Relationship of Glycemia to Cardiovascular Disease ... - Lipids Online
Relationship of Glycemia to Cardiovascular Disease ... - Lipids Online
Relationship of Glycemia to Cardiovascular Disease ... - Lipids Online
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Lago RM, Singh PP, Nes<strong>to</strong> RW. Congestive heart failure and cardiovascular death in<br />
patients with prediabetes and type 2 diabetes given thiazolidinediones: a meta-analysis <strong>of</strong><br />
randomised clinical trials. Lancet. 2007;370:1129-1136.<br />
McAfee AT, Koro C, Landon J, Ziyadeh N, Walker AM. Coronary heart disease<br />
outcomes in patients receiving antidiabetic agents. Pharmacoepidemiol Drug Saf.<br />
2007;16:711-725.<br />
Nissen SE, Wolski K. Effect <strong>of</strong> rosiglitazone on the risk <strong>of</strong> myocardial infarction and<br />
death from cardiovascular causes. N Engl J Med. 2007;356:2457-2471.<br />
Rosen CJ. The rosiglitazone s<strong>to</strong>ry—lessons from an FDA Advisory Committee meeting.<br />
N Engl J Med. 2007;357:844-846.<br />
PROactive: Time <strong>to</strong> Primary Composite<br />
Endpoint: Pioglitazone vs. Placebo<br />
Kaplan-Meier Event Rate<br />
0.25<br />
0.20<br />
N events:<br />
Placebo 572 / 2633<br />
Pioglitazone 514 / 2605<br />
0.15 What if this was a<br />
3-Year Estimate:<br />
6-month trial ?<br />
23.5%<br />
0.10<br />
21.0%<br />
HR 95% CI p value<br />
0.05<br />
Pioglitazone<br />
0.80<br />
0.90<br />
vs. placebo<br />
1.02<br />
0.095<br />
0.0<br />
0 6 12 18 24 30 36<br />
No. at Risk: 5238 5018 4786 4619 4433 4268 693<br />
Time from Randomization (Months)<br />
CI = confidence interval; HR = hazard ratio<br />
Reprinted from Dormandy JA, et al. Lancet. 2005;366:<br />
1279–1289, with permission from Elsevier.<br />
Slide Source<br />
<strong>Lipids</strong> <strong>Online</strong> Slide Library<br />
www.lipidsonline.org<br />
PROactive: Time <strong>to</strong> Primary Composite Endpoint: Pioglitazone vs. Placebo<br />
The Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROactive)<br />
evaluated patients with type 2 diabetes and a his<strong>to</strong>ry <strong>of</strong> cardiovascular disease and<br />
randomized them <strong>to</strong> receive either pioglitazone or placebo. The primary endpoint showed<br />
a nonstatistical benefit in favor <strong>of</strong> pioglitazone.<br />
Reference:<br />
Dormandy JA, Charbonnel B, Eckland DJ, et al, for the PROactive investiga<strong>to</strong>rs.<br />
Secondary prevention <strong>of</strong> macrovascular events in patients with type 2 diabetes in the<br />
PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a<br />
randomised controlled trial. Lancet. 2005;366:1279-1289.<br />
Source: <strong>Lipids</strong> <strong>Online</strong> Slide Library (www.lipidsonline.org) Page 16 <strong>of</strong> 36<br />
© 2009 Baylor College <strong>of</strong> Medicine, Hous<strong>to</strong>n, Texas
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