普瑞巴林治疗神经病理性疼痛的疗效与安全性分析

目的：探讨普瑞巴林治疗神经病理性疼痛的疗效其安全性。方法将58例神经病理性疼痛患者随机分为普瑞巴林组和卡马西平组各29例,分别给予普瑞巴林和卡马西平治疗,所有入组患者均在治疗前及治疗1、2、3、4周时应用疼痛视觉模拟评分法（VAS）、睡眠干扰评分法、汉密尔顿抑郁量表（HAMD）及汉密尔顿焦虑量表（HAMA）进行疗效评定,同时观察两组不良反应情况。结果两组患者治疗后VAS评分、睡眠干扰评分、HAMD、HAMA评分较治疗前均有所降低（P＜0.05）;相同治疗时间内普瑞巴林组比卡马西平组评分降低明显（P＜0.05）;治疗过程中普瑞巴林组不良反应发生率较卡马西平组低（P＜0.05）。结论普瑞巴林治疗神经病理性疼痛疗效好,不良反应发生率低。     

普瑞巴林联合神经妥乐平治疗脊髓损伤患者神经病理性疼痛的疗效观察

目的:探讨神经妥乐平对于脊髓损伤后神经病理性疼痛的临床疗效,同时比较单独使用神经妥乐平与联合使用普瑞巴林和神经妥乐平对神经病理性疼痛的缓解程度、对患者情绪以及睡眠状况的改善情况。方法:选取符合入组标准的脊髓损伤伴神经病理性疼痛患者62例,电脑随机分2组,分别为神经妥乐平组、普瑞巴林联合神经妥乐平组,神经妥乐平组起始剂量为4U bid,普瑞巴林联合神经妥乐平组起始剂量为普瑞巴林75mg bid+神经妥乐平4U bid,间隔3d调整药物剂量,疗程为4周。采用视觉模拟评分量表(visual analogue scale,VAS)、医院焦虑抑郁量表(hospital anxiety and depression scale,HAD)、匹茨堡睡眠质量指数量表(Pittsburgh sleep quality index,PSQI)对患者进行疼痛、情绪和睡眠质量的评估。由专业的康复治疗师对患者服药前和疗程结束后的疗效分别进行评估。结果:单独使用神经妥乐平可以缓解脊髓损伤患者神经病理性疼痛,同时改善患者睡眠质量,治疗前后比较差异有显著性意义(P0.05);而联合使用普瑞巴林和神经妥乐平治疗后,患者的VAS和HAD评分均较神经妥乐平组明显降低,差异有显著性意义(P0.05)。结论:神经妥乐平可以缓解脊髓损伤患者的疼痛症状,联合使用普瑞巴林和神经妥乐平不仅明显缓解脊髓损伤神经病理性疼痛患者的疼痛症状,同时显著改善了患者的焦虑抑郁情绪,提高患者睡眠质量,进而提升患者生存质量,是一种有效的临床治疗方法。     

普瑞巴林对癌性神经病理性疼痛患者睡眠和抑郁的疗效

目的探讨普瑞巴林联合吗啡、恩丹西酮、羟考酮控释片对癌性神经病理性疼痛患者睡眠和抑郁的影响。方法用随机数字法将178例癌性神经病理性疼痛患者分为2组,每组89例。对照组给予吗啡150.0mg和恩丹西酮16.0 mg,溶于0.9%氯化钠注射溶液150 m L中,滴注,完成后给予羟考酮控释片,口服,20 mg,2次/天。观察组加用普瑞巴林,口服,150 mg,2次/天。比较两组镇痛效果、睡眠情况(MOS量表)、抑郁情况[密尔顿焦虑量表(HAMA)、汉密尔顿抑郁量表(HAMD)]。结果观察组疼痛缓解率为8.89%,显著高于对照组的69.66%(P<0.05)。治疗后,观察组MOS-SS量表综合睡眠障碍指数、睡眠量、睡眠干扰、睡眠充足度显著改善(P<0.05),且优于对照组(P<0.05)。治疗后,两组HAMA、HAMD显著降低(P<0.05),且观察组HAMA、HAMD显著低于对照组(P<0.05)。结论普瑞巴林联合吗啡、恩丹西酮、羟考酮控释片可有效缓解癌性神经病理性疼痛患者的疼痛,改善睡眠质量和抑郁状态。     

普瑞巴林联合神经阻滞在神经病理性疼痛患者中的应用效果观察

目的：探讨神经病理性疼痛患者采用普瑞巴林联合神经阻滞治疗的效果。方法：按随机数字表法将2020年7月至2022年7月收治的80例神经病理性疼痛患者分为对照组和研究组,各40例。对照组采用普瑞巴林治疗,研究组在对照组基础上联合神经根阻滞治疗。对比两组临床疗效、疼痛程度、睡眠质量、焦虑和抑郁情绪评分、致炎因子[肿瘤坏死因子-α(TNF-α)、白细胞介素-6(IL-6)、白细胞介素-18(IL-18)、核转录因子-κB(NF-κB)]水平和不良反应。结果：研究组总有效率高于对照组（P<0.05）;治疗后研究组疼痛视觉模拟评分法（VAS）评分、匹兹堡睡眠质量指数量表（PSQI）评分、汉密尔顿焦虑量表（HAMA）和汉密尔顿抑郁量表（HAMD）评分均低于对照组（P<0.05）;治疗后研究组致炎因子水平低于对照组（P<0.05）;两组不良反应发生率对比,差异无统计学意义（P>0.05）。结论：普瑞巴林联合神经阻滞治疗神经病理性疼痛利于减轻患者疼痛程度,治疗效果显著,可有效缓解患者负性情绪,提升其睡眠质量,临床应用安全可靠。     

神经阻滞联合普瑞巴林治疗带状疱疹后神经痛的研究

目的比较单纯口服普瑞巴林和联合神经阻滞两种方法治疗带状疱疹后神经痛(PHN)的效果。方法 60例病程超过6个月的PHN患者分成两组,每组各30例。A组口服普瑞巴林;B组在口服药物的基础上行神经阻滞(三叉神经、肋间神经、椎旁阻滞或腰丛阻滞)。比较两组患者治疗前、治疗后3 d、1周、2周、3周、4周、5周、6周、7周、8周疼痛视觉模拟评分(VAS)和睡眠评分(采用汉密尔顿抑郁量表的第4、5、6项)。比较两组患者疼痛缓解>50%和>30%的人数,以及副作用的发生率。结果两组患者治疗后1~8周VAS和睡眠评分均低于治疗前(P<0.05),B组患者在治疗后3 d VAS及睡眠评分明显低于A组(P<0.01);B组患者疼痛缓解>50%的人数和疼痛缓解>30%的人数高于A组(P<0.05)。两组患者副作用无显著性差异。结论神经阻滞联合口服普瑞巴林治疗带状疱疹后神经痛起效快、止痛作用强,无严重副作用发生。     

加巴喷丁与普瑞巴林治疗带状疱疹后神经痛的效果比较

目的观察加巴喷丁和普瑞巴林治疗带状疱疹后神经痛(post-herpetic neuralgia,PHN)的效果以及对患者睡眠的影响。方法 60例PHN患者按随机数字表法分为加巴喷丁组和普瑞巴林组各30例,分别给予加巴喷丁900 mg/d口服和普瑞巴林150 mg/d口服,疗程均为28天。观察治疗前后疼痛和睡眠的改善情况及药物不良反应。结果两组患者治疗后各时点与治疗前相比疼痛评分随时间下降,睡眠时间增加(P<0.05);普瑞巴林组治疗后各时点的疼痛视觉模拟评分(Visualanalogue scale,VAS)低于加巴喷丁组(P<0.05),24小时睡眠时间大于加巴喷丁组(P<0.05);两组未出现严重的药物不良反应,普瑞巴林组嗜睡发生率明显低于加巴喷丁组(P<0.05),其余不良反应发生率两组间比较差异均无统计学意义(P>0.05)。结论普瑞巴林治疗PHN更安全有效,优于加巴喷丁。     

普瑞巴林治疗老年带状疱疹后神经痛的疗效研究

目的:比较口服普瑞巴林与奥卡西平治疗老年带状疱疹后神经痛(PHN)的临床疗效与安全性。方法:老年PHN患者60例随机分成A、B组各30例,2组均常规给予维生素B1、甲钴胺治疗,A组加口服普瑞巴林治疗,B组则口服奥卡西平,均治疗4周。比较2组患者治疗前、治疗后1、2、4周疼痛视觉模拟评分(VAS)和睡眠评分(汉密尔顿抑郁量表的第4、5、6项)。结果:2组患者治疗后VAS和睡眠评分均低于治疗前(P<0.05),A组在治疗后1周VAS及睡眠评分明显低于B组(P<0.01);A组治疗后疼痛缓解程度优于B组;两组无明显药物不良反应。结论:口服普瑞巴林治疗老年带状疱疹后神经痛起效快、可显著改善睡眠,无严重不良反应发生。     

留置针联合普瑞巴林治疗带状疱疹后遗神经痛

目的比较留置针联合普瑞巴林治疗带状疱疹后遗神经痛(post-herpetic neuralgia,PHN)的疗效。方法选取56例PHN患者,随机分为两组,各28例,均常规予以营养神经药物。对照组予以普瑞巴林300mg/d治疗,治疗组在口服普瑞巴林300mg/d基础上联合留置针治疗,4周为一疗程。用视觉模拟评分(visual analogue scale,VAS)评估患者疼痛程度,比较两组患者在治疗前、治疗2周、治疗4周及停止治疗后4周的疼痛程度,比较24小时持续睡眠时间,并观察不良反应。结果两组治疗后各时期的VAS值较治疗前均下降,差异有统计学意义(P0.05),且各时期治疗组的VAS值较对照组低,差异有统计学意义(P0.05);两组治疗后各时期的24小时持续睡眠时间均较治疗前增加,差异有统计学意义(P0.05)。所有患者在治疗期间均未见严重不良反应。结论留置针联合普瑞巴林治疗PHN可明显缓解患者疼痛。     

超声引导下颈神经根阻滞治疗颈部带状疱疹性神经痛的疗效观察

目的 探讨超声引导下颈神经根阻滞联合普瑞巴林对颈部带状疱疹性神经痛的疗效。方法 选择颈部带状疱疹性神经痛患者60例,随机数字法分为两组,A组(对照组,30例):口服普瑞巴林治疗;B组(阻滞组,30例):口服普瑞巴林联合超声引导下颈神经根阻滞治疗。记录两组患者治疗前(T0)及治疗后第1周(T1)、第2周(T2)、第4周(T3)、第8周(T4)的视觉模拟评分(VAS)、匹兹堡睡眠质量指数(PQSI);普瑞巴林总用量、治疗总有效率以及治疗期间发生的相关不良反应。结果 两组VAS和PQSI在T1～4时比T0降低(P<0.05)。B组患者在T1、T3、T4时VAS评分比A组降低(P<0.05);B组患者在T3、T4时PQSI评分比A组降低(P<0.05);B组口服普瑞巴林总量明显低于A组(P<0.05);B组总有效率高于A组(P<0.05),B组头晕、嗜睡发生率少于A组(P<0.05),B组发生2例无严重后果的神经阻滞并发症。结论 超声引导下颈神经根阻滞联合普瑞巴林能改善带状疱疹性神经痛及睡眠质量,减少普瑞巴林用药量及不良反应。     

普瑞巴林联合神经阻滞治疗老年带状疱疹后三叉神经痛的疗效

目的观察普瑞巴林联合神经阻滞治疗老年带状疱疹后三叉神经痛的效果。方法 45例带状疱疹后三叉神经痛患者随机分为观察组和对照组,对照组采用口服普瑞巴林胶囊,观察组在对照组的基础上加用神经阻滞法。治疗4周后采用视觉模拟评分(VAS)和睡眠质量评分(PSQI)评价临床疗效。结果 2组患者治疗前及治疗1周后VAS评分和PSQI评分均无显著差异(P0.05),但治疗第2、3、4周,2组患者VAS评分和PSQI评分均显著降低,且观察组较对照组降低更为显著,差异有统计学意义(P0.05)。结论普瑞巴林联合神经阻滞治疗老年带状疱疹后三叉神经痛效果好,操作简单,值得临床应用。     

Efficacy and safety of pregabalin in treatment refractory patients with various neuropathic pain entities in clinical routine

AIMS: Conventional approaches to the management of neuropathic pain (NeP) often yield unsatisfactory results. We aimed to investigate pregabalin, a gamma-aminobutyric acid (GABA)-analogue, in a wide range of pregabalin naive patients with treatment refractory NeP. METHODS: Investigator-initiated, 4-week, open, prospective multicentre study in tertiary care. Pregabalin was prescribed at physicians' discretion based on patients' individual responses and tolerability, with or without concomitant analgesics. Consecutive patients were requested to fill in questionnaires at baseline and after 14 and 28 days with numerical pain rating scales (0, none; 10, worst possible), sleep rating scales, parts of the Brief Pain Inventory, Pain Experience Scale, Short Questionnaire on Current Burden and the SF-12 health-related quality of life scale. RESULTS: In 55 patients, the mean pregabalin dose was 142 +/- 26 mg at day 1 and 348 +/- 161 mg at day 28. The mean pain score decreased from 6.5 +/- 1.7 to 5.5 +/- 1.9 at day 14 and to 4.9 +/- 1.8 at day 28 (-24.6%, p < 0.0001). Significant and rapid improvements were noted in the sleep interference score (p < 0.00001), Short Questionnaire on Current Burden (p < 0.01) and SF-12 (somatic score p < 0.001; psychological score p < 0.01). Pregabalin was well tolerated, and only three patients (5%) discontinued treatment prematurely. CONCLUSIONS: Our findings suggest that pregabalin is an effective and well-tolerated drug in difficult-to-treat NeP patients under daily clinical practice conditions. A flexible dosing approach appears appropriate to ensure patient compliance and treatment success.     

A prospective,open‐label,multicentre study of pregabalin in the treatment of neuropathic pain in Latin America

Aims: The objective of this study was to evaluate the safety and efficacy of pregabalin at flexible doses of 150–600 mg/day in Latin American patients with neuropathic pain. Methods: A prospective, multicentre, open‐label, non‐comparative study included patients age ≥ 18 years diagnosed with neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, chemotherapy‐induced peripheral neuropathic pain (PNP), or human immunodeficiency virus‐related PNP. Eligible patients (N = 121) had a score of ≥ 40 mm on the visual analogue scale and a daily pain rating scale (DPRS) score of ≥ 4 throughout screening. Patients received flexible‐dose pregabalin (150–600 mg/day) for 12 weeks, which included a 4‐week dose‐adjustment phase. The primary efficacy measure was change from baseline to end of treatment/last observation carried forward (EOT/LOCF) in weekly mean pain score on the DPRS. Secondary efficacy measures included pain, anxiety, sleep interference, treatment satisfaction and Patient and Clinician Global Impression of Change. Results: Pregabalin significantly reduced the weekly mean pain score on DPRS from baseline to EOT/LOCF [–3.8 (95% CI: ?4.2 to ?3.3); p < 0.0001]. Reductions from baseline to EOT/LOCF were observed for all secondary efficacy outcomes (p < 0.0001). Pain and sleep interference were significantly improved compared with baseline across all weeks of the study, as early as 1 week after initiation of pregabalin (p < 0.0001). The most common adverse events (AEs) were somnolence, dizziness, weight gain and peripheral oedema. Nine (7.4%) patients discontinued the study because of AEs and 25 (20.7%) temporarily stopped or reduced their pregabalin dose because of AEs. Conclusions: Flexible‐dose pregabalin (150–600 mg/day) significantly reduced pain and anxiety and improved sleep and was generally well tolerated in Latin American patients with neuropathic pain.     

Pregabalin for relief of neuropathic pain associated with diabetic neuropathy: A randomized,double‐blind study

Seven published, randomized, placebo‐controlled clinical trials with pregabalin have shown robust efficacy for relief of neuropathic pain from DPN and PHN. An investigation of the efficacy and safety of twice daily pregabalin enrolled 395 adults with painful DPN for ≥1 year in a 12‐week, double‐blind, placebo‐controlled trial. Patients were randomized to placebo, 150, 300, or 600mg/day pregabalin (n=96, 99, 99, and 101). Primary efficacy measure was change from baseline in endpoint mean pain score from patients’ daily pain diaries. Secondary efficacy measures included pain‐related sleep‐interference scores, Patient and Clinical Global Impressions of Change (PGIC, CGIC), and the EuroQOL Health Utilities Index (EQ‐5D). Statistically significant reduction in pain was observed in patients receiving pregabalin 600mg/day, and 46% of patients treated with 600mg/day pregabalin reported ≥50% improvement in mean pain scores from baseline (vs 30% of placebo patients, p=0.036). Number needed to treat to achieve such response was 6.3. Pregabalin 600mg/day was significantly superior to placebo in improving pain‐related sleep‐interference scores (p=0.003), PGIC (p=0.021), and CGIC (p=0.009). (Neither pregabalin 150 nor 300mg/day separated from placebo on these measures, largely because of an atypically large placebo response in one country representing 42% of patients.) All pregabalin dosages were superior to placebo in improving EQ‐5D utility scores (all p≥0.0263 vs placebo). Pregabalin was well tolerated at all dosages; adverse events were generally mild to moderate. Number needed to harm (discontinuation because of adverse events) was 10.3 for pregabalin 600mg/day.     

Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial

A randomized, double-blind, placebo-controlled, parallel-group, multicenter, 8-week trial (with subsequent open-label phase) evaluated the effectiveness of pregabalin in alleviating pain associated with diabetic peripheral neuropathy (DPN). For enrollment, patients must have had at baseline: 1- to 5-year history of DPN pain; pain score ≥40 mm (Short-Form McGill Pain Questionnaire [SF-MPQ] visual analogue scale); average daily pain score of ≥4 (11-point numerical pain rating scale [0=no pain, 10=worst possible pain]). One hundred forty-six (146) patients were randomized to receive placebo (n=70) or pregabalin 300 mg/day (n=76). Primary efficacy measure was endpoint mean pain score from daily patient diaries (11-point numerical pain rating scale). Secondary measures included SF-MPQ scores; sleep interference scores; Patient and Clinical Global Impression of Change (PGIC and CGIC); Short Form-36 (SF-36) Health Survey scores; and Profile of Mood States (POMS) scores. Safety assessment included incidence and intensity of adverse events, physical and neurological examinations, and laboratory evaluations. Pregabalin produced significant improvements versus placebo for mean pain scores (P<0.0001); mean sleep interference scores (P<0.0001); total SF-MPQ score (P<0.01); SF-36 Bodily Pain subscale (P<0.03); PGIC (P=0.001); and Total Mood Disturbance and Tension–Anxiety components of POMS (P<0.03). Pain relief and improved sleep began during week 1 and remained significant throughout the study (P<0.01). Pregabalin was well tolerated despite a greater incidence of dizziness and somnolence than placebo. Most adverse events were mild to moderate and did not result in withdrawal. Pregabalin was safe and effective in decreasing pain associated with DPN, and also improved mood, sleep disturbance, and quality of life.     

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.     

Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens

Pregabalin binds with high affinity to the alpha2-delta subunit protein of voltage-gated calcium channels and, thereby, reduces release of excitatory neurotransmitters. This 12-week randomised, double-blind, multicentre, placebo-controlled, parallel-group study evaluated the efficacy and safety of pregabalin in patients with chronic postherpetic neuralgia (PHN) or painful diabetic peripheral neuropathy (DPN). Patients were randomised to placebo (n=65) or to one of two pregabalin regimens: a flexible schedule of 150, 300, 450, and 600 mg/day with weekly dose escalation based on patients' individual responses and tolerability (n=141) or a fixed schedule of 300 mg/day for 1 week followed by 600 mg/day for 11 weeks (n=132). Both flexible- and fixed-dose pregabalin significantly reduced endpoint mean pain score (primary outcome) versus placebo (P=0.002, P<0.001) and were significantly superior to placebo in improving pain-related sleep interference (P<0.001). The most common adverse events (AEs) for pregabalin-treated patients were dizziness, peripheral oedema, weight gain (not affecting diabetes control), and somnolence. These results are consistent with previous studies' demonstrating pregabalin's efficacy, tolerability, and safety for treatment of chronic neuropathic pain associated with DPN or PHN. Pregabalin dosing aimed at optimal balance of efficacy and tolerability provides significant pain relief and may reduce risks for AEs and therapy discontinuation.     

Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo-controlled clinical trial

This study was designed to assess the efficacy and safety of pregabalin-a novel alpha(2)-delta ligand with analgesic, anxiolytic, and anticonvulsant activity-for treating neuropathic pain in patients with post-herpetic neuralgia (PHN). Two hundred and thirty-eight patients were randomised into this multicentre, doubleblind, placebo-controlled trial to receive 150 (n=81), 300 mg/day (n=76) pregabalin, or placebo (n=81) for 8 weeks. Among the exclusion criteria was failure to respond to previous treatment for PHN with gabapentin at doses > or =1200 mg/day. Endpoint mean pain scores were significantly reduced in patients receiving 150 or 300 mg/day pregabalin compared with placebo. Efficacy was observed as early as week 1 and was maintained throughout the study. Significantly more patients in both pregabalin groups (150 mg, 26%; 300 mg, 28%) were responders (> or =50% decrease in mean pain score from baseline to endpoint) than in the placebo group (10%). Additionally, by week 1 and for the study's duration, 150 and 300 mg/day pregabalin significantly reduced weekly mean sleep interference scores. More pregabalin-treated patients than placebo-treated patients reported that they were 'much improved' or 'very much improved'. Health-related quality-of-life (HRQoL) measurements using the SF-36 Health Survey demonstrated improvement in the mental health domain for both pregabalin dosages, and bodily pain and vitality domains were improved in the 300 mg/day group. The most frequent adverse events were dizziness, somnolence, peripheral oedema, headache, and dry mouth. Pregabalin efficaciously treated the neuropathic pain of PHN. Additionally, pregabalin was associated with decreased sleep interference and significant improvements in HRQoL measures.     

Pregabalin in patients with central neuropathic pain: a randomized, double-blind, placebo-controlled trial of a flexible-dose regimen

The effective treatment of patients suffering from central neuropathic pain remains a clinical challenge, despite a standard pharmacological approach in combination with anticonvulsants and antidepressants. A randomized, double-blinded, placebo-controlled trial evaluated the effects of pregabalin on pain relief, tolerability, health status, and quality of life in patients with central neuropathic pain caused by brain or spinal cord injuries. At baseline and 4 weeks after the start of treatment subjects were evaluated with standard measures of efficacy: pain intensity measured by visual analog scale, health status (Pain Disability Index and EQ-5D) and quality of life (SF-36). Forty patients received escalating doses of either pregabalin (150, 300, and 600 mg/day) or matching placebo capsules. In both groups, patients started with 1 capsule per day (either 150 mg of pregabalin or placebo). If pain relief was insufficient, patients were titrated to a higher dose. There was a statistically significant decrease in mean pain score at endpoint for pregabalin treatment, compared with placebo (P = 0.016). Follow-up observation showed no significant difference in Pain Disability Index scores between the two groups. The pregabalin group, however, showed a statistically significant improvement for the EQ-5D. Pregabalin treatment led to a significant improvement in the bodily pain domain of the SF36. In the other domains, more favorable scores were reported without reaching statistical significance. Pregabalin, in a flexible-dose regime, produced clinically significant reductions in pain, as well as improvements in health status in patients suffering from severe central neuropathic pain.     

Pregabalin: a novel gamma-aminobutyric acid analogue in the treatment of neuropathic pain, partial-onset seizures, and anxiety disorders

BACKGROUND: The US Food and Drug Administration (FDA) approved pregabalin in December 2004 for the treatment of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia. Pregabalin is the first drug approved in the United States and in Europe for both conditions. In June 2005, pregabalin was approved as an adjunctive treatment in adults with partial-onset seizures. The FDA currently is considering the approval of pregabalin as adjunctive therapy in adults with generalized anxiety disorder (GAD) or social anxiety disorder (SAD). OBJECTIVES: The goals of this review were to summarize the pharmacology, pharmacokinetics, efficacy, and tolerability of pregabalin; review its approved uses in the management of neuropathic pain and refractory partial-onset seizures; and investigate its potential use in patients with GAD or SAD. METHODS: Relevant English-language literature was identified through a search of MEDLINE (1993-June 2006) and International Pharmaceutical Abstracts (2000-June 2006). The search terms included pregabalin, Lyrica, S-(+)-3 isobutyl-gaba, PN, DPN, diabetic peripheral neuropathy, PHN, postherpetic neuralgia, partial seizures, epilepsy, generalized anxiety disorder, and CI-1008. RESULTS: In 4 clinical trials in a total of 1068 patients with diabetic peripheral neuropathy, the patients receiving pregabalin 300 to 600 mg/d had significantly greater improvement in mean pain scores than placebo recipients (P < or = 0.01). Patients with postherpetic neuralgia receiving pregabalin 450 to 600 mg/d had significantly greater improvement in relief of pain and pain-related sleep interference than placebo recipients (P < or = 0.002). Patients with refractory partial-onset seizures who received pregabalin 150 to 600 mg/d (divided into 2 or 3 doses) concomitantly with antiepileptic drugs had significantly fewer seizures than placebo recipients (P < or = 0.001). In the 3 studies that evaluated the efficacy of pregabalin in patients with GAD or SAD, the patients receiving pregabalin 200 to 600 mg/d (divided into 2 or 3 daily doses) had a significantly greater reduction in mean pain scores on the Hamilton Anxiety Scale than placebo recipients (P < or = 0.01). Across all the reviewed clinical trials, the most commonly reported adverse effects (AEs) were those affecting the central nervous system, including somnolence (< or =50%), dizziness (< or =49%), and headache (< or =29%). AEs resulted in withdrawal from the study in < or =32% of patients. CONCLUSIONS: Pregabalin appears to be an effective therapy in patients with diabetic peripheral neuropathy, postherpetic neuralgia, and adults with refractory partial-onset seizures. The available data suggest that pregabalin may be beneficial as an adjunctive therapy in adult patients with GAD or SAD.