Navigation Links
No difference in nonsuicide mortality between 2 anti-psychotic drugs
Date:11/12/2010

PHILADELPHIA - The potential for harmful side effects associated with anti-psychotic medications for treating schizophrenia is a frustration for mental-health professionals who must balance this with the positive benefits of drugs. For example, the issue of the antipsychotic drug ziprasidone lengthening the QTc interval, a possible indicator of life-threatening heart arrhythmias, has demanded much attention among clinicians since the drug was introduced in 2001.

Ziprasidone (marketed as Geodon and Zeldox by Pfizer Inc.) was the fifth second-generation anti-psychotic to gain Food and Drug Administration (FDA) approval. These second-generation drugs have been thought to be associated with a lower risk of suicides, better functional capacity, and an improved quality of life for people with schizophrenia. (It is well known that patients with schizophrenia suffer an overall increased risk of death.) But questions remained as to whether the modest QTc prolongation caused by ziprasidone would translate into increased mortality for the patients using it.

A study published online this month in the American Journal of Psychiatry in advance of print publication in February 2011 showed no difference in nonsuicide mortality between people taking ziprasidone and another second-generation anti-psychotic in real-world use.

Because the number of patients exposed to ziprasidone at the time of marketing authorization was too small to allow for estimation of QTc-related effects on mortality, and because such studies would not reflect real-world prescribing practices, the Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC) was initiated to provide safety assurance for the use of the drug. ZODIAC was a post-approval commitment by the drug's manufacturer, Pfizer, Inc., to the FDA.

ZODIAC is an international, multimember, randomized trial designed to examine the risks of nonsuicidal mortality and hospitalization associated with ziprasidone and olanzapine, another second-generation anti-psychotic approved by the FDA for the treatment of schizophrenia and bipolar disorder. Brian Strom, MD, director of the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania School of Medicine, chaired the steering committee that designed and directed the ZODIAC study. Strom is also chair of the Department of Biostatistics and Epidemiology and Vice Dean for Institutional Affairs in the School of Medicine.

Olanzapine (marketed as Zyprexa and other brands names by Eli Lilly and Comp.) was selected for comparison in the study because it was not linked to QTc prolongation in the literature or in a controlled pharmacokinetic study of several agents compared with ziprasidone. The main objective of ZODIAC was to evaluate nonsuicide mortality, which limited the study's ability to provide data on drug efficacy.

ZODIAC, an open-label, randomized trial, enrolled over 18,000 patients with schizophrenia in 18 countries. The primary outcome measure was nonsuicide mortality in the year after initiation of treatment. Patients were randomly assigned to receive treatment with either ziprasidone or olanzapine and followed for one year by unblinded investigators providing usual care. A physician-administered questionnaire was used to collect baseline demographic information, medical and psychiatric history, and concomitant medication use. Follow-up information on hospitalizations and emergency department visits, patients' vital status, and current antipsychotic drug status was also collected.

A total of 205 deaths occurred overall in the study population. Despite the known risk of QTc prolongation with ziprasidone treatment, the findings did not show that ziprasidone is associated with an elevated risk of nonsuicidal mortality relative to olanzapine in real-world use. However the study was not designed to examine the risk of rare cardiac events associated with lengthening of the QTc interval.

"We could not disprove that the drug caused abnormal heart rhythms, but that was not the goal of the study," says Strom. "Our goal was to determine whether there was a difference in risk of nonsuicide death, and there was not."


'/>"/>

Contact: Karen Kreeger
karen.kreeger@uphs.upenn.edu
215-349-5658
University of Pennsylvania School of Medicine
Source:Eurekalert

Related medicine news :

1. Medicare data reveals differences in orthopedic surgical outcomes
2. Your Vote Can Make a Difference in the Lives of Thousands of Tennesseans
3. Survey finds significant racial differences in lung cancer beliefs
4. Few differences in outcomes between open and laparoscopic prostate surgery
5. Visual Cues that Improve Walking for People with Movement Disorders - Study Shows Small Change in Arrangement Can Make a Big Difference in Improvement Gained
6. American Stroke Association Late-Breaking Science Report: Surgery, Stenting to Open Blocked Neck Arteries Similar in Safety, Efficacy, But Show Differences in Stroke, Heart Attack and Death Rates at Certain Ages
7. Poll reveals sleep differences among ethnic groups
8. Poll Reveals Sleep Differences Among Ethnic Groups
9. Transcription factors may dictate differences between individuals
10. Bad Habits Explain Class Differences in Health: Study
11. 5-Hour Energy Challenges College Students To Make a Difference In Their Community
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes , ... mock evacuation of the facility as part of a disaster drill on October 3rd. ... EMS and Shelton City Emergency Manager, as well as the Connecticut Long Term ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Ellevate Network, the ... business to advocate for action towards gender equality at their inaugural Summit in New ... the globe, and reached a social audience of over 3 million. To watch the ...
(Date:10/13/2017)... ... , ... Talented host, actor Rob Lowe, is introducing a ... episode of "Success Files," which is an award-winning educational program broadcasted on PBS ... in-depth with passion and integrity. , Sciatica occurs when the sciatic nerve in ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... “America On ... Christian identity. “America On The Brink” is the creation of published author, William ... several great-grandchildren. As a WWII veteran, he spent thirty years in the Navy. ...
(Date:10/12/2017)... LA (PRWEB) , ... October 12, 2017 , ... Planet ... in the U.S., announced today its plans to open a flagship location in Covington, ... occupy the former Rooms To Go store next to Office Depot in the Holiday ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)... 12, 2017 West Pharmaceutical Services, Inc. ... for injectable drug administration, today announced that it will ... on Thursday, October 26, 2017, and will follow with ... expectations at 9:00 a.m. Eastern Time. To participate on ... The conference ID is 94093362. ...
(Date:10/10/2017)... Calif. , Oct. 10, 2017  NDS received FDA 510(k) ... — a medical-grade battery-powered display stand specifically designed for endoscopy environments. ... transform technology into a clinical solution to support the improvement of ... Innovative Design ... Mobile Wireless Solution ...
(Date:10/4/2017)... 4, 2017  According to the Centers for Disease Control and Prevention ... . PhysicianOne Urgent Care is helping communities across Massachusetts ... , by offering no-cost* flu shots through the end of the month. ... health insurance regulations. ... to get a flu shot is by the end of October, according ...
Breaking Medicine Technology: