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                                                                                          Dott. Carlo Sebastiano Tadeo
                                                                                                Specialista Neurologia

Reboxetine Effective In Late-life Depression

 

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Reboxetine Effective In Late-life Depression


By Lisette Hilton
Special To DG News

 

MIAMI BEACH, Fl -- March 15, 2000 - Reboxetine has surfaced as being well tolerated and effective for the treatment of depression both in geriatric and younger adult patients.

The data also suggests that reboxetine -- a novel, selective noradrenergic reuptake inhibitor -- may be more effective than the selective serotonin reuptake inhibitors (SSRIs) in younger adults with severe depression. The drug might be particularly useful in restoring motivation, activity and social function early in the recovery phase.

It also seems to lack adverse effects on cognition, including the sedative and antimuscarinic effects of amitriptyline and other antidepressants, according to Soo Borson, MD, professor in the department of psychiatry and behavioral sciences and director of geropsychiatry services at University of Washington School of Medicine, in Seattle, WA. Dr. Borson presented these findings on reboxetine March 14, 2000 at the 13th Annual Meeting of the American Association for Geriatric Psychiatry (AAGP), in Miami Beach FL.

Reboxetine seems to work by increasing noradrenergic availability. "We know that norepinephrine is involved in regulating energy, drive and motivation. Affective memory and fear conditioning are clearly involved. And we know that noradrenergic mechanisms are involved in the neurovegetative functions-sleep, regulating the sleep-wake cycle, regulating food intake, endocrine function and peripheral sympathetic function. It's possible that movement-the initiation speed and stamina of individuals-is conditioned in part by noradrenergic mechanisms," Dr. Borson explained.

Reboxetine, a drug that has a selective noradrenergic effect, is the most selective drug available. It is a norepinephrine reuptake blocker, which interacts with a transporter and may have useful effects on age-related defects in norepinephrine function.

There have been a few studies on the efficacy and safety of reboxetine on geriatric depression.The first was an open-label study in 1999, followed by a double-blind comparison with imipramine and a long-term continuation study conducted in individuals who had responded acutely to reboxetine for major depression.

According to Dr. Borson, reboxetine is as effective an antidepressant in terms of responders, clinical global improvement and remission as the old standards, such as imipramine. In comparison with imipramine in a double-blind, randomized, controlled trial, there were fewer dropouts with reboxetine than with imipramine. Side effects with imipramine that were more prominent than with reboxetine were hypotension and death. Insomnia was the only side effect that was more prominent with reboxetine-although the rates of 6 percent versus 3 percent were low. Side effects of dry mouth, constipation, nausea, sweating, headache and urinary hesitancy/retention (especially in men) were equivalent for the two drugs.

A long-term, open-label follow-up study conducted with people who had responded to initial treatment followed the short-term study. Patients, with a mean age of 74 years were administered 4 mg to 8 mg a day of reboxetine. One hundred-sixty patients entered the trial; 139 entered the long-term phase; and 104 completed a year of treatment. About 66 percent of those initially treated completed a long-term trial over a period of a year. Participants represented a so-called "average" geriatric population with MDD or dysthymia. Two-thirds of the participants were women.

The trial was unique in that people with medical co-morbidities were included. They were not included if they had highly unstable medical disorders, but they had a variety of conditions which are common among the elderly.

Those patients who improved with reboxetine over six weeks maintained their gains over the long-term of the study, with an 87.8 percent response rate. The drug was well tolerated over the long-term, with common side effects similar to the short-term study.

Material that has been explored in younger adults but not yet in the geriatric population shows few adverse effects on cognition or motor function in younger adults who take reboxetine. This has been studied through choice reaction time, driving performance and critical flicker fusion, which includes the measure of attention and focus. Some suggest that there may be more rapid improvement in social function with regard to reboxetine than with other antidepressants and that there might be greater efficacy with reboxetine than with SSRIs in severe depression. Measurements with younger adults also have shown accelerated social recovery with reboxetine as compared to fluoxetine or placebo.

Dr. Borson concluded that reboxetine is effective for major depression and dysthymia. It is generally better tolerated. And though it tends to be safer in patients with heart disease, there is a caveat regarding the presence of underlying heart disease in very old people. More studies need to be done to determine the efficacy of lower doses in very old, frail patients, he said. Response rates are comparable to imipramine and published SSRI trials in the elderly. Side effects are mild to moderate and the need to discontinue treatment with reboxetine is unusual. Early response with reboxetine predicts long-term outcome.

"This is what we need to do in geriatric psychiatry to further understand this drug," she said. "We need to look at high-risk subgroups; we need to look at cognitive, motor function and social recovery; examine severe melancholic depression in older people -- it has only been done in the young; and do direct comparisons with an SSRI and a combined reuptake blocker."

 

            

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Aggiornato il: 21 March 2000