RESUMO
OBJECTIVE: The aim of this study was to provide evidence regarding the real-life efficacy of pregabalin in the treatment of peripheral neuropathic pain (NeP) in Denmark. METHODS: In this prospective, observational, noninterventional study, pregabalin (Lyrica(®)) was prescribed following usual clinical practice. Compared with baseline, the primary study end points after 3 months of observation were changes in 1) the average level of pain during the past week, 2) the worst level of pain during the past week, and 3) the least level of pain during the past week. The Wilcoxon signed-rank test was used to perform paired analyses, and a multivariate regression analysis investigated factors driving change in pain. RESULTS: A total of 86 of the 128 patients included were regarded as efficacy evaluable (those completing 3 months of pregabalin treatment). Patients (59 years) were long-time sufferers of peripheral NeP, and 38% of them had comorbidities. The majority had previously been treated with tricyclic antidepressants or gabapentin. The average dose of pregabalin was 81.5 mg/d at baseline and 240 mg/d after 3 months. A clinically and statistically significant improvement of 2.2 points in the average level of pain intensity was found after 3 months. The higher the pain intensity at baseline, the higher was the reduction of the pain score. Positive results were also found for pain-related sleep interference, patients' global impression of change, quality of life, and work and productivity impairment. Twenty-one patients reported 28 adverse events. CONCLUSION: This real-life study indicates that for some patients (two-thirds), addition of pregabalin for peripheral NeP helps to reduce their pain intensity significantly.
RESUMO
BACKGROUND: An earlier study showed that from a societal perspective it was less expensive to encourage patients to self-regulate their medication for GERD (gastro-esophageal reflux disease) by treating patients on-demand. OBJECTIVE: The objective was to investigate whether physician involvement in a clinical trial financed by the pharmaceutical industry subsequently results in higher health care costs. STUDY DESIGN: An open, observational, multicenter study compared direct medical costs and total costs for three groups of patients with different exposure to the clinical trial; (1) Dual exposed, where both the patients and the GP participated in the former clinical trial, (2) GP exposed, where only the GP participated in the former clinical trial and (3) nonexposed, where neither the patients nor the GP participated in the former clinical trial. RESULTS: We did not find any statistically significant differences in neither direct medical nor total costs. However, we did observe a numerical difference in direct medical costs of 24% higher in the dual exposed group compared to the nonexposed group mainly due to a higher consumption of prescribed medication. The higher direct medical cost in the dual exposed group was however counterbalanced by lower observed direct nonmedical and indirect costs. CONCLUSION: Although we did not find any statistical significant differences in health care costs, we did observe a higher consumption of prescribed medication and lower costs of work hours lost if both patient and GPs participated in a former clinical trial. The results may be limited due to a lower number of patients included than expected.
