A cost-consequence analysis of pregabalin versus usual care in the symptomatic treatment of refractory low back pain: sub-analysis of observational trial data from orthopaedic surgery and rehabilitation clinics.
BACKGROUND
low back pain is one of the most common reasons for outpatient consultation in both the primary-care and specialized-care settings. However, few studies have explored the effect of pregabalin in this context.


OBJECTIVE
to prospectively analyse the effect of adding pregabalin on costs and consequences in the treatment of refractory low back pain in routine medical practice.


METHODS
a secondary analysis was carried out in patients aged >or=18 years with a 6-month history of chronic refractory low back pain who had participated in a previous prospective, naturalistic, 12-week, two-visit study (RADIO study). The analysis compared patients receiving pregabalin with those receiving usual care. Severity of pain, healthcare resources utilization, lost workday equivalents due to pain, and related cost-adjusted reductions were assessed. The year of costing for all cost data reported in the study was 2007.


RESULTS
data from a total of 683 patients (49.5% women, mean age 55.0 years), 82.6% of whom were receiving pregabalin, were analysed. Pregabalin was associated with a higher covariable-adjusted reduction in severity of pain, i.e. mean (SD) -3.4 (2.0) compared with -2.0 (2.1) points with usual care on a 10-point neuropathic pain questionnaire (p < 0.001), and a 61.6% response rate (defined as >/=50% reduction in pain from baseline) compared with 37.3% with usual care (p < 0.001). This resulted in fewer lost workday equivalents in the pregabalin group versus usual care (27.8 vs 34.6, p = 0.002), which produced more significant adjusted reductions in indirect costs, i.e. mean (SD) -euro961.8 (euro1242.9) compared with -euro625.8 (euro1169.2) with usual care (p = 0.004). The cost of pregabalin, i.e. mean (SD) euro303.8 (euro175.8) compared with euro37.1 (euro97.0) for usual care (p < 0.001), was offset by larger reductions in the other cost components. While the adjusted total costs were substantially reduced in both groups, pregabalin-treated patients showed more significant reductions, i.e. mean (SD) -euro991.5 (euro1702.3) compared with -euro579.3 (euro2410.3) with usual care (p = 0.023).


CONCLUSIONS
compared with usual care, addition of pregabalin to existing therapy for refractory low back pain was associated with a larger reduction in pain severity and lost workday equivalents. The acquisition cost of pregabalin was offset by a higher reduction in the indirect components of cost, resulting in a significant decrease in total costs.
Traumatology and Orthopaedic Surgery Unit, Hospital Universitario Mutua de Terrassa, Barcelona, Spain. cmorerad@hotmail.com
Carles
C
Morera-Domínguez
Félix
F
Ceberio-Balda
Mariano
M
Flórez-García
Xavier
X
Masramón
Vanessa
V
López-Gómez
D000328:Adult; D000368:Aged; D000700:Analgesics / Q000627:therapeutic use*; D005260:Female; D017048:Health Care Costs; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D019637:Orthopedic Procedures; D000069583:Pregabalin; D011446:Prospective Studies; D005680:gamma-Aminobutyric Acid / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use
D000700:Analgesics; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid