Skip to main content
  • More from ADA
    • Diabetes
    • Clinical Diabetes
    • Diabetes Spectrum
    • ADA Standards of Medical Care
    • ADA Scientific Sessions Abstracts
    • BMJ Open Diabetes Research & Care
  • Subscribe
  • Log in
  • My Cart
  • Follow ada on Twitter
  • RSS
  • Visit ada on Facebook
Diabetes Care

Advanced Search

Main menu

  • Home
  • Current
    • Current Issue
    • Online Ahead of Print
    • Special Article Collections
    • ADA Standards of Medical Care
  • Browse
    • By Topic
    • Issue Archive
    • Saved Searches
    • Special Article Collections
    • ADA Standards of Medical Care
  • Info
    • About the Journal
    • About the Editors
    • ADA Journal Policies
    • Instructions for Authors
    • Guidance for Reviewers
  • Reprints/Reuse
  • Advertising
  • Subscriptions
    • Individual Subscriptions
    • Institutional Subscriptions and Site Licenses
    • Access Institutional Usage Reports
    • Purchase Single Issues
  • Alerts
    • E­mail Alerts
    • RSS Feeds
  • Podcasts
    • Diabetes Core Update
    • Special Podcast Series: Therapeutic Inertia
    • Special Podcast Series: Influenza Podcasts
    • Special Podcast Series: SGLT2 Inhibitors
    • Special Podcast Series: COVID-19
  • Submit
    • Submit a Manuscript
    • Journal Policies
    • Instructions for Authors
    • ADA Peer Review
  • More from ADA
    • Diabetes
    • Clinical Diabetes
    • Diabetes Spectrum
    • ADA Standards of Medical Care
    • ADA Scientific Sessions Abstracts
    • BMJ Open Diabetes Research & Care

User menu

  • Subscribe
  • Log in
  • My Cart

Search

  • Advanced search
Diabetes Care
  • Home
  • Current
    • Current Issue
    • Online Ahead of Print
    • Special Article Collections
    • ADA Standards of Medical Care
  • Browse
    • By Topic
    • Issue Archive
    • Saved Searches
    • Special Article Collections
    • ADA Standards of Medical Care
  • Info
    • About the Journal
    • About the Editors
    • ADA Journal Policies
    • Instructions for Authors
    • Guidance for Reviewers
  • Reprints/Reuse
  • Advertising
  • Subscriptions
    • Individual Subscriptions
    • Institutional Subscriptions and Site Licenses
    • Access Institutional Usage Reports
    • Purchase Single Issues
  • Alerts
    • E­mail Alerts
    • RSS Feeds
  • Podcasts
    • Diabetes Core Update
    • Special Podcast Series: Therapeutic Inertia
    • Special Podcast Series: Influenza Podcasts
    • Special Podcast Series: SGLT2 Inhibitors
    • Special Podcast Series: COVID-19
  • Submit
    • Submit a Manuscript
    • Journal Policies
    • Instructions for Authors
    • ADA Peer Review
Epidemiology/Health Services/Psychosocial Research

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

  1. Bernard Charbonnel, MD1,
  2. John Dormandy, FRCS(ED), FRCS(ENG), DSC2,
  3. Erland Erdmann, MD, FESC, FACC3,
  4. Massimo Massi-Benedetti, MD4,
  5. Allan Skene, PHD5 and
  6. PROactive Study Group
  1. 1Clinique d’Endocrinologie, Nantes Cedex, France
  2. 2Department of Vascular Surgery, St. George’s Hospital, London, U.K
  3. 3Klinik III für Innere Medizin, Köln, Germany
  4. 4Dipartimento di Medicina Interna, Università di Perugia, Perugia, Italy
  5. 5Nottingham Clinical Research Limited, Isaac Newton Centre, Nottingham Science and Technology Park, Nottingham, U.K
  1. 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
PreviousNext
  • Article
  • Figures & Tables
  • Info & Metrics
  • PDF
Loading

Article Figures & Tables

Tables

  • Table 1—

    Baseline characteristics of the PROactive study population and other clinical history (dependent on medical opinion of investigator)

    n5,238
    Demographic data
     Age (years)61.8 ± 7.7
     Male3,463 (66.1)
     Caucasian5,162 (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
     Angina3,010 (57.5)
     Claudication1,239 (23.7)
     Amputation72 (1.4)
     Transient ischemic attack299 (5.7)
     Retinopathy1,214 (23.2)
     Photocoagulation therapy*345 (28.4)
     Nephropathy41 (14.2)
     Neuropathy1,340 (25.6)
     Hypertension3,952 (75.4)
     Current/past smoking722 (13.8)/2,358 (45.0)
    • Data are means ± SD and n (%).

    • *

      ↵* 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
     MI2,445 (46.7)
     Acute coronary syndrome715 (13.7)
     Other evidence of CAD2,521 (48.1)
     Percutaneous coronary intervention/coronary artery bypass graft1,613 (30.8)
     Peripheral arterial obstructive disease1,041 (19.9)
     Stroke985 (18.8)
     Patients meeting one entry criterion2,654 (51.5)
     Patients meeting two entry criteria1,204 (23.4)
     Patients meeting more than three entry criteria1,296 (25.1)
    Proportion of patients at high risk
     Triglycerides1,858 (36.0)
     HDL cholesterol1,679 (32.6)
     LDL cholesterol714 (13.9)
     Combined blood pressure*3,727 (71.2)
     Systolic blood pressure3,405 (65.0)
     Diastolic blood pressure2,279 (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 medication5,024 (95.9)
     Sulfonylurea alone1,000 (19.1)
     Metformin alone515 (9.9)
     Metformin plus sulfonylurea1,294 (24.7)
     Insulin (in combination with oral agents)1,760 (33.6)
     Other antidiabetic agents (alone or in combination)611 (11.7)
    Lipid-lowering medications2,703 (51.6)
     Statins alone2,135 (40.8)
     Fibrates alone448 (8.6)
     Statins plus fibrates110 (2.1)
    Cardiovascular medications4,974 (95.0)
     ACE inhibitors3,286 (62.7)
     β-Blockers2,859 (54.6)
     Calcium channel blockers1,855 (35.4)
     Nitrates2,058 (39.3)
     Angiotensin II antagonists356 (6.8)
     α-Blockers310 (5.9)
     Thiazide diuretics830 (15.8)
     Potassium-sparing diuretics336 (6.4)
     Loop diuretics748 (14.3)
     Cardiac glycosides255 (4.9)
     Antiarrhythmics112 (2.1)
    Antiplatelet medications4,394 (83.9)
     Acetylsalicylic acid3,829 (73.1)
     Ticlopidine/clopidogrel240 (4.6)
     Oral anticoagulants362 (6.9)
    • Data are n (%).

PreviousNext
Back to top
Diabetes Care: 27 (7)

In this Issue

July 2004, 27(7)
  • Table of Contents
  • About the Cover
  • Index by Author
Sign up to receive current issue alerts
View Selected Citations (0)
Print
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email Article

Thank you for your interest in spreading the word about Diabetes Care.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
The Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROactive)
(Your Name) has forwarded a page to you from Diabetes Care
(Your Name) thought you would like to see this page from the Diabetes Care web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Citation Tools
The Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROactive)
Bernard Charbonnel, John Dormandy, Erland Erdmann, Massimo Massi-Benedetti, Allan Skene
Diabetes Care Jul 2004, 27 (7) 1647-1653; DOI: 10.2337/diacare.27.7.1647

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Add to Selected Citations
Share

The Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROactive)
Bernard Charbonnel, John Dormandy, Erland Erdmann, Massimo Massi-Benedetti, Allan Skene
Diabetes Care Jul 2004, 27 (7) 1647-1653; DOI: 10.2337/diacare.27.7.1647
del.icio.us logo Digg logo Reddit logo Twitter logo CiteULike logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • RESEARCH DESIGN AND METHODS
    • RESULTS
    • CONCLUSIONS
    • APPENDIX
    • Acknowledgments
    • Footnotes
    • References
  • Figures & Tables
  • Info & Metrics
  • PDF

Related Articles

Cited By...

More in this TOC Section

  • Suboptimal Use of Cardioprotective Drugs in Newly Treated Elderly Individuals With Type 2 Diabetes
  • Disparities in Diabetes Care Between Smokers and Nonsmokers
  • Insulin Sensitivity and Insulin Secretion Determined by Homeostasis Model Assessment and Risk of Diabetes in a Multiethnic Cohort of Women
Show more Epidemiology/Health Services/Psychosocial Research

Similar Articles

Navigate

  • Current Issue
  • Standards of Care Guidelines
  • Online Ahead of Print
  • Archives
  • Submit
  • Subscribe
  • Email Alerts
  • RSS Feeds

More Information

  • About the Journal
  • Instructions for Authors
  • Journal Policies
  • Reprints and Permissions
  • Advertising
  • Privacy Policy: ADA Journals
  • Copyright Notice/Public Access Policy
  • Contact Us

Other ADA Resources

  • Diabetes
  • Clinical Diabetes
  • Diabetes Spectrum
  • Scientific Sessions Abstracts
  • Standards of Medical Care in Diabetes
  • BMJ Open - Diabetes Research & Care
  • Professional Books
  • Diabetes Forecast

 

  • DiabetesJournals.org
  • Diabetes Core Update
  • ADA's DiabetesPro
  • ADA Member Directory
  • Diabetes.org

© 2021 by the American Diabetes Association. Diabetes Care Print ISSN: 0149-5992, Online ISSN: 1935-5548.