CORRESPONDENCE: LETTER TO THE EDITOR
A Perspective on Coronary Revascularization in the PROactive 05 Study
Daniel M. Riche, PharmD, BCPS* and
Krista M. Dale, PharmD, BCPS
* Department of Pharmacy Practice and Medicine, University of Mississippi Medical Center, Office Annex Building, WW 128, 2500 North State Street, Jackson, Mississippi 39216 (Email: driche{at}sop.umsmed.edu).
Erdmann et al. (1) should be applauded for their recent contribution entitled "The Effect of Pioglitazone on Recurrent Myocardial Infarction in 2,445 Patients With Type 2 Diabetes and Previous Myocardial Infarction". The PROactive 05 study is a post hoc exploratory analysis of patients enrolled in the main PROactive study that entered the study with a previous myocardial infarction (MI) (2). The investigators conclude that in high-risk patients with type 2 diabetes and previous MI, pioglitazone significantly reduced the occurrence of fatal and nonfatal MI and acute coronary syndrome (1). These results provide critically important clinical data for pioglitazone, in light of Nissen and Wolski’s (3) recent analysis suggesting increased risk of MI with rosiglitazone use.
In the PROactive 05 study, cardiac intervention is defined as coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) (1). Approximately 40% of the patients at baseline had a previous PCI/CABG (1). In Table 5 under the heading for individual end points, the investigators reported that coronary revascularization (CABG and PCI) demonstrated a nonsignificant absolute risk reduction (ARR) of 2% (1). This is the most dynamic ARR among any of the individual end points. This finding may be supported by the results of a recent meta-analysis. That meta-analysis evaluated the effect of thiazolidinediones (TZDs) on reducing the risk of repeat target vessel revascularization (TVR) after PCI (4). The results suggested that TZDs, in fact, significantly reduce repeat TVR after PCI (4). Although relative risk is reduced regardless of the TZD used or the presence of diabetes, patients with diabetes and studies evaluating pioglitazone seemed to show the most robust benefit (4).
Because a large portion of patients at baseline had undergone a previous coronary intervention, it would be interesting to evaluate these patients separately to determine if this subgroup would demonstrate a significant reduction in any coronary revascularization. Additionally, it may be compelling to evaluate pioglitazone’s effect on CABG and PCI separately. We suspect that the majority of the absolute risk reduction for this end point is driven by the PCI subset of patients. Such a finding could substantiate the results reported in the meta-analysis by Riche et al. (4) and may cast a new light on the darkening link between TZDs and MI.
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1. Erdmann E, Dormandy JA, Charbonnel B, Massi-Benedetti M, Moules IK, Skene AM. The effect of pioglitazone on recurrent myocardial infarction in 2,445 patients with type 2 diabetes and previous myocardial infarction: results from the PROactive (PROactive 05) study J Am Coll Cardiol 2007;49:1772-1780.[Abstract/Free Full Text]2. Dormandy JA, Charbonnel B, Eckland DJ, et al. 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 Lancet 2005;366:1279-1289.[CrossRef][Web of Science][Medline] 3. Nissen SE, Wolski K. Effect of Rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes N Engl J Med 2007;356:2457-2471.[Abstract/Free Full Text] 4. Riche DM, Valderrama R, Henyan NN. Thiazolidinediones and risk of repeat target vessel revascularization following percutaneous coronary intervention: a meta-analysis Diabetes Care 2007;30:384-388.[Abstract/Free Full Text]
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