ADVANCE: Lessons from the run-in phase of a large study in type 2 diabetes

McIntyre, Harold David and ADVANCE Collaborative Group. (2006) ADVANCE: Lessons from the run-in phase of a large study in type 2 diabetes. Blood Pressure, 15 6: 340-346. doi:10.1080/08037050601066074

Author McIntyre, Harold David
ADVANCE Collaborative Group.
Title ADVANCE: Lessons from the run-in phase of a large study in type 2 diabetes
Journal name Blood Pressure   Check publisher's open access policy
ISSN 0803-7051
Publication date 2006
Sub-type Article (original research)
DOI 10.1080/08037050601066074
Volume 15
Issue 6
Start page 340
End page 346
Total pages 7
Place of publication London, United Kingdom
Publisher Informa Healthcare
Language eng
Subject 110306 Endocrinology
Formatted abstract
ADVANCE is a major international trial assessing the effects of routine compared with more intensive blood pressure lowering and intensive glucose control on macrovascular and microvascular outcomes, among high-risk individuals with type 2 diabetes. We describe the experience of participants receiving active blood pressure lowering therapy during the run-in phase of the study, and the characteristics of participants who withdrew during this phase.

All participants potentially eligible for inclusion in ADVANCE underwent 6 weeks of therapy with fixed low-dose perindopril 2 mg and indapamide 0.625 mg combination daily, as part of an active run-in phase of the study. This treatment was provided in addition to the participants' existing therapeutic regimen, including other blood pressure lowering drugs.


Of the 12 878 registered participants who entered the run-in phase, 11 140 participants were randomized. Only 459 participants (3.6%) withdrew due to suspected intolerance of perindopril-indapamide. The mean blood pressure fell by an average of 8/3 mmHg from 145/81 mmHg (standard deviation 22/11 mmHg) to 137/78 (20/10). Participants who proceeded to randomization were broadly similar to those who withdrew during the run-in phase; however, some features suggest that those randomized were a higher risk group overall.

A substantial fall in blood pressure was observed following 6 weeks of treatment with a fixed low-dose combination of perindopril-indapamide in a broad range of high-risk individuals with type 2 diabetes. Good tolerability and safety of the study drug was confirmed during the active run-in phase of the ADVANCE study.
Keyword Blood pressure
Haemoglobin A
Treatment efficacy
Type 2 diabetes mellitus
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Unknown

Document type: Journal Article
Sub-type: Article (original research)
Collections: Excellence in Research Australia (ERA) - Collection
School of Medicine Publications
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Created: Wed, 04 Mar 2009, 12:25:18 EST by Ms Lynette Adams on behalf of School of Medicine