患有CKD的糖尿病患最好適當控制血糖


  【24drs.com】根據一篇新研究,對於患有慢性腎臟病(CKD)的糖尿病患,糖化血色素(HbA1c))目標介於7%-9%者,則副作用風險降低,若數據超出或低於前述範圍時,風險則會增加。
  
  加拿大Alberta大學的Sabin Shurraw醫師等人在11月28日內科醫學誌刊載的文章中寫道,HbA1c數值較高與多種臨床相關結果,包括死亡率、心血管事件、住院與惡化成腎衰竭有獨立且強烈的關聯。
  
  他們的研究結果和「一般糖尿病患中,患有第3-4期CKD者若有較佳的血糖控制,則傾向可改善臨床結果」之假設一致,但是,若過度治療(HbA1c值低於7%)也可能有傷害。
  
  雖然患有第3-4期CKD之糖尿病患有較佳的血糖控制時,前述4項結果的風險降低,但是,另一個結果:末期腎臟病(ESRD),第4期CKD者的風險降低程度低於3期CKD者。
  
  這篇研究使用的資料,來自2005-2006年該省衛生部與Alberta Kidney Disease Network患有DM和CKD的病患,檢視血糖控制和不佳結果之間的關聯。
  
  CKD之鑑定是透過例行性的血清肌酸酐檢測,定義為估計腎絲球過濾速率(eGFR)小於60.0 mL/分鐘/1.73 m2;總共有23,296名病患符合研究規範,多數(21,155人)為第3期CKD (eGFR,30.0 - 59.9 mL/分鐘/1.73 m2,2,141人為第4期CKD (eGFR,15.0 - 29.9 mL/分鐘/1.73 m2)。
  
  HbA1c中位數為6.9% (範圍2.8% - 20.0%),11%的研究對象其HbA1c值大於9%。
  
  該研究的初級結果為各種原因死亡率,其他結果為心血管事件、住院、惡化為腎臟病(血清肌酸酐值加倍)與ESRD。
  
  追蹤期間中位數為3.8年(範圍1 – 51個月),16%病患死亡、49%住院、16%有任何一種心血管事件、6%惡化性腎臟病、2%發生ERSD。
  
  這篇分析校正了幾項可能的干擾因素:年紀、性別、指標eGFR、個別的健康保險範圍(個別收入指標)、鄰近地區收入中位數、共病症、居住地區等。
  
  研究者發現,對於第3和第4期CKD者,較高的HbA1c值與各種原因死亡率、心血管事件、住院、惡化成腎臟病等風險增加有關(P < .001),但是,在ESRD這個結果方面,第4期CKD者的關連程度低於3期CKD者。
  
  特別的是,對於這2期的CKD,HbA1c值大於9%時,各種原因的死亡率風險顯著高於HbA1c值低於7%者(校正風險比[HR], 1.35;95%信心區間[CI]1.21 - 1.50),不過,這個關聯趨勢呈現U字型,在HbA1c值大於8%或低於6.5%者,死亡率風險比HbA1c值7%者增加。
  
  作者們推測,如同「Action to Control Cardiovascular Risk in Diabetes (ACCORD)」這項試驗的研究對象,有道理的是,患DM和CKD的病患若治療達到HbA1c值低於6.5%,可能會發生因為嚴重低血糖事件、或者平均血糖值驟降而引起傷害。
  
  類似的是,對於第3和第4期CKD者,相較於HbA1c值低於7%者,HbA1c值高於9%時和住院率風險增加(校正相對風險[RR]分別是1.44 [95% CI,1.36 - 1.52]和1.25 [95% CI,1.01 - 1.54])、以及惡化成腎臟病(校正HR,1.77分別是[95% CI,1.48 - 2.13]與1.40 [95% CI,1.17 - 1.67])有關。
  
  不過,對於ESRD,相較於第4期CKD患者(校正HR,1.13 [95% CI,0.80 - 1.59]),HbA1c值較高與第3期CKD患者(校正HR,2.52 [95% CI,1.58 - 4.02])風險更高有關。
  
  作者們推測,這個結果或許可以代表腎臟功能的一個「不歸路」,超過此指標時,更好的血糖控制或許不足以預防腎功能逐漸喪失。
  
  David C. Goff博士受邀評論這篇報告時指出,研究結果強調了考量相對與絕對利益或風險的重要性,特別是檢視風險或治療效果差異的次組時。
  
  來自南卡羅來納州Wake Forest醫學院流行病學與預防系的Goff博士指出,如果要根據估計的校正絕對風險探討這些資料,ESRD在良好與不佳血糖控制的差異為,第3期CKD患者是0.60%、第4期CKD患者則是1.41%
  
  就這個觀點看來,密集的血糖控制可能會使第4期CKD患者對ESRD有比第3期CKD患者大的預防效果,這個推論和作者們僅根據相對風險(潛在的相對風險降低)時有所不同。
  
  不過,Goff博士認為,整體的研究結果強調了HbA1c值高是心血管和腎臟方面結果之風險指標的重要性,因為沒有強力證據針對末期CKD和DM病患,比較慎重的作法是,至少要注意中度風險因素,儘可能使治療處方的可能嚴重風險降到最低。
  
  資料來源:http://www.24drs.com/professional/list/content.asp?x_idno=6667&x_classno=0&x_chkdelpoint=Y
  

In Diabetes With CKD, Moderate Glycemic Control May Be Ideal

By Kate Johnson
Medscape Medical News

November 30, 2011 — In patients with diabetes mellitus (DM) and chronic kidney disease (CKD), hemoglobin A1c (HbA1c) targets that fall between 7% and 9% may be associated with decreased risk for adverse outcomes, whereas levels either above or below this range may increase this risk, according to a new study.

"[W]e found strong and independent associations between higher levels of HbA1c and multiple clinically relevant outcomes, including mortality, [cardiovascular] events, hospitalization, and progression to kidney failure," write Sabin Shurraw, MD, from the University of Alberta in Edmonton, Canada, and colleagues, in an article published in the November 28 issue of the Archives of Internal Medicine.

"Our findings are consistent with the hypothesis that (as in the general population of patients with DM) better glycemic control in patients with stage 3 to 4 CKD tends to improve clinical outcomes, but that overly intensive therapy (ie, HbA1c target level lower than 7%) may be harmful," they write.

However, although risk reduction for 4 outcomes was associated with better glycemic control among patients with both stage 3 and 4 CKD, findings for a fifth outcome, end-stage renal disease (ESRD), showed that the association between better glycemic control and reduced risk was actually weaker for those with stage 4 CKD compared with for those with stage 3 disease.

The study used data on patients with both DM and CKD from the Alberta Kidney Disease Network and the provincial health ministry from 2005 through 2006 to examine the association between glycemic control and adverse outcomes.

CKD was identified through routine serum creatinine measurements and was defined as an estimated glomerular filtration rate (eGFR) of less than 60.0 mL/minute per 1.73 m2.

A total of 23,296 patients met criteria for the study, most (n = 21,155) with stage 3 CKD (eGFR, 30.0 - 59.9 mL/minute per 1.73 m2), and 2141 with stage 4 CKD (eGFR, 15.0 - 29.9 mL/minute per 1.73 m2).

The median HbA1c level was 6.9% (range, 2.8% - 20.0%), and 11% of the participants had an HbA1c level higher than 9%.

The primary outcome for the study was all-cause mortality, with other outcomes being cardiovascular events, hospitalizations, progression of kidney disease (based on a doubling of serum creatinine level), and ESRD.

During the median follow-up period of 3.8 years (range, 1 - 51 months), 16% of patients died, 49% were hospitalized, 16% had any cardiovascular event, 6% had progression of kidney disease, and 2% developed ERSD.

The analysis was adjusted for the following potential confounders: age, sex, index eGFR, individual health insurance premium level (a marker for individual level income), median neighborhood income, comorbidity, and residence location.

The researchers found that for both stage 3 and stage 4 CKD, higher HbA1c levels were associated with an increased risk for all-cause mortality, cardiovascular events, hospitalizations, and progression of kidney disease (P < .001), but for the ERSD outcome, the magnitude of this association was weaker among those with stage 4 CKD compared with those with stage 3 CKD.

Specifically, for both stages of CKD, HbA1c levels above 9% were associated with significantly higher all-cause mortality than HbA1c levels below 7% (adjusted hazard ratio [HR], 1.35; 95% confidence interval [CI], 1.21 - 1.50), although there was a U-shape to this association, in that HbA1c levels greater than 8% or lower than 6.5% were associated with increased mortality compared with levels of 7%.

"As with participants in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, it is plausible that patients with DM and CKD who are treated to an HbA1c level lower than 6.5% might experience iatrogenic harm owing to serious hypoglycemic events or too precipitous a fall in average glucose," the authors speculate.

Similarly, for both stages 3 and 4 CKD, HbA1c levels higher than 9%, compared with those lower than 7%, were associated with an increased risk for hospitalization (adjusted relative risk [RR], 1.44 [95% CI, 1.36 - 1.52] and 1.25 [95% CI, 1.01 - 1.54], respectively), as well as with progression of kidney disease (adjusted HR, 1.77 [95% CI, 1.48 - 2.13] and 1.40 [95% CI, 1.17 - 1.67], respectively).

However, for ERSD, the higher HbA1c level was associated with more risk among in patients with stage 3 CKD (adjusted HR, 2.52 [95% CI, 1.58 - 4.02]) compared with those with stage 4 CKD (adjusted HR, 1.13 [95% CI, 0.80 - 1.59]).

"We speculate that this finding may represent a 'point of no return' for kidney function — beyond which better glycemic control may simply not be enough to prevent progressive kidney function loss," the authors write.

In an invited commentary accompanying the paper, David C. Goff, MD, PhD, writes that the findings "underscore the importance of considering relative and absolute risks (or benefits) when examining potential subgroup differences in risk (or treatment) effects."

If one were to look at the data according to estimated adjusted absolute risks, the difference in risk for ESRD between good and poor glycemic control would be 0.60% in patients with stage 3 CKD and 1.41% in patients with stage 4 CKD, noted Dr. Goff, who is from the Department of Epidemiology and Prevention at Wake Forest School of Medicine in Winston-Salem, North Carolina.

"From this perspective, intensive glucose control might lead to greater absolute prevention of ESRD in stage 4 CKD than in stage 3 CKD, an inference that conflicts with the speculation of the authors based on considering relative risk (and potential relative risk reduction) alone."

However, acknowledging that the overall study results "emphasize the importance of a high HbA1c level as a risk marker for cardiovascular and renal outcomes," Dr. Goff suggests that "[i]n the absence of strong evidence specific to patients with advanced CKD and DM, prudent practice may be to pursue at least moderately intensive risk factor management while minimizing the potential for serious adverse effects of the treatment regimens."

The study was funded by an operating grant from the Heart and Stroke Foundation of Canada, and by an interdisciplinary team grant from the Alberta Heritage Foundation for Medical Research. Four authors were supported by career salary awards from the foundation. One author was also supported by a Government of Canada Research Chair. Four authors were supported by a joint initiative between Alberta Health and Wellness and the Universities of Alberta and Calgary. Dr. Goff is an ACCORD investigator. He has received compensation as a member of the Operations Committee for a trial of a glucose-lowering medication marketed by Merck. He serves as a Data and Safety Monitoring Board member for a trial of a glucose-lowering medication marketed by Takeda.

Arch Intern Med. 2011;171:1920-1927.

    
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