New results from a post-hoc analysis of the
BARI-2D trial show no association between rosiglitazone and
cardiovascular (CV) events.

However, the results confirmed previously reported links between
rosiglitazone and fracture.

Richard Bach (Washington University School of Medicine, St
Louis, Missouri, USA) presented the results of a post-hoc study of
2368 patients enrolled in the BARI-2D (Bypass Angioplasty
Revascularization Investigation 2 Diabetes) study at the American
Diabetes Association 2010 Scientific Sessions held in Orlando,
Florida.

The patients all had Type 2 diabetes and
angiographically-confirmed coronary artery disease (CAD) plus at
least one significant lesion suitable for revascularization. The
trial aimed to assess the long-term outcomes of rosiglitazone
therapy.

The main results of BARI-2D have already been published.
Patients were randomized to treatment with prompt revascularization
and medical therapy versus medical therapy and delayed or no
revascularization, and to insulin sensitization versus insulin
provision. The findings showed that the rate of overall survival
and freedom from CV events did not vary significantly between the
different treatment groups, as previously reported by MedWire
News.

For the purposes of this study, Bach and team compared 992
patients treated with rosiglitazone with 1199 patients who were not
treated with a thiazolidinedione (TZD).

At baseline, the patients were aged 62 years on average, had a
mean glycated hemoglobin level of between 7.5% and 7.8%, and had
had diabetes for approximately 10 years. In addition, a quarter of
patients in both groups had undergone prior revascularization.

Bach reported that, at 4.5 years, patients taking rosiglitazone
had a significantly lower rate of stroke and the combination of
death, myocardial infarction (MI), and stroke per 100 patient years
compared with patients not treated with TZDs. In addition, the rate
of death and MI were non-significantly lower, and chronic heart
failure was non-significantly higher in rosiglitazone-treated
patients.

Co-administration with insulin, metformin, nitrates, and
angiotensin-converting enzyme inhibitors, did not significantly
influence the rate of CV outcomes in rosiglitazone treated
patients.

Notably, as found in previous studies, the relative risk for
fracture was a significant 62% higher in rosiglitazone-treated
patients than in those who took no TZDs. When stratified by gender,
the increase in relative risk was statistically significant in
women only, at 82%.

Bach acknowledged that the study was limited by its
non-randomized nature and added that the fact that many patients on
the study were taking more than one anti-diabetic drug might have
limited the ability of the researchers to discriminate the effects
of any one drug from another.

“I think these data are important because they suggest there is
no significant cardiovascular harm posed by taking rosiglitazone
for patients with Type 2 diabetes and coronary heart disease,” said
Bach.

These new data “contribute to the scientific inquiry regarding
associated events with rosiglitazone.”

He added: ” There is an increase in fractures, but when one
considers the dramatic morbidity and mortality associated with
ischemic cardiovascular events in patients with diabetes, these
data are reassuring.”

MedWire (www.medwire-news.md) is an independent clinical news
service provided by Current Medicine Group, a trading division of
Springer Healthcare Limited. © Springer Healthcare Ltd;
2010

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Revascularization no better than medical therapy for stable IHD in Type 2 diabetics