Effects of pyridoxamine in combined phase 2 studies of patients with type 1 and type 2 diabetes and overt nephropathy.
Am J Nephrol
; 27(6): 605-14, 2007.
Article
em En
| MEDLINE
| ID: mdl-17823506
ABSTRACT
BACKGROUND/AIMS:
Treatments of diabetic nephropathy (DN) delay the onset of end-stage renal disease. We report the results of safety/tolerability studies in patients with overt nephropathy and type 1/type 2 diabetes treated with pyridoxamine, a broad inhibitor of advanced glycation.METHODS:
The two 24-week studies were multicenter Phase 2 trials in patients under standard-of-care. In PYR-206, patients were randomized 11 and had baseline serum creatinine (bSCr)RESULTS:
Adverse events were balanced between the groups (p = NS). Slight imbalances, mainly in the PYR-205/207 groups, were noted in deaths (from diverse causes, p = NS) and serious adverse events (p = 0.05) that were attributed to pre-existing conditions. In a merged data set, pyridoxamine significantly reduced the change from baseline in serum creatinine (p < 0.03). In patients similar to the RENAAL/IDNT studies (bSCr >or=1.3 mg/dl, type 2 diabetes), a treatment effect was observed on the rise in serum creatinine (p = 0.007). No differences in urinary albumin excretion were seen. Urinary TGF-beta1 also tended to decrease with pyridoxamine (p = 0.049) as did the CML and CEL AGEs.CONCLUSION:
These data provide a foundation for further evaluation of this AGE inhibitor in DN.
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Base de dados:
MEDLINE
Assunto principal:
Piridoxamina
/
Complexo Vitamínico B
/
Diabetes Mellitus Tipo 1
/
Diabetes Mellitus Tipo 2
/
Nefropatias Diabéticas
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
/
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Am J Nephrol
Ano de publicação:
2007
Tipo de documento:
Article
País de afiliação:
Estados Unidos