Pregabalin For Peripheral Neuropathic Pain Research Articles

Subtotal vaginal hysterectomy with cervical ring preservation and cervical stump suspension to the sacrospinous ligament in women with pelvic organ prolapse: An exposed cohort study

To evaluate the short-term safety and efficacy of vaginal hysterectomy with cervical preservation in patients with genital prolapse stages II to IV. This is a descriptive case series study. It included women with genital prolapse stages II to IV, indicated for vaginal hysterectomy, with negative cervicovaginal cytology for malignancy, who underwent subtotal vaginal hysterectomy with suspension of the cervical stump to the sacrospinous ligament between June 1 and December 31, 2023, at a high-complexity general clinic. Sociodemographic variables and complications six months postoperatively were analyzed. The surgical technique is presented, and descriptive analysis, along with a detailed surgical technique exposition of cervical stump suspension to the sacrospinous ligament, was conducted. During the described period, 10 patients consulted, of whom eight met the inclusion criteria. The mean duration of the surgical procedure was 133 minutes. Average blood loss was 200 cc. One patient required analgesic use of pregabalin for peripheral neuropathic pain, achieving adequate postoperative pain control. No other intraoperative or postoperative complications were reported. No prolapse recurrence was observed six months postevaluation. Subtotal vaginal hysterectomy with cervical stump suspension to the sacrospinous ligament is a surgical repair technique that could be considered for the management of uterine prolapse. Randomized studies comparing this technique with other management alternatives are needed to evaluate its long-term efficacy and safety.

Comparative Benefit-Risk Assessment for Lidocaine 700mg Medicated Plaster and Pregabalin in Peripheral Neuropathic Pain Following a Structured Framework Approach.

IntroductionPeripheral neuropathic pain (PNP) is difficult to treat. Several oral drugs are recommended as first-line treatments. Nevertheless, many patients cannot obtain sufficient pain relief or do not tolerate systemically active treatments. Topical treatments, with a lower risk of systemic side effects such as lidocaine 700 mg medicated plaster, are also recommended in treatment guidelines. This analysis compares the benefit–risk balance of topical 700 mg lidocaine medicated plaster with the benefit–risk balance of oral pregabalin administration for the treatment of PNP following current recommendations on benefit–risk assessment (BRA) methodology.MethodsThe Benefit–Risk Action Team (BRAT) framework was used as structured approach. Selection of key benefits and risks was supported by a patient survey. Published randomized controlled clinical trials were the main source to identify data related to key benefits and risks. The outcome of randomized clinical trials was compared with real-world evidence (RWE) data for consistency.ResultsIdentified key benefits were pain reduction and improvement in quality of life. Key risks identified were application site reactions, dizziness, confusion, weight gain, peripheral edema, and blurred vision. Overall, there was similarity in key benefits between the comparators; however, a clear advantage regarding key risks in favor of lidocaine 700 mg medicated plaster was observed. This observation was consistent across data from a direct comparison trial, randomized placebo-controlled trials, as well as data from RWE studies. The low number of randomized controlled trials for lidocaine 700 mg medicated plaster was the main limitation.ConclusionGuided by the opinion of patients regarding key benefits and risks deemed important for treatments of peripheral neuropathic pain, our analysis showed that lidocaine 700 mg medicated plaster has a more favorable benefit–risk balance compared to pregabalin (300 and 600 mg daily).Supplementary InformationThe online version contains supplementary material available at 10.1007/s40122-021-00340-2.

Capsaicin patch as effective as pregabalin for peripheral neuropathic pain

Capsaicin patch as effective as pregabalin for peripheral neuropathic pain

A comprehensive drug safety evaluation of pregabalin in peripheral neuropathic pain.

Pregabalin is a commonly used therapy currently recommended as first-line treatment for a number of neuropathic pain (NeP) conditions. Since licensure, a number of clinical trials of pregabalin in different NeP conditions have been completed from which additional data on safety and tolerability can be drawn. In this analysis, patient-level data from 31 randomized clinical trials of pregabalin in peripheral NeP sponsored by Pfizer were pooled and assessed for incidence of adverse events (AEs). Incidence by age, disease condition, and race, together with risk differences and time to onset and resolution of AEs, was assessed. In total, 7,510 patients were included: 4,884 on pregabalin (representing 805 patient-years treatment) and 2,626 on placebo. Pregabalin vs. placebo risk analysis identified 9 AEs with a risk difference, for which the lower limit of the 95% confidence interval (CI) was > 1%: dizziness (risk difference [95% CI]: (17.0 [15.4 to 18.6]), somnolence (10.8 [9.5 to 12.1]), peripheral edema (5.4 [4.3 to 6.4]), weight increase (4.7 [3.9 to 5.5]), dry mouth (2.9 [2.1 to 3.8]), constipation (2.3 [1.5 to 3.2]), blurred vision (2.2 [1.6 to 2.9]), balance disorder (2.0 [1.5 to 2.5]), and euphoric mood (1.6 [1.2 to 2.0]). The most common AEs, dizziness and somnolence, typically emerged within the first 1 to 2 weeks of treatment and resolved 1 to 2 weeks later, without resulting in cessation of treatment. The data from this review provide information, indicating which AEs may be expected in patients treated with pregabalin, and suggest that careful dose titration to the highest tolerable dose is the most appropriate approach in clinical practice.

Predicting Response to Pregabalin from Pretreatment Pain Quality: Clinical Applications of the Pain Quality Assessment Scale

The aim of this study is to assess the Pain Quality Assessment Scale (PQAS) in predicting pregabalin in peripheral neuropathic pain (NP). Post hoc analysis of a double-blind, placebo-controlled, enriched enrollment, randomized withdrawal trial evaluating pregabalin in 99 patients with NP who completed the PQAS, which comprises 20 questions regarding individual pain domains and qualities that are scored into three scales: paroxysmal, deep, and surface. Patients rated the average pain intensity and pain quality using the PQAS at baseline; average pain intensity was assessed again after 40 days of treatment with pregabalin. Associations between pretreatment PQAS scores and treatment response were estimated using Pearson's r. Logistic regression was used to identify pretitration PQAS scores contributing unique variance to predicting treatment response. Fifty participants provided baseline PQAS scores and received pregabalin for the entire length of the study. Nine of 23 PQAS baseline scales and items were significantly associated with treatment response to pregabalin: the paroxysmal and deep scales, and the items assessing the following pain domains and qualities: intensity, electric, tingling, cramping, radiating, throbbing, and deep (P values range, 0.002-0.045; rs range, 0.28-0.43). The PQAS items assessing sharp, hot, and unpleasant pain items demonstrated nonsignificant trends (P < 0.10) to be associated with treatment response. In the logistic regression analysis, pretitration PQAS scores had 77% sensitivity and 83% specificity to correctly identify pregabalin responders. Significantly correlated PQAS items had a sensitivity of 85% and specificity of 76%. Pretitration PQAS scores reliably predicted pregabalin responders in patients with NP.

Efficacy of Pregabalin for Peripheral Neuropathic Pain: Results of an 8-Week, Flexible-Dose, Double-Blind, Placebo-Controlled Study Conducted in China

Background Several classes of medications such as tricyclic antidepressants, anticonvulsants, narcotic analgesics, and α2-δ ligands, such as pregabalin, have been reported to be efficacious in the treatment of painful diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN) in whites. However, no large double-blind, placebo-controlled trials have been reported that evaluated the efficacy of pregabalin for the treatment of neuropathic pain in a Chinese population in China. Objective The aim of this study was to evaluate the efficacy and tolerability of flexible-dose pregabalin in treatment of Chinese patients diagnosed with painful DPN or PHN. Methods This was a double-blind, parallel-group study in which patients were randomized in a 2:1 ratio and treated with either flexible-dose pregabalin, 150 to 600 mg/d, or corresponding flexible-dose placebo for 8 weeks. The primary efficacy end point was change in the mean pain score based on a daily pain rating scale (DPRS; ranging from 0 [no pain] to 10 [worst possible pain]). Secondary end points included Daily Sleep Interference scale, short form-McGill Pain Questionnaire (SF-MPQ) scale, and the Patient Global Impression of Change (PGIC) and Clinician Global Impression of Change (CGIC) scales. Adverse events and physical and laboratory examination results were also collected. Results Pregabalin and placebo treatment groups were well-matched in terms of demographic and patient characteristics. On the primary outcome, end point change in mean DPRS score, treatment with pregabalin (N = 206) resulted in significant improvement compared with results with placebo (N = 102), with a least squares mean difference score of –0.6 ( P = 0.005). With regard to responder rates, 64% and 52% of patients treated with pregabalin and placebo, respectively, reported ≥30% improvement in DPRS scores ( P = 0.04). Treatment with pregabalin also resulted in significant efficacy compared with that of placebo on secondary measures, including SF-MPQ VAS score ( P = 0.012), SF-MPQ present pain intensity index score ( P = 0.003), sleep interference score ( P = 0.023), and PGIC and CGIC scores ( P = 0.004 and P = 0.001, respectively). Adverse events were observed in 50.0% of pregabalin patients and 40.2% of placebo patients ( P = 0.105), with the most common adverse event being dizziness (11.2%). Conclusions Study results suggest that relative to placebo, pregabalin in daily doses of 150 to 600 mg/d was effective and well tolerated in Chinese patients diagnosed with moderate-to-severe DPN or PHN, indicated through improved pain scores and PGIC scores.

A diabetic hemodialysis patient treated with excess pregabalin for peripheral neuropathic pain caused by diabetic neuropathy

症例は63歳，女性，現病歴：56歳時に2型糖尿病に起因する末期腎不全で血液透析を導入され通院透析中であった．発症2か月前より右下肢痛が増悪して，整形外科で治療を受けていたが，症状は軽減せず，糖尿病性神経障害による疼痛の診断で麻酔科を受診した．同科にて末梢性神経障害性疼痛治療薬のリリカ®（一般名：プレガバリン）を1日量150mg，2回分服で処方され服用を開始した．服用開始後3日目より浮遊感，傾眠，脱力感が出現し，服用4日目に当院の救急外来に搬送され神経学的所見，理学所見，頭部CT，血液検査，服薬歴からプレガバリンの過量投与による副作用症状と考えられた．プレガバリンは蛋白結合能が低く透析性が高いため治療としては，連日3日間の血液透析を施行，3回目の透析治療後に症状はほぼ消失した．治療前のプレガバリンの血漿中濃度は，17.4μg/mLで通常維持量での最大血漿中濃度の2.8倍に達していた．また血液透析による薬物濃度低下率は60％を上回っていた．プレガバリンは，腎排泄型薬剤であり，透析患者を含む腎機能障害患者には用法用量を遵守して使用される必要がある．また，過量投与に際しては血漿中に遊離型が多く存在し血液透析が有効と考えられた．

Pregabalin for peripheral neuropathic pain: results of a multicenter, non-comparative, open-label study in Indian patients

The aim of this study was to evaluate the tolerability, safety and efficacy of pregabalin in Indian patients with peripheral neuropathic pain. In this prospective, multicenter, non-comparative, open-label study, patients with peripheral neuropathic pain (n = 111) received pregabalin in doses ranging from 75 to 300 mg twice daily for 3 weeks. Primary efficacy measures included weekly pain score and the Visual Analogue Scale (VAS) score of the Short-Form McGill Pain Questionnaire (SF-MPQ). Despite a short study duration, a significant reduction was seen in weekly pain score (p < 0.0001), as well as VAS score of SF-MPQ (p < 0.0001). Significant improvements were also seen in other pain-related endpoints, weekly sleep interference score, quality of life measures, and patient and clinician ratings of global improvement. Pregabalin was well tolerated, and the most common adverse events were dizziness and somnolence. The short study duration precluded the assessment of longer term safety issues such as weight gain. This study has demonstrated the safety, tolerability and efficacy of pregabalin for peripheral neuropathic pain in Indian patients.

(777): Pregabalin for painful diabetic peripheral neuropathy and postherpetic neuralgia: Onset and duration of analgesia in combined analyses of clinical studies

Numerous studies have demonstrated that pregabalin is effective in diverse types of neuropathic pain. These studies have assessed analgesic onset and duration of effect, relevant concerns in practice. We describe time to onset and duration of analgesia during studies of pregabalin for peripheral neuropathic pain. Data from 7 placebo-controlled RCTs (5-13 weeks long; 300 or 600 mg/d for DPN; 150, 300, or 600 mg/d for PHN; pregabalin, N=940; placebo, N=603) and 4 open-label (OL) extension trials (2 years in duration; flexible dosing; N=444 with dose data and N=251 with pain data) were evaluated in secondary combined analyses.