Brand Name: Vestra
Active Ingredient: reboxetine mesylate
Indication: Treatment of depression
Company Name: Pharmacia & Upjohn
Vestra: Introduction
As a selective norepinephrine reuptake inhibitor (SNRI), Vestra is the first of a new class of antidepressant drugs. This new mechanism of action appears to produce fewer side effects, such as nausea, headache, and sexual dysfunction, compared with traditional antidepressants. Vestra also possesses a faster onset of action compared to selective serotonin reuptake inhibitors (SSRI), tricyclics, and monoamine oxidase inhibitors, commonly used to treat depression.
Vestra: How It Works
A lack of norepinephrine in the central nervous system (CNS) of depressed individuals is hypothesized to be responsible for several specific symptoms of depression, such as lack of energy, interest, and motivation. Vestra inhibits the reuptake of norepinephrine by the presynaptic nerve terminals. As a result, the neurotransmitter remains in the synapse for a longer period of time.
Vestra: Clinical Study Results
Several clinical studies were conducted to determine the safety, efficacy, and tolerability of Vestra. One study involved 283 patients with recurrent DSM-III-R major depression. These patients were randomized to receive either Vestra or placebo for 46 weeks in a double-blind phase. Vestra was associated with a significantly lower relapse rate than placebo (22% vs. 56%; p < 0.001), as well as a greater cumulative probability of maintained response (p = 0.0001) during long-term treatment. The proportion of relapse- free patients who remained in the study was significantly higher in the Vestra group than in the placebo group at the end of the first six months (61% vs. 40%) and the second six months (88% vs. 59%) of treatment.
A double-blind, randomized, parallel-group, multicenter trial, including 168 patients with acute major depressive episodes, was conducted to compare Vestra to fluoxetine, an SSRI. The patients were administered either Vestra 8-10 mg/day or oral fluoxetine 20-40 mg/day for 8 weeks. Both treatments were found to be similarly effective as assessed by the mean reduction in total Hamilton Depression Rating Score, percentage of responders and patients in remission, Clinical Global Impression severity of illness and global improvement scores, and the Montgomery-Asberg Depression Rating Scale. A sub-analysis of patients with severe depression showed Vestra to have superior efficacy compared to fluoxetine. Both treatments resulted in improvement in Social Adaption Self-evaluation Scale total scores; however, the improvement was more evident in patients who received Vestra and achieved remission.
Vestra: What the Patient Should Know
Although clinical trials have shown a reduced risk for nausea, diarrhea, and somnolence with Vestra compared with fluoxetine, the patient should be aware that an increase in risk for dry mouth, constipation, hypotension, paresthesia, urinary hesitancy, and flushing was observed with Vestra in the trials.