Intradural lipomas not associated with spinal dysraphism are rare tumors of the spinal canal. The clinical course of most of the patients with intradural lipoma is slowly progressive with increasing leg weakness and gait disturbance during the first 5 years of life or early adulthood. Since neurologic deficits usually occur very slowly and insidiously, symptoms are present over 2 years in the majority of patients before a diagnosis is made. In view of such a clinical course, a huge intradural lipoma presenting with no neurological deficits in an adult is a very rare case. We present our recent experience with a case of a huge intradural lipoma of the cervical cord without any association with spinal dysraphism and other anomalies of the spine in a neurologically intact adult patient. A review of the literature is also discussed.
Adult ; Diagnosis ; Gait ; Humans ; Leg ; Lipoma* ; Neurologic Manifestations ; Spinal Canal ; Spinal Dysraphism ; Spine

Two separate studies were conducted to establish bioequivalence (BE) for two doses of atorvastatin/metformin sustained-release (SR) fixed dose combination (FDC) versus the same dosage of the individual component (IC) tablets in healthy male subjects under fed conditions (study 1, BE of atorvastatin/metformin SR 20/500 mg FDC; study 2, BE of atorvastatin/metformin SR 20/750 mg FDC). Each study was a randomized, open-label, single oral dose, two-way crossover design. Serial blood samples were collected pre-dose and up to 36 hours post-dose for atorvastatin and 24 hours for metformin. Plasma concentrations of atorvastatin, 2-OH atorvastatin and metformin were analyzed using a validated liquid chromatography tandem mass-spectrometry. A non-compartmental analysis was used to calculate pharmacokinetic (PK) variables and analysis of variance was performed on the lognormal-transformed PK variables. A total of 75 subjects completed the study 1 (36 subjects) and study 2 (39 subjects). The 90% confidence intervals for the adjusted geometric mean ratio of Cmax and the AUC0-t were within the predefined 0.80 to 1.25 range. The number of subjects reporting at least one adverse event following FDC treatments was comparable to that following IC treatments. The two treatments were well tolerated. Therefore, atorvastatin/metformin SR 20/500 mg and 20/750 mg FDC tablets are expected to be used as alternatives to IC tablets to decrease the pill burden and increase patient compliance.
Atorvastatin Calcium* ; Chromatography, Liquid ; Cross-Over Studies* ; Humans ; Male* ; Metformin* ; Patient Compliance ; Pharmacokinetics* ; Plasma ; Tablets* ; Therapeutic Equivalency

BACKGROUND: Complete sequencing, except for intron 1, of the ABO allele in some populations has been reported. However, so far, one report on complete sequencing of the ABO gene in three Korean families with normal ABO phenotypes has been published. This study aimed to establish a reference database of common ABO alleles in Koreans. METHODS: Screening of common ABO alleles, including homozygote form, was performed by direct sequencing of exons 6 and 7 and by real-time PCR using displacing probes in 95 healthy donors. Genomic DNA from the common ABO group (n=8) and some ABO subgroups (n=7) was used in complete sequencing (except for intron 1) of the ABO allele. RESULTS: The sequences of B101/B101 (n=1), O01/O01 (n=1) were identical with the corresponding sequences registered in Genebank. A102 and A105 had a common point mutation, 1142 C>T in intron 4. A102 (n=3/11) and O02 (n=3/3), selected by sequencing of exons 6 and 7, were reclassified into A105 and O65 by whole genomic sequencing, respectively. Analytic results for ABO subgroups were as follows: B3, B101/O01 (n=3) and B101/O02 (n=1); A1B3, A102/B101 (n=1) and A105/B101 (n=1); Ax, A102/O01 (n=1). CONCLUSION: We established a reference database of common ABO alleles in Koreans and found that the molecular basis of introns of ABO alleles in the Korean population differs from that reported in previous studies of other populations.
Alleles ; DNA ; Exons ; Homozygote ; Humans ; Introns ; Mass Screening ; Phenotype ; Point Mutation ; Real-Time Polymerase Chain Reaction ; Tissue Donors

Proton-pump inhibitors (PPIs) are effectively used to treat acid-related diseases, including gastroesophageal reflux disease (GERD); however, many unmet medical needs still exist. As a new treatment option, potassium-competitive acid blockers (P-CABs), such as tegoprazan, have been developed. This study was performed to compare the pharmacokinetics (PKs) between two formulations (test and reference drugs) of tegoprazan 100 mg tablets. A randomized, single oral dose, two-treatment, two-period, two-sequence study was conducted with 12 healthy subjects. Each subject received the test drug or reference drug in the first period and the alternative treatment in the second period. For PK evaluation, blood samples were collected up to 48 hours post-dose in each period. The plasma concentrations of tegoprazan and its active metabolite (M1) were measured by liquid chromatography-tandem mass spectrometry. PK parameters, including maximum plasma concentration (C(max)) and area under the concentration-time curve from zero to the last measurable time (AUC(last)), were estimated using a non-compartmental method. The plasma concentration-time profiles of the two formulations were comparable. The geometric mean ratios [90% confidence intervals (CIs)] of the test drug to the reference drug for C(max) and AUC(last) were 0.98 (0.85–1.12) and 1.03 (0.93–1.13), respectively. The corresponding values of M1 were 0.99 (0.89–1.11) and 1.01 (0.93–1.09), respectively. The two formulations of tegoprazan exhibited comparable PK profiles, fulfilling the regulatory criteria for bioequivalence.
Gastroesophageal Reflux ; Healthy Volunteers ; Humans ; Male ; Mass Spectrometry ; Methods ; Pharmacokinetics ; Plasma ; Tablets ; Therapeutic Equivalency

Background/Aims: Tegoprazan, a novel potassium-competitive acid blocker, is expected to overcome the limitations of proton pump inhibitors and effectively control nocturnal acid breakthrough. To evaluate the pharmacodynamics of tegoprazan versus dexlansoprazole regarding nocturnal acid breakthrough in healthy subjects. Methods: In a randomized, open-label, single-dose, balanced incomplete block crossover study, 24 healthy male volunteers were enrolled and randomized to receive oral tegoprazan (50, 100, or 200 mg) or dexlansoprazole (60 mg) during each of two administration periods, separated by a 7- to 10-day washout period. Blood samples were collected for pharmacokinetic parameter analysis; gastric monitoring was performed for pharmacodynamic parameter evaluation. Results: All 24 subjects completed the study. Average maximum plasma concentration, area under the plasma concentration–time curve, and mean time with gastric pH >4 and pH >6 for tegoprazan demonstrated dose-dependent incremental increases. All the tegoprazan groups reached mean pH ≥4 within 2 hours, whereas the dexlansoprazole group required 7 hours after drug administration. Based on pharmacodynamic parameters up to 12 hours after evening dosing, 50, 100, and 200 mg of tegoprazan presented a stronger acid-suppressive effect than 60 mg of dexlansoprazole. Moreover, the dexlansoprazole group presented a comparable acid-suppressive effect with the tegoprazan groups 12 hours after dosing. Conclusions All the tegoprazan groups demonstrated a significantly faster onset of gastric pH increase and longer holding times above pH >4 and pH >6 up to 12 hours after evening dosing than the dexlansoprazole group.

Background/Aims: Patients with gastroesophageal reflux disease (GERD) frequently experience nighttime heartburn and sleep disturbance. Tegoprazan is a new potassium-competitive acid blocker that can rapidly block acid secretion. This study aims to evaluate the efficacy of tegoprazan compared with esomeprazole in relieving nighttime heartburn and sleep disturbances. Methods: Patients with erosive esophagitis, nighttime heartburn, and sleep disturbances were randomized to receive tegoprazan 50 mg or esomeprazole 40 mg for 2 weeks. The primary endpoint was time to first nighttime heartburn-free interval. The percentage of nighttime heartburn-free days was also compared between the 2 groups. Results: A total of 46 patients were enrolled in this study. Time to the first nighttime heartburn-free interval was shorter with tegoprazan than with esomeprazole but the difference was not statistically significant (1.5 days vs 3 days, P = 0.151). The percentage of nighttime heartburn-free days was higher in the tegoprazan group but the difference was insignificant (57.8% vs 43.1%, P = 0.107). Adverse events occurred in 2 patients. They were mild in severity. Conclusions Tegoprazan may induce faster relief of nighttime heartburn symptoms and may improve sleep disorders associated with nighttime heartburn. Further large-scale studies are required to validate our findings.

Tegoprazan is a novel potassium-competitive acid blocker that treats gastric acid-related diseases. Clarithromycin was widely used as one of various regimens for eradicating Helicobacter pylori. This study compared the pharmacokinetic and safety profile of tegoprazan and clarithromycin between combination therapy and monotherapy to evaluate the potential drug-drug interaction. An open-label, randomized, 6-sequence, 3-period crossover study was conducted in 24 healthy subjects. According to the assigned sequence, the subject was administered the assigned treatment during 5 days in each period. PK parameters of tegoprazan and clarithromycin administered in combination were compared with those of the respective monotherapies. The co-administration of tegoprazan with clarithromycin increased maximum steady-state plasma concentration (C ss,max ) and area under the plasma concentration-time curve in dosing interval at steady-state (AUC ss,tau ) of tegoprazan (1.6-fold in C ss,max and 2.5-fold in AUC ss,tau ) and M1 (2.0-fold in C ss,max , 2.5-fold in AUC ss,tau ) than tegoprazan alone. The C ss,max and AUC sss,tau of 14-hydroxyclarithromycin increased 1.8- and 2.0-fold in co-administration, respectively. The AUC ss.tau of clarithromycin was slightly increased in co-administration, but C ss,max was not changed. Combination of tegoprazan and clarithromycin and those of the respective monotherapies were tolerated in 24 healthy subjects. There may exist drug interaction that lead to reciprocal increase in plasma drug concentrations when tegoprazan and clarithromycin were administrated in combination and no safety concerns were raised. It is suggested that an in-depth analysis of the concentrationresponse relationship is necessary to determine whether these concentration changes warrant clinical action.

BACKGROUND/AIMS: This randomized, double-blind, phase III, multicenter trial was carried out to compare the efficacy and safety of revaprazan, a novel acid pump antagonist, with that of omeprazole in patients with more than one of gastric ulcers. METHODS: Two hundred and ninety two subjects were randomized to 4~8 weeks of treatment with either revaprazan 200 mg or omeprazole 20 mg. The primary efficacy parameter was the cumulative healing rate determined by endoscopy after 4 and 8 weeks of treatment, and the secondary efficacy parameter was an improvement rate of pain. RESULTS: The intention-to-treat analysis revealed revaprazan and omeprazole to have similar cumulative healing rates (93.0% and 89.6%, respectively; p=0.3038). The per-protocol analysis revealed revaprazan and omeprazole to also have similar cumulative healing rates (99.1% and 100%, respectively; p= 0.3229). In both analyses, there were no significant differences in an improvement rate of pain between the two groups. Both drugs were well tolerated. CONCLUSIONS: Revaprazan has similar efficacy to omeprazole in the treatment of patients with gastric ulcer with a once a day application of revaprazan 200 mg or omeprazole 20 mg over a 4 to 8-week period. In terms of safety, revaprazan was well tolerated.
Endoscopy ; Humans ; Omeprazole ; Stomach Ulcer*

BACKGROUND/AIMS: To assess the comparative efficacy and safety of revaprazan, a novel acid pump antagonist, versus omeprazole in patients with duodenal ulcer, we performed a randomized, double-blind, phase III, multicenter trial. METHODS: Two hundred and twenty eight patients were randomized to 4 weeks of treatment with either revaprazan 200 mg or omeprazole 20 mg once daily. Primary efficacy parameter was complete ulcer healing by endoscopy, and secondary parameter was the improvement in the severity of daytime and nighttime pain. RESULTS: Healing rates at 4 weeks (intention-to-treat analysis) were 91.7% with revaprazan 200 mg and 91.3% with omeprazole 20 mg; there were no significant differences between two groups (p=0.9228). In per-protocol analysis, healing rates of revaprazan 200 mg and omeprazole 20 mg were 94.4% and 92.3%, respectively. There was no significant difference in healing rate between two groups (p=0.5666). There was no significant difference between two groups in improvement rates of daytime and nighttime pain. Both drugs were well tolerated. CONCLUSIONS: Revaprazan 200 mg was equivalent to omeprazole 20 mg for both ulcer healing and symptom relief, and was well tolerated in patients with duodenal ulcer.
Duodenal Ulcer* ; Endoscopy ; Humans ; Omeprazole ; Ulcer

BACKGROUND/AIMS: We performed a randomized, double-blind, phase III, multicenter trial to assess the comparative efficacy and safety of revaprazan, which is a novel acid pump antagonist in comparison with ranitidine for treating patients suffering with acute gastritis and acute aggravation of chronic gastritis. METHODS: Five hundred and twelve subjects were randomized to 2 weeks of treatment with either revaprazan 200 mg q.d. or ranitidine 150 mg b.i.d. The primary efficacy parameter was the estimated improvement rate according to endoscopy, and the secondary efficacy parameter was the improvement rate for the subjects' symptoms. RESULTS: The estimated improvement rates at 2 weeks (intention-to-treat analysis) were 79.9% with revaprazan and 60.5% with ranitidine; a significant difference was found between the two groups (p<0.0001). On the per-protocol analysis, the estimated improvement rates for revaprazan and ranitidine were 79.4% and 60.2%, respectively. There was a significant difference in the estimated improvement rates between the two groups (p<0.0001). On both analyses, there were no significant differences between the two groups for the improvement rates of the subjects' symptoms. Both drugs were well tolerated. CONCLUSIONS: The efficacy of revaprazan was higher than that of ranitidine for the estimated improvement rate according to endoscopy and also for the symptomatological improvement rate, and revaprazan was well tolerated by the subjects suffering with gastritis.
Endoscopy ; Gastritis* ; Humans ; Ranitidine