Transdermal buprenorphine for the treatment of moderate to severe chronic pain: results from a large multicenter, non-interventional post-marketing study in Poland

Abstract

Objective:

To evaluate the use of a buprenorphine transdermal patch (Transtec) in routine clinical practice, including dosage, indications, efficacy and tolerability.

Research design and methods:

This prospective, open-label, non-comparative, non-interventional, post-marketing study was performed in Poland by 339 investigators in a range of clinical practice settings. Patients with chronic moderate to severe cancer pain, or chronic severe non-cancer pain that was insufficiently controlled by non-opioids, were prescribed buprenorphine transdermal patch 35, 52.5 or 70 μg/hour (changed twice weekly), and followed up for 3 months. Additional analgesia, and adjuvant/supportive treatments were allowed at the discretion of the physician.

Main outcome measures:

The study enrolled 4030 patients, with a mean age of 62.8 years. Most patients had cancer-related pain (80.7%). Non-cancer pain was generally musculoskeletal or neuropathic. A starting dose of 35, 52.5 or 70 μg/hour was used in 73.4%, 21.5%, and 4.8% of patients, respectively. Buprenorphine dose was increased in 44.7% of patients during the observation, generally from 35 to 52.5 μg/hour. Mean pain intensity (using a 100 mm visual analogue scale) decreased by 73.5% from 62.3 mm at baseline to 16.5 mm after 3 months. Most patients rated pain relief as ‘very good’ (41.4%) or ‘good’ (44.5%). Sleep quality also improved. 48.1% of patients needed no additional analgesics during buprenorphine treatment. Most patients (96%) rated the buprenorphine transdermal patch as ‘very easy’ or ‘easy’ to change. The most common treatment-related reasons for discontinuation were lack of analgesic effect (3.3% of patients) and adverse drug reactions (ADRs, 0.8%). ADRs, all non-serious, occurred in 34 patients (0.8%), most commonly local skin reactions or vomiting. At study end, it was planned to continue treatment with transdermal buprenorphine in 70.1% of patients. The main limitations related to the observational study design, balanced by advantages gained from the ‘real life’ exploration of transdermal buprenorphine use.

Conclusions:

In routine Polish clinical practice, transdermal buprenorphine was effective and generally well-tolerated in patients with chronic moderate to severe cancer pain or chronic severe non-malignant pain insufficiently controlled by non-opioids.

Key words::

• Analgesia
• Cancer pain
• Non-cancer pain
• Transdermal buprenorphine

Transparency

Declaration of funding

Funding for this study was provided by Grünenthal SP., Poland.

Declaration of financial/other relationships

A.P-M. has disclosed that she received investigator honoraria from Grünenthal. J.D. has disclosed that he acted as a paid consultant/advisor for Grünenthal SP., Poland. CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors thank Kathy Croom and David Figgitt PhD, on behalf of Content Ed Net (Madrid), for providing editorial support in the preparation of this manuscript. This editorial support was funded by Grünenthal GmbH, Germany.

Notes

*Transtec is manufactured by Grünenthal GmbH, Aachen, Germany.

*Transtec is manufactured by Grünenthal GmbH, Aachen, Germany.