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Comparison of the efficacy and safety of pregabalin for postherpetic neuralgia in Chinese and international patients.

ABSTRACT: Purpose:Pregabalin is indicated for postherpetic neuralgia (PHN) in multiple countries, including China. This analysis compared pregabalin efficacy and safety in Chinese and international patients with PHN. Patients and methods:Data from Chinese and international randomized, double-blind, placebo-controlled trials were compared. Pregabalin was administered at fixed (150, 300, or 600 mg/day) or flexible (150-600 mg/day) doses. The main efficacy measure was mean pain score change at endpoint on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. Secondary efficacy measures included proportions of 30% and 50% pain responders, pain-related sleep interference (PRSI) scores, and proportions of Patient Global Impression of Change (PGIC) responders. The incidences of serious adverse events (SAEs) and adverse events (AEs) were used to assess safety. The effect of baseline pain severity on efficacy was tested. The proportions of patients with severe baseline pain who had moderate or mild pain at endpoint were also assessed. Results:A total of 1166 patients were analyzed: 312 Chinese and 854 international. Overall, results were similar between Chinese and international patients. Pregabalin statistically significantly improved mean pain score versus placebo (least squares mean difference [95% CIs]: Chinese, -0.8 [-1.2, -0.5]; international, -1.3 [-1.6, -1.0]; both p<0.001). Pregabalin was statistically significantly better than placebo in Chinese and international patient groups in the proportions of 30% and 50% pain responders, PRSI scores, and proportions of PGIC responders. Baseline pain severity did not affect efficacy, except for some measures in Chinese patients with moderate baseline pain. Similar proportions of pregabalin-treated patients with severe baseline pain had moderate or mild pain at endpoint in both groups. SAE and AE profiles were comparable in Chinese and international patient groups, except incidences were commonly higher in international patients. Conclusion:Chinese and international patients with PHN exhibit comparable pregabalin efficacy and safety, highlighting the utility of pregabalin for diverse PHN patient populations.

SUBMITTER: Parsons B

PROVIDER: S-EPMC6126478 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Comparison of the efficacy and safety of pregabalin for postherpetic neuralgia in Chinese and international patients.

Parsons Bruce B Pan Xiaoping X Xie Li L Chen YuXuan Y Ortiz Marie M Whalen Ed E

Journal of pain research 20180903

<h4>Purpose</h4>Pregabalin is indicated for postherpetic neuralgia (PHN) in multiple countries, including China. This analysis compared pregabalin efficacy and safety in Chinese and international patients with PHN.<h4>Patients and methods</h4>Data from Chinese and international randomized, double-blind, placebo-controlled trials were compared. Pregabalin was administered at fixed (150, 300, or 600 mg/day) or flexible (150-600 mg/day) doses. The main efficacy measure was mean pain score change at ...[more]

PMID: 30214280

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Project description:Background: Postherpetic neuralgia (PHN) is one of the most common complications of herpes zoster (HZ), and there is still a lack of effective therapies. An increasing number of studies have found that compared to traditional therapy, moxibustion treatment is beneficial for the treatment of PHN, although current evidence remains inconclusive. This systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to evaluate the efficacy and safety of moxibustion for PHN. Methods: We conducted a broad literature review of a range of databases from inception to December 2020, including the Cochrane Library, PubMed, EMBASE, Web of Science, Clinical Trails, China National Knowledge Infrastructure (CNKI), VIP Database for Chinese Technical Periodicals (VIP), China Biomedical Network Information, and Wanfang databases. We included RCTs that compared moxibustion to pharmacological therapies, herbal medicine, or no treatment for treating PHN. The main outcome measure was efficacy rate and Visual Analog Scale (VAS); the secondary outcome measure was adverse events. Data accumulation and synthesis included meta-analysis, publication bias, sensitivity analysis, risk-of-bias assessment, and adverse events. Results: We included 13 RCTs involving 798 patients. Compared with the controls (pharmacological therapies, herbal medicine, or no treatment), moxibustion achieved a significantly higher efficacy rate (odds ratio [OR]: 3.65; 95% [confidence interval]: [2.32, 5.72]; P < 0.00001). Subgroup analysis of the distinct moxibustion modalities showed that both Zhuang medicine medicated thread and thunder-fire moxibustions obtained higher clinical efficacy than the control group. Compared with the controls, moxibustion resulted in significantly lower scores on the VAS (Weighted Mean Difference (MD) = -1.79; 95% CI: [-2.26, -1.33]; P < 0.00001). However, there was no significant difference in terms of safety between moxibustion and the controls (OR = 0.33; 95% CI [0.06, 1.77]; P = 0.19). Conclusion: Due to the lack of methodological quality as well as the significant heterogeneity of the included studies, it remains difficult to draw a firm conclusion on the efficacy and safety of moxibustion for the treatment of PHN. Future high-quality studies are urgently needed.

Project description:BackgroundTreatment of postherpetic neuralgia (PHN) is more complicated in elderly patients, and multiple daily dosing, complex titration, and high incidences of adverse events can be limiting for many pharmacological treatment options.ObjectiveThe aim of this study was to determine whether the efficacy and tolerability of once-daily gastroretentive gabapentin (G-GR) is similar between elderly patients (≥75 years) and younger patients (<75 years).MethodsData from two phase III, placebo-controlled studies of 1,800 mg G-GR once daily with dinner in patients with PHN were integrated and analyzed by age subgroups (<75 years, n = 527; ≥75 years, n = 192). Efficacy assessments at endpoint (week 10) included baseline-adjusted change in average daily pain (ADP) and average daily sleep interference (SIS) scores, the proportion of responders (≥30 % pain reduction), and the proportion of patients feeling "Much" or "Very Much" improved on the Patient Global Impression of Change (PGIC).ResultsCompared with placebo, patients in both age subgroups treated with G-GR (placebo/G-GR) had greater reductions in mean ADP (≥75: -21.9/-34.2 %, p = 0.0348; <75: -29.9/-38.3 %, p = 0.0079) and SIS (≥75: -1.3/-2.4, p = 0.0017; <75: -1.8/-2.7, p < 0.0001), more patients were responders (≥75: 30.4/52.0 %, p = 0.0025; <75: 45.0/54.7 %, p = 0.0265), and more felt "Much" or "Very Much" improved on the PGIC (≥75: 20.7/35.0 %, p = 0.0272; <75: 33.6/44.9 %, p = 0.0077). The most common (placebo/G-GR) adverse events (AEs) were dizziness (≥75: 3.3/12.0 %; <75: 1.8/10.4 %), nausea (≥75: 1.0/5.4 %; <75: 2.9/4.2 %), and somnolence (≥75: 0/5.0 %; <75: 3.7/4.2 %). For all patients, AEs rapidly decreased to low steady levels after 4-5 weeks of treatment. The incidence of serious AEs was low and they were reported more frequently in the placebo than in the G-GR group.ConclusionsTherapy with once-daily G-GR was as effective for treating pain associated with PHN in elderly patients as it was in younger patients. G-GR was well tolerated, and the incidence of the most common AEs did not appear to be age related.

Project description:BackgroundPostherpetic neuralgia (PHN) is the most common sequela of herpes zoster, and the efficacy of the treatment regimens recommended in the guidelines is not entirely reliable. Acupuncture and moxibustion are widely used complementary alternative therapies that have a positive effect on the treatment of PHN. However, there are various forms of acupuncture and moxibustion, and there are differences in efficacy between the different forms.MethodsThe retrieval work of randomised controlled trials (RCTs) of acupuncture for PHN in English databases (including PubMed, Cochrane Library, Embase, Web of Science) and Chinese databases (including China National Knowledge Infrastructure (CNKI), WeiPu database, WanFang database, and China Biomedical Literature Database) were conducted from the time of database creation to June 2022. Literature screening, data extraction, and evaluation of risk of bias for the included studies were carried out independently by two researchers, and data analysis was performed using Stata 14.2 software.ResultsA total of 30 RCTs including 2138 patients with PHN were included. In terms of pain improvement, acupoint embedding + Western medicine group, bloodletting-cupping group, and bloodletting-cupping + Western medicine group ranked top. In terms of total efficiency, acupuncture + Western medicine group, bloodletting-cupping + Western medicine group, and acupoint embedding group ranked top. There were no statistically significant differences in the incidence of adverse events between treatment regimens.ConclusionsIn a comprehensive comparison of the outcome indicators of 14 different treatment regimens, we considered acupoint injection + Western medicine and bloodletting-cupping + Western medicine to be the best combinations for the treatment of PHN. Due to the limitations of the study, the above conclusions still need to be validated in further multi-centre, large-sample prospective randomised controlled clinical trials.

Dataset Information

Comparison of the efficacy and safety of pregabalin for postherpetic neuralgia in Chinese and international patients.

Publications

Comparison of the efficacy and safety of pregabalin for postherpetic neuralgia in Chinese and international patients.

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