Journal ArticleDOI
ADVANCE: lessons from the run-in phase of a large study in type 2 diabetes.
TLDR
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.Abstract:
Background. 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. Methods.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. Results.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. Conclusions. 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.read more
Citations
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Journal ArticleDOI
Randomized clinical trials with run-in periods: frequency, characteristics and reporting
TL;DR: It is suggested that current trials with run-in periods are interpreted with caution and that updates of reporting guidelines for randomized trials address the issue.
Journal ArticleDOI
Prevalence of chronic kidney disease and risk factors for its progression: A cross-sectional comparison of Indians living in Indian versus U.S. cities
Shuchi Anand,Shuchi Anand,Dimple Kondal,Maria E. Montez-Rath,Yuanchao Zheng,Roopa Shivashankar,Kalpana Singh,Priti Gupta,Ruby Gupta,Vamadevan S. Ajay,Viswanathan Mohan,Rajendra Pradeepa,Nikhil Tandon,Nikhil Tandon,Mohammed K. Ali,Mohammed K. Ali,K.M. Venkat Narayan,K.M. Venkat Narayan,Glenn M. Chertow,Namratha R. Kandula,Dorairaj Prabhakaran,Alka M. Kanaya +21 more
TL;DR: Prevalence of CKD among Indians living in Indian and U.S. cities is similar and Persons with CKD living inIndian cities face higher likelihood of experiencing end-stage renal disease since they have more severe kidney disease and little evidence of risk factor management.
Journal ArticleDOI
Advances in reducing the burden of vascular disease in type 2 diabetes
TL;DR: Successful implementation of this treatment, with a single combination tablet of perindopril and indapamide, should be practical and affordable in most clinical settings worldwide and has the capacity to save countless lives and to reduce the burden of coronary disease and renal disease burden among millions of people with type 2 diabetes.
Journal ArticleDOI
Combination Antihypertensive Therapy with Perindopril and Indapamide in Patients with Essential Hypertension: Effect on Endothelial and Cognitive Markers of Vascular Improvement.
E A Zheleznykh,Y. Danilogorskaya,E. V. Privalova,Y N Belenkov,Anastasia A. Schendrygina,I S Chekneva,N. Pavlov,Mikhail I. Tishman +7 more
TL;DR: SPC PER/IND at full doses for 12 months improves endothelial function, structural and functional parameters of the microcirculation, as well as cognitive function in patients with arterial hypertension at high cardiovascular risk.
Journal ArticleDOI
Nuevas perspectivas en el tratamiento del paciente diabético. Estudio ADVANCE
TL;DR: Los resultados indican that, por cada 79 pacientes tratados de esta manera, se evitaria 1 muerte cada 5 anos.
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Proceedings ArticleDOI
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