Pregabalin In Patients Research Articles

EE350 Cost-Effectiveness of Mirogabalin in Treatment of Diabetic Peripheral Neuropathic Pain in Mainland China

Diabetic peripheral neuropathic pain (DPNP) is a chronic microvascular complication of diabetes mellitus associated with debilitating pain, high morbidity, and poor quality of life. The objective of this study was to compare the cost-effectiveness of mirogabalin, a potent and selective αlpha-2-delta ligand, with pregabalin in patients with DPNP from the healthcare system perspective in mainland China.

Assisted withdrawal of pregabalin in drug and alcohol users

The risks of prescribing pregabalin to patients already addicted to illicit drugs or alcohol almost always outweigh the benefits, therefore deprescribing pregabalin is usually appropriate. This article outlines safe and realistic protocols to reduce and stop pregabalin in patients with major addiction problems.

Pregabalin in Patients with Post-Traumatic Peripheral Neuropathic Pain: A Meta-Analysis of Randomized Controlled Trials.

To investigate the safety and efficacy of pregabalin versus placebo in post-traumatic peripheral neuropathic pain (PTNP). PubMed, Cochrane Library, Web of Science, and Google Scholar were searched for relevant evidence up to January 2022. The Cochran tool was used to assess the quality of randomized clinical trials (RCTs). Data analysis was performed using Comprehensive Meta-Analysis software. Three RCTs involving 821 patients were included in the meta-analysis. A significant difference was observed between pregabalin and placebo in terms of the pain score (the standardized mean difference [SMD] = -0.481, 95% CI: -0.75 to 0.20, P=0.04) and sleep interference (MD= -0.481, 95% CI: -0.75 to 0.20, P=0.00). There was also a significant difference between pregabalin and placebo regarding somnolence (risk ratio [RR] = 2.78; 95% CI: 1.64 to 4.71, P=0.00), dizziness (RR=4.13; 95% CI: 2.71 to 6.28, P=0.00), and disturbance in attention (RR: 2.97; 95% CI: 1.02 to 8.65, P=0.04). However, no significant difference was observed between pregabalin and placebo in terms of headache (RR=1.20; 95% CI: 0.70 to 2.06, P=0.50), fatigue (RR=1.42; 95% CI: 0.82 to 2.47, P=0.20), nausea (RR=1.52; 95% CI: 0.88 to 2.62, P=0.13), constipation (RR=1.84; 95% CI: 0.78 to 4.29, P=0.15), and discontinuation (RR=1.52; 95% CI: 0.45 to 5.06, P=0.49). Compared with placebo, pregabalin showed better efficacy in reducing PTNP and improving sleep interference. However, it was associated with higher adverse events. Further RCTs is needed to confirm these findings.

The effect of pregabalin on postoperative pain after anterior cruciate ligament reconstruction: A systematic review of randomized clinical trials.

Despite the enormous success of anterior cruciate ligament (ACL) reconstruction, acute neuropathic pain can develop postoperatively and is both distressing and difficult to treat once established. Pregabalin, an anticonvulsant agent that selectively affects the nociceptive process, has been used as a pain relief agent. The purpose of this systematic review of randomized controlled trials (RCTs) was to evaluate the pain control effect of pregabalin versus placebo after ACL reconstruction. A search of the literature was performed from inception to June 2022, using PubMed, Scopus, Google Scholar, Web of Science, Cochrane and EBSCO. Studies considered for inclusion were RCTs that reported relevant outcomes (postoperative pain scores, cumulative opioid consumption, adverse events) following administration of pregabalin in patients undergoing ACL reconstruction. Five placebo-controlled RCTs involving 272 participants met the inclusion criteria. 75mg and 150mg oral pregabalin was used in included trials. Two studies used a single dose of pregabalin one hour before anesthesia induction. Two studies used pregabalin 1hour before anesthesia induction and 12hours after. One study used daily pregabalin 7days before and 7days after surgery. Out of five papers, three papers found significantly lower pain intensity and cumulative opioid consumption in pregabalin group compared with placebo group. However, a decrease in pain scores was found in all trials. Pregabalin administration was associated with dizziness and nausea. The use of pregabalin may be a valuable asset in pain management after ACL reconstruction. However, future studies with larger sample size and longer follow-up period are required.

Cardiovascular risk of gabapentin and pregabalin in patients with diabetic neuropathy

BackgroundGabapentin and pregabalin are commonly prescribed medications to treat pain in patients with diabetic neuropathy. Gabapentin and pregabalin can cause fluid retention, which is hypothesized to be associated with cardiovascular diseases. However, whether long-term use of gabapentin and pregabalin is associated with adverse cardiovascular diseases remains unknown. This study aims to examine the association between gabapentin use, pregabalin use and several adverse cardiovascular events.MethodsThis retrospective cohort study used propensity score matching within patient electronic health records (EHRs) from a multicenter database with 106 million patients from 69 health care organizations in the US. The study population comprised 210,064 patients who had a diagnosis of diabetic neuropathy and were prescribed diabetic neuropathy medications in their EHRs. The exposure cohort comprised patients who were prescribed gabapentin or pregabalin to treat diabetic neuropathy. The comparison cohort comprised patients who were not prescribed either gabapentin or pregabalin but were prescribed other drugs to treat diabetic neuropathy. The outcomes of interest were myocardial infarcts, strokes, heart failure, peripheral vascular disease, and venous thromboembolic events. We calculated hazard ratios (HRs) and 95% confidence intervals (CIs) for 3-month and 5-year risk for adverse cardiovascular events between the propensity score-matched cohorts.ResultsBoth gabapentin and pregabalin were associated with increased risk of 5-year adverse cardiovascular events compared with the comparison group. In patients prescribed gabapentin, the highest risk was observed for deep venous thrombosis (HR: 1.58, 95% CI 1.37–1.82), followed by pulmonary embolism (HR: 1.5, 95% CI 1.27–1.76), peripheral vascular disease (HR: 1.37, 95% CI 1.27–1.47), stroke (HR: 1.31, 95% CI 1.2–1.43), myocardial infarction (HR: 1.25, 95% CI 1.14–1.38) and heart failure (HR: 1.14, 95% CI 1.07–1.21). In patients prescribed pregabalin, the highest risk was observed for deep venous thrombosis (HR: 1.57, 95% CI 1.31–1.88), followed by peripheral vascular disease (HR: 1.35, 95% CI 1.22–1.49), myocardial infarction (HR: 1.29, 95% CI 1.13–1.47), pulmonary embolism (HR: 1.28, 95% CI 1.04–1.59), stroke (HR: 1.26, 95% CI 1.12–1.42), and heart failure (HR: 1.2, 95% CI 1.11–1.3). There were significant associations between short-term (3 month) gabapentin use and heart failure, myocardial infarction, peripheral vascular disease, deep venous thrombosis, and pulmonary embolism. Short-term (3 month) pregabalin use was associated with deep venous thrombosis, peripheral vascular disease.ConclusionIn patients with diabetic neuropathy who were prescribed gabapentin and pregabalin, there is an increased risk for heart failure, myocardial infarction, peripheral vascular disease, stroke, deep venous thrombosis, and pulmonary embolism with long-term use. Our findings suggest that increased risk for adverse cardiovascular events, along with other side effects, the efficacy of pain control and the degree of tolerance of the patient, should be considered when prescribing gabapentin and pregabalin long-term in patients with diabetic neuropathy.

Xiaoketongbi Formula vs pregabalin for painful diabetic neuropathy: A single-center, randomized, single-blind, double-dummy, and parallel controlled clinical trial.

BackgroundWe assessed the efficacy and safety of the Xiaoketongbi Formula (XF) vs. pregabalin in patients with painful diabetic neuropathy (PDN).MethodsPatients with PDN (n = 68) were included in a single‐center, randomized, single‐blind, double‐dummy, parallel controlled clinical trial. The primary outcome was the change in the Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI‐DPN). Secondary outcomes evaluated included the reduction of BPI‐DPN >50%, changes in the numeric rating scale‐11 (NRS‐11) score for pain, Daily Sleep Interference Diary (DSID), Patient Global Impression of Change (PGIC), nerve conduction velocity (NCV), and adverse events.ResultsAfter 10 weeks of treatment, the BPI‐DPN score reduced from 42.44 ± 17.56 to 26.47 ± 22.22 and from 52.03 ± 14.30 to 37.85 ± 17.23 in the XF and pregabalin group (P s < 0.001), respectively. The difference in the absolute change in BPI‐DPN score between both groups was −1.79 (95% CI: −9.09, 5.50; p = 0.625). In the XF and pregabalin groups, 44.1% (15/34) and 20.6% (7/34) of patients reported a BPI‐DPN reduction >50% (p = 0.038), respectively. There were no significant differences between groups in NRS‐11 and DSID (P s > 0.05). A significantly greater number of patients in the XF group felt “significantly improved” or “improved” than in the pregabalin group (35.3% (12/34) vs. 11.8% (4/34), p = 0.045). The absolute change in motor nerve conduction velocity of the right median nerve was significantly different between both groups (XF group 0.7 ± 2.3 vs. pregabalin group −2.2 ± 4.1, p = 0.004). No serious adverse events were reported in either group.ConclusionsXF is equivalent to pregabalin in reducing pain symptoms and improves the quality of life in patients with PDN. In addition, XF has the potential to improve nerve function by increasing NCV.

Post-operative Analgesic and Opioid-sparing Effect of a Single-dose Pre-operative Oral Pregabalin in Gynaecological Surgeries.

Post-operative pain treatment is a major challenge in our environment. Opioids may cause respiratory depression post-operatively. Therefore, any combination of opioid and non-opioid analgesics that provides quality post-operative pain control and reduces opioid consumption with its attendant side effects will be highly desirable. The aim of this article is to evaluate analgesic benefits and opioid-sparing effects of pre-operative oral pregabalin in patients who undergo abdominal gynaecological surgeries. A prospective randomized double-blind placebo-controlled study is carried out at University of Ilorin Teaching Hospital, Kwara State, Nigeria. Eighty-two patients scheduled for gynaecological surgeries were randomized into two equal groups. The patients in the control and study groups received a placebo drug and oral pregabalin 150 mg, respectively, 1 h before induction of general anaesthesia. Post-operative pain intensity using a five-point Verbal Rating Scale, time to first request for analgesia, and 24 h post-operative pethidine consumptions were assessed. Mean values were compared using Student's t-test. Categorical data were compared with the χ 2 test. Level of significance was set at 5% (0.05) and power of the study was 80%. Demographic characteristics were comparable between the two groups. The median pain score was 0-2 (no pain-moderate pain) throughout the study. Post-operative static and dynamic pain scores at 1, 4, and 12 h were significantly higher in the placebo group (<0.001). Twenty-four hours post-operatively, there were no significant differences in static and dynamic pain scores between the two groups (P=0.131 and P=0.384, respectively). Time to first analgesic requirement and total pethidine consumed within 24 h post-operative were 47 ± 19 vs. 258 ± 137 min (P=0.001) and 326.19 ± 62.70 vs. 192.86 ± 55.84 mg (P=0.001) in the control and study groups, respectively. The pre-operative use of pregabalin reduced post-operative opioid requirement by 40.9% in the study group. Nausea and vomiting were more common in the placebo group, whereas dizziness, blurring of vision, and sedation were more common in the pregabalin group. A single pre-operative dose of 150 mg oral pregabalin had significantly greater analgesic effects compared with placebo and reduced post-operative opioid requirements in patients undergoing myomectomy or total abdominal hysterectomy. It should be considered an adjuvant in multimodal pain management regimens following gynaecological surgeries.

Analgesic Efficacy of Gabapentin and Pregabalin in Patients Undergoing Laparoscopic Bariatric Surgeries: a Systematic Review and Meta-analysis.

This meta-analysis investigated the effect of oral gabapentinoids (i.e., pregabalin and gabapentin) on analgesic consumption (i.e., primary outcome) and pain relief (i.e., secondary outcome) in patients following bariatric surgery. Analysis of five eligible trials published between 2010 and 2019 including 363 participants receiving gabapentinoids revealed a significantly lower morphine consumption [mean difference (MD) = - 15.1mg, p = 0.004; evidence certainty: low] and risk of nausea/vomiting [risk ratio (RR) = 0.49, p = 0.002; evidence certainty: high] at postoperative 6-24h. There was also a lower pain score at postoperative 0-4h (MD = - 1.41, p < 0.00001; evidence certainty: low) and 6-12h (MD = - 0.9, p = 0.007; evidence certainty: low) compared with controls, while pain severity at postoperative 24h was comparable between two groups. In summary, preoperative oral gabapentinoids optimized postoperative pain outcomes and reduced risk of nausea/vomiting following bariatric surgery.

Predicting Treatment Response with Sensory Phenotyping in Post-Traumatic Neuropathic Pain.

Currently available treatments for neuropathic pain are only modestly efficacious when assessed in randomized clinical trials and work for only some patients in the clinic. Induced-pain or gain-of-function phenotypes have been shown to predict response to analgesics (vs placebos) in patients with neuropathic pain. However, the predictive value of these phenotypes has never been studied in post-traumatic neuropathic pain. Mixed-effects models for repeated measures were used to evaluate the efficacy of pregabalin vs placebo in subgroups with induced-pain phenotypes (i.e., hyperalgesia or allodynia) in data from a recent, multinational randomized clinical trial (N = 539) that identified phenotypic subgroups through the use of a structured clinical exam. The difference in mean pain score between the active and placebo groups (i.e., delta) after 15 weeks of treatment for the subgroup with hyperalgesia was -0.76 (P = 0.001), compared with 0.19 (P = 0.47) for the subgroup that did not have hyperalgesia. The treatment-by-phenotype interaction, which tests whether subgroups have statistically different treatment responses, was significant (P = 0.0067). The delta for the subgroup with allodynia was -0.31 (P = 0.22), compared with -0.30 (P = 0.22) for the subgroup that did not have allodynia (treatment-by-phenotype interaction P = 0.98). These data suggest that hyperalgesia, but not allodynia, predicts response to pregabalin in patients with chronic post-traumatic neuropathic pain. This study extends the growing data supporting the utility of induced-pain phenotypes to predict response to analgesics in post-traumatic neuropathic pain. Sensory phenotyping in large, multisite trials through the use of a structured clinical exam has the potential to accelerate the development of new analgesics and improve the generalizability of clinical trial results.

Evaluation of the postoperative morphine-sparing effect of oral premedicants used as pre-emptive analgesics in breast-conserving cancer surgeries: A randomised placebo-controlled trial.

Background and Aims:Breast cancer surgeries are associated with both nociceptive and neuropathic pain, requiring strong analgesics. We aimed to evaluate the postoperative morphine-sparing effect of pre-emptive oral premedication with tramadol versus pregabalin in patients undergoing breast-conserving cancer surgeries (BCCS).Methods:This prospective, randomised, placebo-controlled trial was carried out at tertiary care centre on 90 patients undergoing BCCS randomised into three groups of 30 each. Group C received placebo, Group T received tramadol 100 mg and Group P received pregabalin 75 mg as oral premedication, 1 hour before surgery. General anaesthesia was administered. Postoperatively morphine 1 mg.h-1 through intravenous PCA was started at a visual analogue scale score ≥4. Total morphine consumption in 24 hours was calculated and its sparing effect was evaluated as the primary outcome.Results:The median with interquartile range (IQR) of total postoperative morphine consumed in 24 hours, was found to be 22 mg (IQR 0-25.77), 15 mg (IQR 0-16) and 17.50 mg (IQR 0-19.25) in groups C, T, P respectively, (P = 0.000, 0.003, 0.060). The median duration of analgesia in group C was 5.40 hours (IQR 3.30-11.40), 11.6 hours (IQR 9.30-24.0) in group T and 8.60 hours (IQR 6.97-16.27) in group P (P value C/T = 0.000, C/P = 0.007, T/P = 0.002). The postoperative side effects were comparable.Conclusion:Oral tramadol 100 mg and oral pregabalin 75 mg as premedication reduced the 24 hours postoperative morphine requirement as compared to placebo in BCCS. However, tramadol 100 mg provided superior analgesia for longer duration than pregabalin 75 mg and was associated with more side effects.

Impact of concurrent gabapentin or pregabalin with high-dose melphalan in patients with multiple myeloma undergoing autologous hematopoietic stem cell transplant.

Melphalan is an alkylating agent used in both autologous (ASCT) and allogeneic stem cell transplantation. It is a substrate of L-type amino acid transporter-1 (LAT-1) and LAT-2, which are involved in its tissue penetration and elimination. Gabapentin and pregabalin, common concomitant medications in patients with multiple myeloma undergoing ASCT, are also substrates of LAT transporters, raising concern for potential competitive inhibition of melphalan transport. We evaluated whether concurrent use of gabapentin or pregabalin in patients receiving high-dose melphalan (≥140mg/m2 ) prior to ASCT impacted frequency and severity of melphalan-related adverse events. We aimed to determine if concurrent administration of gabapentin or pregabalin and melphalan increased melphalan toxicity. This was a single-center, retrospective evaluation including patients ≥18years of age who received high-dose melphalan as part of a conditioning regimen at the Winship Cancer Institute of Emory University between August 1, 2010 and April 1, 2020 and were followed through their transplant admission. After identification and inclusion of patients who received melphalan in combination with gabapentin or pregabalin, patient matching based on age (±5years), sex, and melphalan dose (140mg/m2 or 200mg/m2 ) was utilized to generate a comparable cohort of patients who received melphalan alone. The primary outcome was hospital length of stay (LOS); secondary outcomes included supportive care requirements between days +4 and day +14 and time to neutrophil and platelet-20 engraftment. Among 176 patients evaluated in each group, median hospital LOS was 16days, median time to neutrophil engraftment was 14days, and median time to platelet-20 engraftment was 16days in both groups. In addition, there were no significant differences in supportive care requirements between groups. In this study, use of gabapentin or pregabalin in combination with melphalan did not impact safety of the conditioning regimen in patients undergoing ASCT.

Применение прегабалина для лечения периферической и центральной нейропатической боли у взрослых (научный обзор)

Предпосылки. Прегабалин является габапентиноидом нового поколения с улучшенными фармакологическими свойствами. Нейропатическая боль — актуальная проблема современной медицины, в отдельных случаях трудно поддающаяся лечению. В связи с этим цель настоящего обзора сводится к оценке эффективности прегабалина при лечении периферической и центральной нейропатической боли в клинических исследованиях высокого уровня. Материалы и методы. В настоящий обзор были включены рандомизированные контролируемые исследования (РКИ) с двойным слепым дизайном и их метаанализы. Результаты. В выполненных исследованиях была подтверждена обезболивающая активность прегабалина у пациентов с нейропатической болью: при болевой диабетической нейропатии (9 РКИ), постгерпетической невралгии (4 РКИ), центральной нейропатической боли вследствие повреждения спинного мозга (3 РКИ), посттравматической периферической нейропатической боли, включая хроническую послеоперационную боль (2 РКИ), нейропатической боли при раке (2 РКИ). Требует дальнейшего уточнения эффективность препарата при центральной нейропатической боли вследствие повреждения головного мозга и хронической боли в нижней части спины (в обоих случаях по 2 РКИ с результатами «есть эффект/нет эффекта»). Дополнительно у пациентов с нейропатической болью прегабалин уменьшал нарушение сна, улучшал общее состояние и качество жизни. Кроме того, уменьшалась выраженность аллодинии при постгерпетической невралгии, тревоги при центральной нейропатической боли, снижалась потребность в морфине при нейропатической боли вследствие рака и выраженность обусловленных им запоров, усиливались эффекты нестероидных противовоспалительных средств при хронической боли в нижней части спины. Эффективность прегабалина у пожилых пациентов была сравнима с таковой у более молодых пациентов. Прегабалин назначают в дозе 75 мг/день в 1 прием или в дозе 150 мг/день в 2 приема. Затем дозу постепенно увеличивают до 300–600 мг/день таким образом, чтобы соотношение эффективность/безопасность было оптимальным. Обезболивающий эффект начинает появляться в первую неделю терапии, в зависимости от выбранного дозового режима и тяжести патологии. Побочные эффекты при лечении прегабалином носят легкий и умеренный характер, часто самостоятельно исчезают по ходу лечения. Наиболее частыми побочными эффектами были головокружение (прегабалин — 26,3 %, плацебо — 9 %), сонливость (16,8 и 7 % соответственно) и периферические отеки (8,9 и 0,4 % соответственно). Несмотря на то что частота побочных эффектов для прегабалина превышала таковую для плацебо и в ряде случаев приводила к прекращению приема препарата, авторы исследований сообщают о хорошей переносимости прегабалина. Выводы. Результаты исследований высокого уровня подтверждают эффективность прегабалина в лечении пациентов с периферической и центральной нейропатической болью. Для препарата была характерна хорошая переносимость.

Prevalence of pregabalin prescribing trends from various outpatient department: A prospective observational study from a tertiary care teaching hospital at South India

Background: We assessed utilization patterns, profile of diagnoses, and fixed dose combination (FDC) with pregabalin in patients with various indications. Aims and Objectives: The aim of the study was to estimate the prevalence of pregabalin prescribing pattern among the patients attending the various outpatient departments (OPDs) of a tertiary care hospital at Trichy in South India. Materials and Methods: A hospital-based prospective observational study was planned and conducted over a period of 12 months. Patients who attended the various OPDs were included in the study. Prescriptions were collected from the respective consulting departments and pharmacy. Results: A total of 2490 patients prescription were analyzed. There was female preponderance (54.22%). Majority (45.74%) were in the age group of 51–64 years. General medicine was the highest (41.36%) visited patients. Neuropathic pain was the most prevalent disease condition among the various age group (57.67%), and predominant between 40 and 65 years (55.86%). Total of 12,220 drugs were prescribed, most frequently prescribed drugs belong to category of plain pregabalin 75 mg (53.37%) with female predominance, with maximum prescription from the medicine department (40%). Among the FDC, pregabalin 75 mg with nortriptyline 10 mg was the highest prescribed drug by the orthopedic department (41%). Extended release pregabalin 75 mg (13.04%) and low dose pregabalin 50 mg (2.19%) were also prescribed in our study. Conclusion: The prevalence of pregabalin prescription was maximum to neuropathic pain followed by radicular pain, trigeminal neuralgia, claudication, and herpetic neuralgia. Plain pregabalin 75 mg is preferred by most of the departments, few preferred extended release of 75 mg. Among the various FDC, pregabalin 75 mg with nortriptyline 10 mg and with methylcobalamine 750 mcg were prescribed by many departments.

Effectiveness of pregabalin treatment for trigger points in patients with comorbid myofascial pain syndrome and fibromyalgia syndrome: a randomized controlled trialIntroduction

Aim of the study Myofascial pain syndrome (MPS) is a common problem in the general population. MPS should not be a local/peripheral painful syndrome and considered to be a syndrome of central sensitivity. We aimed to investigate the effect of pregabalin in patients with MPS in this study. Materials and methods We randomized 40 patients into two groups, and 17 patients per group completed the study. Female patients in group I received pregabalin and exercise therapy, whereas those in group II received exercise therapy alone. All patients were evaluated as follows: for pain by visual analog scale (VAS); trigger-point pressure pain threshold-(PPT) by algometry; neuropathic pain using the Douleur Neuropathique en 4 Questions (DN4) and quality of life with the Short Form-36 (SF36). Evaluations were performed pre-treatment and at the end of the first and third months of treatment. Clinical trial ID: NCT04600037, retrospectively registered 20/10/2020. Results In group I, significant improvements were observed in VAS, trigger-point-PPT, physical component summary-SF-36, at the first and third months. In group II, statistically significant improvements were observed in VAS, trigger-point-PPT after the first and third months. Group I showed statistically better improvements in VAS, trigger points-PPT, physical component summary-SF36 compared with group II by the third month. Conclusion Pregabalin treatment is effective for controlling trigger points. Pregabalin treatment is also more effective than exercise treatment at improving quality of life in patients with MPS.

Cost-Effectiveness of Mirogabalin for the Treatment of Diabetic Peripheral Neuropathic Pain in Taiwan

ObjectivesTo assess the cost-effectiveness of 30 mg of mirogabalin versus no treatment or 300 mg of pregabalin in patients with diabetic peripheral neuropathic pain (DPNP) from a third-party perspective in Taiwan. MethodsA Markov model, developed with cycles of 2-week and a 1-year timeframes, consisted of 3 health states: mild, moderate, and severe pain. Average daily pain score (ADPS) was assessed at the end of each 2-week cycle. All patients entered the model in moderate (4 ≤ ADPS < 7) or severe (7 ≤ ADPS ≤ 10) pain health states. At the end of each cycle, patients remained in their assigned health state or transitioned to a different health state according to their pain score change. Efficacy data were informed by the pivotal phase III clinical trial (J303, NCT02318706) or by a network meta-analysis. Utility values were obtained from published literature, and resource use and cost data from Taiwanese clinical experts and Taiwan National Health Insurance Administration. One-way sensitivity, scenario, and probabilistic analyses were conducted to test the robustness of the results. ResultsA head-to-head analysis demonstrated that 30 mg of mirogabalin is a cost-effective treatment option versus placebo for DPNP. The base-case deterministic analysis estimated quality-adjusted life years (QALY) gains of 0.02 at an incremental cost of 9697 New Taiwan dollars (NT$) (equal to $323) versus placebo (incremental cost-effectiveness ratio [ICER]: 489 310 NT$/QALY [$15 860/QALY]). Mirogabalin was also cost-effective compared with 300 mg of pregabalin (ICER: 18 476 NT$/QALY [$600/QALY]). Sensitivity and scenario analyses results confirmed the robustness. ConclusionEconomic analysis suggests that mirogabalin 30 mg, a potent and selective α2δ ligand, is a cost-effective treatment option for DPNP in Taiwan, with an ICER below the willingness-to-pay threshold.

Comparative study of safety and efficacy of pregabalin, gabapentin and amitriptyline in management of neuropathic pain

Background: Neuropathic pain has a significant negative impact on the patients’ quality of life. Now a day’s anticonvulsants and antidepressants drugs are often used as first-line drugs for the treatment of neuropathic pain. The present study aims to evaluate the safety and efficacy of gabapentin, amitriptyline, and pregabalin in patients of severe neuropathic pain not controlled by simple analgesics.Methods: A total of 360 patients diagnosed with cases of chronic lumbar radiculopathy based on symptoms, clinical examination, X-ray, and magnetic resonance imagining (MRI) scan of the lumbosacral spine, were randomized into three groups. Group A patients received pregabalin 75 mg, Group B patients received gabapentin 300 mg, and Group C patients received amitriptyline 10 mg, respectively. Pain intensity was measured at the baseline, after 1 month and after 2 months with the Numeric pain rating scale (NPRS). Adverse drug reaction reported by the patient or observed by the clinician during the study was reported using the adverse drug reaction (ADR) reporting form.Results: At baseline, the mean±SD of NPRS score in Group A was 8.42±1.48, in Group B and Group C were 8.53±1.94 and 8.33±1.26 respectively with an F-value of 0.843 and p value of 0.584, which was not statistically significant. At 1 month, the mean±SD of NPRS score in Group A was 7.23±1.58, in Group B and Group C were 7.43±2.03 and 7.99±2.10 respectively with F-value of 1.58 and p value of 0.085 which was not statistically significant. At 2 months, the mean±SD of NPRS score in Group A was 4.38±2.72, in Group B and Group C were 4.74±2.86 and 6.32±2.31 respectively with F-value of 5.53 and p value of 0.002 which was statistically significant.Conclusions: Pregabalin has the advantages in terms of the NPRS score over gabapentin and amitriptyline. Gabapentin has fewer reported adverse effects and hence better patient compliance on long term use. Amitriptyline is more cost effective than pregabalin which is an important factor to keep in mind while treating patients.

Increasing the dosage of pregabalin in patients with focal epilepsy decreases the frequency of seizures and ameliorates symptoms of anxiety, depression and insomnia.

The effectiveness of the treatment depends on the adequate dosage of medications. In clinical practice, drugs are often used at doses that are too low, which results in suboptimal levels of clinical improvement. The aim of the study was to evaluate the effects of increasing the dose of previously taken pregabalin in a group of patients with focal epilepsy and generalized anxiety disorder (GAD). This open study involved 993 patients (46 ± 14 years old) suffering from epilepsy with focal seizures and concomitant GAD treated with pregabalin add-on therapy. The severity of anxiety was assessed with GAD-7 Scale. The number of epileptic seizures was monitored before and after the increase of the pregabalin dose. On the initial visit, the mean daily dose of pregabalin was 159 ± 82 mg. During the study period (nine months) the mean dose was increased to 327 ± 163 mg. After nine months, based on the intention-to-treat analysis, 27.1% (N = 253) of the subjects experienced seizure resolution, and 57.8% (N = 539) reduction in seizure frequency by at least 50%. At the beginning of the study, despite pregabalin administration, 60.7% of patients were above the diagnostic threshold for GAD diagnosis. The add-on therapy resulted in the improvement of the depressive and anxiety symptoms, and insomnia, greater in those that experienced seizure resolution or reduction in their frequency. (1) Patients with focal epilepsy with concomitant anxiety disorder experience reduction in seizure frequency, improvement of anxiety, depressive symptoms and insomnia using PGB as an add-on therapy. (2) Our data suggest that pregabalin as an add-on treatment is a reasonable choice for patients with focal epilepsy who have concomitant symptoms of an anxiety disorder.

PMU21 Cost-Effectiveness of Lidocaine 5% Medicated Plaster Compared with Pregabalin for the Treatment of Postherpetic Neuralgia (PHN) and Diabetic Neuropathy (DNP) in Colombia

To assess the cost-effectiveness of the lidocaine 5% medicated_plaster compared with pregabalin for the treatment of PHN and DNP from the Colombian General Social Security Health System (GSSHS) perspective. Based on the results of a head-to-head trial [Baron_2009] comparing the lidocaine plaster and pregabalin in patients with PHN or DNP a Markov model [Dakin_2007] was constructed, from the perspective of the Columbian health care system (GSSHS). The model assesses the use of lidocaine_plaster monotherapy as first line treatment vs pregabalin over a 12-month time horizon. The model estimates treatments costs and utilities according to the pain relief status and presence of adverse events (AE) through the initial 30-day run-in period and maintenance therapy. Patients without ≥30% reduction in NRS-3 scale added a second analgesic drug. If despite the combined scheme, patients were still without adequate pain relief or dropped out due to AE they switched to another analgesic option. 2020 Drug Price Information System was used for drug costs and the SOAT 2020 tariff catalog for procedures. The mean total therapy cost per patient with PHN or DPN treated with the lidocaine_plaster was USD$1,193, and USD$1,181 respectively compared with USD$1,195 and $936 for pregabalin. Treatment with the lidocaine_plaster was related to greater numbers of QALYs (0.895 in PHN and 0.898 in DPN) than with pregabalin (0.798 and 0.831 QALYs respectively). The lidocaine_plaster dominated pregabalin in the treatment of patients with PHN, being less costly and more effective. In DPN the lidocaine_plaster costs USD$3,673 per QALY gained relative to pregabalin. Probabilistic sensitivity analysis indicated that the findings are robust. According to our model calculation the 5% lidocaine medicated plaster is cost saving as first line treatment option in PHN and a highly cost-effective for the management of patients with DPN in Colombia compared with pregabalin form the Colombian GSSHS perspective.

A 3-way Cross-over Study of Pregabalin, Placebo, and the Histamine 3 Receptor Inverse Agonist AZD5213 in Combination With Pregabalin in Patients With Painful Diabetic Neuropathy and Good Pain-reporting Ability.

In this study, patients with painful diabetic neuropathy were trained using an experimental pain paradigm in an attempt to enroll a subset of patients who are "pain connoisseurs" and therefore more able to discriminate between active and placebo treatments. AZD5213, a novel histamine H3 receptor inverse agonist+pregabalin, pregabalin, and placebo were then tested in a 3-period cross-over. The study did not provide any evidence of clinical efficacy for AZD5213 when combined with pregabalin in the treatment of painful diabetic neuropathy. The training of study patients in pain reporting and subsequent enrichment with good pain reporters also did not enable the robust detection of the efficacy of pregabalin relative to placebo in a small sample size. Further work is required before recommending the use of "connoisseur" patients in future neuropathic pain studies.

Healthcare expenditure and its predictors in a cohort of Australians living with sciatica.

To estimate the healthcare resource utilisation of an Australian cohort of people with sciatica and explore individual-level factors associated with expenditure. Healthcare utilisation (services and medication) data from a randomised, double-blind, placebo-controlled trial of pregabalin in patients with sciatica (n = 185) were analysed to estimate healthcare expenditure of participants over 12months. Associations between key baseline socio-economic, pain and quality of life characteristics and healthcare expenditure were examined using generalised linear imputation models. On average, participants accessed AUD$1,134 of healthcare over the year, predominantly made up of $114 of medication and $914 of health services, which included $418 of physiotherapy services. Participants randomised to receive pregabalin incurred higher expenditure ($1,263 compared to $1,001 for placebo), which was largely driven by pregabalin ($158) and greater health services ($107). Healthcare expenditure was significantly higher for participants prescribed pregabalin, earning greater than $1,700 per week ($88,400 per year) and reporting poorer quality of life (physical and mental). Our results suggest inefficiency in the use of healthcare resources due to increased healthcare resource utilisation in people with sciatica treated with pregabalin, compared to placebo. Costs of treating sciatica varied based on individual quality of life and socio-economic characteristics.