Invega (Paliperidone) - Drug Information, Research, Clinical Trials, News

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Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks) in these subjects revealed a risk of death in the drug-treated subjects of between 1.6 to 1.7 times that seen in placebo-treated subjects. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated subjects was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. INVEGA™ (paliperidone) Extended-Release Tablets is not approved for the treatment of patients with dementia-related psychosis.

INVEGA SUMMARY

INVEGA™
(paliperidone)
Extended-Release Tablets

Paliperidone, the active ingredient in INVEGA™ Extended-Release Tablets, is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. INVEGA™ contains a racemic mixture of (+)- and (-)- paliperidone.

INVEGA™ (paliperidone) Extended-Release Tablets is indicated for the acute and maintenance treatment of schizophrenia.

The efficacy of INVEGA™ in the acute treatment of schizophrenia was established in three 6-week, placebo-controlled, fixed-dose trials in subjects with schizophrenia.

The longer-term benefit of maintaining schizophrenic patients on monotherapy with INVEGA^TM after achieving a responder status for 6 weeks was demonstrated in a controlled trial (see CLINICAL PHARMACOLOGY: Clinical Trials). The physician who elects to use paliperidone for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.