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New tool to improve patient understanding of long-acting injectable antipsychotic therapies (LAT) unveiled in April issue of Psychiatry 2009

Titusville, NJ, May 27, 2009 ? A new instrument for improving patient understanding and acceptance of long-acting injectable antipsychotic therapy (LAT) has been published in the April edition of Psychiatry 2009.1 This novel, psychosocial approach encompasses Goal setting, Action planning, Initiating treatment, and Nurturing motivation (GAIN) through the use of a clinical discussion tool.

Nonadherence to oral antipsychotic medications is one of the most significant clinical challenges in psychiatry and behavioral medicine, with rates of nonadherence estimated to be as high as 50 and 75 percent in the first and second years of treatment.2,3 Despite evidence suggesting that continuous antipsychotic treatment is more effective than interrupted treatment, and the fact that LAT is strongly recommended in many cases4, the prescription of LAT remains low in the United States. GAIN was developed to assist physicians and other clinicians by providing them with an effective approach to engage patients in a discussion of the consideration of LAT and in overcoming any related barriers.

“Long acting injectable therapies have typically been reserved for the most difficult patients where nonadherence to medication has been identified as a primary obstacle, usually because of repeated relapses. Utilizing long-acting therapies administered by a healthcare professional more widely has an advantage over daily oral formulations in that healthcare professionals will know when their patients are not taking their medications before the consequences of nonadherence occur. Early intervention may well prevent relapse,” said Nina R. Schooler, Ph.D. Professor of Psychiatry & Behavioral Sciences at State University of New York Downstate Medical Center. “However, it is often difficult for clinicians to discuss injectable medications with patients because of reluctance to take injections and stigma. With GAIN, we now have an effective tool to use in approaching a recommendation and have the possibility to help more patients with schizophrenia as we work together to control their symptoms.”

Risperidone long-acting therapy (RLAT, or RISPERDAL® CONSTA®), for the treatment of symptoms of schizophrenia, is one of several long-acting injectable products available. RISPERDAL CONSTA is the only long-acting injectable form of a class of newer medicines known as atypical antipsychotics approved in the U.S. RISPERDAL CONSTA is a proven medicine with an innovative delivery system that allows it to be given every two weeks. RISPERDAL CONSTA can help reduce the symptoms that are part of schizophrenia. A number of new atypical antipsychotic LAT formulations are also expected to be available in the future, which provided further rationale for the development of GAIN.

The Schizophrenia Treatment Acceptance Response Trial (START), an initial application of the GAIN approach, evaluated acceptance of RLAT versus approach as usual. Clinicians who used GAIN found it easy to implement and almost all indicated that they would use this tool with their current and future patients.5 Rates of patient acceptance and adherence to treatment were high for both arms (and indistinguishable), which was attributed to the positive effects of more frequent contact between patients and treatment teams than is typical. Further evaluation of the efficacy of GAIN in other clinical settings is needed to understand the full utility of the tool.

About GAIN

GAIN is based on the principles of Motivational Enhancement Therapy (MET), a patient-centered approach that seeks to evoke the patient’s own motivation for change. As a MET-based instrument developed by a collaborative consensus of an eight-member steering committee of psychiatrists, psychologists and nurses, GAIN is a structured clinical discussion tool to support productive patient dialogue relative to LAT. GAIN aims to maintain patients’ desire to continue treatment and addresses barriers such as needle phobia, stigma associated with injectable antipsychotics, and concerns about adverse effects. GAIN may be a practical tool for aligning clinician-patient expectations and enhancing long-term maintenance of therapy. The GAIN manuscript and links to the tool can be found at http://www.psychiatrymmc.com/.

About Janssen

Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., based in Titusville, N.J., is the only large pharmaceutical company in the U.S. dedicated solely to mental health. As the company celebrates its 50th year in mental health, it currently markets prescription medications for the treatment of schizophrenia, bipolar mania and the treatment of symptoms associated with autistic disorder. For more information about Janssen, visit www.janssen.com.

IMPORTANT SAFETY INFORMATION FOR CONSUMERS ABOUT RISPERDAL® CONSTA®

Elderly Patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL® CONSTA® (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with RISPERDAL® CONSTA® and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL® CONSTA® and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.

High blood sugar and diabetes have been reported with RISPERDAL® CONSTA® and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment with RISPERDAL® CONSTA®. Complications of diabetes can be serious and even life threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.

RISPERDAL® CONSTA® and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection. The connection between prolactin levels and side effects is unknown.

Some people taking RISPERDAL® CONSTA® may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional’s dosing instructions, this side effect can be reduced or it may go away over time.

RISPERDAL® CONSTA® may affect your alertness or driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional.

RISPERDAL® CONSTA® should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional.

Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with RISPERDAL® CONSTA®. Caution should be exercised when RISPERDAL® CONSTA® is administered to a nursing woman.

RISPERDAL® CONSTA® may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.

Some medications interact with RISPERDAL® CONSTA®. Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while on RISPERDAL® CONSTA®.

In a study of people taking RISPERDAL® CONSTA®, the most common side effects in the treatment of schizophrenia were headache, tremors, dizziness, restlessness, tiredness, constipation, indigestion, sleepiness, weight gain, pain in the limbs, and dry mouth.

If you have any questions about RISPERDAL® CONSTA® or your therapy, talk with your doctor.

References

1 Lasser, RA, Schooler, NR, Kujawa, M, Jarboe, Kathleen, Docherty, John, Weiden, P. A New Psychosocial Tool for Gaining Patient Understanding and Acceptance of Long-acting Injectable Antipsychotic Therapy. Psychiatry (Edgemont) 2009;6(4):22-27.

2 Corrigan PW, Liberman RP, Engel JD. From noncompliance to collaboration in the treatment of schizophrenia. Hosp Community Psychiatry. 1990; 41: 1203-1211.

3 Perkins DO. Predictors of noncompliance in patients with schizophrenia. J Clin Psychiatry. 2002;63:1121-1128.

4 Lehman AF, Steinwachs DM. Translating research into practice: the Schizophrenia Patient Outcomes Research Team (PORT) treatment recommendations. Schizophr Bull. 1998;24:1-10

5 Janssen, data on file




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