Ref18C14
Randomized open study of the dose-effect relationship
of a short course of IdB 1016 (Siliphos®) in patients with viral
or alcoholic hepatitis
A. Vailati, L.Aristia, E. Sozze, F. Milani, V. Inglese, PO. Calenda,
P.A. Gossolo, E. Ascari
1. Department of Internal Medicine and Medical Therapy, 2. Medical
Clinic, University of Pavia, Italy
M. Lampertico, S. Comis, C. Marena
Medical Department, Inverni della Beffa, Via Ripamonti 99, 20041
Milan, Italy
Not on Medline
SUMMARY: A phase-II randomised open trial was performed to clinically
evaluate the dose-response relationship to IdB 1016 (Siliphos®),
in patients with chronic hepatitis of either alcoholic or viral
cause.
The results suggest that treatment with (Siliphos®)
is of benefit in patients with viral or alcohol-induced hepatitis
at the dose of 160 mg per day. But significant benefits were found
at the dose of 240 mg per day. Still greater benefits were found
with the dosage at 360 mg per day. All of these dosages are measured
in silybin, which is 33% of the total in Siliphos®, with phosphatidylcholine
making up the balance. Therefore you must multiply by three to
get the actual corresponding dosage of (Siliphos®).
The lowest dose had some beneficial effect, but this study collected
sufficient clinical and statistical evidence to indicate as minimum
recommended dose the 240 mg per day (measured as silybin).
Since
there are no evidences of greater risks of adverse events with
the 360 mg per day does, whereas there are indications this may
provide greater effects on more parameters than the 240 mg dose,
the use of the highest dose may be considered in patients in need
of either a faster onset or of a greater extent in the pharmacodynamic
action of IdB 1060 (Siliphos®).
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