■ 試験デザイン
We identified all patients living in Denmark who were aged 40 years or older and were diagnosed with incident diabetes between Jan 1, 1996, and Dec 31, 2009.
We randomly selected 15,679 individuals from the database who had used statins regularly until their diagnosis of diabetes (statin users) and matched them in a 1:3 ratio with 47,037 individuals who had never used statins before diagnosis (non-statin users). Our primary outcome was to compare the cumulative incidence of diabetic retinopathy, diabetic neuropathy, diabetic nephropathy, or gangrene of the foot in statin users versus non-statin users.
Median follow-up was 2·7 years (range 0-13).
T コホート内症例対照研究 中央値2.7年(range 0-13)
P 40歳以上で糖尿病と診断されたデンマークのすべての患者
E n=15,679 スタチン使用群
C n=47,037 スタチン非使用群
O 糖尿病患者網膜症、糖尿病性神経障害、糖尿病腎症、糖尿病足壊疽の発症
■ 結果
Compared with non-statin users, statin users had a lower cumulative incidence of diabetic retinopathy (hazard ratio 0·60, 95% CI 0·54-0·66; p<0·0001), diabetic neuropathy (0·66, 0·57-0·75; p<0·0001), and gangrene of the foot (0·88, 0·80-0·97; p=0·010), but not diabetic nephropathy (0·97, 0·85-1·10; p=0·62). These results were similar after adjusting for the competing risk of death, after matching for a propensity score, after adjusting for visits to a family doctor, and by stratification on covariates. The corresponding multivariable adjusted hazard ratio for risk of diabetes in the total population was 1·17 (95% CI 1·14-1·21; p<0·0001). INTERPRETATION:
スタチンを使用すると糖尿病発症リスクは17％増加するものの、糖尿病になった場合の網膜症発症は40％、神経障害発症は34％、足壊疽発症は12％減らせるようですね。腎症は差が出なかったようですが、観察期間が中央値2.7年であることが影響している可能性があります。
■ 参照文献
Nielsen SF eat al, Lancet Diabetes Endocrinol. 2014 Nov;2(11):894-900. PMID: 25217178