Andrén L, Andreasson A, Eggertsen R
Department of Medicine/Clinical Pharmacology, Gothenburg University, Sahlgrenska University Hospital, Vita Stråket 11, S-413 45, Gothenburg, Sweden.
Eur J Clin Pharmacol. 2007 Oct;63(10):913-6. doi: 10.1007/s00228-007-0345-x. Epub 2007 Aug 15.
The aim of this study was to assess the effect of treatment with a St. John's wort product (Movina) on cholesterol [total cholesterol, low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol] and triglyceride levels in patients with hypercholesterolemia on treatment with a stable dose of atorvastatin in a controlled, randomised, open, crossover interaction study.
Sixteen patients with hypercholesterolemia treated with a stable dose of atorvastatin (10-40 mg/daily) for at least 3 months were treated with Movina one tablet (containing 300 mg of hypericum perforatum) twice daily and control (a commercially available multivitamin tablet Vitamineral). After a run-in period of 4 weeks, patients were randomised to treatment with either Movina or control for 4 weeks in a crossover design. The atorvastatin dose was kept unchanged during the study period (12 weeks), and assessments of total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides were performed in the morning with the patients in the fasting condition. The difference between control and active treatment in LDL cholesterol after 4 weeks of treatment was the primary endpoint.
All patients completed the study. The St. John's wort product significantly increased the serum level of LDL cholesterol compared with control (2.66 mmol/l compared with 2.34 mmol/l, p = 0.004). A significant increase in total cholesterol was also observed (5,10 mmol/l compared with 4.78 mmol/l, p = 0.02). No statistically significant change was observed in HDL cholesterol (1.59 mmol/l and 1.56 mmol/l, p = 0.49) or in triglycerides (1.87 mmol/l and 1.94 mmol/l, p = 0.60). No product-related side effects were reported
An interaction was observed between the studied St.-John's-wort-containing product and atorvastatin. Physicians and patients should be aware of this interaction and if treatment with a St. John's wort product is considered necessary, then there may be a need for increasing the dose of atorvastatin.
本研究旨在通过一项对照、随机、开放、交叉相互作用研究,评估一种圣约翰草产品(Movina)对接受稳定剂量阿托伐他汀治疗的高胆固醇血症患者的胆固醇[总胆固醇、低密度脂蛋白(LDL)胆固醇和高密度脂蛋白(HDL)胆固醇]及甘油三酯水平的影响。
16例接受稳定剂量阿托伐他汀(10 - 40毫克/每日)治疗至少3个月的高胆固醇血症患者,每日两次服用一片Movina(含300毫克贯叶连翘)及对照药物(一种市售复合维生素片Vitamineral)。经过4周的导入期后,患者采用交叉设计随机接受Movina或对照药物治疗4周。在研究期间(12周),阿托伐他汀剂量保持不变,于早晨患者空腹状态下测定总胆固醇、HDL胆固醇、LDL胆固醇及甘油三酯水平。治疗4周后LDL胆固醇对照与活性治疗之间的差异为主要终点。
所有患者均完成研究。与对照相比,圣约翰草产品显著升高了LDL胆固醇的血清水平(分别为2.66毫摩尔/升和2.34毫摩尔/升,p = 0.004)。总胆固醇也观察到显著升高(分别为5.10毫摩尔/升和4.78毫摩尔/升,p = 0.02)。HDL胆固醇(分别为1.59毫摩尔/升和1.56毫摩尔/升,p = 0.49)或甘油三酯(分别为1.87毫摩尔/升和1.94毫摩尔/升,p = 0.60)未观察到统计学上的显著变化。未报告与产品相关的副作用。
观察到所研究的含圣约翰草产品与阿托伐他汀之间存在相互作用。医生和患者应知晓这种相互作用,若认为有必要使用圣约翰草产品进行治疗,则可能需要增加阿托伐他汀的剂量。