After 12 Months, Largest-Ever Real-World Schizophrenia Study Shows Atypical Antipsychotics More Effective Than Typicals with Ran
November 20 2003 - 2:00AM
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Cumulative Olanzapine Benefits vs. Other Atypicals May Lead to
Better Patient Outcomes Over Time
Twelve-month results from the world's largest real-world schizophrenia
study show that people receiving atypical, or newer generation,
antipsychotics benefited more than those receiving the older typicals
across a range of efficacy and safety parameters. The data also
indicated that patients treated with olanzapine (Zyprexa(R))
experienced a range of modest but identifiable advantages when
compared to those treated with other leading antipsychotics. The
12-month results of the ongoing Schizophrenia Outpatient Health
Outcomes (SOHO) study were presented during the annual meeting of the
German Association of Psychiatrists, Psychotherapists and Neurologists
(DGPPN).
"First-year results of this study clearly indicate that atypicals
provide advantages across a range of efficacy and safety parameters,
including the management of positive, negative, depressive and
cognitive symptoms, when compared to typicals," said Dieter Naber, MD,
Professor and Chairman, Department of Psychiatry, University of
Hamburg.
"Among the first-line atypicals, patients remained longer on
olanzapine than on other drug therapies during the first year of the
SOHO study. In clinical practice, we see that a therapy's enduring
efficacy helps patients and physicians work together toward realizing
a patients individual potential," said Professor Dr. Naber.
As a study of schizophrenia treatments, SOHO is unprecedented in size
and scope, evaluating a total of more than 17,750 patients in two
studies in 37 countries. Ten countries in Western Europe and 27
countries throughout Asia, Central and Eastern Europe, Latin America
and the Middle East are involved in the study. The observational trial
is collecting data in the real-world setting of physicians' offices
over three years. By evaluating patients who seek treatment in typical
outpatient settings, SOHO differs from traditional clinical trials,
which often have rigid exclusion criteria that limit the kinds of
patients who participate. The SOHO study complements this traditional
approach by providing data on people's daily experiences with
antipsychotics.
SOHO: 12-Month Findings
Atypicals vs. Typicals
-- Patients taking atypicals had superior outcomes to those taking
typicals in the management of positive (delusions and hallucinations),
negative (diminished emotion, lack of interest), depressive, cognitive
and overall symptoms.
-- Patients taking atypicals had a lower incidence of extrapyramidal
symptoms (EPS) of shaking, spasms, or restlessness, when compared with
patients on typicals.
-- Patients taking atypicals required anticholinergic drugs less often
to control tremors than those treated with typicals.
Olanzapine vs. Other Treatments
-- Patients treated with olanzapine showed clinical improvement in
positive, negative, depressive, cognitive and overall symptoms
compared to patients on risperidone (Risperdal(R)), quetiapine
(Seroquel(R)), oral typical and depot typical antipsychotics. No
significant differences were found between olanzapine and clozapine
(Clozaril(R)), which is typically used as a second-line antipsychotic.
-- Olanzapine-treated patients were more likely to continue therapy
throughout the first year of the study without changing medications
when compared to those taking other first-line atypical
antipsychotics.
-- Olanzapine-treated patients had the lowest overall rate of EPS
compared with patients on all other studied drugs.
-- Fewer patients treated with olanzapine required the use of an
anticholinergic drug.
-- Weight gain was highest in patients treated with olanzapine and
clozapine as compared with other drugs.
SOHO Study Design
The study is collecting long-term data on several antipsychotic
treatments, including typicals, depot formulations and atypicals such
as olanzapine, clozapine, quetiapine, risperidone and amisulpride
(Solian(R)). The study is sponsored by Eli Lilly and Company.
The SOHO study will look at more than 30 areas over the course of
three years to assess how treatment patterns affect patients' living
conditions, clinical status, health-related quality of life, and
ability to work and socialize. It will also assess treatment
tolerability, compliance, victimization, violence and resource use.
Patients undergoing treatment in the outpatient setting for
schizophrenia were enrolled if, at the direction of the treating
psychiatrist, they started or changed antipsychotic medication. Three
treatment groups were established post hoc: olanzapine, risperidone
and 'other antipsychotics' (non-olanzapine including risperidone)
treatment. Measures of treatment effectiveness (overall, positive,
negative, cognitive and depressive domains), safety (incidence of EPS
or tardive dyskinesia), side effects (sexual dysfunction and weight
gain) and functional status (social and work functioning) were taken
at the start of the study (baseline) and at three, six and 12-months.
About Schizophrenia
Schizophrenia is a severe and debilitating psychosis often
characterized by acute episodes of delusions (false beliefs that
cannot be corrected by reason), hallucinations (usually in the form of
non-existent voices) and long-term impairments such as diminished
emotion, lack of interest and depressive signs and symptoms. It is
usually associated with a disruption in social and family
relationships.
Schizophrenia is the most common severe mental illness. There are as
many as 50 million people with schizophrenia worldwide, more than 33
million of them in developing countries. Symptoms of schizophrenia
usually begin to appear in the teenage years or early to mid-twenties.
Olanzapine Background
Olanzapine is currently indicated in the European Union (EU), the
United States, Australia, and Canada for the acute and long-term
treatment of schizophrenia, and the short-term treatment of acute
manic episodes associated with bipolar disorder. In addition,
olanzapine is indicated in the EU and Australia for the prevention of
recurrence in patients with bipolar disorder whose manic episode has
responded to olanzapine treatment, making it the first atypical
antipsychotic to be approved as a mood stabilizing medication.
Olanzapine was also the first atypical antipsychotic to prove its
long-term effectiveness in patients with schizophrenia. Since
olanzapine was introduced in 1996, it has been prescribed to more than
12.5 million people worldwide.
In clinical trials, olanzapine was generally well tolerated. However,
as with all medications, olanzapine is associated with some side
effects, the most common being somnolence and weight gain. Other
common treatment-emergent adverse events may include dry mouth,
dizziness, asthenia (muscle weakness), akathisia (restlessness),
constipation, increased appetite, modest elevations of prolactin,
postural hypotension, parkinsonism, oedema, asymptomatic elevations of
hepatic transaminase, and tremor. Hyperglyceamia and/or development or
exacerbation of diabetes occasionally associated with ketoacidosis or
coma has been reported very rarely (less than 0.01%). As with other
atypicals, appropriate clinical monitoring is advisable particularly
in diabetic patients and in patients with risk factors for the
development of diabetes mellitus.
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