The Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROactive)
Can pioglitazone reduce cardiovascular events in diabetes? Study design and baseline characteristics of 5,238 patients
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Tables
- Table 1—
Baseline characteristics of the PROactive study population and other clinical history (dependent on medical opinion of investigator)
n 5,238 Demographic data Age (years) 61.8 ± 7.7 Male 3,463 (66.1) Caucasian 5,162 (98.5) Duration of type 2 diabetes (years) 9.5 ± 7.0 Physical examination measurements Weight (kg) 88.0 ± 15.6 BMI (kg/m2) 30.9 ± 4.8 Waist circumference (cm) 105.3 ± 11.9 Systolic blood pressure (mmHg) 143.4 ± 17.8 Diastolic blood pressure (mmHg) 83.0 ± 9.7 Laboratory data Triglycerides (mmol/l) 2.24 ± 1.81 HDL cholesterol (mmol/l) 1.16 ± 0.31 LDL cholesterol (mmol/l) 2.96 ± 0.95 Creatinine (μmol/l) 82.55 ± 23.2 HbA1c (%) 8.08 ± 1.41 Other clinical history Angina 3,010 (57.5) Claudication 1,239 (23.7) Amputation 72 (1.4) Transient ischemic attack 299 (5.7) Retinopathy 1,214 (23.2) Photocoagulation therapy* 345 (28.4) Nephropathy 41 (14.2) Neuropathy 1,340 (25.6) Hypertension 3,952 (75.4) Current/past smoking 722 (13.8)/2,358 (45.0) Data are means ± SD and n (%).
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↵* Expressed as a percentage of patients with retinopathy.
- Table 2—
Entry criteria and proportion of patients at high risk as determined by IDF risk assessment guidelines
Entry criteria MI 2,445 (46.7) Acute coronary syndrome 715 (13.7) Other evidence of CAD 2,521 (48.1) Percutaneous coronary intervention/coronary artery bypass graft 1,613 (30.8) Peripheral arterial obstructive disease 1,041 (19.9) Stroke 985 (18.8) Patients meeting one entry criterion 2,654 (51.5) Patients meeting two entry criteria 1,204 (23.4) Patients meeting more than three entry criteria 1,296 (25.1) Proportion of patients at high risk Triglycerides 1,858 (36.0) HDL cholesterol 1,679 (32.6) LDL cholesterol 714 (13.9) Combined blood pressure* 3,727 (71.2) Systolic blood pressure 3,405 (65.0) Diastolic blood pressure 2,279 (43.5) Data are n (%).
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↵* Combined blood pressure ″high risk″ is defined as systolic blood pressure at ″high risk″ (≥140 mmHg) and/or diastolic blood pressure at ″high risk″ (≥85 mmHg).
- Table 3—
Concomitant medications
Blood glucose-lowering medications Any medication 5,024 (95.9) Sulfonylurea alone 1,000 (19.1) Metformin alone 515 (9.9) Metformin plus sulfonylurea 1,294 (24.7) Insulin (in combination with oral agents) 1,760 (33.6) Other antidiabetic agents (alone or in combination) 611 (11.7) Lipid-lowering medications 2,703 (51.6) Statins alone 2,135 (40.8) Fibrates alone 448 (8.6) Statins plus fibrates 110 (2.1) Cardiovascular medications 4,974 (95.0) ACE inhibitors 3,286 (62.7) β-Blockers 2,859 (54.6) Calcium channel blockers 1,855 (35.4) Nitrates 2,058 (39.3) Angiotensin II antagonists 356 (6.8) α-Blockers 310 (5.9) Thiazide diuretics 830 (15.8) Potassium-sparing diuretics 336 (6.4) Loop diuretics 748 (14.3) Cardiac glycosides 255 (4.9) Antiarrhythmics 112 (2.1) Antiplatelet medications 4,394 (83.9) Acetylsalicylic acid 3,829 (73.1) Ticlopidine/clopidogrel 240 (4.6) Oral anticoagulants 362 (6.9) Data are n (%).