Abstract
Objective
Thiazolidinediones (TZDs) are used in patients with Type 2 diabetes mellitus, but evidence is mixed regarding the influence of medications of this class on target vessel revascularization. The aim of this meta-analysis is to evaluate the effect of TZDs on repeat target vessel revascularization following percutaneous coronary intervention.
Research design and methods
We searched Medline, EMBASE, Cinahl, and the Cochrane Database from earliest available date through December 2007. Criteria for inclusion in our meta-analysis included the use of randomized control trial and the availability of target vessel revascularization. Relative risks (RRs) with 95% confidence intervals (CIs) of target vessel revascularization (TVR) and restenosis were estimated using a fixed-effects meta-analysis of seven randomized controlled trials ( n =347, including 178 receiving pioglitazone and 169 receiving rosiglitazone).
Results
One hundred seventy-eight patients were treated with pioglitazone, and 169 were treated with rosiglitazone. Pioglitazone is associated with a significantly lower risk of target vessel revascularization or restenosis (TVR: n =37/96 vs. 7/94; RR, 5.91; 95% CI, 3.00–11.7; P <.0001, restenosis: n =42/96 vs. 8/94; RR, 6.48; 95% CI, 3.37–12.4; P <.0001). Rosiglitazone had no effect on target vessel revascularization ( n =56/131 vs. 51/124; RR, 1.11; 95% CI, 0.63–1.96; P =.793).
Conclusions
Pioglitazone is associated with a significantly decreased risk of target vessel revascularization, but rosiglitazone does not reduce the risk of target vessel revascularization following percutaneous coronary intervention.
1
Introduction
Despite the advent of improved mechanics and drug-eluting stents (DESs), the cumulative restenosis rate remains 20–30% in the general percutaneous coronary intervention (PCI) population and approaches 40% among patients with diabetes . Diabetes is still a risk factor for restenosis after DES in coronary artery .
Thiazolidinediones (TZDs), which are novel insulin-sensitizing agents, are a class of antidiabetes agents. Rosiglitazone (Avandia; Glaxo Smith Kline) and pioglitazone (Actos; Takeda/Lilly) are commercially available for the treatment of Type 2 diabetes. Recent meta-analysis demonstrated that TZDs effectively reduce the risk of repeated target vessel revascularization (TVR) following PCI . The PROactive study has suggested that the efficacy of pioglitazone reduces mortality in Type 2 diabetes mellitus . However, rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes .
We conducted a meta-analysis of randomized controlled trials published through December 2007 to evaluate the effects of pioglitazone and rosiglitazone on repeated TVR following PCI.
2
Methods
2.1
Selection of trials
We searched Medline, EMBASE, Cinahl, and the Cochrane Database from earliest available date through December 2007. A search strategy using the Medical Subject Headings and text keywords “thiazolidinedione,” “rosiglitazone,” “pioglitazone,” “restenosis,” “coronary,” and “stent” was utilized. The criteria for eligibility for this meta-analysis were that the trial be randomized and controlled. A total of seven trials enrolling 347 patients met these criteria and formed the basis of this analysis. Two trials were excluded because troglitazone were used, and one trial was excluded because drug-eluting stent was used ( Fig. 1 ).
2.2
Statistical analysis
This meta-analysis was completed through the use of SPSS 150J for Windows (SPSS, Chicago IL, USA). Relative risk (RR) and 95% confidence interval (CI) for risk factors and significance level for chi-square are given. Statistical heterogeneity was evaluated via the Q statistic. P <.01 was considered representative of significant statistical heterogeneity.
2
Methods
2.1
Selection of trials
We searched Medline, EMBASE, Cinahl, and the Cochrane Database from earliest available date through December 2007. A search strategy using the Medical Subject Headings and text keywords “thiazolidinedione,” “rosiglitazone,” “pioglitazone,” “restenosis,” “coronary,” and “stent” was utilized. The criteria for eligibility for this meta-analysis were that the trial be randomized and controlled. A total of seven trials enrolling 347 patients met these criteria and formed the basis of this analysis. Two trials were excluded because troglitazone were used, and one trial was excluded because drug-eluting stent was used ( Fig. 1 ).
2.2
Statistical analysis
This meta-analysis was completed through the use of SPSS 150J for Windows (SPSS, Chicago IL, USA). Relative risk (RR) and 95% confidence interval (CI) for risk factors and significance level for chi-square are given. Statistical heterogeneity was evaluated via the Q statistic. P <.01 was considered representative of significant statistical heterogeneity.
3
Results
The seven trials included in this meta-analysis are summarized in Table 1 and classified according to the drug treatment. Four trials were treated with pioglitazone and 3 trials were treated with rosiglitazone. The RRs of randomized control trials (RCTs) evaluating the effects of pioglitazone and rosiglitazone for TVR and restenosis are shown in Figs. 2 and 3 .
| Study | Mean age (years) | TZD dose (mg/day) | Initiation | Study population |
|---|---|---|---|---|
| Takagi et al. , n =44 | 64.5 | Pioglitazone 30 mg/day | 8±2 days | Type 2 diabetes mellitus |
| Marx et al. , n =48 | 62.5 | Pioglitazone 30 mg/day | Before the procedure | No diabetes |
| Nishio et al. , n =54 | 66.9 | Pioglitazone 30 mg/day | 2 weeks | Type 2 diabetes mellitus with insulin resistance |
| Katayama et al. , n =32 | 60.7 | Pioglitazone 30 mg/day | Not reported | No diabetes with metabolic syndrome |
| Osman et al. , n =16 4 | 55.4 | Rosiglitazone to 8 mg/day | Within 6 hours | Type 2 diabetes mellitus |
| Choi et al. , n =83 | 60.4 | Rosiglitazone 8 mg/day | Before | Type 2 diabetes mellitus the procedure |
| Wang et al. , n =70 | 61.2 | Rosiglitazone 4 mg/day | Not reported | Type 2 diabetes mellitus |
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