | null; HR 0.92; CI: 95% CI 0.79-1.08 |
| Effect modifiers | [{"modifier": "sex", "interaction_p": "p=0.011", "direction": "reverses", "stratum_details": "Men appeared more likely to benefit from fenofibrate; women showed a suggestion of detriment. Female placebo CVD rate 6.6% over 4.7 years was only 50% of male placebo rate.", "plain_language": "This drug combo seemed to help men but may have been harmful for women, and researchers don't yet know why.", "annotation_notes": "Prespecified subgroup analysis. The investigators were surprised by this finding; it was NOT observed in FIELD."}, {"modifier": "race", "interaction_p": "p=0.09", "direction": "attenuates", "stratum_details": "White subjects seemed to have a better outcome with fenofibrate than non-white subjects.", "plain_language": "White patients appeared to benefit more, but this was not a statistically strong finding.", "annotation_notes": "Trend only (p=0.09); under investigation."}, {"modifier": "baseline lipid profile (dyslipidemia: TG>=204 mg/dl and HDL-C<=34 mg/dl)", "interaction_p": "p=0.057", "direction": "amplifies", "stratum_details": "Dyslipidemic subgroup (17% of cohort): 31% lower CVD event rate (17.3% vs 10.1% in placebo groups). Gender heterogeneity not apparent within this subgroup.", "plain_language": "Patients who had both high triglycerides and very low good cholesterol saw real heart benefit from adding fenofibrate -- about a third fewer heart attacks and strokes.", "annotation_notes": "Prespecified subgroup. Concordant with similar subgroup findings across FIELD, VA-HIT, HHS, BIP trials."}] |
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Source
PMC4509601
The ACCORD-Lipid study: implications for treatment of dyslipidemia in Type 2 diabetes mellitus