The DOI matches its Crossref record; 38 of the 38 references it cites were found in a registry or an index.
Effects of Pyridoxamine in Combined Phase 2 Studies of Patients with Type 1 and Type 2 Diabetes and Overt Nephropathy
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 1:1 and had baseline serum creatinine (bSCr) ≤2.0 mg/dl. In PYR-205/207, randomization was 2:1 and bSCr was ≤2.0 for PYR-205 and ≧2.0 but ≤3.5 mg/dl for PYR-207. Treated patients (122 active, 90 placebo) received 50 mg pyridoxamine twice daily in PYR-206; PYR-205/207 patients were escalated to 250 mg twice daily. 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 ≧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-β1 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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Cites
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Biochemistry and molecular cell biology of diabetic complications
Brownlee, M. (2001) · Nature · doi:10.1038/414813a · Cited by 9,107
Brenner, B. M., Cooper, M. E., de Zeeuw, D., Keane, W. F., Mitch, W. E., Parving, H.-H., Remuzzi, G., Snapinn, S. M., Zhang, Z., & Shahinfar, S. (2001) · New England Journal of Medicine · doi:10.1056/nejmoa011161 · Cited by 7,493
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The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy
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The Pathobiology of Diabetic Complications
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Brownlee, M. D. (1995) · Annual Review of Medicine · doi:10.1146/annurev.med.46.1.223 · Cited by 1,312
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Ziyadeh, F. N., Hoffman, B. B., Han, D. C., Iglesias-de la Cruz, M. C., Hong, S. W., Isono, M., Chen, S., McGowan, T. A., & Sharma, K. (2000) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.120055097 · Cited by 907
Cited by
DeFronzo, R. A., Ferrannini, E., Groop, L., Henry, R. R., Herman, W. H., Holst, J. J., Hu, F. B., Kahn, C. R., Raz, I., Shulman, G. I., et al. (2015) · Nature Reviews Disease Primers · doi:10.1038/nrdp.2015.19 · Cited by 2,611
Thomas, M. C., Brownlee, M., Susztak, K., Sharma, K., Jandeleit-Dahm, K. A. M., Zoungas, S., Rossing, P., Groop, P.-H., & Cooper, M. E. (2015) · Nature Reviews Disease Primers · doi:10.1038/nrdp.2015.18 · Cited by 1,230
Natural products to drugs: natural product-derived compounds in clinical trials
Butler, M. S. (2008) · Natural Product Reports · doi:10.1039/b514294f · Cited by 1,075
The Role of Advanced Glycation End Products in Progression and Complications of Diabetes
Goh, S.-Y., & Cooper, M. E. (2008) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2007-1817 · Cited by 987
Advanced glycation endproducts in food and their effects on health
Poulsen, M. W., Hedegaard, R. V., Andersen, J. M., de Courten, B., Bügel, S., Nielsen, J., Skibsted, L. H., & Dragsted, L. O. (2013) · Food and Chemical Toxicology · doi:10.1016/j.fct.2013.06.052 · Cited by 751
Metadata
- Authors
- Williams, M. E., Bolton, W. K., Khalifah, R. G., Degenhardt, T. P., Schotzinger, R. J., & McGill, J. B.
- Venue
- American Journal of Nephrology
- Publisher
- S. Karger AG
- Published
- 2007
- Volume
- 27
- Issue
- 6
- Pages
- 605-614
- ISSN
- 0250-8095 (ISSN-L)
- 1421-9670
- OpenAlex
- W1990313130
- Cited by
- 253
- References
- 38
- FWCI
- 9.05
- Type
- journal article
- Language
- en
- Open access
- closed
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