Long-term Treatment with Zyprexa(R) Demonstrated Significant Improvement Versus Risperidone in Treating Negative Symptoms in Peo
05 May 2004 - 6:00AM
PR Newswire (US)
Long-term Treatment with Zyprexa(R) Demonstrated Significant
Improvement Versus Risperidone in Treating Negative Symptoms in
People with Schizophrenia NEW YORK, May 4 /PRNewswire-FirstCall/ --
A new study shows that long-term treatment with Zyprexa(R)
(olanzapine) showed significant improvement versus long-term
treatment with risperidone in improving the symptoms and social
functioning of schizophrenia patients with prominent negative
symptoms. Zyprexa was also shown to have significantly fewer
treatment-emergent side effects, including significantly less
sexual dysfunction. This study was presented at the annual meeting
of the American Psychiatric Association in New York. "For people
with schizophrenia, seemingly ordinary social endeavors such as
sustaining relationships and keeping a job can be ambitious goals,"
said Dr. Jose M. Olivares, Psychiatry Department at the Complejo
Hospitalario Universitario Xeral-Cies in Vigo, Spain. Negative
symptoms, such as apathy, low levels of initiative and absence of
emotional expression, are the prime cause of low social function in
most people with schizophrenia. Patients who are poorly motivated
cannot function adequately at school or work, and their personal
relationships suffer due to unresponsiveness and inattention to
social cues. (1) "The ultimate goal in treating people with
schizophrenia is not only to get them well by reducing symptoms,
but also to help them to achieve a satisfactory and meaningful
level of social functioning," said Bruce Kinon, M.D., medical
advisor, U.S. Medical Neurosciences, Eli Lilly and Company. "To
that end, physicians need therapies that demonstrate long-term
effectiveness especially in improving motivation to sustain social
relationships and become engaged in vocational rehabilitation." Key
Findings The study was a one-year, multi-center, randomized,
open-label study of outpatients with schizophrenia with prominent
negative symptoms. Patients were randomly assigned to treatment
with Zyprexa (120 patients) or risperidone (115 patients). Results
of the study are presented in two different posters, one focusing
on negative, positive and overall symptomatology and safety and the
second focusing on social functioning. Zyprexa vs. Risperidone:
Response Rates and Improved Symptoms * At the end of the one-year
study, the Zyprexa group had a significantly higher response rate
(69.2 percent) than the risperidone group (48.7 percent). The
response rate was defined as a 30 percent improvement in global
score on the Scale for the Assessment of Negative Symptoms (SANS).
* During the study, treatment-emergent extrapyramidal symptoms
(such as muscle stiffness, tremors or rigidity), or worsening of
the previous symptoms, occurred at a significantly lower rate among
Zyprexa patients (28.9 percent) than in the risperidone group (50.4
percent). Negative symptoms may be, to some extent, related to
extrapyramidal side effects. * Significantly fewer Zyprexa-treated
patients (1.6 percent) experienced sexual dysfunction when compared
to risperidone-treated patients (7.3 percent). Zyprexa vs.
Risperidone: One-Year Results in Social Functioning * In the same
study, Zyprexa treatment significantly improved overall social
functioning compared to risperidone treatment. Social functioning
improvements were determined by the total score and individual
behavioral category scores on the Social Functioning Scale (SFS). *
The mean improvement in SFS total scores was significantly higher
in the Zyprexa group (7.75 in Zyprexa-treated patients and -0.92 in
risperidone- treated patients). * Zyprexa treatment resulted in a
greater numerical improvement than risperidone treatment in all SFS
categories and reached statistically significant differences in
such categories as social engagement or withdrawal, independence
(performance), independence (competence), recreation activities,
and employment. * The greatest difference between the Zyprexa and
risperidone groups was found in the occupation/employment category
(0.86 v. -3.06). Study Design This was a multi-center, randomized,
open-label, parallel, dose-flexible study evaluating Zyprexa and
risperidone in patients with prominent negative symptoms for one
year. Patients were assigned to treatment with an initial dose of
at least 10 mg/day of Zyprexa (N=120) or at least 3 mg/day of
risperidone (N=115), with the mean doses of 12.2 mg/day for Zyprexa
and 4.9 mg/day for risperidone during the studies. The study was
conducted in Spain. 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. About Zyprexa
Zyprexa is indicated in the United States for the short-term and
long-term treatment of schizophrenia, for maintenance in the
treatment of bipolar disorder, and either alone or in combination
with lithium or valproate (Depakote(R), Abbott) for the short-term
treatment of acute mixed or manic episodes associated with bipolar
disorder. In addition, on March 29, 2004, Zyprexa IntraMuscular
(olanzapine for injection), was approved by the FDA for the control
of acute agitation associated with schizophrenia and bipolar mania.
Since Zyprexa was introduced in 1996, it has been prescribed to
more than 14 million people worldwide. The most common
treatment-emergent adverse event associated with Zyprexa in
placebo-controlled, short-term schizophrenia and bipolar mania
trials was drowsiness. Other common events were dizziness, weight
gain, personality disorder (COSTART term for nonaggressive
objectionable behavior), constipation, restlessness, episodes of
low blood pressure, dry mouth, weakness, upset stomach, increased
appetite, and tremor. A small number of patients experienced
asymptomatic elevations of certain liver enzymes; none of these
patients experienced jaundice. Hyperglycemia, in some cases
associated with ketoacidosis, coma, or death, has been reported in
patients treated with atypical antipsychotics including Zyprexa.
Assessment of the relationship between atypical antipsychotic use
and glucose abnormalities is complicated by the possibility of an
increased background risk of diabetes mellitus in patients with
schizophrenia and the increasing incidence of diabetes mellitus in
the general population. All patients taking atypicals should be
monitored for symptoms of hyperglycemia. Persons with diabetes who
are started on atypicals should be monitored regularly for
worsening of glucose control; those with risk factors for diabetes
should undergo baseline and periodic fasting blood glucose testing.
Patients who develop symptoms of hyperglycemia during treatment
should undergo fasting blood glucose testing. Prescribing should be
consistent with the need to minimize the risk of neuroleptic
malignant syndrome, tardive dyskinesia, seizures and low blood
pressure. In short-term (six-week) acute bipolar mania trials in
combination with lithium or valproate, the most common treatment
emergent adverse event associated with Zyprexa and lithium or
valproate was dry mouth. Other common events were weight gain,
increased appetite, dizziness, back pain, constipation, speech
disorder, increased salivation, amnesia and abnormal burning or
tingling of the skin. Although the efficacy of Zyprexa in elderly
patients with dementia has not been established in clinical trials
and Zyprexa is not approved for use in this patient population, it
is important to note the label for Zyprexa includes a warning for
elderly patients with dementia. The warning states that strokes or
mini-strokes (also called transient ischemic attacks or TIAs),
including fatalities were reported in elderly patients with
dementia-related psychosis participating in Zyprexa clinical
trials. In addition, Lilly has completed a medical review of five
placebo-controlled trials in elderly patients with dementia, and
found an increased incidence of mortality from any cause in the
Zyprexa group compared to patients who took placebo (3.5% vs.
1.5%). In this review, risk factors that predisposed Zyprexa
patients to increased mortality included age greater than 80 years,
sedation, simultaneous use of certain sedative and anti-anxiety
medications (called benzodiazepines) or presence of pulmonary
conditions such as pneumonia. Lilly is currently addressing this
mortality data with the FDA. Full prescribing information is
available at http://www.zyprexa.com/ . About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of first-in-class and best-in-class
pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent
scientific organizations. Headquartered in Indianapolis, Ind.,
Lilly provides answers - through medicines and information -- for
some of the world's most urgent medical needs. Additional
information about Lilly is available at http://www.lilly.com/ .
LillyAnswers ensures that low-income Medicare enrollees with the
greatest need have complete access to the Lilly products they
require. The centerpiece of the patient assistance program, the
LillyAnswers card, allows seniors and people with disabilities
under Medicare to pay a flat $12 fee for a 30-day supply of certain
retail distributed Lilly drugs, including Zyprexa. Since Lilly
implemented LillyAnswers in 2002, hundreds of thousands of people
without prescription drug insurance have received more than a half
million Lilly products. LillyAnswers enrollment applications are
available by calling the toll-free number: 1-877-RX-LILLY
(1-877-795-4559) or online at http://www.lillyanswers.com/ .
Certain of the matters discussed herein with respect to clinical
studies and Lilly's products may constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements are based on
current expectations, estimates and projections about the industry,
management beliefs and certain assumptions made by management.
Investors are cautioned that matters subject to forward- looking
statements involve risks and uncertainties, including economic,
competitive, governmental, technological and other factors
discussed in the company's filings with the Securities and Exchange
Commission, which may affect the business and prospects of the
company. For further discussion of these and other risks and
uncertainties, see Lilly's filings with the United States
Securities and Exchange Commission. Lilly undertakes no duty to
update forward-looking statements. (1) Tandon, R., M. Jibson.
Negative Symptoms of Schizophrenia: How to Treat Them Most
Effectively. Current Psychiatry, vol. 1, issue 9. September 2002.
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Eli Lilly and Company CONTACT: Marni Lemons, +1-317-433-8990, cell:
+1-317-997-5604, or Kindra Strupp, +1-317-277-5170, cell:
+1-317-652-7571, both of Eli Lilly and Company
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