A phase 3 study evaluating the use of gabapentin alone and in combination with an antidepressant in women with hot flashes who had an inadequate response with antidepressant monotherapy demonstrated that gabapentin reduced hot flashes by approximately 50%, whereas the combination of an anti-depressant with gabapentin appeared to offer no additional benefit.
Adverse events associated with the use of atypical antipsychotic medications in the management of psychosis, aggression, and agitation in patients with Alzheimer's disease (AD) may outweigh any benefit the treatments provide, according to a double-blind, placebo-controlled study published in the New England Journal of Medicine (NEJM).
Intramuscular injectable formulation of atypical antipsychotic approved for the treatment of agitation associated with schizophrenia or bipolar disorder, manic or mixed
Schizophrenia is a chronic disease usually diagnosed when patients are in their mid- to late 20s; therefore, patients may receive decades of exposure to antipsychotic agents over their lifetime. Whenever long-term pharmacotherapy is required for a disease, the cardiovascular implications of that therapy need to be considered. This fact was recently highlighted by the removal of the cyclo-oxygenase-2 inhibitors rofecoxib and valdecoxib from the US market because of marked elevations in cardiovascular risk.
Patients taking clozapine for schizophrenia should be regularly monitored because of an increased risk for metabolic abnormalities, according to a study published in the American Journal of Psychiatry.
A review of agents in late-stage development for the treatment of generalized anxiety disorder and sleep disorders (August 2006).
Bupropion extended-release tablets
Investigators conducting a population-based, nested case-control study observed an association between the daily dose level of selective serotonin reuptake inhibitors (SSRIs) and a decreased risk of colorectal cancer among patients aged 5 to 85 years old. No consistent association was found between colorectal cancer risk and the use of tricyclic antidepressants (TCAs).
A review of agents in late-stage development for the treatment of depression (July 2006).
This central nervous system stimulant delivered via a transdermal patch is the first and only non-oral therapy to receive approval for the treatment of attention deficit/hyperactivity disorder (ADHD).
Selegiline is an irreversible inhibitor of monoamine oxidase (MAO) whose mechanism of action in the treatment of depression is not fully understood.
FDA officials are reviewing an unexpected recommendation from the agency's Drug Safety and Risk Management Advisory Committee to add black box warnings to attention deficit/hyperactivity disorder (ADHD) stimulant medications. In addition to advising the agency about clinical trial designs that could better assess cardiovascular risks associated with ADHD therapies, members of the advisory committee called for immediate action to caution prescribers and patients about potential adverse events associated with these drugs. Concerns about increased risk of myocardial infarction, stroke, and sudden death have emerged with increased prescribing of stimulant ADHD drugs for adults and children?an estimated 4 million patients use these mediations, including more than 1 million adults.
Quetiapine (Seroquel, AstraZeneca), olanzapine (Zyprexa, Lilly), and risperidone (Risperdal, Janssen) are equally effective in patients experiencing first episode psychosis, according to data presented in late October during the Breaking News session at the European College of Neuropsychopharmacology (ECNP) Congress.
A review of antipsychotic agents in late-stage development (August 2005).
SSRI approved for generalized anxiety disorder
Atypical antipsychotic receives bipolar indication
Antipsychotic administered as 1 injection every 2 weeks
Maintenance therapy for schizophrenia
Combination therapy for acute bipolar mania
Antiepileptic approved for long-term maintenance treatment of bipolar disorder
Panic disorder is the most common anxiety disorder in the primary-care setting. It is characterized by episodes of acute, unexpected, and unprovoked anxiety and is often associated with depression and/or agoraphobia. Symptoms may become so pervasive that many life situations may be avoided. Management of panic disorder includes cognitive behavioral therapy, patient education, and pharmacotherapy. This article focuses on the rationale of drug therapy, methods of management, and other clinical considerations such as side effects. In addition, newer formulations are available that may subsequently change how patients are managed. Selective serotonin reuptake inhibitors (SSRIs) are considered first-line therapy, with tricyclic antidepressants (TCAs) as a possible alternative if the patient fails to respond. These agents are also useful in the management of comorbid depression. Benzodiazepines offer more rapid anxiolysis and may be used in combination with an SSRI for bridging. Although monoamine oxidase inhibitors (MAOIs) have been studied, they do not have a significant role in the pharmacological management of panic disorder. (Formulary 2003;38:431?38.)
Alprazolam, which was previously approved for the treatment of anxiety and panic disorder, has now received FDA approval as extended-release tablets for the treatment of panic disorder.
Selective serotonin reuptake inhibitors (SSRIs) experienced increased usage in the 1990s due to their low toxicity and minimal adverse effects. Throughout this period, several clinical reports indicated a link between the use of SSRIs and various bleeding disorders. A recent study published in the Archives of Internal Medicine found a distinct correlation between the use of SSRIs and upper gastrointestinal (GI) tract bleeding. The population-based cohort study was conducted within the 490,000 residents of a northern Denmark county over a five-year period.
Antidepressant now approved for use in pediatric patients
Atomoxetine, a norepinephrine reuptake inhibitor, is the first nonstimulant agent approved for the treatment of ADHD (Strattera, Lilly). It has been approved for use in pediatric and adult patients. Atomoxetine improves ADHD symptom severity versus placebo, as evaluated by the ADHD Rating Scale (ADHD RS), and its efficacy appears comparable to immediate-release methylphenidate. Atomoxetine requires dosage titration and may be administered once or twice daily. Common side effects seen in both pediatric and adult patients include nausea, decreased appetite, and dizziness. Dosage adjustments are necessary for patients receiving atomoxetine and cytochrome P450 2D6 inhibitors. Based on average wholesale price (AWP), atomoxetine is more costly than existing ADHD therapies. Atomoxetine provides an alternative ADHD therapy for patients who may fail or cannot tolerate conventional treatments.
