• Journal of Korean Foot and Ankle Society
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• v.26 no.4
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• pp.177-182
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• 2022

Purpose: The efficacy and safety of low-dose pregabalin and alpha lipoic acid in diabetic neuropathy were evaluated and analyzed. Materials and Methods: This study designed a retrospective study that included patients with diabetic neuropathic pain. From 2009 to 2022, 100 patients who suffered from diabetic neuropathic pain were included in this study. The patients were divided into group I (pregabalin 150 mg/day with alpha lipoic acid 600 mg/day) and group II (pregabalin 300 mg/day with alpha lipoic acid 600 mg/day). The visual analogue scale (VAS), medication side effects, and neurometer results were compared. Results: The mean follow-up period of the above patients was 120.23 weeks in group I and 149.05 weeks in group II. The average VAS score in group I decreased by 3.23 points, and the average VAS score in group II decreased by 2.86 points. Approximately 24.3% of group I had side effects, such as dizziness, sleepiness, and gastrointestinal trouble, while 76.7% of patients in group II had side effects. Sixtyseven patients had a neurometer examination before and after the medication, and there is no statistical difference between the two groups. Conclusion: The combination of low-dose pregabalin (pregabalin 150 mg/day) and alpha lipoic acid in diabetic neuropathy had a similar clinical effect and less frequent medication side effects than regular dose pregabalin (pregabalin 300 mg/day) and alpha lipoic acid. Therefore, low-dose pregabalin (pregabalin 150 mg/day) and alpha lipoic acid should be considered in treating diabetic neuropathy.

• Journal of Korean Neurosurgical Society
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• v.67 no.2
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• pp.202-208
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• 2024

Objective : Failed back surgery syndrome (FBSS) is a common long-term complication following spine surgeries characterized by chronic persistent pain; different strategies of management were employed to deal with it. This clinical trial aims to compare the efficacy of Pregabalin and Gabapentin in the management of this condition. Methods : A double-blind, randomized, comparative study (clinical trial registry NCT05324761 on 11th April 2022) with two parallel arms with Pregabalin and Gabapentin were used in arms one and two, respectively. Visual analog scale was used for basal and endpoint assessment of pain. T-test and analysis of covariance were used to deal with different variables. A pairwise test was used to compare pairs of means. Results : Of 66 patients referred to the trial, 64 were eligible, with 60 patients completing the 30 days trial. Both pregabalin and gabapentin effectively reduce pain, with significant p-values of 0.001 for each group. However, the pregabalin group was superior to gabapentin in pain reduction (p=0.001). Gender was an insignificant factor (p=0.574 and p=0.445 for the pregabalin and gabapentin groups, respectively, with a non-significant reduction (p=0.393) for both groups in total. Location of stenosis before surgery and type of surgery performed show non-significant effect on pain reduction for both groups. Conclusion : Both pregabalin and gabapentin effectively and safely relieve neuropathic pain associated with FBSS; pregabalin was significantly more effective irrespective of the patients' gender.

• Journal of Yeungnam Medical Science
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• v.35 no.2
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• pp.240-243
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• 2018

Negative myoclonus (NM) is a jerky, shock-like involuntary movement caused by a sudden, brief interruption of muscle contraction. An 80-year-old man presented with multifocal NM and confusion. Two days before the onset of NM, he commenced the intake of pregabalin at a dose of 150 mg/day for neuropathic pain. His NM resolved completely and mental status improved gradually after the administration of lorazepam intravenously and the discontinuation of pregabalin. Our study suggests that pregabalin can cause NM even in patients without a history of seizures.

• The Korean Journal of Pain
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• v.35 no.1
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• pp.59-65
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• 2022

Background: There is still unmet need in treating neuropathic pain and increasing awareness regarding the use of drug combinations to increase the effectiveness of treatment and reduce adverse effects in patients with neuropathic pain. Methods: This study was performed to determine the individual and combined effects of pregabalin, tianeptine, and clopidogrel in a rat model of neuropathic pain. The model was created by ligation of the L5-L6 spinal nerve in male Sprague-Dawley rats; mechanical allodynia was confirmed using von Frey filaments. Drugs were administered to the intrathecal space and mechanical allodynia was assessed; drug interactions were estimated by isobolographic or fixed-dose analyses. Results: Intrathecal pregabalin and tianeptine increased the mechanical withdrawal threshold in a dose-dependent manner, but intrathecal clopidogrel had little effect on the mechanical withdrawal threshold. An additive effect was noted between pregabalin and tianeptine, but not between pregabalin and clopidogrel. Conclusions: These findings suggest that intrathecal coadministration of pregabalin and tianeptine effectively attenuated mechanical allodynia in the rat model of neuropathic pain. Thus, pregabalin plus tianeptine may be a valid option to enhance the efficacy of neuropathic pain treatment.

• The Korean Journal of Pain
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• v.24 no.3
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• pp.131-136
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• 2011

Background: Pregabalin is an anticonvulsant and analgesic agent that interacts selectively with the voltage-sensitive-$Ca^{2+}$-channel alpha-2-delta subunit. The aim of this study was to evaluate whether the analgesic action of intrathecal (IT) pregabalin is associated with KATP channels in the rat formalin test. Methods: IT PE-10 catheters were implanted in male Sprague-Dawley rats (250.300 g) under inhalation anesthesia using enflurane. Nociceptive behavior was defined as the number of hind paw flinches during 60 min after formalin injection. Ten min before formalin injection, IT drug treatments were divided into 3 groups: normal saline (NS) $20\;{\mu}l$ (CON group); pregabalin 0.3, 1, 3 and $10\;{\mu}g$ in NS $10\;{\mu}l$ (PGB group); glibenclamide $100\;{\mu}g$ in DMSO $5\;{\mu}l$ with pregabalin 0.3, 1, 3 and $10\;{\mu}g$ in NS $5\;{\mu}l$ (GBC group). All the drugs were flushed with NS $10\;{\mu}l$. Immunohistochemistry for the $K_{ATP}$ channel was done with a different set of rats divided into naive, NS and PGB groups. Results: IT pregabalin dose-dependently decreased the flinching number only in phase 2 of formalin test. The log dose response curve of the GBC group shifted to the right with respect to that of the PGB group. Immunohistochemistry for the $K_{ATP}$ channel expression on the spinal cord dorsal horn showed no difference among the groups 1 hr after the formalin test. Conclusions: The antinociceptive effect of pregabalin in the rat formalin test was associated with the activation of the $K_{ATP}$ channel. However, pregabalin did not induce $K_{ATP}$ channel expression in the spinal cord dorsal horn.

• Journal of Oral Medicine and Pain
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• v.41 no.1
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• pp.1-6
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• 2016

Purpose: To investigate the efficacy of pregabalin for patients with primary burning mouth syndrome (BMS) who are unresponsive to topical clonazepam therapy. Methods: By searching the clinical electronic records from the Department of Oral Medicine, Pusan National University Dental Hospital from 2012 to 2014, a retrospective analysis was performed on patients with primary BMS who were treated with topical clonazepam therapy during this period. Of the patients who were unresponsive to this therapy, 19 patients who were subsequently treated with pregabalin were included in the study. A pain assessment was performed using the 11-point numerical rating scale at first visit, following topical clonazepam therapy, and again after pregabalin therapy. The treatment outcomes were statistically analyzed using the Wilcoxon signed rank test. Results: Following additional pregabalin administration, the mean pain score was slightly reduced. A total of 7 patients reported a marked response (>50% pain reduction), and 3 patients reported a slight reduction in pain. Pain reduction following pregabalin therapy was statistically significant (p<0.05). Conclusions: Pregabalin has a slight therapeutic effect on patients with primary BMS. Therefore, we recommend pregabalin as an alternative drug for BMS patients who are unresponsive to topical clonazepam therapy.

• The Korean Journal of Pain
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• v.24 no.1
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• pp.22-30
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• 2011

Background: Pregabalin has been shown to have analgesic effect in acute pain models. The primary objective was to examine the efficacy a single dose of pregabalin, would have on morphine consumption following lumbar discectomy. Methods: With ethical approval a randomized, placebo-controlled prospective trial was undertaken in 32 patients (ASA I-II, 18-65 years) with radicular low back pain for > 3 months undergoing elective lumbar discectomy. Patients received either oral pregabalin 300 mg (PG Group) or placebo (C Group) one hour before surgery. Pain intensity, the accumulative morphine consumption and adverse effects were recorded for 24 hours following surgery. Functional, psychological and quantitative sensory testing were also assessed. Results: Fourteen patients out of the 32 recruited were randomized to receive pregabalin. Morphine consumption was reduced (absolute difference of 42.3%) between groups with medium effect size. (Mann-Whitney; U =52.5, z-score= 2.84, P = 0.004, r = 0.14). This was not associated with a significant difference in the incidence of adverse effects between the two groups. The median pain intensity (VAS) on movement was not significantly different between groups. Conclusions: A single pre-operative dose of pregabalin (300 mg) did not result in a reduction in pain intensity compared to placebo in this patient cohort but the significant reduction in morphine consumption suggests that a fixed peri-operative dosing regime warrants investigation.

• Journal of Yeungnam Medical Science
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• v.35 no.1
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• pp.40-44
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• 2018

Background: Pregabalin has been studied as a single or multimodal analgesic drug for postoperative pain management in different types of surgeries. We evaluated the analgesic effect of 150 mg of pregabalin in resolving post-gastrectomy pain. Methods: Forty-four patients were randomized into two groups: a pregabalin group that received oral pregabalin (150 mg) 2 h before anesthetic induction, and a control group that received placebo tablets at the same time. Data on postoperative pain intensity (visual analog scale [VAS], at 30 min, 2 h, 4 h, and 24 h), consumption of fentanyl in patient-controlled analgesia (PCA), and the proportion of patients requiring rescue analgesics at different time intervals (0-2 h, 2-4 h, and 4-24 h) were collected during the 24 h postoperative period. Results: The VAS scores did not show significant differences at any time point and consumption of fentanyl in PCA and the proportion of patients requiring rescue analgesics did not differ between the two groups. The groups did not differ in the occurrence of dizziness, sedation, and dry mouth. Conclusion: A preoperative 150 mg dose of pregabalin exerts no effect on acute pain after gastrectomy.

• Journal of Pharmaceutical Investigation
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• v.41 no.4
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• pp.255-262
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• 2011

Method using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) was developed and validated for the determination of pregabalin in plasma samples. Acquisition was performed by monitoring the transitions: m/z 160.1${\rightarrow}$142.2 for pregabalin and m/z 423.2${\rightarrow}$207.1 for losartan (as an internal standard). After cold acetonitrileinduced protein precipitation of the plasma samples, separation was performed with C18 column by isocratic mobile phase consisted of 10 mM ammonium acetate and acetonitrile (15:85, v/v). Results were linear over the concentration ranged from 0.1 to $10{\mu}g$/mL and the correlation coefficients (r) were $\geq0.99$. Intra- and inter-day precisions were $\leq6.02$ and $\leq11.04%$, respectively, and intra- and inter-day accuracies were 96.60-101.09 and 98.10-102.60%, respectively. This validated method was successfully applied to a bioequivalence study of two formulations of pregabalin, Daewoong pregabalin capsule (Daewoong Pharm. Co., Ltd.) and Lyrica$^{(R)}$ capsule (Pfizer Korea Ltd.) in twenty eight healthy Korean volunteers. The subjects received a single oral dose of each formulation (150 mg as pregabalin) in a randomized $2{\times}2$ crossover study and plasma samples were obtained from each subject at predetermined time intervals. Then, the pharmacokinetic parameters ($AUC_{0-t}$, $C_{max}$ and $T_{max}$) were calculated and statistically analyzed to assess the differences between two formulations. The 90% confidence intervals for the log-transformed data were acceptable range of log 0.8-log 1.25 (e.g., log 1.0048-log 1.0692 for AUC0-t, log 0.9142-log 1.0421 for $C_{max}$). Thus, $AUC_{0-t}$ and $C_{max}$ met the criteria of the Korea Food and Drug Administration (KFDA) for bioequivalence test indicating that Daewoong pregabalin capsule was bioequivalent to Lyrica$^{(R)}$ capsule.

• Journal of Dental Anesthesia and Pain Medicine
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• v.22 no.5
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• pp.377-385
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• 2022

Background: Postoperative endodontic pain is an enigma for the dentist. This study aimed to evaluate the analgesic effect of 300 mg gabapentin or 75 mg pregabalin in reducing postoperative endodontic pain compared with a placebo. Methods: Ninety patients who needed root canal treatment with an initial numerical rating scale (NRS) pain score of > 4 (T0) were randomly divided into three groups (n=30). Patients were then administered either 300 mg gabapentin (group A), 75 mg pregabalin (group B), or a placebo (group C) 30 min prior to the start of endodontic treatment. A single operator performed single-visit endodontics, and pain was evaluated immediately after endodontic treatment (T1) and at 4 h (T2), 8 h (T3), 12 h (T4), 24 h (T5), 48 h (T6), and 72 h (T7) using the NRS. Ibuprofen/paracetamol (400 mg/325 mg) was administered as a rescue dose if needed. Results: Pregabalin performed significantly better when compared with gabapentin at all time points except at 72 h after treatment (P=0.170). The placebo group showed significantly higher pain scores than the other two groups. The percentage of pain relief was maximum for pregabalin (92.1%), followed by gabapentin (87.6%) and placebo (69.1%) at 72 h after treatment completion. Conclusion: This study showed that pretreatment with a single dose of pregabalin and gabapentin both had greater analgesic effects than a placebo. They can be effectively used to reduce postoperative endodontic pain.