Changes in biomarkers of bone turnover in an aripiprazole add-on or switching study.

BACKGROUND: The association between mental illness and osteoporosis and fractures is particularly pronounced in psychotic disorders. Antipsychotic use has previously been described to affect bone density. METHOD: A 52-week follow-up of patients switched to aripiprazole or with aripiprazole added on, conducting a specific analysis of markers of bone turnover: urinary NTX (a biomarker of bone resorption) and serum BSAP (a biomarker of bone formation). Baseline and serial measurements of bone markers NTX, BSAP and of hormones prolactin, oestrogen and testosterone were done at weeks 0 and 1, 2, 6, 12, 26 and 52, respectively. RESULTS: NTX concentration reduced over time but this did not reach significance in the whole group (log-NTX: ß=-0.0012, p=0.142). For BSAP the addition of or replacement with aripiprazole produced a significant reduction (log-BSAP: ß=-0.00039, p=0.002). Analysis with prolactin similarly showed a significant reduction (log-prolactin: ß=-0.0024, p<0.001); other hormones did not change significantly. Sensitivity analysis to compare the switchers to aripiprazole versus the "add-on" showed that the former group had a significant reduction in NTX. CONCLUSIONS: We found that switching to aripiprazole was associated with changes in molecular biomarkers of bone resorption, indicating a more favourable profile for bone health.

Costs and outcomes associated with an aripiprazole add-on or switching open-label study in psychosis.

Health service providers increasingly need to consider not only the efficacy and safety of a therapy, but also its cost. Our hypothesis was that in our previously reported aripiprazole add-on or switching study, the improved outcomes would be associated with reduced costs. We here report data from this study, now to 52-week follow-up, with 27 total recruits (outpatients partially refractory or intolerant of their current antipsychotic regime). Serial clinical ratings included the Quality of Life Scale and Client Service Receipt Inventory, applied at baseline (N = 24), week 26 (N = 21) and 52 (N = 18). Cost data were unavailable for the drop outs. On last observation carried forward (LOCF) analysis, there was a significant increase in the Quality of Life Scale between baseline and one year (p = 0.007). There were also reductions over time in total direct and indirect costs. For study completers, the total costs at the one-year follow-up period were £ 482 less than those for the corresponding baseline period, with the Quality of Life Scale score at one year being 21.6 points (or 16.4 on LOCF analysis) higher. Therefore, in the completers, improved outcome was associated with reduced costs. Cost-effectiveness could be similarly investigated in a controlled trial.

Change in sexual dysfunction with aripiprazole: a switching or add-on study.

Sexual dysfunction and raised prolactin are common adverse effects of many anti-psychotics. Aripiprazole is an atypical anti-psychotic associated with a reduction in prolactin level in anti-psychotic-induced hyperprolactinemia. Our hypothesis was that switching from another anti-psychotic to aripiprazole would be associated with a reduction in sexual dysfunction. An open label switch to aripiprazole was offered to 27 subjects with inadequate therapeutic response or intolerance to another anti-psychotic, who were followed up for 26 weeks. Serial clinical ratings included the Anti-psychotic Non-Neurological Side-Effects Rating Scale (ANNSERS), and the Sexual Functioning Questionnaire. Our primary analysis point was week 12. In both sexes, there was a significant reduction in prolactin by week 12 (P = 0.003), accompanied by a significant improvement in libido (P = 0.028). In males, both erectile and ejaculatory difficulties were also significantly reduced (P = 0.04 and P = 0.017, respectively). In females, menstrual dysfunction was also significantly reduced at week 12 (P = 0.04). By week 26, the changes in all of the above remained significant, and were accompanied by a significant increase in satisfaction in overall sexual functioning (P = 0.007), despite the fact that 54.5% of subjects at were also taking their original antipsychotic. There was also a significant decrease in the total ANNSERS score (P < 0.001) and a significant improvement in all other measures of psychopathology (PANSS, CGI-S/I, GAF-S/D, and QoL). We conclude that switching to aripiprazole or the addition of aripiprazole to another antipsychotic regime is associated with a reduction in sexual dysfunction.