New England Journal of Medicine· 2013Q1
Tip 2 Diyabetli Hastalarda Akut Koroner Sendrom Sonrası Alogliptin
Alogliptin after Acute Coronary Syndrome in Patients with Type 2 Diabetes
- 2.525atıf
- Q1SCImago
- 2013yıl
Kısa özet
Tip 2 diyabet ve yakın zamanda geçirilmiş akut koroner sendromu olan hastalarda, DPP-4 inhibitörü alogliptin plaseboya kıyasla majör olumsuz kardiyovasküler olay riskini artırmamıştır.
Yapay zekâ ile başlık ve abstract'tan üretildi; tam metin okunmaz.
Ana noktalar
- Alogliptin, tip 2 diyabetli ve yakın zamanda akut koroner sendrom geçirmiş hastalarda majör olumsuz kardiyovasküler olayların önlenmesinde plaseboya göre non-inferior bulunmuştur.
- Birincil sonlanım noktası (kardiyovasküler ölüm, MI veya inme) için hazard oranı 0.96 olarak bulunmuştur (güven aralığının üst sınırı 1.16).
- Alogliptin, plaseboya kıyasla ortalama %0.36 puan HbA1c düşüşü sağlamıştır.
- Alogliptin ve plasebo grupları arasında hipoglisemi, kanser ve pankreatit oranları benzerdi.
Yapay zekâ ile başlık ve abstract'tan üretildi; tam metin okunmaz.
Özet (abstract)
BACKGROUND: To assess potentially elevated cardiovascular risk related to new antihyperglycemic drugs in patients with type 2 diabetes, regulatory agencies require a comprehensive evaluation of the cardiovascular safety profile of new antidiabetic therapies. We assessed cardiovascular outcomes with alogliptin, a new inhibitor of dipeptidyl peptidase 4 (DPP-4), as compared with placebo in patients with type 2 diabetes who had had a recent acute coronary syndrome. METHODS: We randomly assigned patients with type 2 diabetes and either an acute myocardial infarction or unstable angina requiring hospitalization within the previous 15 to 90 days to receive alogliptin or placebo in addition to existing antihyperglycemic and cardiovascular drug therapy. The study design was a double-blind, noninferiority trial with a prespecified noninferiority margin of 1.3 for the hazard ratio for the primary end point of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. RESULTS: A total of 5380 patients underwent randomization and were followed for up to 40 months (median, 18 months). A primary end-point event occurred in 305 patients assigned to alogliptin (11.3%) and in 316 patients assigned to placebo (11.8%) (hazard ratio, 0.96; upper boundary of the one-sided repeated confidence interval, 1.16; P<0.001 for noninferiority). Glycated hemoglobin levels were significantly lower with alogliptin than with placebo (mean difference, -0.36 percentage points; P<0.001). Incidences of hypoglycemia, cancer, pancreatitis, and initiation of dialysis were similar with alogliptin and placebo. CONCLUSIONS: Among patients with type 2 diabetes who had had a recent acute coronary syndrome, the rates of major adverse cardiovascular events were not increased with the DPP-4 inhibitor alogliptin as compared with placebo. (Funded by Takeda Development Center Americas; EXAMINE ClinicalTrials.gov number, NCT00968708.).
Yazarların özeti; kaynağından alınmıştır. New England Journal of Medicine, 2013 · DOI ↗
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Alan: Endokrinoloji, Diyabet ve Metabolizma
Endocrinology, Diabetes and MetabolismMedicine