Interaction between a commercially available St. John's wort product (Movina) and atorvastatin in patients with hypercholesterolemia.
OBJECTIVE
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.


METHODS
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.


RESULTS
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


CONCLUSIONS
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.
Andrén
L
L
Department of Medicine/Clinical Pharmacology, Gothenburg University, Sahlgrenska University Hospital, Vita Stråket 11, S-413 45, Gothenburg, Sweden. lennart.andren@pharm.gu.se
Andreasson
A
A
Eggertsen
R
R
D018435:ATP Binding Cassette Transporter, Subfamily B; D020168:ATP Binding Cassette Transporter, Subfamily B, Member 1 / Q000096:biosynthesis; D000368:Aged; D000069059:Atorvastatin; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D018592:Cross-Over Studies; D051544:Cytochrome P-450 CYP3A; D003577:Cytochrome P-450 Enzyme System / Q000096:biosynthesis; D004790:Enzyme Induction; D005260:Female; D006538:Heptanoic Acids / Q000493:pharmacokinetics / Q000627:therapeutic use*; D041743:Herb-Drug Interactions; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D020902:Hypericum; D007413:Intestinal Mucosa / Q000378:metabolism; D007422:Intestines / Q000187:drug effects* / Q000201:enzymology; D008099:Liver / Q000187:drug effects* / Q000201:enzymology; D008297:Male; D008875:Middle Aged; D028321:Plant Preparations / Q000494:pharmacology*; D011758:Pyrroles / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood; D015854:Up-Regulation
C513055:ABCB1 protein, human; D018435:ATP Binding Cassette Transporter, Subfamily B; D020168:ATP Binding Cassette Transporter, Subfamily B, Member 1; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D028321:Plant Preparations; D011758:Pyrroles; D014280:Triglycerides; D003577:Cytochrome P-450 Enzyme System; D002784:Cholesterol; D000069059:Atorvastatin; D051544:Cytochrome P-450 CYP3A; C510163:CYP3A4 protein, human
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