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| |  APA: Antipsychotic, Aripiprazole, Continues To Show Efficacy In Schizoaffective Disease, Few Side Effects By Ed Susman Special to DG News
NEW ORLEANS, LA -- May 8, 2001 -- The investigational agent, aripiprazole (Bristol-Myers’ Squibb), continues to show that it is effective in treating schizophrenia and schizoaffective disease without demonstrating negative side effects. In a study presented today at the 154th annual meeting of the American Psychiatric Association, researchers said aripiprazole at two different dosage levels was as effective as risperidone in markedly decreasing symptoms in a 404-patient study. "Aripiprazole provides effective treatment for acute relapse of schizophrenia and may have tolerability advantages over other available antipsychotics," said William Carson, MD, a physician researcher at Bristol-Myers Squibb, Wallingford, Connecticut. Dr. Carson and colleagues evaluated the efficacy and safety of aripiprazole in patients hospitalized due to an acute relapse of schizophrenia or schizoaffective disorder in a Phase III, multicenter, double-blind, placebo-controlled study. Following a 35 day washout period, 103 patients were assigned to receive placebo; 101 patients were given 20/mg/day of aripiprazole; another 101 patients were assigned to receive 30 mg/day of aripiprazole and 99 patients received 3 mg of risperidone twice a day. The study lasted four weeks. The active treatments decreased scores on standard tests of schizophrenia symptoms similarly. Aripiprazole and risperidone were also well tolerated. Neither drug produced significant extrapyramidal symptoms. Mean plasma prolactin levels showed no change with aripiprazole but increased five-fold over placebo in the risperidone group. The incidence of QTc prolongation-defined as being greater than 10 percent over baseline-was similar to placebo in the aripiprazole group, and approximately two-fold greater than placebo in the risperidone group. Weight gain was similar in the active groups, but were higher than placebo patients. "This study confirms previous findings," said Dr. Jeffrey Lieberman, professor and vice-chairman of psychiatry at the University of North Carolina, Chapel Hill, "which demonstrated that aripiprazole was superior to placebo in controlling the symptoms of schizophrenia and appeared to have a favorable tolerability profile. "Due to major unmet need for this patient population, the results of ongoing aripiprazole clinical trials will be of great interest," he added. Dr. Lieberman said aripiprazole could be described as the first agent in the third generation of antipsychotics. First were the so-called conventional antipsychotics that were characterized by their ability to create extrapyramidal symptoms; then came the atypical psychotics which include risperidone and olanzapine. The third generation, Dr. Lieberman said, are the aripiprazoles, which are partial agonists, and have a completely distinct mechanism of action. He said that the serious side effects seen with other antipsychotics should have appeared by now since aripiprazole has been given to more than 2,000 patients, and some patients have been on the drug for more than two years. Dr. Lieberman said that he expects other manufacturers-now able to view the success of aripiprazole-to begin developing similar drugs.
Related Link: Bristol-Myers Squibb.
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