Background: Pregabalin is frequently prescribed for chronic non-cancer pain. No previous study has examined its off-label use.
Objectives: Our primary aim was to assess the proportion of patients taking pregabalin for conditions approved by Health Canada ('on-label') and compare their perspectives on its use to those who use pregabalin for other conditions ('off-label').
Methods: Patients who have used pregabalin within the past year were recruited from two registries of chronic non-cancer pain patients treated in tertiary care clinics: the Quebec Pain Registry and the Fibromyalgia Patients Registry. Data on the use of pregabalin and its perceived benefits were collected from the registries and from completed questionnaires.
Results: Out of 4339 screened chronic non-cancer pain patients, 355 (8.18%) met the study selection criteria. Three-quarters of them (268/355) used pregabalin for pain conditions not approved by Health Canada and were therefore regarded as off-label users. The most prevalent condition for pregabalin use was lumbar back pain (103/357; 28.85%). There were no significant differences between on- and off-label users in their perceived satisfaction from pregabalin therapy and its effect on function and quality of life. Among former users, the most prevalent reason for discontinuation was adverse effects, mainly dry mouth and weight gain.
Conclusions: We conclude that despite specific indications for pregabalin prescription, it is mainly used off-label, notably for low back pain. Nevertheless, off-label users were equally satisfied with its clinical effects. Although formal exploration of the broader analgesic properties of pregabalin is warranted, treating heterogeneous chronic pain conditions with pregabalin may be legitimate.
Limitations: The main limitations of the study are patients' low response rate, the recruitment of participants solely from a tertiary pain center and not from the general patient population and a possible recall bias that may have arisen from the retrospective nature of the study.
Keywords: Chronic pain; Health Canada; Off-label; Pharmacotherapy; Pregabalin.