• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• v.24 no.4
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• pp.207-212
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• 2013

Objectives : We investigated the long-term tolerability of escitalopram in Korean adolescents. Methods : The subjects were 37 adolescents, who had been diagnosed with depressive disorder in accordance to DSM-IV. Clinical effectiveness was assessed by Clinical Global Impression-Improvement (CGI-I) scale at the final follow-up visit. Tolerability was assessed through a medical record of the reason for discontinuation of escitalopram and documented adverse events. Results : The mean duration of treatment was $78.1{\pm}89.5$ days, and the mean dosage was $10.0{\pm}4.4$mg/day. Out of the total 37 patients, two (5%) patients sustained use of escitalopram. Twelve patients (32.4%) discontinued use of escitalopram due to target symptom remission, and 23 patients (61.9%) due to insufficient efficacy. Six patients (16.2%) had at least one documented adverse event. However, no suicidal ideation or self-injurious behavior was reported. Significant differences in clinical symptom improvement efficacy were seen between the patients who were receiving escitalopram for less than 8 weeks (4.3%, 1/13) and those for more than 8 weeks (92.9%, 13/14). There was no significant difference between the tolerability of monotherapy compared to the concomitant use group. Conclusion : The results of this study suggest that long-term use of escitalopram may result in superior efficacy than shortterm use, and is tolerable in Korean adolescents with depression.

• Korean Journal of Biological Psychiatry
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• v.3 no.1
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• pp.102-108
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• 1996

This was an open trial to evaluate the efficacy and safety of moclobemide twice daily for treatment of Korean patients with major depressive disorder(DSM-III-R). The duration of the trial was 6 weeks with the initial dose of moclobemide being fixed lor the first two weeks at 300mg/day(150mg twice daily, each token after morning and evening meals). Thereafter, when necessary, the dose was allowed to increase to 600mg/day or decrease to 150mg/day according to the seventy of the depression and/or the tolerability of the drug. Hypnotics and/or sedatives from a benzodiazepine group could be concomitantly administered at usual dosage. Patients were assessed at baseline and at days 14, 28 and 42. Efficacy was primarily judged on the Hamilton Rating Scale for Depression(HAM-D) and Beck Depression Inventory(BDI). Patients had to score at least 17 respectively an both scales to enter the trial. Secondary efficacy parameters included Clinical Global Impression(CGI) for severity of illness and improvement. Safety and tolerability were judged on reported adverse events, vital signs and laboratory parameters. In addition, there was a series of questions and assessments for the psychiatrists and patients to complete at the end of the trial Twenty nine patients completing trial were included in the analysis of efficacy : of thirty one patients participating in the safety and tolerability analysis, those who withdraw voluntarily without particular reasons or violated the treatment schedule were not included. The efficacies as determined by HAM-D, BDI or CGI were found to be significant compared to baseline. The number of responders defined as patients with a total score of 10 or less or with a total score of 50% or less of the baseline score on HAM-D and BDI were 17(59%) and 18(62%) respectively. Regarding safety and tolerability, nine patients(29%) reported mild adverse events probably related to moclobemide : of these one patient dropped out because of poor tolerability : however, there were no appreciable changes in blood pressure, pulse rate, body weight or laboratory parameters for all patients over the trial period. Furthermore, the physicians' and patients' opinions at final evaluation showed that moclabemide has a good antidepressant effect as well as a favorable tolerability. In conclusion, a twice-daily dosage schedule with maclobemide is recommendable for the treatment of Korean patients with major depressive disorder since its efficacy and safety were demonstrated in this study.

• Clinical and Experimental Pediatrics
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• v.62 no.7
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• pp.269-273
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• 2019

Purpose: There is limited data on the use of perampanel in children under 12 years of age. We evaluated the efficacy and tolerability of adjunctive perampanel treatment in children under 12 years of age with refractory epilepsy. Methods: This retrospective observational study was performed in Kyungpook National University Hospital from July 2016 to March 2018. A responder was defined as a patient with ${\geq}50%$ reduction in monthly seizure frequency compared with the baseline. Adverse events and discontinuation data were obtained to evaluate tolerability. Results: Twenty-two patients (8 males, 14 females) aged 3.1-11.4 years (mean, $8.0{\pm}2.5years$) were included in this study. After an average of 9.2 months (range, 0.5-19 months) of follow-up, 15 patients (68%) showed a reduction in seizure frequency, including 5 patients (23%) with seizure freedom. The age at epilepsy onset was significantly lower (P=0.048), and the duration of epilepsy was significantly longer (P=0.019) in responders than in nonresponders. Nine patients (41%) experienced adverse events, including somnolence (23%), respiratory depression (9%), violence (4.5%), and seizure aggravation (4.5%). The most serious adverse event was respiratory depression, which required mechanical ventilation in 2 patients (9%). Eight patients (36%) discontinued perampanel due to lack of efficacy or adverse events. Three out of 4 patients (75%) who discontinued perampanel due to adverse events had an underlying medical condition. Conclusion: Perampanel offers a treatment option for refractory epilepsy in children. Adjunctive treatment with perampanel requires special consideration in those with underlying medical conditions to prevent serious adverse events.

• Journal of Gastric Cancer
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• v.19 no.2
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• pp.183-192
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• 2019

Purpose: Due to adverse events, dose reduction or withdrawal of adjuvant chemotherapy is required for some patients. To identify the predictive factors for tolerability to postoperative adjuvant S-1 monotherapy in gastric cancer (GC) patients, we evaluated the predictive values of blood indicators. Materials and Methods: We analyzed 98 patients with pStage II/III GC who underwent postoperative adjuvant S-1 monotherapy. We retrospectively analyzed correlations between 14 parameters obtained from perioperative routine blood tests to assess their influence on the withdrawal of postoperative adjuvant S-1 monotherapy, within 6 months after discontinuation. Results: Postoperative adjuvant chemotherapy was discontinued in 21 patients (21.4%) within 6 months. Univariable analysis revealed that high preoperative albumin-bilirubin (ALBI) scores had the highest odds ratio (OR) for predicting the failure of adjuvant S-1 chemotherapy (OR, 6.47; 95% confidence interval [CI], 2.08-20.1; cutoff value, -2.696). The high ALBI group had a significantly shorter time to failure of postoperative adjuvant S-1monotherapy (hazard ratio, 3.48; 95% CI, 1.69-7.25; P=0.001). Multivariable analysis identified high preoperative ALBI score as an independent prognostic factor for tolerability (OR, 10.3; 95% CI, 2.33-45.8; P=0.002). Conclusions: Preoperative ALBI shows promise as an indicator associated with the tolerability of adjuvant S-1 monotherapy in patients with pStage II/III GC.

• Parasites, Hosts and Diseases
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• v.44 no.3
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• pp.221-228
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• 2006

We conducted a study to compare the safety and tolerability of anti-relapse drugs elubaquine and primaquine against Plasmodium vivax malaria. After standard therapy with chloroquine, 30 mg/kg given over 3 days, 141 patients with P. vivax infection were randomized to receive primaquine or elubaquine. The 2 treatment regimens were primaquine 30 mg once daily for 7 days (group A, n = 71), and elubaquine 25 mg once daily for 7 days (group B, n = 70). All patients cleared parasitemia within 7 days after chloroquine treatment. Among patients treated with primaquine, one patient relapsed on day 26; no relapse occurred with elubaquine treatement. Both drugs were well tolerated. Adverse effects occurred only in patients with G6PD deficiency who were treated with primaquine (group A, n = 4), whose mean hematocrit fell significantly on days 7,8 and 9 (P= 0.015, 0.027, and 0.048, respectively). No significant change in hematocrit was observed in patients with G6PD deficiency who were treated with elubaquine (group B, n = 3) or in patients with normal G6PD. In conclusion, elubaquine, as anti-relapse therapy for P. vivax malaria, was as safe and well tolerated as primaquine and did not cause clinically significant hemolysis.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• v.19 no.3
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• pp.147-155
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• 2008

Objectives: The purpose of this study was to evaluate the efficacy and tolerability of osmotic release oral system-methylphenidate (OROS-MPH) in children with attention-deficit hyperactivity disorder (ADHD) and comorbid psychiatric disorders. Methods: This was an 8-week open label study of OROS-MPH monotherapy. The subjects were 113 children with ADHD aged 6-12 years. Outcome measures were the Korean version of the parent ADHD Rating Scale (K-ARS), Korean version of the Conners Parent Rating Scale (K-CPRS), Clinical Global Impression-Severity and Clinical Global Impression-Improvement. Side effects were monitored using Barkley's Side Effect Rating Scale. We compared the change-over-time in the mean scores of the outcome measure according to the comorbidity of disruptive behavior disorder, depressive disorder, anxiety disorder, and tic disorder. Results: The mean K-ARS and K-CPRS scores were significantly decreased, regardless of the comorbidity. The mean doses of OROS-MPH and dropout rate did not differ significantly according to comorbidity. The OROS-MPH was well tolerated, regardless of the comorbidity. However, children with tic disorder reported a higher frequency of tics or nervous movements between the $2^{nd}\;and\;8^{th}$ week than those without tic disorder. Conclusion: The OROS-MPH is effective for decreasing the symptoms of ADHD, and it is well tolerated, even by patients with comorbid psychiatric disorders.

• Journal of Ginseng Research
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• v.44 no.2
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• pp.229-237
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• 2020

Background: We investigated the tolerability and pharmacokinetic properties of various ginsenosides, including Rb1, Rb2, Rc, Rd, and compound K, after single or multiple administrations of red ginseng extract in human beings. Methods: Red ginseng extract (dried ginseng > 60%) was administered once and repeatedly for 15 days to 15 healthy Korean people. After single and repeated administration of red ginsengextract, blood sample collection, measurement of blood pressure and body temperature, and routine laboratory test were conducted over 48-h test periods. Results: Repeated administration of high-dose red ginseng for 15 days was well tolerated and did not produce significant changes in body temperature or blood pressure. The plasma concentrations of Rb1, Rb2, and Rc were stable and showed similar area under the plasma concentration-time curve (AUC) values after 15 days of repeated administration. Their AUC values after repeated administration of red ginseng extract for 15 days accumulated 4.5- to 6.7-fold compared with single-dose AUC. However, the plasma concentrations of Rd and compound K showed large interindividual variations but correlated well between AUC of Rd and compound K. Compound K did not accumulate after 15 days of repeated administration of red ginseng extract. Conclusion: A good correlation between the AUC values of Rd and compound K might be the result of intestinal biotransformation of Rb1, Rb2, and Rc to Rd and subsequently to compound K, rather than the intestinal permeability of these ginsenosides. A strategy to increase biotransformation or reduce metabolic intersubject variability may increase the plasma concentrations of Rd and compound K.

• Korean Journal of Biological Psychiatry
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• v.6 no.1
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• pp.96-101
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• 1999

Background : Since dysthymia begins in late childhood or adolescence and has a chronic course, long-term pharmacotherapy may be required. New generation antidepressant, moclobemide, with more acceptable side effect profiles, is effective in the treatment of dysthymia. The main objective of this study was to determine whether they exhibit comparable efficacy and tolerability in dysthymia to amitriptyline. Method and Materials : The efficacy and tolerability of the moclobemide and amitriptyline, were compared in a eight-week single-centre double-blind study in patients(n=37) with dysthymia using he HAMD-17, the Clinical Global Impression Scale(CGI), the Montgomery-Asberg Depression Rating Scale (MADRS), Efficacy Index-Therapeutic Index(EITE), 4-point Index Side Effect Scale(4-PISES), and Efficacy Index- Side Effect Scale(EISE). Results : A total of 37 patients entered the study, 19 were randomly assigned to the moclobemide group and 18 to be amitriptyline group. Demo-graphic and illness characteristics were similar in both groups. There were no significant difference between two groups at the total 17-HDRS score, the HAMD-17% improvement, the total MADRS score, CGI response, and the EITE. In the comparison of EISE between two groups, the scores of the moclobemide group were relatively lower than the amitriptylinen group in full treatment. And the differences were significant(moclobemide group $1.39{\pm}0.61$ ; amitriptyline group $2.00{\pm}0.85$, p<.001). At the 4-PISE, There was no serious or treatment threatening side effects. And there was no specific difference in side effects between two groups. The moclobemide group reported higher EIR scores than the amitriptyline group at every follow up day, but the differences were not significant. And, there was no significant differences in the scores of five HRQOL subcategories which is compared between two groups at every follow up days. Conclusions : In terms of 17-HDRS and MADRS, moclobemide and amitriptyline are equally effective at least in allevating dysthymic symptoms. But moclobemide tended to be less troubling and better tolerated than amitriptyline. Therefore, moclobemide treatment can be used as a safe, and higher satisfactory treatment strategy for the dysthymia.

• Korean Journal of Biological Psychiatry
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• v.20 no.1
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• pp.12-20
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• 2013

Objectives We investigated the tolerability, safety, and treatment response to flexible-dose paliperidone ER in patients with non-acute schizophrenia in whom previous antipsychotic drugs were ineffective. Methods This 24-week interim analysis of the 48-week multicenter, prospective, open-label study assessed effectiveness using the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Schizophrenia-Severity (CGI-SCH-S) Scale, Personal and Social Performance (PSP) and Drug Attitude Inventory (DAI). Safety and tolerability were assessed using the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) and Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS). Results Effectiveness was assessed in 169 patients. Significant improvement in the PANSS total score was observed by week-1 and continued until week-24. The response rate was 33%. The CGI-SCH-S and PSP total scores significantly improved during 24 weeks ; however, no change occurred in the total DAI. Fifty-nine percent of patients reported adverse events, of which extrapyramidal symptoms were the most frequent (19.0%). The DIEPSS and LUNSERS scores were improved after 24 week. Conclusions Switching to the flexible-dose paliperidone ER from an ineffective antipsychotic drug was safe, tolerable, and showed a good treatment response in Korean patients with schizophrenia.

• 대한생식의학회:학술대회논문집
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• 1995.12a
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• pp.52-52
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• 1995