New Research Supports Use of Risperdal In Elderly Psychotic Patients

SAN DIEGO, May 21 -- Three studies presented today at the annual meeting of the American Psychiatric Association suggest that Risperdal (risperidone) may be safe, effective and well tolerated in elderly psychotic patients. These new data corroborate the safety, efficacy and tolerability of Risperdal already demonstrated in 27 double-blind and open clinical studies of adults, and clinical experience in more than three million patients worldwide.

Original clinical studies of Risperdal did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. However, additional data presented today from 103 elderly psychotic patients has been submitted to worldwide health authorities for review and concurrence. "Psychiatrists are looking for better ways to meet the special treatment challenges of older psychotic patients, many of whom have complicated medical histories and are taking multiple medications," said Dilip V. Jeste, M.D., director of the Geriatric Psychiatry Clinical Research Center at the San Diego VA Medical Center. "Together, these studies provide compelling evidence that low doses of risperidone, in fact, much lower doses than in younger patients, are effective in managing psychoses in the elderly.

Overall, the side effects reported for risperidone in these open-label studies were predictable and manageable -- an important consideration for this fragile patient population." In a multicenter, open-label trial of 103 patients who took a mean daily dose of Risperdal of 2.4 mg for a mean of 72 days(1), clinical improvement at endpoint was seen in 50 percent of all patients, as measured by a 20 percent or greater improvement in the Positive and Negative Symptom Scale (PANSS)(1). When these results were coupled with improvement on the Clinical Global Impression (CGI) scale, 45 percent of all patients were improved at endpoint. Interim results of a long-term, international multicenter study of elderly psychotic patients treated with Risperdal oral solution (1 mg/mL)(2), found that 70 percent of patients who completed the trial had improved positive and negative symptom scores as measured by the CGI scale.

Patients received Risperdal over a three-month period, with daily doses titrated from 0.5 mg to a mean daily dose of 3.7 mg at endpoint. Substantial improvement was seen on the CGI scale during the first month of treatment, followed by further reduction of symptom scores over subsequent months. In a study of hospitalized psychotic elderly patients, Risperdal was effective in 85 percent of the 108 subjects who completed the trial(3). Patients received a mean dose of 1.6 mg of Risperdal per day. Nearly half of the patients enrolled had previously been considered resistant to another antipsychotic. More than 75 percent had cardiovascular or other diseases which required the continued use of other medications. "Despite the complications of treating this study population, Risperdal effectively controlled psychotic symptoms in the majority of patients," said Carlos Zarate, Jr., M.D., assistant professor of psychiatry, Harvard Medical School and director of the Bipolar and Psychotic Disorders Outpatient Service, McLean Hospital. "In addition, there was no indication that Risperdal interacted harmfully with the patients' other medications."

Risperdal is indicated for the management of the manifestations of psychotic disorders, including schizophrenia, schizoaffective disorder and the psychotic features associated with bipolar disorder. Clinical studies have shown that the incidence of extrapyramidal symptoms with Risperdal, while dose dependent, is comparable to placebo at recommended doses. The most common side effects reported in clinical trials were insomnia, agitation, EPS, headache, anxiety and rhinitis; less common were somnolence, dizziness, constipation, nausea and tachycardia. Risperdal may also cause orthostatic hypotension, a form of intermittent low blood pressure, especially during the initial dosing period.

(1) Madhusoodanan S, "Risperidone in Elderly Patients with Psychotic Disorders." Poster presentation at the annual meeting of the American Psychiatric Association. Wednesday, May 21, 1997, 3-5 p.m. Poster #601. (2) Davidson M, et al, "Long-Term Efficacy, Safety and Tolerability of Risperidone in Elderly Psychotic Patients." Poster presentation at the annual meeting of the American Psychiatric Association. Wednesday, May 21, 1997, 3-5 p.m. Poster #598. (3) Zarate CA, Baldessarini, RJ, "Risperidone in Psychogeriatric Patients." Poster presentation at annual meeting of the American Psychiatric Association. Thursday, May 22, 1997, noon-2 p.m. Poster #724.

SOURCE Janssen Pharmaceutica

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