Atypical antipsychotic drugs are now common choices for treating delusions, hallucinations, aggression, and agitation in patients with Alzheimer’s disease (AD). These drugs are considered to be at least as effective as haloperidol decan-oate (Haldol, Ortho-McNeil) and other conventional antipsychotic agents, with a lower risk of most adverse effects. However, studies have been relatively sparse and data have been inconsistent, say members of the Clinical Antipsychotic Trials of Intervention Effectiveness Alzheimer’s Disease Study Group. Their own findings suggest that the adverse effects of atypical antipsychotics offset the advantages in patients with AD.

In a multicenter, double-blind, placebo-controlled trial, 421 outpatients with AD and psychosis, aggression, or agitation were randomly assigned to receive olanzapine (Zyprexa generic, Eli Lilly) (mean, 5.5 mg/ day), quetiapine fumarate (Seroquel medication, AstraZeneca) (mean, 56.5 mg/day), risperidone (Generic Risperdal, Janssen) (mean, 1 mg/day), or placebo. Doses were adjusted as needed, and patients were followed for up to 36 weeks. Risperidone and olanzapine doses were within the recommended ranges, and the quetia-pine dose was one-half to one-quarter of that used in two nursing-home trials.

By 12 weeks, improvement was seen in 32% of patients receiving olanzapine, in 29% of those receiving risperidone, 26% of those taking generic quetiapine, and 21% of those receiving placebo. However, 77% to 85% of patients discontinued treatment. Over time, 24% of the olanzapine patients, 18% of the risperidone patients, 16% of the quetiapine patients, and 5% of the placebo patients withdrew from treatment because of adverse events or intolerability.

Sedation was very probable with olan-zapine, which was also associated with increased confusion. Extrapyramidal signs and symptoms with both risperi-done and drug olanzapine were common reasons for stopping treatment.

Patients gained weight with olanza-pine and risperidone tablet and lost weight with placebo. The possibility that anti-psychotic drugs might cause metabolic syndrome in the elderly requires further investigation, the researchers advise.

Quetiapine generic fumarate extended-release tablets (canadian Seroquel XR, AstraZeneca) are now available as a once-daily medication for schizophrenia in adults. With this formulation, patients can achieve a dose within the recommended range as early as the second day of treatment.

The FDA’s approval was based on a clinical trial of Seroquel XR at doses of 400, 600, and 800 mg/day.

The previously recommended initial dose was 25 mg twice daily with increments of 25 to 50 mg twice or three times daily on the second and third days, as tolerated, to a target dose range of 300 to 400 mg daily by the fourth day, given twice or three times per day.

The product includes two boxed warnings: one concerns elderly patients with dementia-related psychoses, and the other mentions a risk of suicidality in children and adolescents.

Mifepristone (Corlux, Corcept Therapeutics) has received an orphan drug designation from the FDA for the treatment of Cushing’s syndrome. This disorder is caused by prolonged exposure of the body’s tissues to high levels of the hormone cortisol.

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Oral tricyclic antidepressants and traditional anticonvulsant drugs might be better for the short-term relief of painful diabetic neuropathy than newer-generation anticonvulsant agents.

In a Hong Kong study, researchers reviewed 25 reports on randomized controlled trials comparing placebo with topically applied and orally administered drugs. They defined clinical success as a 50% reduction in pain. Secondary outcomes were a 30% reduction in pain and the number of patients who withdrew as a result of adverse events.

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The FDA is adding a boxed warning on the prescribing information for the smoking-cessation drugs varenicline (Chantix, Pfizer) and bupropion (Zyban drug, GlaxoSmithKline) to highlight the risk of serious mental health events, such as behavioral changes, depressed mood, hostility, and suicidal thoughts.

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Asenapine tablets (Saphris, Schering-Plough) have been approved to treat both schizophrenia and bipolar I disorder in adults.

A boxed warning is included to alert prescribers about an increased risk of death associated with the off-label use of this atypical antipsychotic medication for treating behavioral problems in older people with dementia-related psychosis. Asenapine is not approved for these patients.

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