Controlled-Release Oxycodone and Pregabalin in the Treatment of Neuropathic Pain: Results of a Multicenter Italian Study

Abstract

Aims: The aim of our study was to compare the efficacy, safety, and quality of life of combination therapy with controlled-release (CR) oxycodone plus pregabalin versus monotherapy with either CR oxycodone or pregabalin in patients with neuropathic pain. Materials and Methods: Patients with moderate to severe neuropathic pain, despite the use of various pharmacologic treatments prior to study entry, were enrolled (n = 409) and treated with CR oxycodone plus pregabalin (n = 169), CR oxycodone (n = 106), and pregabalin (n = 134). Pain intensity was rated on an 11-point numerical rating scale (NRS). Results: The combination of CR oxycodone plus pregabalin and CR oxycodone monotherapy were both more effective for alleviating neuropathic pain than pregabalin monotherapy (reduction in NRS value: 80, 76, and 46%, respectively; p ≤ 0.003). Significantly greater improvements from baseline in quality of life were reported with combination therapy than with monotherapy (p = 0.0009). At the end of treatment, the majority (91.2%) of patients receiving CR oxycodone plus pregabalin found that the treatment had been ‘effective’ or ‘very effective’. Combination therapy also allowed a dose reduction of both agents (22% for CR oxycodone and 51% for pregabalin) compared with the dosages of the respective monotherapies. Combination therapy had a superior safety profile compared with pregabalin monotherapy. Conclusions: The combination of CR oxycodone plus pregabalin may represent a valuable addition to the existing pharmacotherapy for neuropathic pain and warrants further investigation.

Treatment Considerations for Patients With Neuropathic Pain and Other Medical Comorbidities

“…In addition, risk of adverse effects and interactions may increase with combination therapies, as reviewed by Virani et al 15 A combination of gabapentin and an opioid (oxycodone or morphine) achieved better analgesia than either drug alone, but doses may need to be adjusted to improve tolerability. [16][17][18] Combined gabapentin and nortriptyline therapy is more efficacious than either drug given alone for postherpetic neuralgia. 19 Some studies have shown negative results of combination therapy.…”

Long-Term Efficacy of OROS® Hydromorphone Combined with Pregabalin for Chronic Non-Cancer Neuropathic Pain

“…These results are in line with our findings in two previous studies. The first study, an open-label, multicenter comparison of pregabalin alone and in combination with oxycodone, demonstrated that the combination therapy was more efficacious and resulted in more rapid resolution of pain [12]. The second was an observational study (very similar in design to the present study) conducted on clinical data of 1,051 patients with chronic non-cancer neuropathic pain that confirmed the long-term (12 months) effectiveness of combination therapy with oxycodone and pregabalin [13].…”

“…Moreover, clinical studies with different experimental designs [12][13][14][15] have shown that combination therapy is effective and has a favorable tolerability profile regardless of the molecules used.…”

“…We have previously conducted clinical trials of combination therapy with calcium channel modulators (pregabalin) and opioid analgesics (controlled-release oxycodone). A randomized study [12] revealed that combination therapy is more efficacious than either drug alone, while a long-term observational study [13] has shown that this combination has good efficacy and tolerability profiles.…”

Tratamento da dor em queimados

“…The most common examples are: intravenous opioid infusion, with or without patient-controlled analgesia, long-term opioids (methadone) administered orally, or prolonged enteral absorption opioids (controlled-release morphine or oxycodone). Tramadol and opioids also promote a benefi cial effect in neuropathic pain 26,27 . There is no evidence in literature regarding the superiority of a particular opioid for neuropathic pain treatment 24 .…”