Abstract
BackgroundStudies assessing the efficacy of pioglitazone solely for primary stroke prevention in Asian patients with type 2 diabetes mellitus (DM) and present multiple cardiovascular (CV) risk factors are rare. Thus, we aimed to assess the effect of pioglitazone on primary stroke prevention in Asian patients with type 2 DM without established CV diseases but with risk factors for CV diseases.MethodsBetween 2000 and 2012, we enrolled patients aged ≥ 18 years, who were newly diagnosed with type 2 diabetes and had at least one of the following CV risk factors: hypertension and hyperlipidemia. Patients with a history of stroke and those using insulin or glucagon-like peptide-1 agonist for more than 3 months were excluded. Patients were divided into the pioglitazone and non-pioglitazone groups based on their receipt of pioglitazone during the follow-up period. Propensity-score matching (1:1) was used to balance the distribution of the baseline characteristics and medications. Follow-up was terminated upon ischemic stroke development, withdrawal from the insurance system, or on December 31, 2013, whichever occurred first. The overall incidence of new-onset ischemic stroke in the two groups was subsequently compared. The subgroup analyses of ischemic stroke were conducted using different baseline features. Additionally, the effect of pioglitazone exposure dose on the occurrence of ischemic stroke was evaluated. Chi square test, Student’s t-test, competing risk regression models, Kaplan–Meier method, and log-rank test were some of the statistical tests conducted.ResultsA total of 13 078 patients were included in the pioglitazone and non-pioglitazone groups. Compared with patients who did not receive pioglitazone, those administered pioglitazone had a lower risk of developing ischemic stroke (adjusted hazard ratio: 0.78; 95% confidence interval: 0.62–0.95). The subgroup analyses defined by different baseline features did not reveal significant alterations in the observed effect of pioglitazone. Moreover, a significant decreasing trend in ischemic stroke risk with an increase in pioglitazone dose (p-value for trend = 0.04) was observed.ConclusionPioglitazone use decreased the risk of new-onset ischemic stroke in Asian patients with type 2 DM and CV risk factors.Trial registration number CMUH104-REC2-115-CR4
Highlights
Studies assessing the efficacy of pioglitazone solely for primary stroke prevention in Asian patients with type 2 diabetes mellitus (DM) and present multiple cardiovascular (CV) risk factors are rare
The Longitudinal Health Insurance Database (LHID), which is a subset of the National Health Insurance Research Database (NHIRD), includes historical claims data for one million subjects who were randomly sampled from the entire insured population from 1996 to 2000
The number of patients treated with angiotensin-converting-enzyme inhibitor (ACEI), angiotensin receptor blockers (ARB), α-blocker, β-blocker, calcium channel blockers (CCB), diuretics, and other anti-hypertensive agents was similar between the two groups
Summary
Studies assessing the efficacy of pioglitazone solely for primary stroke prevention in Asian patients with type 2 diabetes mellitus (DM) and present multiple cardiovascular (CV) risk factors are rare. A meta-analysis of the above three trials demonstrated that treatment with pioglitazone in stroke patients with insulin resistance, prediabetes, and DM was associated with a significantly lower risk of recurrent stroke (HR 0.68, 95% CI 0.50–0.92, p = 0.01) [12]. Data from these studies provide strong evidence to support the use of pioglitazone for secondary stroke prevention, and it is possible that the results could be extended in the future to populations without a history of stroke [13]. Studies assessing the efficacy of pioglitazone solely for primary stroke prevention in Asian patients with type 2 DM and present multiple CV risk factors are rare
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