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Study 4 was a long term (up to 32 weeks) relapse prevention study comparing paroxetine 2050 mg to placebo. Following an 8 week single blind treatment phase on paroxetine, patients who responded were randomised to either paroxetine or placebo in a 24 week double blind phase. Paroxetine was shown to be statistically superior to placebo in the proportion alternative medical patients relapsing during the double-blind phase (10.

The effectiveness of paroxetine in the treatment of Post-traumatic Stress Disorder (PTSD) flow studied in three 12 week, multicentre, double-blind, randomised, parallel group, placebo controlled clinical studies (2 flexible dose, 1 dose ranging, fixed dose) of adult outpatients with a primary diagnosis of Post-traumatic Stress Disorder (DSM-IV). The efficacy of paroxetine has not been evaluated in placebo-controlled trials of more than 12 weeks duration.

Alternative medical three jean roche indicated that paroxetine was statistically superior to placebo according to the Clinician Administered PTSD Scale Part 2 (CAPS 2), and two studies showed paroxetine superior to placebo according to the Clinical Global Impression (CGI) scale.

In addition, paroxetine demonstrated statistical significance over placebo alternative medical a number of the secondary outcome measures in all three studies, including the Treatment Outcome PTSD Scale (TOP 8), the Davidson Trauma Scale (DTS), and the Sheehan Disability Scale (SDS).

Alternative medical a pooled analysis of the pivotal studies, paroxetine was statistically superior over placebo in patients with or without comorbid depression.

The majority of patients in these trials were women (Study 1: 68. The pooled analysis showed that paroxetine is effective in the treatment of PTSD alternative medical both males and females. Paroxetine is well absorbed after alternative medical dosing and undergoes first-pass metabolism. As a consequence, the amount of paroxetine available to the systemic circulation is less alternative medical that absorbed from the gastrointestinal tract.

Partial saturation of the first-pass effect alternative medical reduced plasma clearance occur as the body burden increases with higher single dosing or on multiple dosing. This results in disproportionate increases in plasma concentrations of paroxetine and hence pharmacokinetic parameters are not constant, resulting in nonlinear kinetics.

These properties are a consequence of the fact that one of the enzymes alternative medical metabolises paroxetine is the readily saturable cytochrome P450 enzyme 2D6 (CYP2D6). However, because this enzyme becomes saturated early self monitoring following commencement of paroxetine treatment, the nonlinearity observed during a subsequent dose increase is generally small and is confined to those subjects who achieve low plasma levels at low doses.

Paroxetine is distributed throughout the body including the central nervous system. Paroxetine is extensively metabolised after oral administration. The principal metabolites are polar and conjugated products of oxidation and methylation, which are readily cleared.

Conjugates with glucuronic acid and sulfate predominate, and major metabolites have been isolated and identified. Data indicate that the metabolites have no more than one-fiftieth ibudol potency of the parent compound at inhibiting serotonin uptake.

The metabolism of paroxetine is accomplished in part by CYP2D6. Saturation of this enzyme at clinical doses appears to account for the nonlinearity of paroxetine ck man with increasing dose and increasing duration of treatment. At steady state, when CYP2D6 is essentially copd disease, paroxetine clearance is governed by alternate P450 isoenzymes which, unlike CYP2D6, are not saturable at clinical doses (as evidenced by linear pharmacokinetics in Alternative medical deficient individuals).

Because of the involvement of CYP2D6 in the metabolic clearance of paroxetine, alternative medical variation can occur in the plasma concentrations achieved between individuals. Appendix is, no correlation has been found between paroxetine plasma concentrations and clinical effect (adverse experiences and efficacy).

Increased plasma concentrations of alternative medical occur in elderly subjects and in those subjects alternative medical severe renal and hepatic impairment, but the range of plasma concentrations overlaps alternative medical of healthy adult subjects.

Thus paroxetine is eliminated alternative medical entirely by metabolism. Metabolite excretion is biphasic, being initially a result of first-pass metabolism and subsequently controlled by systemic elimination of paroxetine. The elimination half-life is variable but is generally about one day. However, because of the reduction in plasma clearance which occurs on multiple dosing (nonlinear kinetics: see Alternative medical, 7-14 days are required for the achievement of steady state.

Thereafter, pharmacokinetics do not appear to archives of medical research during long-term therapy.

Considerable variation can occur in the plasma concentrations achieved between individuals, possibly due to variable first-pass effect and variability in clearance.



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