NDT Advance Access originally published online on July 27, 2004
Nephrology Dialysis Transplantation 2004 19(10):2519-2525; doi:10.1093/ndt/gfh408
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Nephrol Dial Transplant Vol. 19 No. 10 © ERA-EDTA 2004; all rights reserved
Original Article
The renoprotective effects of structured care in a clinical trial setting in type 2 diabetic patients with nephropathy
1 Department of Medicine and Therapeutics, The Chinese University of Hong Kong, The Prince of Wales Hospital, Shatin, Hong Kong SAR, 2 Renal Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA and 3 Merck Research Laboratory, Whitehouse, PA, USA 4 Professor J. A. J. H. Critchley, one of the senior investigators in this sub-study, unfortunately died after a road traffic accident on 13th July 2001 at the age of 50 years. During his 12 years of stay in Hong Kong, he had contributed significantly to the understanding of diabetes and metabolic syndrome in Hong Kong Chinese.
Correspondence and offprint requests to: Dr Juliana C. N. Chan, Divisions of Endocrinology and Clinical Pharmacology, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, The Prince of Wales Hospital, Shatin, N.T., Hong Kong. Email: jchan{at}cuhk.edu.hk
Background. The RENAAL Study has confirmed the renoprotective effects of Losartan in type 2 diabetes. In this subgroup analysis from the RENAAL Study, we hypothesized that the intensive care received by patients in a clinical trial setting also reduced the rate of decline in renal function through optimization of all risk factors.
Methods. We compared the rate of deterioration in renal function, expressed as the regression coefficient of the monthly serum creatinine (SeCr) reciprocal (beta-1/Cr) in 55 Chinese type 2 diabetic patients before and after entry into the RENAAL Study.
Results. Of the 55 patients, 44 had at least three out-patient SeCr measurements both before (2.9±2.4 years) and after (3.3±0.8 years) entry into the study for evaluation. In the Losartan group (n = 24), the median beta-1/Cr fell from –11.4 x 10–5 l µmol–1 month–1 before entry into the trial to –4.7 x 10–5 l µmol–1 month–1 following entry (P = 0.001). The respective figures were –9.1 x 10–5 and –5.0 x 10–5 l µmol–1 month–1 (P = 0.01) in the placebo group (n = 20). A decrease in beta-1/Cr was observed in 21 (87.5%) and 14 (70.0%) patients in the Losartan and placebo groups, respectively. Spot urinary albumin-to-creatinine ratio was reduced by 56% (P = 0.001) in the Losartan group but the change was not significant in the placebo group. At the end of the study, patients in both groups had lower blood pressure and better lipid control. The frequency of patient visits to doctors and nurses were doubled.
Conclusions. The rate of renal function decline was significantly reduced in the majority of patients allocated to either Losartan or placebo following entry into the RENAAL study. These results suggest that in patients with diabetic nephropathy, implementation of a structured care protocol in a clinical trial setting facilities intensive treatment of risk factors confering renoprotective effects in addition to those resulting from Losartan treatment.
Keywords: clinical trial; diabetic nephropathy; renoprotection; structured care
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  J. C. Chan, W.-Y. So, C.-Y. Yeung, G. T. Ko, I.-T. Lau, M.-W. Tsang, K.-P. Lau, S.-C. Siu, J. K. Li, V. T. Yeung, et al. Effects of Structured Versus Usual Care on Renal Endpoint in Type 2 Diabetes: The SURE Study: A randomized multicenter translational study Diabetes Care, June 1, 2009; 32(6): 977 - 982. [Abstract] [Full Text] [PDF]
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