Reboxetine: a review of antidepressant tolerability

The tolerability of reboxetine was evaluated in 2613 adult (aged 18-65 years) or elderly (aged > 65 years) patients with depressive illness treated with reboxetine, comparator agents or placebo, who entered both short- and long-term, controlled and uncontrolled clinical trials. The reboxetine adverse-event profile in acute depression was established by comparison with placebo in 746 patients. Overall, 69% of 373 patients treated with reboxetine experienced adverse events compared with 57% of 373 patients in the placebo group. The majority of adverse events were moderate in severity, and discontinuation because of adverse events was low and comparable in both the reboxetine (8%) and the placebo (7.5%) group. When compared with imipramine, reboxetine was better tolerated. Most side-effects were less common in the reboxetine than the imipramine cohort, and fewer patients receiving reboxetine (10% in adult patients; 11% in elderly patients) discontinued treatment because of adverse events than those receiving imipramine (14% in adult patients; 16% in elderly patients). Compared with fluoxetine, the total frequency of adverse events was similar in reboxetine-treated patients (67%) and fluoxetine-treated patients (65%). In the fluoxetine group, 7% discontinued because of adverse events compared to 12% in the reboxetine group and 12% in the corresponding placebo group. In a 12-month placebo-controlled study, discontinuation because of adverse events in both groups was low (reboxetine 4%; placebo 1%), and the total frequency of adverse events was only marginally higher with reboxetine (28%) than with placebo (23%). Overall, no consistent changes were found in laboratory tests or electrocardiogram recordings and there was no indication of withdrawal symptoms upon abrupt reboxetine discontinuation. Reboxetine, a novel selective noradrenaline reuptake inhibitor, is well tolerated by adults and the elderly during short- and long-term treatment for depression.