Thiazolidinediones藥物與Metformin對心臟衰竭有益


  Feb. 8, 2004 - 一項發表於2月8日循環期刊上的回顧性分析、觀察性試驗結果指出,Thiazolidinediones類藥物與Metformin不僅是無害的,而且實際上對糖尿病與心臟衰竭老年病患是有益的;研究人員表示,需要進一步的隨機分派試驗來證實這項發現。
  
  來自科羅拉多州丹佛健康醫學中心的Frederick A. Masoudi醫師與其同事表示,儘管美國食品藥物管理局反對這項作法,但Thiazolidinediones類藥物與Metformin這類的胰島素敏感化藥物,經常使用於治療有心臟衰竭的糖尿病病患;然而,這是否會造成不好的後果仍然是未知的。
  
  透過來自國家心臟照護計畫(NHC)的健康保險資料,研究人員針對Thiazolidinediones類藥物與Metformin的處方,及16,417位因心臟衰竭住院後死亡的糖尿病病患,與再次住院之間的關連進行分析。
  
  以Thiazolidinediones類藥物治療的2,226位病患,其原始1年死亡率為30.1%,而1,864位接受Metformin治療的病患為24.7%,低於12,069位沒有接受這兩種藥物治療病患的36.0%(這兩組之間比較的P值皆<.0001);多變項分析顯示,接受Thiazolidinediones類藥物的死亡風險顯著地較低(風險比〔HR〕為0.87,95%信賴區間〔CI〕為0.80-0.94),且接受Metformin治療的死亡風險同樣較低(HR為0.87,95%CI為0.78-0.97)。
  
  以Sulofonylureas類藥物或是胰島素治療,並不會影響死亡率;雖然服用不同藥物種類之間,因為任何因素而住院的比例沒有差異,但使用Thiazolidinediones類藥物的病患,因心臟衰竭而住院的比例較高(HR為1.06,95%CI為1.00-1.09),而使用Metformin治療的病患,因心臟衰竭而住院的比例較低(HR為0.92,95%CI為0.92-0.99)。
  
  研究人員表示,這項觀察性試驗暗示,Thiazolidinediones類藥物與Metformin與死亡率的增加無關,而且可能改善糖尿病與心臟衰竭老年病患的結果;這些發現並不支持目前反對使用胰島素敏感化藥物於許多(即使不是全部)心臟衰竭患者的建議,但強調嚴密觀察接受Thiazolidinediones類藥物治療心臟病患的重要性。
  
  該項試驗的限制因素,包括這是項觀察性試驗、治療醫師與醫院之間可能的差異、以及同一家醫院內一群病患造成之無法衡量的干擾因素、未確認出院後的藥物療程、缺乏較年輕或是門診病患的一般性、以及無法評估除了死亡率與住院外的其他重要結果。
  
  研究人員的結論是,最好以隨機分派臨床試驗來釐清胰島素敏感化藥物使用的最佳臨床方式,這對於治療快速增加的糖尿病與心臟病患來說是非常重要的。
  
  聯邦醫療保險與醫療補助計畫服務贊助這項分析;國家衛生研究院與國家老年化機構贊助其中2位研究人員;部分研究人員接受阿斯特捷利康、輝瑞、武田製藥、葛蘭素威康、必治妥、以及/或是墨克藥廠的資金贊助。

Thiazolidinediones and Metform

By Laurie Barclay, MD
Medscape Medical News

Feb. 8, 2004 — Thiazolidinediones and metformin are not only not harmful, but may actually be helpful for older patients with diabetes and heart failure, according to the results of a retrospective, observational study published in the Feb. 8 issue of Circulation. The investigators suggest that randomized trials are warranted.

"Insulin-sensitizing drugs of the thiazolidinedione class and metformin are commonly prescribed to treat diabetes in patients with heart failure despite strong warnings from the Food and Drug Administration against this practice," write Frederick A. Masoudi, MD, MSPH, from Denver Health Medical Center in Colorado, and colleagues. "Whether this results in adverse outcomes is unknown."

Using a Medicare cohort derived from the National Heart Care Project (NHC), the investigators studied the relationship between prescribing thiazolidinediones and metformin and the outcomes of death and rehospitalization among 16,417 elderly diabetic patients after hospitalization for heart failure.

Crude 1-year mortality rates were lower for the 2,226 patients treated with a thiazolidinedione (30.1%) and for the 1,861 patients treated with metformin (24.7%) than for the 12,069 patients treated with neither drug (36.0%, P < .0001 for both comparisons). Multivariate analysis suggested that risk of death was significantly lower with thiazolidinedione treatment (hazard ratio [HR] 0.87, 95% confidence interval [CI], 0.80 to 0.94) or metformin treatment (HR = .87, 95% CI 0.78 to 0.97).

Treatment with sulfonylureas or insulin did not affect mortality. Although admissions for all causes did not differ with either medication class, risk of readmission for heart failure was higher with thiazolidinedione treatment (HR 1.06, 95% CI 1.00 to 1.09) and lower with metformin treatment (HR 0.92, 95% CI 0.92 to 0.99).

"This observational study suggests that thiazolidinediones and metformin are not associated with increased mortality and may improve outcomes in older patients with diabetes and heart failure," the authors write. "These findings do not support the existing recommendations against the use of insulin sensitizers in many, if not all, patients with heart failure but emphasize the importance of close monitoring of patients treated with thiazolidinediones."

Study limitations include observational design, possible differences in the treating physicians and hospitals and the clustering of patients within hospitals causing unmeasured confounding, inability to identify changes in medication regimens after hospital discharge, lack of generalizability to younger or ambulatory patients, and inability to assess other important outcomes beyond mortality and readmission.

"Further clarification of the best clinical approach to the use of insulin-sensitizing drugs, optimally with randomized clinical trials, will be important in advancing the treatment of the rapidly growing population with both diabetes and heart failure," the authors conclude.

The Centers for Medicare & Medicaid Services, sponsored this analysis. The National Institutes of Health and National Institutes of Aging supported two of the authors. Some authors report various financial arrangements with AstraZeneca, Pfizer, Takeda Pharmaceuticals, GlaxoSmithKline, Bristol-Myers Squibb, and/or Merck.

Circulation. 2005;111:xxx-xxx

Reviewed by Gary D. Vogin, MD

    
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