Pregabalin as mono- or add-on therapy for patients with refractory chronic neuropathic pain: a post-marketing prescription-event monitoring study

Abstract

This observational study examined the outcome of two different therapeutic strategies in the treatment of chronic neuropathic pain by including pregabalin (PGB) as mono- or add-on therapy in one of two treatment options. Patients with a pain score of > or =4, refractory to usual care for neuropathic pain for at least 6 months, were allocated consecutively to one of two treatment strategies according to the decision of the physician: complete switch to a flexible-dosage, monotherapeutic or add-on therapy with pregabalin (PGB group), or change established doses and combinations of pre-existing mono- or combination therapy without pregabalin (non-PGB group). After 4 weeks (primary endpoint) a significant improvement in pain reduction was documented in both intention-to treat (ITT) analysis (PGB group, n = 85: mean pain score reduction of 3.53, SD 2.03, p < 0.001; non-PGB group, n = 102; mean pain score reduction of 2.83, SD 2.23, p < 0.001) and per-protocol (PP) analysis (PGB group, n = 79: mean pain score reduction 3.53 vs. 2.83, p < 0.05; non-PGB group, n = 81; 3.5 vs. 2.9, p < 0.05) compared to baseline. Comparison of the results observed in the two groups shows that patients in the PGB group achieved significantly greater pain reduction. These results demonstrate that PGB administered twice daily is superior to treatment regimes without PGB in reducing pain and pain-related interference in quality of life.

A Review of Pregabalin for the Treatment of Peripheral and Central Neuropathic Pain and Its Place in the Treatment of Chronic Pain

“…Several studies have been published on the use or pregabalin in patients with treatment-refractory neuropathic pain. [82][83][84][85][86][87] However, none of these studies was a randomized clinical trial; therefore, the data we are presenting below should be interpreted with caution.…”

“…83 In one of the two comparative studies, 197 patients with chronic neuropathic pain of several origins who had shown unsatisfactory responses to other treatments were assigned, according to a neurologist's decision, to either receive pregabalin (add-on or monotherapy) or change the dose and/or combinations that the patients were receiving previously. 84 After 4 weeks, the patients assigned to pregabalin showed a significantly greater pain reduction than the patients on the other regimens. 84 The second comparative study consisted of a secondary analysis of a prospective, naturalistic 12-week study in which 683 patients with refractory low-back pain, 83% of whom had received pregabalin, were analyzed.…”

“…84 After 4 weeks, the patients assigned to pregabalin showed a significantly greater pain reduction than the patients on the other regimens. 84 The second comparative study consisted of a secondary analysis of a prospective, naturalistic 12-week study in which 683 patients with refractory low-back pain, 83% of whom had received pregabalin, were analyzed. 86 The authors found a 62% response rate in the pregabalin-treated patients and a 37% rate in those patients under usual care (P , 0.001).…”

Add-On Treatment with Pregabalin for Patients with Uncontrolled Neuropathic Pain Who Have Been Referred to Pain Clinics

“…Several non-randomized studies have evaluated the impact of pregabalin for the treatment of refractory neuropathic pain [10–18]; however, these studies were carried out in a primary care setting [10, 11, 13, 14], were focused on specific clinical entities [10, 12, 17], specifically evaluated patients refractory to gabapentin [13, 14], and/or used an economic model for the evaluation [15, 16]. In addition, patients with neuropathic pain, especially those with refractory pain, are commonly treated by combining two or more drugs [19].…”

PRECISE - pregabalin in addition to usual care for sciatica: study protocol for a randomised controlled trial

“…Another study demonstrated patients had a positive response to pregabalin but the study design limited the conclusions [28]. Observational studies have reported positive results with pregabalin treatment but these trial designs contain bias [29,30]. Therefore, while there are some indications that pregabalin may be a successful treatment for patients with sciatica, high quality evidence is needed.…”