Abstract
We appreciate the interest of Sardar et al in our randomized clinical trial on intensive glucose regulation in patients with acute coronary syndrome with elevated blood glucose level on admission. They raise several relevant issues.
An explanation, other than random chance, for the observed 12-minute difference in median time from admission to randomization could be sought in the admission diagnosis. Non–ST-segment elevation myocardial infarction (NSTEMI) was more common in the patients randomized to intensive vs conventional glucose management (21.4% vs 15.0%). For patients with NSTEMI, elevated troponin level was a prerequisite for enrollment. Hence, laboratory results should be awaited, which delayed inclusion by approximately 1 hour.
Apparently, there were no differences in anticoagulation strategies and bleeding rates between the 2 study arms (Table). The low hypoglycemia rate in our trial was remarkable and might be explained by the dedicated protocol with frequent glucose measurements in the setting of a single-center clinical trial. We acknowledge that hypoglycemia rates might be higher in other routine settings.
In our trial report, we focused on in-hospital clinical outcomes because we anticipated that potential (adverse) effects of intensive insulin therapy would appear on short notice. Also, our study was not powered to draw conclusions regarding mortality. This being said, we are currently planning to undertake a long-term clinical follow-up study in all randomized patients.
An explanation, other than random chance, for the observed 12-minute difference in median time from admission to randomization could be sought in the admission diagnosis. Non–ST-segment elevation myocardial infarction (NSTEMI) was more common in the patients randomized to intensive vs conventional glucose management (21.4% vs 15.0%). For patients with NSTEMI, elevated troponin level was a prerequisite for enrollment. Hence, laboratory results should be awaited, which delayed inclusion by approximately 1 hour.
Apparently, there were no differences in anticoagulation strategies and bleeding rates between the 2 study arms (Table). The low hypoglycemia rate in our trial was remarkable and might be explained by the dedicated protocol with frequent glucose measurements in the setting of a single-center clinical trial. We acknowledge that hypoglycemia rates might be higher in other routine settings.
In our trial report, we focused on in-hospital clinical outcomes because we anticipated that potential (adverse) effects of intensive insulin therapy would appear on short notice. Also, our study was not powered to draw conclusions regarding mortality. This being said, we are currently planning to undertake a long-term clinical follow-up study in all randomized patients.
| Original language | English |
|---|---|
| Pages (from-to) | 826-827 |
| Number of pages | 2 |
| Journal | JAMA Internal Medicine |
| Volume | 174 |
| Issue number | 5 |
| DOIs |
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| Publication status | Published - May 2014 |
Research programs
- EMC COEUR-09