L Andrén1, A Andreasson, R Eggertsen. 1. Department of Medicine/Clinical Pharmacology, Gothenburg University, Sahlgrenska University Hospital, Vita Stråket 11, S-413 45, Gothenburg, Sweden. lennart.andren@pharm.gu.se
Abstract
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 ofatorvastatin in a controlled, randomised, open, crossover interaction study. METHODS:Sixteen patients with hypercholesterolemia treated with a stable dose ofatorvastatin (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 CONCLUSION: 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.
RCT Entities:
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 CONCLUSION: 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.
Authors: K Sugimoto; M Ohmori; S Tsuruoka; K Nishiki; A Kawaguchi; K Harada; M Arakawa; K Sakamoto; M Masada; I Miyamori; A Fujimura Journal: Clin Pharmacol Ther Date: 2001-12 Impact factor: 6.875
Authors: Peter S Sever; Björn Dahlöf; Neil R Poulter; Hans Wedel; Gareth Beevers; Mark Caulfield; Rory Collins; Sverre E Kjeldsen; Arni Kristinsson; Gordon T McInnes; Jesper Mehlsen; Markku Nieminen; Eoin O'Brien; Jan Ostergren Journal: Drugs Date: 2004 Impact factor: 9.546
Authors: D Dürr; B Stieger; G A Kullak-Ublick; K M Rentsch; H C Steinert; P J Meier; K Fattinger Journal: Clin Pharmacol Ther Date: 2000-12 Impact factor: 6.875
Authors: John C LaRosa; Scott M Grundy; David D Waters; Charles Shear; Philip Barter; Jean-Charles Fruchart; Antonio M Gotto; Heiner Greten; John J P Kastelein; James Shepherd; Nanette K Wenger Journal: N Engl J Med Date: 2005-03-08 Impact factor: 91.245
Authors: Steven E Nissen; E Murat Tuzcu; Paul Schoenhagen; B Greg Brown; Peter Ganz; Robert A Vogel; Tim Crowe; Gail Howard; Christopher J Cooper; Bruce Brodie; Cindy L Grines; Anthony N DeMaria Journal: JAMA Date: 2004-03-03 Impact factor: 56.272