Treatment retention with risperidone long-acting injection: 24-month results from the Electronic Schizophrenia Treatment Adherence Registry (e-STAR) in six countries

Abstract

Objective:

To assess treatment retention on risperidone long-acting injection (RLAI) and outcomes in schizophrenia patients for whom 24 months of follow-up data in the electronic Schizophrenia Treatment Adherence Registry (e-STAR) were available.

Research design and methods:

e-STAR is an ongoing, international, multicenter, prospective, observational registry assessing use of antipsychotics in patients with schizophrenia or schizoaffective disorder in a normal clinical practice setting. Parameters were assessed prior to and post-initiation of RLAI. Data presented are from six European countries that enrolled patients in e-STAR after they initiated treatment with RLAI.

Main outcome measures:

Clinical and demographic information were collected at baseline and treatment-related data, including RLAI discontinuation, psychiatric hospitalization and medication utilization, were collected prospectively every 3 months. Data collection continued for 24 months, even for patients who discontinued RLAI therapy. Hospitalization and medication utilization were also collected retrospectively by chart review for the 12-month period prior to RLAI initiation.

Results:

A total of 1659 patients (mean age, 39.2; 18.3% inpatients) completed the study. Twenty-four months after initiating therapy (initial RLAI dose = 33.6 mg) 85% of patients (n = 1410) remained on RLAI (completers) while 15% discontinued therapy. The main reasons for discontinuation were insufficient response (28.5%), patient/family choice (26.1%), adverse events (9.6%) and unacceptable tolerability (6.0%). At baseline, compared to completers, discontinuers were younger (37.4 vs. 39.6 years, p = 0.01), had schizophrenia for a shorter time (10.2 vs. 11.9 years, p = 0.02), had lower Global Assessment of Functioning (GAF) scores (43.5 vs. 48.0, p = 0.0001), higher utilization of benzodiazepines (56.5 vs. 43.3%) and more initiated therapy as inpatients (30 vs. 16%). With RLAI therapy GAF scores improved significantly (p < 0.001) for both groups but the 24-month value for discontinuers was lower than that of completers (55.4 vs. 67.2). Compared to the pre-RLAI initiation period, at 12 months post-initiation completers had greater reductions than discontinuers in the percent of patients hospitalized (66.2% reduction vs. 29.2%) and in the length (68% reduction vs. 0%) and number (80.0 vs. 14.3%) of hospital stays, differences that remained at 24 months. The most common adverse events while patients were taking RLAI were nervous system disorders (6.8%), psychiatric disorders (5.6%), weight increase (3.2%), reproductive system and breast disorders (2.5%) and gastrointestinal disorders (2.1%).

Conclusions:

These observational data confirm that RLAI is an effective treatment in schizophrenia and high levels of adherence to therapy offers an opportunity for effective long-term disease management and significant sustained decreases in hospitalization.

Key words::

• Hospitalization
• Observational study
• Risperidone long-acting injection
• Schizophrenia
• Treatment discontinuation

Transparency

Declaration of funding

This study was supported by research grants from Janssen-Cilag Spain, Janssen-Cilag Czech Republic, Janssen-Cilag Netherlands, Janssen-Cilag Sweden, Janssen-Cilag Belgium, and Janssen-Cilag Slovakia. The publication of this article was supported by Johnson & Johnson Pharmaceutical Services.

Declaration of financial/other relationships

J. Peuskens has disclosed that he has been the recipient of monetary compensation for speaking engagements from several pharmaceutical companies: Janssen-Cilag, Lundbeck, AstraZeneca, Eli Lilly, Bristol-Myers Squibb, Sanofi-Synthélabo and Pfizer; and that he is a member of advisory boards for several pharmaceutical companies including Janssen Cilag, Lundbeck, AstraZeneca, Eli Lilly, Bristol-Myers Squibb, Sanofi-Synthélabo and Pfizer. J.M.O. has disclosed that he has been on advisory boards of Eli Lilly, Janssen-Cilag and AstraZeneca; and that he has been the recipient of compensation from Janssen-Cilag, Lundbeck, AstraZeneca, Eli Lilly, Bristol-Myers Squibb, Sanofi-Synthélabo and Pfizer. J. Pecenak has disclosed that he has been on the advisory boards of Eli Lilly, Servier and AstraZeneca; and also that he has been the recipient of compensation from Eli Lilly, Servier, AstraZeneca and Pfizer. I.T., H.b.d.W. and L.E. have disclosed that they have been recipients of compensation from several pharmaceutical companies. S.R. has disclosed that she is an employee of SGS Life Science Services, a private research organization that provides services to various pharmaceutical companies. K.A. and A.J. have disclosed that they are both employees of Johnson & Johnson Pharmaceutical Services.

Peer reviewers may receive honoraria from CMRO for their reviewing work. Peer Reviewer 1 has disclosed that he/she has acted as a consultant/ advisor to Eli Lilly; Peer Reviewer 2 has disclosed that he/she has been a recipient of research grants from Takeda and Eli Lilly.

Acknowledgments

The authors would like to thank John I McCormick, PhD, of McKesson Specialty for his assistance with manuscript preparation. This assistance was supported by Johnson & Johnson Pharmaceutical Services. The authors also would like to acknowledge the entire e-STAR study group from Belgium, Czech Republic, the Netherlands, Slovakia, Spain and Sweden.

Parts of this study were previously presented at the International Society for Pharmacoeconomics and Outcomes Research meeting in Dublin, 20–23 October 2007.