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Drugs in R & D

, Volume 9, Issue 4, pp 243–250 | Cite as

Effect of NCB-02, Atorvastatin and Placebo on Endothelial Function, Oxidative Stress and Inflammatory Markers in Patients with Type 2 Diabetes Mellitus

A Randomized, Parallel-Group, Placebo-Controlled, 8-Week Study
  • P. UsharaniEmail author
  • A. A. Mateen
  • M. U. R. Naidu
  • Y. S. N. Raju
  • Naval Chandra
Original Research Article

Abstract

Background and objective: Hyperglycaemia leads to increased oxidative stress resulting in endothelial dysfunction. ACE inhibitors, antioxidants and HMG-CoA reductase inhibitors (statins) have been shown to improve endothelial function. The aim of this study was to compare the effects of NCB-02 (a standardized preparation of curcuminoids), atorvastatin and placebo on endothelial function and its biomarkers in patients with type 2 diabetes mellitus.

Methods: A total of 72 patients with type 2 diabetes were randomized to receive NCB-02 (two capsules containing curcumin 150 mg twice daily), atorvastatin 10 mg once daily or placebo for 8 weeks. Endothelial function assessment was performed at baseline and post-treatment using digital volume plethysmography (salbutamol [albuterol] challenge test) to measure change in reflective index, an indicator of arterial vascular tone. Blood samples were similarly collected at baseline and post-treatment for estimations of malondialdehyde, endothelin-1 (ET-1), interleukin-6 (IL-6) and tumour necrosis factor-α (TNFα). Pre-and posttreatment safety assessments were also conducted. ANOVA and paired t-test evaluations were used for comparison.

Results: A total of 67 patients completed the study. At baseline, there was no significant difference in the various parameters tested. In all three groups, the change in reflective index at baseline was <6% as assessed by the salbutamol challenge test, indicating the presence of endothelial dysfunction. Compared with baseline, there was a significant improvement in endothelial function after treatment with atorvastatin (mean ± SD: −3.63 ± 3.17% vs −8.95 ± 6.80%, respectively) and NCB-02 (−2.69 ± 3.02% vs −8.19 ± 5.73%, respectively). Similarly, patients receiving atorvastatin or NCB-02 showed significant reductions in the levels of malondialdehyde, ET-1, IL-6 and TNFα. No significant improvements were obtained in patients administered placebo.

Conclusion: NCB-02 had a favourable effect, comparable to that of atorvastatin, on endothelial dysfunction in association with reductions in inflammatory cytokines and markers of oxidative stress. Further studies are needed to evaluate the potential long-term effects of NCB-02 and its combination with other herbal antioxidants.

Keywords

Curcumin Endothelial Dysfunction Atorvastatin Endothelial Function Malondialdehyde 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgements

The authors would like to thank Dr S.K. Mithra, Executive Director R&D, Himalaya Healthcare Pvt Ltd, Bangalore, India for providing the study medication and the research grant for the conduct of the study. The authors would also like to thank Ms P. Sridevi of Sristek Consultancy for performing the statistical analysis. The authors have no conflicts of interest that are directly relevant to the content of this study.

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Copyright information

© Adis Data Information BV 2008

Authors and Affiliations

  • P. Usharani
    • 1
    Email author
  • A. A. Mateen
    • 1
  • M. U. R. Naidu
    • 1
  • Y. S. N. Raju
    • 2
  • Naval Chandra
    • 2
  1. 1.Department of Clinical Pharmacology and TherapeuticsNizam’s Institute of Medical SciencesPanjagutta, HyderabadIndia
  2. 2.Department of General MedicineNizam’s Institute of Medical SciencesHyderabadIndia

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