Abstract
Background and Purpose—
The
insulin sensitizer, pioglitazone, reduces cardiovascular risk in
patients after an ischemic stroke or transient ischemic attack but
increases bone fracture risk. We conducted a secondary analysis of the
IRIS trial (Insulin Resistance Intervention After Stroke) to assess the
effect of pretreatment risk for fracture on the net benefits of
pioglitazone therapy.
Methods—
IRIS
was a randomized placebo-controlled trial of pioglitazone that enrolled
patients with insulin resistance but without diabetes mellitus within
180 days of an ischemic stroke or transient ischemic attack.
Participants were recruited at 179 international centers from February
2005 to January 2013 and followed for a median of 4.8 years. Fracture
risk models were developed from patient characteristics at entry. Within
fracture risk strata, we quantified the effects of pioglitazone
compared with placebo by estimating the relative risks and absolute
5-year risk differences for fracture and stroke or myocardial
infarction.
Results—
The
fracture risk model included points for age, race-ethnicity, sex, body
mass index, disability, and medications. The relative increment in
fracture risk with pioglitazone was similar in the lower (&l
Conclusions—
A
simple point score identifying patients at low risk for fracture may
assist in selecting patients with a favorable benefit-risk profile for
pioglitazone therapy after ischemic stroke or transient ischemic attack.
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