BACKGROUND:Patients with Type 2 diabetes and albuminuria are at high risk to progress to end-stage renal disease (ESRD). Although angiotensin receptor blockers confer renoprotection, many diabetic patients still develop overt nephropathy and reach ESRD. Glycosaminoglycans belong to the same family as heparin and heparinoids. Pilot studies with sulodexide, a glycosaminoglycan, have shown that sulodexide can reduce urinary albumin excretion rates in diabetic patients. No hard renal end-point data are available. METHODS: Two multicentre, double-masked, randomized placebo controlled trials were designed to study the renoprotective potential of sulodexide. The Sulodexide Microalbuminuria Trial examined the efficacy of sulodexide given over 26 weeks in 1000 patients with Type 2 diabetes, hypertension and microalbuminuria. The Sulodexide Overt Nephropathy Trial examined the efficacy of sulodexide in 2240 patients with Type 2 diabetes, hypertension and proteinuria > or = 900 mg/24 h. RESULTS: The primary outcome of The Sulodexide Microalbuminuria Trial was (i) conversion to normoalbuminuria and at least a 25% decrease in the urinary albumin creatinine ratio (UACR), or (ii) at least a 50% reduction in UACR. The primary outcome of The Sulodexide Overt Nephropathy Trial was time to a composite end point of doubling of serum creatinine or ESRD. CONCLUSIONS: The sulodexide nephropathy programme will document whether therapy with sulodexide confers renal protection in Type 2 diabetes and nephropathy.
RCT Entities:
BACKGROUND:Patients with Type 2 diabetes and albuminuria are at high risk to progress to end-stage renal disease (ESRD). Although angiotensin receptor blockers confer renoprotection, many diabeticpatients still develop overt nephropathy and reach ESRD. Glycosaminoglycans belong to the same family as heparin and heparinoids. Pilot studies with sulodexide, a glycosaminoglycan, have shown that sulodexide can reduce urinary albumin excretion rates in diabeticpatients. No hard renal end-point data are available. METHODS: Two multicentre, double-masked, randomized placebo controlled trials were designed to study the renoprotective potential of sulodexide. The SulodexideMicroalbuminuria Trial examined the efficacy of sulodexide given over 26 weeks in 1000 patients with Type 2 diabetes, hypertension and microalbuminuria. The Sulodexide Overt Nephropathy Trial examined the efficacy of sulodexide in 2240 patients with Type 2 diabetes, hypertension and proteinuria > or = 900 mg/24 h. RESULTS: The primary outcome of The SulodexideMicroalbuminuria Trial was (i) conversion to normoalbuminuria and at least a 25% decrease in the urinary albumin creatinine ratio (UACR), or (ii) at least a 50% reduction in UACR. The primary outcome of The Sulodexide Overt Nephropathy Trial was time to a composite end point of doubling of serum creatinine or ESRD. CONCLUSIONS: The sulodexidenephropathy programme will document whether therapy with sulodexide confers renal protection in Type 2 diabetes and nephropathy.
Authors: David K Packham; Rory Wolfe; Anne T Reutens; Tomas Berl; Hiddo Lambers Heerspink; Richard Rohde; Sara Ivory; Julia Lewis; Itamar Raz; Thomas B Wiegmann; Juliana C N Chan; Dick de Zeeuw; Edmund J Lewis; Robert C Atkins Journal: J Am Soc Nephrol Date: 2011-10-27 Impact factor: 10.121
Authors: L N Broekhuizen; B A Lemkes; H L Mooij; M C Meuwese; H Verberne; F Holleman; R O Schlingemann; M Nieuwdorp; E S G Stroes; H Vink Journal: Diabetologia Date: 2010-09-25 Impact factor: 10.122
Authors: Ji Hun Song; Hee Seung Chin; Oh Woong Kwon; Su Jin Lim; Ha Kyoung Kim Journal: Graefes Arch Clin Exp Ophthalmol Date: 2014-08-12 Impact factor: 3.117