- Safety & Recalls
- Regulatory Updates
- Drug Coverage
- COPD
- Cardiovascular
- Obstetrics-Gynecology & Women's Health
- Ophthalmology
- Clinical Pharmacology
- Pediatrics
- Urology
- Pharmacy
- Idiopathic Pulmonary Fibrosis
- Diabetes and Endocrinology
- Allergy, Immunology, and ENT
- Musculoskeletal/Rheumatology
- Respiratory
- Psychiatry and Behavioral Health
- Dermatology
- Oncology
From the 67th annual scientific sessions of the American Diabetes Association: PROactive: Pioglitazone improves CV outcomes in patients with renal dysfunction, type 2 diabetes, and macrovascular disease
The use of pioglitazone in patients with renal dysfunction, type 2 diabetes, and macrovascular disease can reduce the risk of death, nonfatal myocardial infarction (MI), and stroke according to results presented at the 67th annual scientific sessions of the American Diabetes Association.
Key Points
The use of pioglitazone in patients with renal dysfunction, type 2 diabetes, and macrovascular disease can reduce the risk of death, nonfatal myocardial infarction (MI), and stroke, according to the results of the Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROactive). The results were presented at the 67th Annual Scientific Sessions of the American Diabetes Association.
This retrospective analysis involving 5,238 patients also identified chronic kidney disease (CKD) as an independent risk factor for major cardiovascular events and death in this high-risk population, according to Erland Erdmann, MD, University of Cologne, Germany. All patients had type 2 diabetes and macrovascular disease; 597 (11.6%) also had renal dysfunction, defined as a glomerular filtration rate <60 mL/min/1.73 m2 .
The patients were randomized to pioglitazone 45 mg/d (n=2,605) or placebo (n=2,633) in addition to other glucose-lowering and cardiovascular medications. The mean follow-up was 34.5 months.
Overall, pioglitazone use was associated with a nonsignificant 10% decrease in the incidence of this end point. However, use of the agent was associated with a significant 16% reduction (P=.027) in the combined secondary end point of death, nonfatal MI, and stroke compared with placebo.
The incidence of this secondary end point was greater among all patients with renal dysfunction compared with all patients with normal renal function (18.3% vs 11.5%, HR=1.65; 95% CI, 1.35–2.03).
Among patients with renal dysfunction, 23.7% of those randomized to pioglitazone experienced the primary end point compared with 30.7% of those randomized to placebo, which translated into a nonsignificant 25% difference (95% CI, 0.55–1.03). The incidence of the secondary end point among patients with renal dysfunction who received pioglitazone compared with those who received placebo was statistically significant (14.6% vs 21.4%; HR=0.66; 95% CI, 0.45–0.98).
