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

Epidemiology/Health Services/Psychosocial Research

The Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROactive)

¹Clinique d’Endocrinologie, Nantes Cedex, France
²Department of Vascular Surgery, St. George’s Hospital, London, U.K
³Klinik III für Innere Medizin, Köln, Germany
⁴Dipartimento di Medicina Interna, Università di Perugia, Perugia, Italy
⁵Nottingham Clinical Research Limited, Isaac Newton Centre, Nottingham Science and Technology Park, Nottingham, U.K

Address correspondence and reprint requests to Professor Bernard Charbonnel, MD, PROactive, Clinique d’Endocrinologie, Hotel Dieu, Place Alexis Ricordeau, 44093 Nantes Cedex 1, France. E-mail: bernard.charbonnel{at}sante.univ-nantes.fr

Diabetes Care 2004 Jul; 27(7): 1647-1653. https://doi.org/10.2337/diacare.27.7.1647

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
HbA_1c (%)	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)

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 (%).
*
↵* 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)