New Treatment for Alzheimer's Disease, gets FDA Approval

A new treatment for mild to moderate Alzheimer'sdisease derived from the bulbs of daffodils - was approved Feb. 28, 2001 by the U.S. Food and Drug Administration (FDA)--galantamine hydrobromide (Reminyl^®)--and will be available by prescription in May.

An estimated 4 million Americans have Alzheimer's disease--a progressive loss of cognitive function so severe that it interferes with an individual's ability to function.. The disorder is the third-most-expensive illness in the United States, behind only heart disease and cancer and is expected to affect l4 million by the middle of the next century.

According to Gary Small, MD, Director of the Center on Aging and professor of psychiatry and biobehavioral sciences at the University of California in "Alzheimer's disease patients progressively deteriorate. But the studies show that galantamine hydrobromide (Reminyl) can benefit many individuals with the disease. In studies lasting up to six months, many patients' symptoms initially improved or stabilized, and even when they begin to decline, they remained better than those who were treated with placebo."

Data from four placebo-controlled, double-blind clinical trials involving over 2,650 patients show that galantamine hydrobromide (Reminyl) can have a beneficial effect on patients' daily function and ability to think. In studies ranging from 12 to 26 weeks, the effectiveness of galantamine hydrobromide (Reminyl) was measured using two primary tools:

–The cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog).

–The Clinician's Interview-Based Impression of Change plus Caregiver Information (CIBIC-plus), which showed overall scores statistically superior for those taking galantamine hydrobromide (Reminyl) compared to the placebo.

Overall, the most common side effects experienced by patients who followed the recommended schedule for galantamine hydrobromide (Reminyl) were primarily gastrointestinal in nature. Side effects that occurred in 5% or greater of patients included nausea, vomiting, anorexia, diarrhea and weight loss.

Developed by the Janssen Research Foundation under a co-development and licensing agreement with the UK-based Shire Pharmaceuticals Group plc, Reminyl is a major CNS [central nervous system] addition for Janssen, which is committed to improving the lives of both Alzheimer's disease patients and their caregivers.

Reminyl also has been approved in 21 other countries to date, including most major European markets and will be marketed by Janssen Pharmaceutica and Ortho-McNeil Pharmaceutical in the United States.

Antipsychotic Side Effects: A Multi-National Survey

Although physicians identify antipsychotic treatment side effects as a major cause of noncompliance, a multinational survey presented at the American Psychiatric Association Institute on Psychiatric Services today finds that doctors frequently underestimate the prevalence of the problem.¹ Antipsychotic medications are essential for the management of serious mental illness, but compliance can be a problem.

Compliance with treatment is critical to successful treatment of mental illness. Awareness and the ability to openly discuss side effects that affect compliance is the first step to develop strategies for coping with them.

In a multi-national survey, researchers found that psychiatrists agree extrapyramidal symptoms (EPS) are a main contributor to noncompliance, but a proportion said they do not normally discuss the side effect with their patients. Psychiatrists and nurses appear to underestimate the prevalence of EPS when compared with the experiences of the patients themselves.

Nearly three-quarters of patients with sexual dysfunction, said they had not communicated this information to their doctors. Patients may be uncomfortable discussing sexual dysfunction with their doctors, therefore, it's essential to recognize potential problems and proactively ask patients about them.

How Changing Medication Can Help

Although the newer atypical antipsychotic medications are much less likely to cause EPS, it can still happen.Patients should tell their doctors if a medication is causing troublesome side effects, because the newer medications have side effect differences.

"After being diagnosed with schizoaffective disorder, my doctors put me on an atypical antipsychotic, but it made me impotent and left me with an insatiable appetite. I complained about these side effects, found a new doctor who listened, said I could with the increased appetite, but not the impotence. My medication was changed and it has worked great on my symptoms without the appetite or impotence." said Lee who has struggled with mental illness for more than 15 years.

Stories like Lee's are not uncommon. Troubling side effects can cause noncompliance and incomplete treatment. Doctors and patients need frank and open discussions about side effects, before they can begin exploring solutions, like changing medications.

1 Hellewell, J., Mullen J. Schizophrenia Treatment and its Associated Side Effects: The Attitudes and Perceptions of Healthcare Professionals, Patients, and Their Carers. Poster presented at the American Psychiatric Association Institute on Psychiatric Services, New Orleans, Oct. 29 to Nov. 2, 1999

2 Weiden, P., Scheifler, P., Diamond, R., Ross, R. Breakthroughs in Antipsychotic Medications. New York: W.W. Norton & Company, 1999.