Yale University School of Medicine, New Haven, Connecticut, USA.
Ann Intern Med. 2012 Apr 17;156(8):560-9. doi: 10.7326/0003-4819-156-8-201204170-00003.
Fibric acid derivatives (fibrates) have been shown to increase serum creatinine level in randomized trials.
To assess renal outcomes in elderly adults within 90 days of a new fibrate prescription.
Population-based cohort study.
Ontario, Canada.
Patients aged 66 years or older with a new outpatient prescription for a fibrate or ezetimibe (comparator drug) between January 2004 and December 2008.
Hospitalization for an increase in serum creatinine level (primary outcome) and consultation with a nephrologist, receipt of dialysis for severe acute kidney injury, all-cause mortality, and increases in serum creatinine level (secondary outcomes). All outcomes were assessed within 90 days of a new prescription for ezetimibe or a fibrate.
Compared with ezetimibe users (n = 61,831), fibrate users (n = 19,072) were more likely to be hospitalized for an increase in serum creatinine level (adjusted odds ratio, 2.4 [95% CI, 1.7 to 3.3]) and were more likely to consult a nephrologist (absolute risk difference, 0.15% [CI, 0.01% to 0.29%]; adjusted odds ratio, 1.3 [CI, 1.0 to 1.6]). There were no differences between groups in the risk for all-cause mortality or receiving dialysis for severe acute kidney injury. In a subpopulation of 1110 patients (fibrates, n = 220; ezetimibe, n = 890), 9.1% of fibrate users and 0.3% of ezetimibe users had an increase in serum creatinine level of 50% or more (absolute difference, 8.8% [CI, 4.5% to 13.1%]; odds ratio, 29.6 [CI, 8.7 to 100.5]). Risks were greater among fibrate users with chronic kidney disease.
Because hospitalizations for an increase in serum creatinine level were underestimated, absolute differences may be misleading. Most patients (91%) were prescribed fenofibrate. Serum creatinine levels were measured as part of routine care and were not available for everyone or at predefined times.
New fibrate use in elderly adults was associated with an increase in serum creatinine level and a small 90-day absolute increase in hospitalizations and nephrologist consultations. There was no detectable effect on dialysis for severe acute kidney injury or on mortality. The mechanism and clinical significance of the increase in serum creatinine level with fibrates is unclear.
Ontario Ministry of Health and Long-Term Care Drug Innovation Fund.
随机试验表明，纤维酸衍生物（贝特类药物）会使血清肌酐水平升高。
评估新开具贝特类药物处方后 90 天内老年患者的肾脏结局。
基于人群的队列研究。
加拿大安大略省。
2004 年 1 月至 2008 年 12 月期间，年龄在 66 岁或以上且新开具贝特类药物或依折麦布（对照药物）门诊处方的患者。
血清肌酐水平升高导致住院（主要结局）以及咨询肾病专家、因严重急性肾损伤行透析、全因死亡率和血清肌酐水平升高（次要结局）。所有结局均在新开具依折麦布或贝特类药物处方后 90 天内进行评估。
与依折麦布使用者（n=61831）相比，贝特类药物使用者（n=19072）更有可能因血清肌酐水平升高而住院（校正优势比，2.4 [95%CI，1.7 至 3.3]），且更有可能咨询肾病专家（绝对风险差异，0.15%[CI，0.01%至 0.29%]；校正优势比，1.3 [CI，1.0 至 1.6]）。两组间全因死亡率或因严重急性肾损伤行透析的风险无差异。在 1110 例患者（贝特类药物组，n=220；依折麦布组，n=890）的亚组中，9.1%的贝特类药物使用者和 0.3%的依折麦布使用者的血清肌酐水平升高 50%或以上（绝对差异，8.8%[CI，4.5%至 13.1%]；比值比，29.6 [CI，8.7 至 100.5]）。在患有慢性肾脏病的贝特类药物使用者中，风险更高。
由于血清肌酐水平升高导致的住院人数被低估，绝对差异可能具有误导性。大多数患者（91%）被开了非诺贝特。血清肌酐水平是作为常规护理的一部分进行测量的，并非所有人或在预设时间都可以获得。
在老年患者中使用新的贝特类药物与血清肌酐水平升高以及 90 天内住院和咨询肾病专家的绝对人数略有增加有关。未发现对严重急性肾损伤的透析或死亡率有影响。贝特类药物引起的血清肌酐水平升高的机制和临床意义尚不清楚。
安大略省卫生部和长期护理药物创新基金。
