|
"Secondary prevention of macrovascular
events in patients with type 2
diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial
in macroVascular Events): a randomised controlled trial, by John A.
Dormandy and 20 others, on behalf of the PROactive investigators, The
Lancet, 366(9493): 1279-89, 8 October 2005.
[Authors' affiliations: 13 institutions
worldwide]
Abstract: "Background Patients
with type 2 diabetes are at high risk of fatal and non-fatal myocardial
infarction and stroke. There is indirect evidence that agonists of
peroxisome proliferator-activated receptor gamma (PPAR gamma) could reduce
macrovascular complications. Our aim, therefore, was to ascertain whether
pioglitazone reduces macrovascular morbidity and mortality in high-risk
patients with type 2 diabetes. Methods We did a prospective,
randomised controlled trial in 5238 patients with type 2 diabetes who had
evidence of macrovascular disease. We recruited patients from primary-care
practices and hospitals. We assigned patients to oral pioglitazone titrated
from 15 mg to 45 mg (n=2605) or matching placebo (n=2633), to be taken in
addition to their glucose-lowering drugs and other medications. Our primary
endpoint was the composite of all-cause mortality, non-fatal myocardial
infarction (including silent myocardial infarction), stroke, acute coronary
syndrome, endovascular or surgical intervention in the coronary or leg
arteries, and amputation above the ankle. Analysis was by intention to
treat. This study is registered as an International Standard Randomised
Controlled Trial, number ISRCTN NCT00174993. Findings Two patients
were lost to follow-up, but were included in analyses. The average time of
observation was 34.5 months. 514 of 2605 patients in the pioglitazone group
and 572 of 2633 patients in the placebo group had at least one event in the
primary composite endpoint (HR 0.90, 95% CI 0.80-1.02, p=0.095). The main
secondary endpoint was the composite of all-cause mortality, non-fatal
myocardial infarction, and stroke. 301 patients in the pioglitazone group
and 358 in the placebo group reached this endpoint (0.84, 0.72-0.98,
p=0.027). Overall safety and tolerability was good with no change in the
safety profile of pioglitazone identified. 6% (149 of 2065) and 4% (108 of
2633) of those in the pioglitazone and placebo groups, respectively, were
admitted to hospital with heart failure;mortality rates from heart failure
did not differ between groups. Interpretation Pioglitazone reduces
the composite of all-cause mortality, non-fatal myocardial infarction, and
stroke in patients with type 2 diabetes who have a high risk of
macrovascular events."
This 2005 report from The Lancet was
cited 44 times in current journal articles indexed by Thomson
Scientific during July-August 2007. Only one other medicine paper published
in the last two years, aside from reviews, garnered a higher number of
citations during that two-month period. Prior to the most recent bimonthly
count, citations to the paper have accrued as follows:
May-June 2007: 37 citations
March-April 2007: 31
January-February 2007: 40
November-December 2006: 34
September-October 2006: 39
July-August 2006: 28
May-June 2006: 28
March-April 2006: 17
January-February 2006: 16
November-December 2005: 4
September-October 2005: 1
Total citations to date: 319
SOURCE: Hot
Papers Database (Included with a subscription to the print newsletter Science
Watch®, available from the
Research Services Group. Packaged on a CD that is mailed with each Science
Watch issue, the Hot
Papers Database contains data on hundreds of highly cited papers published
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organization, journal, field, and more. Total citations, as well as citations
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