[11 September 2000, Munich] -- Although many physicians rely on intramuscular injections of antipsychotic drugs to treat patients who need emergency treatment for psychotic agitation, new research has found that the oral-solution form of Risperdal™ (risperidone) is just as effective and may be a more acceptable alternative for both caregivers and patients(1).
The study, which was presented today at a major international neuropsychopharmacology congress in Munich, found that Risperdal works as quickly and is as effective in reducing symptoms of psychotic agitation as an intramuscular (IM) injection of haloperidol, an older, conventional antipsychotic. Both medications were administered in combination with the antianxiety drug lorazepam.
"When there are two drugs that are equally efficacious, a physician's next consideration when selecting an antipsychotic drug in emergency situations should be patient choice and compliance," said Dr Glenn Currier, lead investigator and assistant professor of the departments of psychiatry and emergency medicine at the University of Rochester. "When patients experiencing psychotic agitation -- usually due to schizophrenia -- end up in the emergency room, they often are confused, scared and paranoid. Injections are painful, and can be perceived as hostile and 'coercive.' This can be a significant barrier to the physician's ability to deliver good care, and to the patient's ability to accept it."
In contrast, an oral solution (liquid) is more easily administered in emergency situations than pills, and is non-invasive. Patients also can continue on the same medication when they leave the hospital, which encourages long-term compliance. Dr. Currier adds that an oral-solution formulation offers benefits to caregivers as well. Injections expose staff members at hospitals and other facilities to an increased risk of needlepricks and a resultant exposure to diseases such as AIDS and hepatitis -- especially when health-care workers are interacting with agitated, sometimes violent patients.
In an acute setting, intra-muscular injections of antipsychotics are sometimes considered for use to calm the patient. However, for a condition such as schizophrenia the tranquilising effect is of secondary importance to the antipsychotic effect. The new evidence suggests that the oral liquid has a similarly rapid onset of action as an intra-muscular injection and is as efficacious.(1)
In the prospective, "naturalistic" study, 60 acutely psychotic patients treated in the emergency room of a large, urban medical centre were given either Risperdal oral solution (2 mg) in combination with oral lorazepam (2 mg) or IM haloperidol (5 mg) along with IM lorazepam (2 mg), the standard treatment at this institution. Symptoms of psychotic agitation included excessive excitement, hostility, poor impulse control and delusional behavior.
The degree of agitation experienced by the patients, and the improvement demonstrated following treatment, was assessed using the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression (CGI) scale. The agitation scores for patients in both groups (who had comparable agitation scores at baseline) declined significantly at both 30 and 60 minutes following administration of medication. PANSS scores dropped sharply from the "extreme" 20-25 range to 7-12 within the first 30 minutes, then dropped to the 2-5 range -- much closer to a score of 1, which signifies "absent" symptoms.
There also were no significant differences between the groups' CGI ratings, which were evaluated at 15-, 30-, 60- and 120-minute intervals. On average, all patients' CGI scores approached 2, near the "very much improved" end of the scale (with 7 representing symptoms that are "very much worse").
No adverse side effects were reported in the Risperdal group, with one patient requiring IM haloperidol to manage continued agitation. One patient who received IM haloperidol experienced acute dystonia (abnormal muscle tone).
"As the only atypical antipsychotic available in an oral solution, Risperdal provides an important option for emergency-room physicians and their patients suffering from acute psychotic episodes," says Dr Ramy Mahmoud, director of CNS medical affairs at Janssen.
For further information, please contact:
Melissa Katz, Janssen Pharmaceutica
T:00-32-7596-5263
Anna Korving, Ketchum
T: 00-44-7710-420-523
Roseann Ward, Ketchum
T: 00-44-7932-798-151
John Gisborne, Ketchum
T: 00-44-20-7465-8753
E: john.gisborne@ketchumcomms.co.uk
Note to Editors:
Janssen Pharmaceutica is headquartered in Beerse, Belgium. Risperdal™ is marketed globally by Janssen-Cilag, and in partnership with NV Organon in the European Union (except for Italy, Spain and Finland, where it is marketed by Janssen-Cilag only), Norway, Switzerland, Brazil and Argentina. Janssen Pharmaceutica has been a member of the Johnson & Johnson family of companies since 1961. Johnson & Johnson is the world's largest and most comprehensive manufacturer of healthcare products, serving the pharmaceutical, professional and consumer markets.
Reference:
1. G.W.Currier et al. Risperidone oral solution versus intramuscular haloperidol for control of psychotic agitation. The Journal of the European College of Neuropsychopharmacology, Volume 10, Supplement 3, September 2000, page S296.