Dormandy JA 2005 Quality rating: Good

Design:

Study design: RCT DB Parallel

  • Run-in : None
  • Setting: Multicenter
  • Wash out : None
  • Country: Multiple European

Sample: Number Screened/Eligible/Enrolled Number Withdrawn/Lost to follow-up/Analyzed

5602/5238/5238 363/2/5238

Inclusion criteria:

Patients with DM2 who were aged 35–75 years; A1c >6.5% (or local laboratory equivalent) despite treatment with diet or oral agents, with or without insulin; evidence of extensive macrovascular disease (1 or more of MI, stroke, coronary artery bypass surgery, percutaneous coronary intervention, ≥ 6m prior to study; or acute coronary syndrome ≥ 3m prior to study; or objective evidence of coronary artery disease or arterial disease of the leg)

Exclusion criteria:

DM1, taking only insulin, had planned coronary or peripheral revascularization; New York Heart Association Class II/III heart failure or above; ischaemic ulcers, gangrene or chest pain in the leg; had hemodialysis; >2.5 times the upper limit of normal concentrations of alanine aminotransferase

Comments:

PROactive (PROspective pioglit Azone Clinical Trial in macro Vascular Events); 321 centers in 19 European countries.

Primary endpoint: time from randomization to: all-cause mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, endovascular or surgical intervention on the coronary or leg arteries, or amputation above the ankle.

Secondary endpoint: time to death from any cause, non-fatal myocardial infarction (excluding silent myocardial infarction), or stroke.

Analyzed by ITT principles; no cross-overs; 2 patients lost to follow-up; 16% or PIO and 17% of placebo group discontinued study medication before death or final visit.

Population:

  • Mean age: 61.8 years
  • Ethnicity: 98.5% Caucasian
  • Gender: 34% Female
  • Type 2 diabetes duration (SD): 9.5 (NR) years

Intervention: monotherapy

Duration:

Table

Laboratory measures:

Table

Laboratory measures:

Table

Physiologic outcomes:

Table

Health outcomes:

Table

P value NR if not specified.

From: Evidence Tables

Cover of Drug Class Review: Thiazolidinediones
Drug Class Review: Thiazolidinediones: Final Report Update 1 [Internet].
Norris SL, Carson S, Thakurta S, et al.
Portland (OR): Oregon Health & Science University; 2008 Aug.
Copyright © 2008, Oregon Health & Science University, Portland, Oregon.

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