Compliance as a stable function in the treatment course of bipolar disorder in patients stabilized on olanzapine: results from a 24-month observational study.

Alexandra Kutzelnigg,Claudia Deix,Tamás Treuer,Yulia D'Yachkova,Martin Kopeinig,Siegfried Kasper,Dagmar Doby,Ágnes Fábián,Young-Chul Shin,Chih-Ken Chen,María Gloria Pujol-Luna

doi:10.1186/s40345-014-0013-x

Abstract

Compliance is a key factor in the maintenance treatment of bipolar disorder. This noninterventional study was conducted to explore factors associated with higher levels of compliance in bipolar patients, all treated in routine clinical settings. Bipolar outpatients (Clinical Global Impression of Severity score ≤3) who had been stabilized with olanzapine mono- or combination therapy for ≥4 weeks were enrolled in the study. Compliance to medication was assessed at baseline and after 3, 6, 9, 12, 18, and 24 months by a physician-rated, 4-point categorical scale using the following classification: noncompliant (patients being compliant to treatment schedule less than 20% of the time) and low (20% to 59% of the time), moderate (60% to 79% of the time), and high (≥80% of the time) levels of compliance. Both baseline and post-baseline factors were used in a generalized estimating equations (GEE) model to predict the likelihood of high compliance. Of 891 eligible patients, 657 patients completed the 24-month observation period. High levels of compliance (≥80%) were observed in 67% of patients at baseline, increasing to 80% in study completers. High compliance at baseline was identified as a strong predictor of compliance during study participation (odds ratio (OR) = 6.9, 95% confidence interval (CI) = 5.0 to 9.5, p < 0.001). Factors associated with high compliance during the study (GEE model) included greater life satisfaction (p = 0.002), better insight into illness (p < 0.001), less work impairment (p = 0.007), and fewer days of inpatient care (p = 0.002). Compliance ratings varied by country (p < 0.001) and duration of post-baseline treatment (p = 0.014). In conclusion, a number of clinical, functional, and social factors were identified as predictors of compliance in patients with bipolar disorder. As compliance is crucial for the long-term management of these patients, more attention should be directed towards compliance itself and factors associated with compliance levels in everyday treatment settings.

Highlights

Compliance with pharmacological treatment is crucial for response to medication and for long-term outcome in any chronic medical condition (Haynes et al 2002)
Low compliance ratings were most frequently reported in Taiwan; the highest proportion of noncompliance was recorded in Mexico
We found a nonlinear relationship between the duration of the first treatment regimen and compliance, in that the rate of compliance was higher for short (≤30 days) and longer (>90 days) treatment regimens than for treatment regimens lasting for 31 to 90 days (p = 0.014)

Summary

Introduction

Compliance with pharmacological treatment is crucial for response to medication and for long-term outcome in any chronic medical condition (Haynes et al 2002). Several pharmacological treatment strategies have been proposed for relapse prevention in patients with bipolar disorder (Beynon et al 2009) such as mood stabilizers (Goodwin et al 2003; Grunze et al 2009) and, according to more recent guidelines, second-generation antipsychotics (Goodwin 2009; Grunze et al 2009, 2010; Yatham et al 2013; Hirschfield 2014). Olanzapine is considered as first-line treatment for bipolar I disorder for both acute episodes and relapse prevention (Grunze et al 2009; Yatham et al 2006) and has been systematically studied in a large number of studies as monotherapy or in combination with mood stabilizers and antidepressants, such as fluoxetine, in all of these indications (Baker et al 2003; Tohen et al 1999, 2002, 2003, 2005, 2006)

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