糖尿病治療薬は心不全リスクを低下させ、心不全を予防する可能性がある (LBCT 02)

EMPA-REG OUTCOME：新たなクラスの2型糖尿病治療薬は心不全による入院および死亡を減少させる
EMPA-REG OUTCOME: New class of type 2 diabetes drug reduces hospitalizations and deaths from heart failure
新たなクラスの2型糖尿病治療薬（SGLT2阻害 薬）が心不全による入院および死亡を有意に低下させることが初めて示された。SGLT2阻害薬は尿中への糖排泄を増加させることにより血糖値を低下させる。EMPA-REG OUTCOMEとして知られる大規模臨床試験から得られたこの結果は、2015年American Heart Association（AHA）学会で発表された。心疾患リスクファクターを有する2型糖尿病患者が、標準治療に加えエンパグリフロジン（10mgまたは25mg)またはプラセボを1日1回内服する群のいずれかにランダムに割り付けられた。実薬投与群では、プラセボ投与群に比べ体重減少に加え血糖値および血圧低下が大であった。さらに、心不全による入院（35%）、心不全による入院および心疾患による死亡の合計（34%）、および心不全による入院および死亡（39%）が有意に減少したことも明らかにした。AHA学会でのこの結果は、9月にEuropean Association for the Study of Diabetes年次集会で初めて発表された結果を敷衍したもので、New England Journal of Medicineに掲載された。
Full Text

For the first time, research shows that a new class of type 2 diabetes drugs (SGLT2 inhibitors) significantly reduce hospitalizations and death from heart failure. The findings, from a large clinical trial known as EMPA-REG OUTCOME, were presented by Yale professor of medicine and clinical chief of endocrinology, Dr. Silvio E. Inzucchi, at the 2015 American Heart Association (AHA) Scientific Session in Orlando, Florida.

Many individuals with type 2 diabetes also have heart failure. Treatment for heart failure is limited and prior efforts to treat patients with type 2 diabetes drugs showed no benefit for heart failure. But a new class of type 2 diabetes drugs (SGLT2 inhibitors) that reduce blood reduce blood glucose levels by increasing its excretion in the urine had not been studied.

In the EMPA-REG trial, patients with type 2 diabetes and risk factors for heart disease were randomized to receive once-daily doses of either the glucose-lowering drug empagliflozin (10 mg or 25 mg doses), or a placebo. The drug or placebo was given in addition to standard care.

At the end of the trial period, investigators found that patients treated with the drug experienced greater reductions in blood glucose and blood pressure, as well as weight loss, compared to those on placebo. They also found major significant reductions in hospitalizations for heart failure (35%); the combined result for heart failure hospitalization or dying from heart disease (34%); and the combined result for being hospitalized or dying from heart failure (39%).

Additionally, Inzucchi and his colleagues analyzed outcomes for subgroups of patients who had heart failure at the beginning of the trial and those who did not. "We found that reductions in the hospitalization outcomes were similar between the two subgroups," he said. "So, one conclusion that could be proposed is that the drug not only appeared to prevent deterioration in patients who already had heart failure but also appeared to prevent that condition from developing in patients who never had it before."

The findings reported Nov. 9 at the AHA session amplify results first presented at the annual meeting of the European Association for the Study of Diabetes in September and published by The New England Journal of Medicine.