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PARKINSN  June 1997, Week 4

PARKINSN June 1997, Week 4

Subject:

Multiple-dose tolcapone

From:

Forrests Mom <[log in to unmask]>

Reply-To:

Parkinson's Information Exchange <[log in to unmask]>

Date:

Tue, 24 Jun 1997 05:20:38 -0400

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (105 lines)

                                  [Pfizer]

                                   [Folio]

Title
     Multiple-dose clinical pharmacology of the
     catechol-O-methyl-transferase inhibitor tolcapone in elderly sub=
jects.
Author
     Dingemanse J; Jorga K; Z=FCrcher G; Fotteler B; Sedek G; Nielsen=
 T; van
     Brummelen P
Address
     Department of Clinical Pharmacology, F. Hoffmann-La Roche Ltd, B=
asel,
     Switzerland.
Source
     Eur J Clin Pharmacol, 50:47-55, 1996
Abstract
     OBJECTIVE: The purpose of this study was to assess the multiple-=
dose
     clinical pharmacology of tolcapone, a novel
     catechol-O-methyltransferase (COMT) inhibitor, in elderly subjec=
ts.
     METHODS: The drug was administered orally t.i.d. for 7 days to f=
our
     sequential groups of eight elderly subjects (gender ratio 1:1) a=
t doses
     of 100, 200, 400 and 800 mg in a double-blind, randomised,
     placebo-controlled, ascending-multiple-dose design. On days 2 an=
d 7, a
     single dose of levodopa/benserazide 100/25 mg was given 1 h afte=
r the
     first intake of tolcapone. Plasma concentrations of tolcapone; i=
ts
     metabolite 3-O-methyltolcapone, levodopa and 3-O-methyldopa were
     determined during the course of the study in conjunction with CO=
MT
     activity in erythrocytes. RESULTS: Tolcapone was well tolerated =
at all
     dose levels, with a slight increase in gastrointestinal adverse =
events
     in females at higher doses. The drug was rapidly absorbed and
     eliminated and showed no changes in pharmacokinetics with time d=
uring
     multiple doses of 100 and 200 mg t.i.d. At doses of 400 and 800 =
mg
     t.i.d., tolcapone accumulated moderately as reflected in increas=
ed Cmax
     and AUC values. Despite the long halflife of 3-O-methyltolcapone=
 (39
     h), only minor accumulation occurred due to suppression of its
     formation by tolcapone. The pharmacodynamics of tolcapone did no=
t
     change during the week of treatment as reflected in inhibition o=
f COMT
     activity in erythrocytes, the derived parameters of the plasma
     concentration-effect relationship (inhibitory Emax model with co=
nstant
     EC50 values) and the effect on levodopa pharmacokinetics (1.6 to
     2.5-fold increase in bioavailability). This suggests the absence=
 of
     tolerance development and the insignificance of the altered
     pharmacokinetics at 400 and 800 mg t.i.d. with regard to the
     pharmacodynamics. CONCLUSION: The results of this study offer pr=
omising
     perspectives for the application of tolcapone as adjunct therapy=
 to
     levodopa in the treatment of Parkinson's disease.
Language
     Eng
Unique Identifier
     96311493

---------------------------------------------------------------------=
-------

MESH Headings
     Aged; Benzophenones (AE/*PD/PK); Biotransformation; Catechol
     Methyltransferase (*AI/BL); Dopamine Agents (PD); Dose-Response
     Relationship, Drug; Double-Blind Method; Enzyme Inhibitors (AE/*=
PD/PK);
     Erythrocytes (DE/EN); Female; Half-Life; Human; Levodopa (PD); M=
ale;
     Middle Age

---------------------------------------------------------------------=
-------

Publication Type
     CLINICAL TRIAL; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
ISSN
     0031-6970
Country of Publication
     GERMANY

---------------------------------------------------------------------=
-------
                           http://www.medscape.com
                   Medscape is produced by Medscape, Inc.
    All material on this server Copyright =A9 1994, 1995, 1996, 1997 =
by the
                            publishers involved.

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June 2002, Week 5
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June 2002, Week 1
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April 2002, Week 5
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April 2002, Week 3
April 2002, Week 2
April 2002, Week 1
March 2002, Week 5
March 2002, Week 4
March 2002, Week 3
March 2002, Week 2
March 2002, Week 1
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December 2001, Week 2
December 2001, Week 1
November 2001, Week 5
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November 2001, Week 3
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November 2001, Week 1
October 2001, Week 5
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October 2001, Week 3
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October 2001, Week 1
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September 2001, Week 2
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August 2001, Week 3
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July 2001, Week 1
June 2001, Week 5
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June 2001, Week 1
May 2001, Week 5
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April 2001, Week 5
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April 2001, Week 3
April 2001, Week 2
April 2001, Week 1
March 2001, Week 5
March 2001, Week 4
March 2001, Week 3
March 2001, Week 2
March 2001, Week 1
February 2001, Week 4
February 2001, Week 3
February 2001, Week 2
February 2001, Week 1
January 2001, Week 5
January 2001, Week 4
January 2001, Week 3
January 2001, Week 2
January 2001, Week 1
December 2000, Week 5
December 2000, Week 4
December 2000, Week 3
December 2000, Week 2
December 2000, Week 1
November 2000, Week 5
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November 2000, Week 3
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November 2000, Week 1
October 2000, Week 5
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October 2000, Week 1
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August 2000, Week 3
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May 2000, Week 1
April 2000, Week 5
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April 2000, Week 3
April 2000, Week 2
April 2000, Week 1
March 2000, Week 5
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March 2000, Week 3
March 2000, Week 2
March 2000, Week 1
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February 2000, Week 4
February 2000, Week 3
February 2000, Week 2
February 2000, Week 1
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January 2000, Week 4
January 2000, Week 3
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January 2000, Week 1
December 1999, Week 5
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December 1999, Week 3
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November 1999, Week 3
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October 1999, Week 5
October 1999, Week 4
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October 1999, Week 1
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March 1999, Week 3
March 1999, Week 2
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November 1998, Week 3
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October 1998, Week 5
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October 1998, Week 3
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September 1998, Week 5
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August 1998, Week 1
July 1998, Week 5
July 1998, Week 4
July 1998, Week 3
July 1998, Week 2
July 1998, Week 1
June 1998, Week 5
June 1998, Week 4
June 1998, Week 3
June 1998, Week 2
June 1998, Week 1
May 1998, Week 5
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May 1998, Week 3
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May 1998, Week 1
April 1998, Week 5
April 1998, Week 4
April 1998, Week 3
April 1998, Week 2
April 1998, Week 1
March 1998, Week 5
March 1998, Week 4
March 1998, Week 3
March 1998, Week 2
March 1998, Week 1
February 1998, Week 5
February 1998, Week 4
February 1998, Week 3
February 1998, Week 2
February 1998, Week 1
January 1998, Week 5
January 1998, Week 4
January 1998, Week 3
January 1998, Week 2
January 1998, Week 1
December 1997, Week 5
December 1997, Week 4
December 1997, Week 3
December 1997, Week 2
December 1997, Week 1
November 1997, Week 5
November 1997, Week 4
November 1997, Week 3
November 1997, Week 2
November 1997, Week 1
October 1997, Week 5
October 1997, Week 4
October 1997, Week 3
October 1997, Week 2
October 1997, Week 1
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September 1997, Week 4
September 1997, Week 3
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September 1997, Week 1
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August 1997, Week 3
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August 1997, Week 1
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June 1997, Week 3
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June 1997, Week 1
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May 1997, Week 3
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May 1997, Week 1
April 1997, Week 5
April 1997, Week 4
April 1997, Week 3
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March 1997, Week 3
March 1997, Week 2
March 1997, Week 1
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October 1996, Week 1
September 1996, Week 5
September 1996, Week 4
September 1996, Week 3
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April 1996, Week 4
April 1996, Week 3
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April 1996, Week 1
March 1996, Week 5
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March 1996, Week 3
March 1996, Week 2
March 1996, Week 1
February 1996, Week 5
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February 1996, Week 3
February 1996, Week 2
February 1996, Week 1
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January 1996, Week 4
January 1996, Week 3
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January 1996, Week 1
December 1995, Week 5
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December 1995, Week 3
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