研究瑞舒伐他汀与阿托伐他汀治疗对成年印度男性 25 羟维生素 D 浓度的影响：一项随机对照试验。

To study impact of treatment with Rosuvastatin versus Atorvastatin on 25 hydroxy Vitamin D concentrations among adult Indian men- a randomized control trial.

机构信息

Department of Pediatric Growth and Endocrine Unit, Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Pune, Maharashtra, India.

Department of Paediatric Endocrinology, Royal Manchester Children's Hospital, Manchester, UK.

出版信息

Indian J Pharmacol. 2020 Sep-Oct;52(5):365-371. doi: 10.4103/ijp.IJP_93_18.

DOI:10.4103/ijp.IJP_93_18

PMID:33283767

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8025761/

Abstract

BACKGROUND

Dyslipidemias are on the rise and are increasingly being treated with statins. As the metabolism of cholecalciferol and cholesterol are interrelated, reduction in cholesterol synthesis by statins is likely to affect Vitamin D status.

OBJECTIVES

(1) The aim is to study the effect of treatment with statins (Atorvastatin/Rosuvastatin) on 25-hydroxy-Vitamin-D (25OHD) among newly detected subjects with dyslipidemia for 6 months (2) To study the impact of 25OHD concentrations on the efficacy of statin treatment.

MATERIALS AND METHODS

This was a prospective, balanced randomized (1:1), open-label, parallel-group study, in apparently healthy Indian adult men (south Asian, 40-60 years). At baseline, serum lipids and 25OHD concentrations were measured. Based on the Adult Treatment Panel III guidelines, subjects were divided as per lipid concentrations into controls (who did not require statin treatment) and intervention (who required statin treatment) groups. Random allocation of subjects was done in two groups for receiving intervention for 6 months: Atorvastatin group (n = 52, received Atorvastatin) or Rosuvastatin group (n = 52, received Rosuvastatin). Lipids and 25OHD concentrations were measured at the end line.

RESULTS

Atorvastatin group presented significant reduction (P < 0.05) in 25OHD, total cholesterol (TC) and low-density-lipoprotein-cholesterol (LDL-C) concentrations at the end line. In the Rosuvastatin group, significant drop in TC, LDL-C and high-density lipoprotein cholesterol (concentrations (P < 0.05) was observed, while 25OHD concentrations showed no significant change. Mean 25OHD concentrations were significantly correlated with a reduction in LDL-C concentrations in Atorvastatin group.

CONCLUSIONS

Treatment with Atorvastatin resulted in a reduction in 25OHD concentrations; further, its efficacy in reducing LDL-C concentrations was related to the 25OHD concentrations.

摘要

背景

血脂异常的发病率正在上升，并且越来越多地使用他汀类药物进行治疗。由于胆钙化醇和胆固醇的代谢是相互关联的，因此他汀类药物降低胆固醇的合成可能会影响维生素 D 状态。

目的

（1）本研究旨在研究新诊断的血脂异常患者在 6 个月内使用他汀类药物（阿托伐他汀/罗苏伐他汀）治疗对 25-羟维生素 D（25OHD）的影响；（2）研究 25OHD 浓度对他汀类药物治疗效果的影响。

材料和方法

这是一项前瞻性、平衡随机（1:1）、开放标签、平行组研究，纳入了来自印度的成年男性（南亚人，年龄 40-60 岁）。在基线时，测量血清脂质和 25OHD 浓度。根据成人治疗小组 III 指南，根据血脂浓度将受试者分为对照组（无需他汀类药物治疗）和干预组（需要他汀类药物治疗）。将受试者随机分配到两组中，接受 6 个月的干预：阿托伐他汀组（n = 52，接受阿托伐他汀）或罗苏伐他汀组（n = 52，接受罗苏伐他汀）。在终点测量脂质和 25OHD 浓度。

结果

阿托伐他汀组在终点时 25OHD、总胆固醇（TC）和低密度脂蛋白胆固醇（LDL-C）浓度显著降低（P < 0.05）。在罗苏伐他汀组中，TC、LDL-C 和高密度脂蛋白胆固醇（浓度（P < 0.05）显著下降，而 25OHD 浓度无显著变化。阿托伐他汀组的平均 25OHD 浓度与 LDL-C 浓度降低显著相关。