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Pharmacopsychiatry 2013; 46(03): 94-107
DOI: 10.1055/s-0032-1330033
Original Paper
© Georg Thieme Verlag KG Stuttgart · New York

Safety, Effectiveness and Tolerance of Buprenorphine-Naloxone in the Treatment of Opioid Dependence: Results from a Nationwide Non-Interventional Study in Routine Care

S. M. Apelt
1   Certum Consulting – Scientific Research, Oberbergkirchen, Germany
2   Psychiatric Hospital, Ludwig Maximilian University, Munich, Germany
,
N. Scherbaum
3   LVR-Klinikum Essen, Universität Duisburg-Essen, Suchtforschungsgruppe an der Klinik für Psychiatrie und Psychotherapie, Essen, Germany
,
J. Gölz
4   Praxiszentrum Kaiserdamm, Berlin, Germany
,
M. Backmund
2   Psychiatric Hospital, Ludwig Maximilian University, Munich, Germany
5   PiT – Praxis im Tal. Munich, Germany
,
M. Soyka
2   Psychiatric Hospital, Ludwig Maximilian University, Munich, Germany
6   Privatklinik Meiringen, Willigen, Meiringen, Switzerland
› Author Affiliations
Further Information

Publication History

received 30 June 2012
revised 26 October 2012

accepted 29 October 2012

Publication Date:
04 January 2013 (online)

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Abstract

Introduction:

Buprenorphine is well known in the treatment of opioid dependence. Despite a high safety profile and good tolerance buprenorphine has been subject to misuse and diversion. To reduce misuse the antagonist naloxone was added and the 4:1 combination of buprenorphine-naloxone was launched in Germany in March 2007. On the basis of the results from international clinical trials a non-interventional study was conducted to gather data on safety, effectiveness, retention and acceptability of buprenorphine-naloxone in the treatment of opioid dependent patients in routine care.

Methods:

A nationwide multicentre 12-month prospective, non-interventional, post-marketing, surveillance study was carried out with 12 assessment points in N=384 opioid dependent patients currently in maintenance treatment from N=69 general practitioners, clinics and outpatient clinics in Germany.

Results:

N=337 data sets were eligible for analysis. The rates of patients with serious and non-serious adverse events were low with 1.2% and 17.5%, respectively. No deaths occurred during the observational period and only one hospitalization was documented. Concomitant drug use decreased for all illicit substances. Mental health and quality of life measured with standardized self-assessment questionnaires improved significantly. The 12-month retention rate was 57.1%. Of the n=181 patients still in treatment at the end of the observation period, 96.7% continued treatment with buprenorphine-naloxone.

Conclusion:

The findings of the non-interventional study indicate high effectiveness and safety of buprenorphine-naloxone in the treatment of opioid dependence. The medication was well accepted by opioid dependent patients in long-term substitution treatment with substantial reductions of concomitant drug use and measurable improvement in quality of life.

Key words

buprenorphine-naloxone - dependence treatment - buprenorphine - naloxone - opioids - routine care - safety
 

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