Assessment of a pharmacokinetic and pharmacodynamic interaction between simvastatin andGinkgo bilobaextracts in healthy subjects

Abstract

1. Ginkgo biloba extract (GBE) is one of the most commonly used herbal remedies worldwide. It is usually concomitantly administrated with statins to treat diseases in geriatric patients. We aim to determine the influence of GBE on the pharmacokinetics (PK) and pharmacodynamics of simvastatin, which is currently unknown. 2. An open-label, randomized, two-period, two-treatment, balanced, crossover study was performed in 14 healthy volunteers. Subjects received simvastatin 40 mg once daily, co-treated with placebo or GBE 120 mg twice daily. Each treatment was administered for 14 d, separated by a wash-out period of 1 month. Simvastatin, simvastatin acid and lipoprotein concentrations were assessed. 3. GBE administration reduced mean simvastatin area under the curve (AUC)0-24, AUC0-∞ and Cmax by 39% (p = 0.000), 36%(p = 0.001) and 32% (p = 0.002), respectively, but did not cause significant differences in simvastatin acid PK or its cholesterol-lowering efficacy. 4. GBE consumption decreased simvastatin system exposure, but did not affect simvastatin acid PK. However, we cannot rule out the possibility for a pharmacodynamic interaction between GBE and simvastatin in vivo.

Does Adjuvant Treatment With Ginkgo Biloba to Statins Have Additional Benefits in Patients With Dyslipidemia?

“…Thus, concomitant treatment with statins and ginkgo biloba leaves may result in a reduction of hepatic toxicity of statins. This assumption was supported by a high dose of ginkgo biloba leaves could slightly decrease the plasma statins concentrations ( Liu et al, 2009 ; Guo et al, 2012 ).…”

Therapeutic Risk and Benefits of Concomitantly Using Herbal Medicines and Conventional Medicines: From the Perspectives of Evidence Based on Randomized Controlled Trials and Clinical Risk Management

“…Coadministration of Ginkgo biloba extract 120 mg twice daily with simvastatin 40 mg once daily for 2 weeks could significantly decrease simvastatin AUC (0–infinity) and C max by 36% and 32%, respectively, but it could not affect the pharmacokinetics of simvastatin acid (active metabolite) and cholesterol-lowering efficacy in healthy volunteers [25]. …”

Efficacy and safety of <em>Ginkgo biloba</em> extract as an &ldquo;add-on&rdquo; treatment to metformin for patients with metabolic syndrome: a pilot clinical study

“…This finding is a very interesting observation since GKB extract is one of the most widely consumed supplements in Europe and United States. There are many previous reports on GKB antioxidative characteristics and benefits to healthy subjects, 20 but we attempted to assess its effect on MTS patients with symptoms poorly regulated by Met alone. Generally, people may co-administer GKB extract with other prescribed medications and sometimes may even forget to address this issue to the primary care physicians.…”