6月5日 NEJM的新文章，給大家參考：
Background
A recent meta-analysis raised concern regarding an increased risk of myocardial
infarction and death from cardiovascular causes associated with rosiglitazone
treatment of type 2 diabetes.
Methods
We conducted an unplanned interim analysis of a randomized, multicenter, openlabel,
noninferiority trial involving 4447 patients with type 2 diabetes who had inadequate
glycemic control while receiving metformin or sulfonylurea, in which
2220 patients were assigned to receive add-on rosiglitazone (rosiglitazone group),
and 2227 to receive a combination of metformin plus sulfonylurea (control group).
The primary end point was hospitalization or death from cardiovascular causes.
Results
Because the mean follow-up was only 3.75 years, our interim analysis had limited
statistical power to detect treatment differences. A total of 217 patients in the rosiglitazone
group and 202 patients in the control group had the adjudicated primary
end point (hazard ratio, 1.08; 95% confidence interval [CI], 0.89 to 1.31). After the
inclusion of end points pending adjudication, the hazard ratio was 1.11 (95% CI,
0.93 to 1.32). There were no statistically significant differences between the rosiglitazone
group and the control group regarding myocardial infarction and death
from cardiovascular causes or any cause. There were more patients with heart failure
in the rosiglitazone group than in the control group (hazard ratio, 2.15; 95%
CI, 1.30 to 3.57).
Conclusions
Our interim findings from this ongoing study were inconclusive regarding the effect
of rosiglitazone on the overall risk of hospitalization or death from cardiovascular
causes. There was no evidence of any increase in death from either cardiovascular
causes or all causes. Rosiglitazone was associated with an increased risk of
heart failure. The data were insufficient to determine whether the drug was associated
with an increase in the risk of myocardial infarction. (ClinicalTrials.gov number,
NCT00379769.)
相關文章請參考：http://blog.pixnet.net/mulicia/post/4815347
Background
A recent meta-analysis raised concern regarding an increased risk of myocardial
infarction and death from cardiovascular causes associated with rosiglitazone
treatment of type 2 diabetes.
Methods
We conducted an unplanned interim analysis of a randomized, multicenter, openlabel,
noninferiority trial involving 4447 patients with type 2 diabetes who had inadequate
glycemic control while receiving metformin or sulfonylurea, in which
2220 patients were assigned to receive add-on rosiglitazone (rosiglitazone group),
and 2227 to receive a combination of metformin plus sulfonylurea (control group).
The primary end point was hospitalization or death from cardiovascular causes.
Results
Because the mean follow-up was only 3.75 years, our interim analysis had limited
statistical power to detect treatment differences. A total of 217 patients in the rosiglitazone
group and 202 patients in the control group had the adjudicated primary
end point (hazard ratio, 1.08; 95% confidence interval [CI], 0.89 to 1.31). After the
inclusion of end points pending adjudication, the hazard ratio was 1.11 (95% CI,
0.93 to 1.32). There were no statistically significant differences between the rosiglitazone
group and the control group regarding myocardial infarction and death
from cardiovascular causes or any cause. There were more patients with heart failure
in the rosiglitazone group than in the control group (hazard ratio, 2.15; 95%
CI, 1.30 to 3.57).
Conclusions
Our interim findings from this ongoing study were inconclusive regarding the effect
of rosiglitazone on the overall risk of hospitalization or death from cardiovascular
causes. There was no evidence of any increase in death from either cardiovascular
causes or all causes. Rosiglitazone was associated with an increased risk of
heart failure. The data were insufficient to determine whether the drug was associated
with an increase in the risk of myocardial infarction. (ClinicalTrials.gov number,
NCT00379769.)
相關文章請參考：http://blog.pixnet.net/mulicia/post/4815347
全站熱搜
留言列表
醫藥類 (14)
