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September 23, 2005
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According to CATIE, Zyprexa(R) More Effective on Discontinuation Rate than Other Antipsychotics Studied.
PR Newswire; 9/19/2005
Patients Taking Zyprexa Had a Longer Duration of Successful Treatment
INDIANAPOLIS, Sept. 19 /PRNewswire-FirstCall/ -- Zyprexa(R) (olanzapine) was more effective on discontinuation rate in patients with schizophrenia than were other medications studied, according to the conclusions of the Clinical Antipsychotic Trial of Intervention Effectiveness (CATIE). This unprecedented study conducted by the National Institute of Mental Health will appear in the Sept. 22 issue of the New England Journal of Medicine. CATIE was designed to evaluate the overall clinical effectiveness of antipsychotics in the treatment of schizophrenia, as measured by any-cause medication discontinuation, a measure that integrates both the patients' and the doctors' judgment of how well a medication works, its safety and how well the patient tolerates the treatment.
"We are pleased that CATIE showed Zyprexa to be more effective on discontinuation rate than other medications studied," said Robert Baker, M.D., medical director, U.S. neuroscience, Eli Lilly and Company. "The study also had favorable findings for Zyprexa in terms of duration of successful treatment and risks of rehospitalization. This is important to patients and doctors because research shows that patients who stay on their medication generally have greater improvement in symptoms, reducing hospitalization and costs, and may function better in their daily lives."
The study authors also noted that patients taking Zyprexa experienced greater weight gain and increases in measures of glucose and lipid metabolism versus patients using other antipsychotics that were studied. Information about adverse events related to increases in blood glucose levels, lipid metabolism and weight gain is included in the Zyprexa product label. For patients who discontinued treatment due to adverse events, more patients taking Zyprexa discontinued because of weight gain and metabolic events.
CATIE found that for Zyprexa the average time to discontinuation was 9.2 months as compared with 4.6 months for quetiapine, 4.8 months for risperidone, 3.5 months for ziprasidone and 5.6 months for perphenazine. The differences were statistically significant for olanzapine compared with risperidone and quetiapine, but not for perphenazine or ziprasidone.
Patients taking Zyprexa also experienced fewer hospitalizations for schizophrenia than patients taking other medications. Total PANSS (Positive and Negative Syndrome Scale) scores improved over time in all groups, and patients taking Zyprexa had greater initial improvement.
"Schizophrenia is a complex disorder. Even in the group with the lowest discontinuation rate -- patients on Zyprexa -- more than half discontinued treatment within 18 months. This is why Lilly continues to invest in research seeking new treatments as well as programs to help patients benefit more fully from treatments available today," said Baker. "We believe this study can help clinicians renew their focus on aggressively finding the treatment that will achieve the best possible results for each patient with schizophrenia."
Zyprexa is indicated in the United States for the short- and long-term treatment of schizophrenia, acute mixed and manic episodes of bipolar I disorder, and maintenance treatment of bipolar disorder. Since Zyprexa was introduced in 1996, it has been prescribed to more than 18 million people worldwide.
Zyprexa is not approved for the treatment of patients with dementia- related psychosis. Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared with those patients taking a placebo. In addition, compared to elderly patients with dementia-related psychosis taking a placebo, there was a significantly higher incidence of cerebrovascular adverse events in elderly patients with dementia-related psychosis treated with Zyprexa.
Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including Zyprexa.
Prescribing should be consistent with the need to minimize the risk of neuroleptic malignant syndrome, tardive dyskinesia, seizures and orthostatic hypotension.
The most common treatment-emergent adverse event associated with Zyprexa in placebo-controlled, short-term schizophrenia and bipolar mania trials was somnolence. Other common events were dizziness, weight gain, personality disorder (COSTART term for nonaggressive objectionable behavior), constipation, akathisia, postural hypotension, dry mouth, asthenia, dyspepsia, increased appetite and tremor.
Full prescribing information, including a boxed warning, 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/. C-LLY
CONTACT: Heather Lusk, +1-317-433-5600, or Carole Copeland, +1-317-277-3661, both of Eli Lilly and Company
COPYRIGHT 2005 PR Newswire Association LLC
OREGON: MENTAL HEALTH SYSTEM BLASTED
Seattle Post-Intelligencer (Seattle, WA); 9/19/2005
MEDFORD -- The family of a mentally ill man killed two days after his release from a psychiatric ward says the death raises questions about hospital protocol and compassion.
"I'll use the word, if nobody else will: They dumped him," said Larry Safley, brother of Jay Safley, 45, of Central Point, found stabbed to death last week in a Medford alley.
"They slipped him out as soon as they could. They knew he had nowhere to go and no money. And they also knew he was not stable."
Dr. Gary Safley, a Medford pediatrician and Jay Safley's father, said the system abandons the mentally ill and excludes their families from helping.
A psychiatrist from Rogue Valley Medical Center's psychiatric unit said Jay Safley, who had bipolar disorder, was "absolutely not psychotic" when he was released on Sept. 9.
He was given a detailed plan for future care, which was not followed, said Dr. Richard Phillips, medical director of psychiatry.
COPYRIGHT 2005 Seattle Post-Intelligencer. All rights reserved. Reproduced with the permission of the Dialog Corporation by Gale Group.
NIMH-Funded Study Examines the Use of Antipsychotic Medications for the Treatment of Schizophrenia.
PR Newswire; 9/19/2005
WILMINGTON, Del., Sept. 19 /PRNewswire-FirstCall/ -- Results published in the New England Journal of Medicine from a National Institute of Mental Health-funded study compared the use of atypical antipsychotic medications, including SEROQUEL(R) (quetiapine fumarate), and a first generation antipsychotic medication for the treatment of schizophrenia. The study, titled Clinical Antipsychotic Trials of Intervention Effectiveness-Schizophrenia (CATIE-SZ), was a randomized, controlled study of 1,493 patients with schizophrenia.
"AstraZeneca appreciates the value CATIE-SZ adds to the body of evidence evaluating antipsychotic medication in schizophrenia. The study points to the importance of balancing the risks and benefits to patients when choosing an antipsychotic. The balance of efficacy and tolerability that SEROQUEL provides makes it an ideal choice in the treatment of schizophrenia," said Glenn Gormley, M.D., Ph.D., Chief Medical Officer, AstraZeneca. "The findings released represent the first of many anticipated study reports of this multi- phase study."
The authors noted that the high discontinuation rate (74%) provides evidence of the difficulties in treating individuals with schizophrenia. The most common reason for discontinuation was the patient's independent decision to stop treatment. "These findings emphasize the importance of patient- physician communication in maximizing treatment success," added Dr. Gormley.
"Schizophrenia and its treatment are both complex. Patients are unique and respond to different drugs in different ways. As a result, no one antipsychotic medicine is best suited for all patients, underscoring the need for multiple treatment options," said Dr. Gormley. "SEROQUEL provides significant benefits to patients with this complex and serious illness."
SEROQUEL is the #1 prescribed atypical in the United States(1) and has a well-established safety and efficacy profile. It is the only first line atypical with an extrapyramidal symptom (EPS) profile, including akathisia, no different from placebo across the dose range.(2)
For more information about SEROQUEL and schizophrenia, please visit http://www.schizophrenia-dialogue.com/.
Schizophrenia is a serious brain disorder with symptoms including distorted perceptions of reality, hallucinations and delusions, confused thinking, and flat or blunted emotions.(3) The first signs of schizophrenia typically emerge in the teenage years or early twenties.(3) Almost 2.2 million Americans - or 8 out of every 1,000 people - suffer from schizophrenia.(4) Medications are important in the management of symptoms.(5) Approximately 70 percent of patients with schizophrenia clearly improve when treated with antipsychotic drugs,(4) which are classified into two categories - "typical" and "atypical" antipsychotics.(4)
SEROQUEL is an atypical antipsychotic approved for the treatment of acute manic episodes associated with bipolar I disorder and for the treatment of schizophrenia. In 2004, sales for SEROQUEL reached $2 billion. SEROQUEL has had more than 13 million patient exposures worldwide since its launch in 1997.
IMPORTANT SAFETY INFORMATION
SEROQUEL is indicated for the treatment of acute manic episodes associated with bipolar I disorder, as either monotherapy or adjunct therapy with lithium or divalproex, and the treatment of schizophrenia. Patients should be periodically reassessed to determine the need for continued treatment.
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death compared to placebo (4.5% vs. 2.6%, respectively). SEROQUEL is not approved for the treatment of patients with dementia-related psychosis.
Prescribing should be consistent with the need to minimize the risk of tardive dyskinesia. A rare condition referred to as neuroleptic malignant syndrome has been reported with this class of medications, including SEROQUEL.
Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including SEROQUEL. Patients starting treatment with atypical antipsychotics who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing.
Precautions include the risk of seizures, orthostatic hypotension and cataract development.
The most commonly observed adverse events associated with the use of SEROQUEL in clinical trials were somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain, postural hypotension, pharyngitis, SGPT increase, dyspepsia, and weight gain.
For full prescribing information for SEROQUEL, please visit the Web site http://www.seroquel.com/.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com.
This press release contains forward-looking statements with respect to AstraZeneca's business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company's Annual Report/Form 20-F for 2003.
(1) All atypical prescriptions: Total prescriptions. Jan. 05-Aug. 05. New prescriptions. Sept. 04-Aug 05. IMS Health. National Prescription Audit.
(2) Data on file, DA-SER-33.
(3) National Alliance for the Mentally Ill: "About Mental Illness/Schizophrenia" fact sheet. Reviewed by Daniel Weinberger, M.D.: October 2003.
(4) Torrey Fuller E. "Surviving Schizophrenia: A Manual for Families, Consumers, and Providers: Fourth Edition." New York: HarperCollins, 2001.
(5) Miller, Rachel and Susan E. Mason. "Diagnosis Schizophrenia: A Comprehensive Resource." New York: Columbia University Press, 2002.
CONTACT: Jim Minnick, AstraZeneca, +1-302-886-5135, firstname.lastname@example.org; or Lynn Gionta, AstraZeneca, +1-302-885-5672, email@example.com
Web site: http://www.astrazeneca-us.com/ http://www.schizophrenia-dialogue.com/ http://www.seroquel.com/
Company News On-Call: http://www.prnewswire.com/comp/985887.html
COPYRIGHT 2005 PR Newswire Association LLC
No-one to blame for Camden killings.(News)
The Birmingham Post (England); 9/21/2005
No one is to blame for leaving the Camden Ripper free to murder three women, a report has found.
Sex-obsessed psychiatric patient Anthony Hardy, (53), received three life sentences at the Old Bailey in November 2003 for murdering and mutilating prostitutes.
He dumped body parts in dustbins near his north London home.
Later several other women came forward to report they had been raped by him.
A year-long inquiry, commissioned by the North Central London Strategic Health Authority, into the crucial decisions surrounding Hardy's health care treatment in 2002 found he had an untreatable personality disorder but was not mentally ill.
The panel concluded: "Hardy's mental illness was purely coincidental to the murders."
They said: "It is not the proper role of mental health services to contain people who may be violent but whose violence is not connected to the mental illness.
On hearing this, Tina Harvey who claimed she was raped by Hardy two weeks before he killed two of his victims in December 2002, said: "Sorry, I've just got to laugh."
The former masseuse and mother-of-two claimed that when Hardy attacked her at his home, his eyes flashed in such a terrifying way that he could only have been mentally ill.
She said: "He was trying to crush me and kill me.
"He was not the character of the personality disorder.
"It was of a mentally ill man."
Hardy killed all his victims at his Camden flat in 2002.
The first was 38-year-old Sally White on January 19 or 20, but police and pathologists were thrown off track, believing she had died from cardiovascular disease.
A coroner's inquest found the death was due to natural causes.
Later that year, Hardy was detained under the Mental Health Act at the psychiatric unit in Muswell Hill, north London, for daubing abuse over a neighbour's door.
Within six weeks of his release in November he had killed twice.
He murdered Elizabeth Valad, aged 29, on December 2 and Bridgette Maclennan, aged 34, on Christmas Day.
Papers read out in a high court hearing earlier this year said the decision to release was taken despite warnings by his responsible medical officer that Hardy was "vulnerable to relapse" and that women "in a relationship with him" were "at risk".
But at the time Hardy killed all the women his mental state was clinically normal and he was neither manic nor depressed or psychotic, the report said.
His killings cannot be linked to his mental illness of bipolar affective disorder, for which he was being treated.
His mental illness was "purely coincidental" to the murders, according to Robert Robinson of the independent review panel which produced the report
COPYRIGHT 2005 Birmingham Post & Mail Ltd
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The Warning Signs Of An Impending Bipolar Disorder Manic Episode
Bipolar disorder - as the name implies - involves two distinct set of symptoms. One set throws the individual down into the depths of a massive depression. The other places the individual who suffers with bipolar disorder at the top of a peak manic episode.
Most everyone can eventually recognize the warning signs of an impending depressive episode related to bipolar disorder. More likely than not, individuals with bipolar disorder try very hard to avoid it.
However, for many individuals with bipolar disorder, it's more difficult to recognize the signs of an impending manic episode. After all, a manic episode of bipolar disorder can be mistaken in some cases - especially in the very early formation -- for the lifting of the corresponding mood swing of the depression.
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