Subject Profile Assessment of Cases Recommended with Nutritional Supplement Containing Red Yeast Rice, Grape Seed Extract and Black Pepper Extract: A Prospective, Multicentric, Post-marketing Study.

OBJECTIVE

To assess the profile and general health indices in subjects prescribed with a nutritional supplement containing red yeast rice, grape seed extract and black pepper extract (NS-YGP; PreLipid®; Abbott Healthcare Pvt. Ltd.) in routine clinical setting in India.

METHODS

In this prospective, postmarketing observational study, consecutive subjects recommended NS-YG at their outpatient department were recruited from 39 sites in India. The primary outcome of interest was to identify the profiles of subjects recommended with NS-YGP. The secondary outcome measures were to evaluate the changes in lipid profile from baseline to 3 and 6 months and assess the safety of NS-YGP.

RESULTS

A total of 573 subjects were enrolled, of which 527 (92%) completed the study. Majority of subjects receiving NS-YGP were males (76.6%), non-obese (85.9%) and had borderline dyslipidemia (87.3%) at the time of enrolment. There was a significant improvement in lipid profile over a period of 6 months; with a significant decline in the levels of total cholesterol, low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol (non-HDL-C) and triglycerides from baseline to month 3 and 6 (p < 0.0001 for each parameters). Furthermore, HDL-C level significantly improved from baseline till month 6 (p = 0.0007). There was a significant change in levels of other laboratory parameters, including creatine phosphokinase, serum creatinine, hemoglobin and white blood cells from baseline to 3 and 6 months (p< 0.05). No adverse events were reported in the study.

CONCLUSION

Most of the subjects prescribed with NS-YG had borderline elevated lipid levels. NS-YGP significantly improved lipid profile and was safe, well-tolerated and can be recommended in the primordial prevention of borderline dyslipidemia.

© Journal of the Association of Physicians of India 2011.