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                                                                                          Dott. Carlo Sebastiano Tadeo
                                                                                                Specialista Neurologia

Olanzapina approvata per episodi maniacali


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FDA Approves Zyprexa (Olanzapine) For Manic Episodes In Bipolar Disorder

INDIANAPOLIS, IN -- March 20, 2000 -- Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved Zyprexa(R) (olanzapine) for marketing for the short-term treatment of acute manic episodes associated with bipolar disorder.

Bipolar disorder, also known as manic depressive illness, is a lifelong illness characterized by disruptive swings in mood -- from manic episodes, marked by euphoria and irritability, to periods of depression. Mania is a period of abnormal elation and/or irritability, often accompanied by an unrealistic belief in one's own abilities, increased sex drive, delusions, and alcohol or drug abuse. People with bipolar disorder also may experience mixed episodes, marked by symptoms of mania and clinical depression occurring simultaneously.(1)

Approximately three million Americans suffer from bipolar disorder.(2) An estimated one in four persons with the illness attempts suicide, one of the highest incidence-rates for any psychiatric disorder.(3)

"In short-term clinical trials, it appears that Zyprexa acts as a mood stabilizer to manage the manic phase of bipolar illness easily, safely and effectively. Additionally, unlike some other medications, Zyprexa does not require blood monitoring," said Mauricio Tohen, M.D., Dr. P.H., lead investigator, Lilly Research Laboratories. "Zyprexa can stabilize mood in a range of bipolar patients with manic symptoms, potentially avoiding impulsive or reckless behavior that can lead to serious problems."

Mania associated with bipolar disorder, while manageable with proper therapy, can be difficult to diagnose and, therefore, may be treated incorrectly.

"The majority of patients with bipolar disorder seek treatment during a depressive phase. This can leave the manic phase of the disease undetected, leading to inappropriate treatment and worsening of symptoms," said Paul Keck, M.D., professor and vice chairman for research, University of Cincinnati College of Medicine. "Accurate diagnosis and proper treatment are critical to managing the illness and allowing people the chance to lead healthy, productive lives."

The FDA's approval of Zyprexa for the treatment of acute manic episodes associated with bipolar disorder was based on results from two placebo-controlled trials involving patients with a primary diagnosis of bipolar disorder: one three-week trial involving 67 patients and one four-week trial involving 115 patients. The trials included patients with manic and mixed episodes, with or without psychotic features, and with or without a rapid-cycling course.

Zyprexa led to a significant improvement in mania, as measured by the Young-Mania Rating Scale (YMRS).

Zyprexa was generally well tolerated, with four adverse events reported significantly more frequently in the Zyprexa group than in the placebo group: somnolence (drowsiness), dry mouth, dizziness and asthenia (loss of strength). No participants discontinued the study due to any of these events. Other common events that did not separate statistically from placebo were constipation, dyspepsia (indigestion), increased appetite, and tremor.

The recommended beginning dose of Zyprexa to treat acute manic episodes is 15 or 10 milligrams, taken once a day, at any time, without regard to meals.

Zyprexa also is indicated in the United States for the management of the manifestations of psychotic disorders as demonstrated in short-term clinical trials with schizophrenia patients. Since Zyprexa was introduced in 1996, it has been prescribed to nearly four million people worldwide.

In the original schizophrenia registration trials, Zyprexa was generally well tolerated. However, as with all medications, Zyprexa was associated with some side effects. In the original six-week, acute-phase schizophrenia trials, the most common treatment-emergent adverse event associated with Zyprexa was somnolence. Other common events were dizziness, weight gain, constipation, akathisia (restlessness) and postural hypotension. Modest elevations of prolactin were also seen, although mean changes from baseline to
endpoint were not statistically significantly different between Zyprexa and placebo. A small number of patients experienced asymptomatic elevations of hepatic transaminase; none of these patients developed jaundice or drug-induced hepatitis.

Eli Lilly and Company is a global research-based pharmaceutical corporation headquartered in Indianapolis, Ind., that is dedicated to creating and delivering innovative pharmaceutical-based health care solutions that enable people to live longer, healthier and more active lives.

Zyprexa(R) (olanzapine, Lilly)

(1) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). American Psychiatric Association, 1994.

(2) Practice Guideline for Treatment of Patients with Bipolar Disorder. American Psychiatric Association, 1995.

(3) Goodwin FK, Jameson, KR. Manic Depressive Illness. Oxford University Press, 1990.


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Aggiornato il: 25 March 2000