Tenenbaum Alexander, Motro Michael, Fisman Enrique Z, Adler Yehuda, Shemesh Joseph, Tanne David, Leor Jonathan, Boyko Valentina, Schwammenthal Ehud, Behar Solomon
Cardiac Rehabilitation Institute, Chaim Sheba Medical Center, Tel-Hashomer 52621, Israel.
Eur Heart J. 2005 Oct;26(19):2032-8. doi: 10.1093/eurheartj/ehi310. Epub 2005 May 4.
To assess the effect of fibric acid derivative bezafibrate on incidence of type 2 diabetes in obese patients over a median 6.3 years follow-up period.
The study sample comprised 339 non-diabetic obese patients (body mass index > or = 30.0 kg/m2) aged 42-74. Patients received either bezafibrate retard 400 mg (178 patients) or placebo (161 patients) once daily. Development of new diabetes was recorded in 98 patients: in 56 (37.0%) from the placebo group vs. 42 (27.1%) from the bezafibrate group, (P log-rank=0.01). The median time (interquartile range) until onset of new diabetes was significantly delayed in patients on bezafibrate when compared with those on placebo: 4.0 (2.1-5.0) vs. 2.0 (0.5-3.5) years, P=0.002. Multivariable analysis identified bezafibrate treatment as an independent predictor of reduced risk of new diabetes with hazard ratio (HR) 0.59 [95% confidence interval (CI) 0.39-0.91]. Other significant variables associated with future overt type 2 diabetes in obese patients were triglycerides (50 mg/dL increment) with HR 1.15 (95% CI 1.02-1.28) and fasting glucose (10 mg/dL increment) with HR 2.27 (95% CI 1.83-2.81).
Bezafibrate, when compared with placebo, reduced the incidence and delayed the onset of type 2 diabetes in obese patients over a long-term follow-up period.
评估在中位6.3年的随访期内,纤维酸衍生物苯扎贝特对肥胖患者2型糖尿病发病率的影响。
研究样本包括339例42 - 74岁的非糖尿病肥胖患者(体重指数≥30.0kg/m²)。患者每日一次接受400mg缓释苯扎贝特(178例患者)或安慰剂(161例患者)治疗。98例患者出现新发糖尿病:安慰剂组56例(37.0%),苯扎贝特组42例(27.1%),(对数秩检验P = 0.01)。与接受安慰剂治疗的患者相比,接受苯扎贝特治疗的患者发生新发糖尿病的中位时间(四分位间距)显著延迟:4.0(2.1 - 5.0)年 vs. 2.0(0.5 - 3.5)年,P = 0.002。多变量分析确定苯扎贝特治疗是新发糖尿病风险降低的独立预测因素,风险比(HR)为0.59 [95%置信区间(CI)0.39 - 0.91]。与肥胖患者未来显性2型糖尿病相关的其他显著变量包括甘油三酯(每增加50mg/dL),HR为1.15(95%CI 1.02 - 1.28)和空腹血糖(每增加10mg/dL),HR为2.27(95%CI 1.83 - 2.81)。
与安慰剂相比,在长期随访期内,苯扎贝特降低了肥胖患者2型糖尿病的发病率并延迟了其发病时间。