Background: Patients with neuropathic pain (NeP) often receive combination therapy with
multiple agents in the hopes of improving both pain and any comorbidities that may be present.
While pregabalin is often recommended as a first-line treatment of NeP, few studies have examined
the effects of concomitant medications on the efficacy of pregabalin.
Objective: To examine the effects of concomitant medications on the efficacy and safety of
pregabalin for the treatment of NeP.
Study Design: Data were derived from 7 randomized placebo-controlled trials of pregabalin
(150, 300, 600, and flexible 150 – 600 mg/d) for the treatment of postherpetic neuralgia (PHN)
and 2 randomized placebo-controlled trials for the treatment of NeP due to spinal cord injury (SCINeP). On each day, patients rated the severity of their pain and pain-related sleep interference
(PRSI) over the previous 24 hours on a scale from 0 to 10, with higher scores indicating greater
severity. Patients were also continually monitored for the occurrence of adverse events.
Setting: A pooled retrospective analyses of data from randomized clinical trials.
Methods: Changes from baseline in mean weekly pain and PRSI scores were compared between
patients who received concomitant NeP medications and patients who did not receive concomitant
NeP medications. Results of these comparisons are presented separately for the PHN (through 4,
8, and 12 weeks) and SCI-NeP (through 12 weeks) cohorts. Common adverse events are also
presented for each treatment group.
Results: Pregabalin significantly improved both pain and PRSI scores relative to placebo at most
dose levels and time points examined. Notably, little difference was observed in the extent of
therapeutic response to pregabalin between patients who received concomitant NeP medications
and patients who did not receive concomitant NeP medications. Additionally, the profile of
treatment-emergent adverse events appeared to be largely unaffected by the use of concomitant
NeP medications in the pooled patient population.
Limitations: Our analysis is limited in that the original trials of pregabalin were not powered to
examine the effects of concomitant NeP medications.
Conclusions: The data presented here demonstrate that therapeutic response to pregabalin and
the occurrence of adverse events in patients with NeP are generally unaffected by the concurrent
use of other NeP medications.
Trial Registration numbers: NCT00159666; NCT00301223; NCT00407745
Key words: Pregabalin, neuropathic pain, pain-related sleep interference, concomitant
medications, postherpetic neuralgia, spinal cord injury, efficacy, safety