Columbia University Medical Center

Older Long-Acting Injectable Antipsychotics an Effective, Less-Expensive Option for Patients with History of Non-Adherence

NEW YORK, NY (May 19, 2014) – A study of long-acting injectable antipsychotics for people with schizophrenia found that the newer, second-generation, medication paliperidone palmitate was no more effective than the older, less expensive haloperidol decanoate. This was so, even though the doses of the older medication given in the study were considerably lower than standard doses of the past. The study will be published in the May 21st issue of JAMA.

Scott Stroup, MD, MPH, and colleagues affiliated with the National Institute of Mental Health-supported Schizophrenia Trials Network compared the two medications in 311 patients diagnosed with schizophrenia or schizoaffective disorder. “The two drugs were very similar to each other, and both were better than expected at preventing relapse,” said Dr. Stroup, a professor of psychiatry at Columbia University and the New York State Psychiatric Institute.

Treatment adherence is a challenge for many patients with schizophrenia, especially with oral medications that must be taken daily. Many experts believe that the use of long-acting injectable antipsychotics to improve adherence is underused.

“The use of long-acting injectable medications is an important strategy that may lead to fewer relapses and better outcomes,” said Dr. Stroup. “We should think of using long-acting injectables when there is a risk of relapse due to medication non-adherence. But it’s not necessary to start with an expensive, new long-acting medication.”

“This study,” he said, “also demonstrates the importance of independently funded research to provide unbiased comparisons of new and established medications. Comparative effectiveness research studies such as this one help determine the appropriate role for new treatments.”

Though few study participants in either group stopped treatment because of side effects, the drugs tended to have different side effects. Patients who were assigned the newer antipsychotic reported more weight gain, while those assigned the older antipsychotic had more neurologic side effects, particularly restlessness. All patients, therefore, should be carefully monitored throughout treatment, said Dr. Stroup.

The study was funded by the National Institute of Mental Health grants (R01MH081107 an dR01MH081234).

The title of the paper is “Effectiveness of Paliperidone Palmitate vs. Haloperidol Decanoate for Maintenance Treatment of Schizophrenia: A Randomized Clinical Trial.” The other contributors are Joseph P. McEvoy and Peter F. Buckley (Georgia Regents University); Matthew Byerly (UT Southwestern Medical Center); Robert M. Hamer, Rosalie Dominik, Neepa Ray and Tania M. Wilkins (University of North Carolina); Marvin S. Swartz (Duke University); and Robert A. Rosenheck (Yale University).

    McEvoy reports personal fees from Lilly, grants and personal fees from Merck, grants and personal fees from Sunovion, personal fees from Otsuka, personal fees from Alkermes, grants and personal fees from Roche/Genentech, personal fees from Envivo, grants from GlaxoSmithKline, and grants from Psychogenics outside the submitted work. Dr.Byerly reports research support from Otsuka outside the submitted work. Dr.Dominik reports no competing interests. Dr.Hamer reports grants from NIMH during the conduct of the study; personal fees from Novartis, personal fees from Lilly, personal fees from Roche, personal fees from Pfizer, personal fees from Winston & Strawn, personal fees from Protein Sciences, personal fees from Sheppard Mullin, personal fees from Alkermes, personal fees from Allergan, personal fees from Rakoczy Molino Mazzochi Siwik, personal fees from AstraZeneca, personal fees from the Veterans Administration, and personal fees from Abbot/Abvie, personal feesfromBioline,personal fees fromTitan, personal fees from Duke University, personal fees from Columbia University, personal fees from Goldberg Segalla, personal fees from Cenerx, personal fees from National University ofSingapore/Duke, and personal fees from Neurogex outside the submitted work. Dr. Rosenheck reports personal fees from testifying as an expert in Jones ex rel. the State of Attorney General of Texas in Texas v. Janssen Phamaceutica et al and personal fees from Otsuka outside the submitted work. Dr. Swartz reports personal fees from Med-IQ outside the submitted work. Ms.Wilkins reports no competing interests. Ms.Ray reports no competing interests. Dr. Buckley reports grants and personal fees from NIMH, grants from Ameritox, and grants from Posit Science outside the submitted work. Dr. Lamberti reports no competing interests. Dr. Stroup reports participation in CME activities funded by Genentech outside the submittedwork.

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