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Evaluation of the Safety and Efficacy of Pregabalin in ... - PAINWeek

Evaluation of the Safety and Efficacy of Pregabalin in ... - PAINWeek

Evaluation of the Safety and Efficacy of Pregabalin in ... -

79 Evaluation of the Safety and Efficacy of Pregabalin in Older Patients With Neuropathic Pain David Semel, T. Kevin Murphy, Gergana Zlateva, Raymond Y. Cheung, Birol Emir Pfizer Global Pharmaceuticals, New York, NY, United States Purpose Chronic neuropathic pain conditions, such as postherpetic neuralgia (PHN) and diabetic peripheral neuropathic pain (DPN), can be challenging to manage in older patients, who tend to have comorbid medical conditions and take several medications. Older patients are typically underrepresented in clinical trials of analgesics, thus the safety and efficacy of analgesics in this population may not be apparent from a single clinical study. The objective of the current analysis was to evaluate the safety and efficacy of pregabalin in older patients (age ≥65 years) using pooled data from clinical studies of pregabalin in patients with DPN or PHN. Method Clinical studies that met the following criteria were selected: Pfizer-sponsored studies of pregabalin in patients with PHN or DPN; were completed before the end of 2006; were randomized, parallel, placebocontrolled, and double blind; had ≥1 fixed-dose pregabalin treatment arm; had in-house, patient-level efficacy/safety data available; had similar treatment durations; and had same primary outcome. Data from patients who received placebo or fixed-dose pregabalin 150, 300, or 600 mg/day were pooled and stratified into the following age categories: 18-64 years, 65-74 years, and ≥75 years. The primary efficacy measure was the endpoint mean pain score on daily pain rating scale (DPRS; no pain=0; worst possible pain=10). Other measures included sleep interference score on Daily Sleep Interference Scale (DSIS; pain did not interfere with sleep=0; pain completely interfered with sleep=10) and safety. A treatment-byage interaction analysis was performed using analysis of covariance with terms for treatment, age category, protocol, baseline pain, and treatment-by-age category interaction. Results Eleven studies met the selection criteria and had a similar study design with a 1-week baseline period followed by 5 to 13 weeks of placebo-controlled, double-blind treatment. In total, 2516 patients were included in the pooled analysis (white, n=2435; male, n=1347; DPN, n=1513; PHN, n=1003; pregabalin 150 mg/day, n=427; pregabalin 300 mg/day, n=496; pregabalin 600 mg/day, n=672; placebo, n=921; 18- 64 years, n=1236; 65-74 years, n=766; and ≥75 years, n=51). Baseline mean pain scores and mean sleep interference scores were comparable among age and dosage groups. In the older (≥65 y) age groups, pregabalin significantly improved mean pain score at endpoint versus placebo across all doses (difference versus placebo [SEM] from -0.770 [0.231] to -1.81 [0.304]; P≤0.0009). Placebo-corrected least squares mean differences in pain with pregabalin were not different between age groups: -0.155 (95% CI: -0.412, 0.109; P=0.2497) for patients aged 18 to 64 years versus ≥75 years; -0.157 (95% CI: -0.419, 0.105; P=0.2402) for patients aged 65 to 74 years versus ≥75 years; and 0.002 (95% CI: -0.215, 0.218; P =0.9882) for patients aged 18 to 64 years versus 65 to 74 years. Similar improvements in sleep interference were observed across age groups. The most common AEs that occurred in ≥10% of any age or treatment group were dizziness, somnolence, peripheral edema, asthenia, dry mouth, weight gain, and infection. Study discontinuations owing to AEs and the relative risks for the most common AEs tended to increase with pregabalin dose, but a relationship between these safety measures and age or neuropathic pain condition were not apparent. Conclusions The efficacy and safety of pregabalin in older patients with neuropathic pain were comparable to those observed in younger patients with neuropathic pain. The safety profile for pregabalin did not appear to be

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