Tigecycline is a broad spectrum antibiotic which has been used for complicated intra-abdominal infection and complicated skin and soft tissue infection by multi-drug resistant bacteria. However recent meta-analysis studies have raised a concern for adverse events of tigecycline. We analyzed retrospectively adverse events, associated factors of adverse events in multi-drug resistant bacteria caused infections treated with tigecycline in Korean patients. One hundred-sixty patients treated with tigecycline from July 2009 to September 2013 were enrolled in this study. Their clinical and microbiologic data were reviewed. History of invasive procedure within 7 days and recent operation within 3 months were associated with adverse events. The most common adverse events were nausea and vomiting. Associated factors of nausea were soft tissue injury and recent operation within 3 months. In this study, nausea was the most common adverse event in patients who received tigecycline. Although it is not serious complication, monitoring of adverse events is required to increase compliance.
Bacteria ; Compliance ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Incidence* ; Intraabdominal Infections ; Nausea ; Retrospective Studies ; Skin ; Soft Tissue Infections ; Soft Tissue Injuries ; Vomiting

Hepatitis C virus (HCV) infection in chronic kidney disease (CKD) is associated with increased liver-related morbidity and mortality rates, accelerated progression to end-stage renal disease, and risk of cardiovascular events. CKD patients with HCV infection require antiviral therapy. Pegylated interferon (peg-IFN) plus ribavirin was the standard of care for HCV-infected CKD patients before the introduction of first-generation direct-acting antiviral (DAA) oral anti-HCV agents. Peg-IFN-based treatment has a low virologic response rate and poor compliance, resulting in a high dropout rate. Recently, several clinical trials of all-DAA combination regimens have reported excellent antiviral efficacy and few adverse drug reactions in HCV-infected patients with CKD. These positive results have revolutionized the treatment of chronic HCV infection in this population. In this review, we address the impact of chronic HCV infection in CKD patients, and discuss their management using next-generation DAAs.
Compliance ; Drug-Related Side Effects and Adverse Reactions ; Hepacivirus* ; Hepatitis C* ; Hepatitis* ; Humans ; Interferons ; Kidney Failure, Chronic ; Kidney Transplantation ; Mortality ; Renal Insufficiency, Chronic* ; Ribavirin ; Standard of Care

Successful treatment is very high in patients with first episode schizophrenia (FES). On the other hand, the problem is a frequent relapse often caused by non-compliance. The non-compliance rate in patients with FES is 40–60% within 1 year. The causes of non-compliance are diverse, such as poor insight, drug side effects, attitude of caregiver, social stigma, etc. Clinicians should be able to provide appropriate psychosocial intervention and long acting injectable antipsychotics (LAI) to overcome non-compliance. Recently, there is solid and accumulating evidence demonstrating superiority of LAI over oral medication in terms of reducing relapse or rehospitalization. In particular, a substantial portion (approximately 30–50%) of patients and caregivers prefer LAI to oral medication. Shared decision-making is the process that clinicians and patients/caregiver should go through in order to obtain the full benefits from LAI.
Antipsychotic Agents ; Caregivers ; Compliance ; Decision Making ; Drug-Related Side Effects and Adverse Reactions ; Hand ; Humans ; Recurrence* ; Schizophrenia* ; Social Stigma

Co-administration of tadalafil and tamsulosin HCl in patients with benign prostate hyperplasia and erectile dysfunction is increasing in clinical settings. Development of fixed-dose combination (FDC) of tadalafil and tamsulosin HCl could contribute to improving patients' adherence and treatment efficacy. We evaluated the pharmacokinetics and safety profiles of a newly developed fixed-dose combination capsule of tadalafil 5 mg/tamsulosin HCl 0.4 mg in comparison with co-administration of each formulation in healthy volunteers under fasted and fed conditions. Two randomized, open-label, single-dose, two-way, crossover studies were completed in 29 subjects under fasted condition, and 33 subjects under fed condition. Serial blood sample collection for PK analysis was conducted up to 72 hours after dosing, and PK parameters were calculated using non-compartmental analysis. Geometric mean ratios and 90% confidence intervals of the C(max) and AUC(last) were used to evaluate comparative bioavailability. In both fasted and fed condition studies, the bioequivalence was established. The most common adverse drug reactions were orthostatic hypotension and headache with no statistical difference between treatment groups. All subjects with orthostatic hypotension recovered at follow-up test. Although changes in vital signs from baseline were statistically significant, there were no subjects with systolic blood pressure < 90 mmHg and there were no clinically meaningful signs or symptoms associated. FDC of tadalafil and tamsulosin HCl can be an alternative to co-administration of individual drugs for providing better compliance. Changes in blood pressure should be kept in mind when tadalafil and tamsulosin HCl are co-administered in clinical settings.
Biological Availability ; Blood Pressure ; Compliance ; Cross-Over Studies ; Drug-Related Side Effects and Adverse Reactions ; Erectile Dysfunction ; Follow-Up Studies ; Headache ; Healthy Volunteers* ; Humans ; Hyperplasia ; Hypotension, Orthostatic ; Male ; Pharmacokinetics* ; Prostate ; Tadalafil ; Therapeutic Equivalency ; Treatment Outcome ; Vital Signs

BACKGROUND/AIMS: There are no studies that looked into the bubble eliminating efficacy of polyethylene glycol with ascorbic acid (PEGA), which has been one of the shortcomings of polyethylene glycol (PEG). In this study, we compared newly introduced PEGA regimen by adding either simethicone or 1 L of water. METHODS: A prospective randomized controlled study was carried out at Dongguk Universtiy Gyeongju Hospital from July 2014 to September 2014. A total of 90 patients were randomly assigned to 3 groups; PEGA group (n=30) which served as control, simethicone addition group (n=30) to which simethicone 400 mg was additionally prescribed, and water addition group (n=30) to whom additional 1 L of water was given. Cleansing effectiveness, gas elimination efficacy, side effects, and patient satisfaction were compared between the groups. RESULTS: PEGA group demonstrated the highest cleansing effectiveness, but there was no statistically significant difference among the groups. Simethicone addition group showed significantly lesser amount of bubbles than the other groups (2.57±2.05 vs. 1.10±1.83 vs. 2.60±2.84, p=0.017). The rates of side effects in each group were 20.00% vs. 16.77% vs. 53.33%. Water addition group had significantly more side effects than the PEGA group and the simethicone addition group (p=0.003). The patient satisfaction score of each group was 3.37±0.85 vs. 3.73±0.74 vs. 3.20±0.66 with simethicone addition group showing significantly higher satisfaction than water addition group (p=0.020). CONCLUSIONS: PEGA bowel preparation agent showed satisfactory bowel cleansing despite the decrease in dosage, and addition of simethicone resulted in better bubble elimination.
Adult ; Ascorbic Acid/*chemistry ; Cathartics/adverse effects/chemistry/*pharmacology ; Colon/*drug effects ; Colonoscopy ; Female ; Humans ; Male ; Middle Aged ; Patient Compliance ; Polyethylene Glycols/adverse effects/*chemistry/pharmacology ; Prospective Studies ; Simethicone/*chemistry ; Water/*chemistry

BACKGROUND/AIMS: The aims of this study were to compare the bowel-cleansing efficacy, patient affinity for the preparation solution, and mucosal injury between a split dose of poly-ethylene glycol (SD-PEG) and low-volume PEG plus ascorbic acid (LV-PEG+Asc) in outpatient scheduled colonoscopies. METHODS: Of the 319 patients, 160 were enrolled for SD-PEG, and 159 for LV-PEG+Asc. The bowel-cleansing efficacy was rated according to the Ottawa bowel preparation scale. Patient affinity for the preparation solution was assessed using a questionnaire. All mucosal injuries observed during colonoscopy were biopsied and histopathologically reviewed. RESULTS: There was no significant difference in bowel cleansing between the groups. The LV-PEG+Asc group reported better patient acceptance and preference. There were no significant differences in the incidence or characteristics of the mucosal injuries between the two groups. CONCLUSIONS: Compared with SD-PEG, LV-PEG+Asc exhibited equivalent bowel-cleansing efficacy and resulted in improved patient acceptance and preference. There was no significant difference in mucosal injury between SD-PEG and LV-PEG+Asc. Thus, the LV-PEG+Asc preparation could be used more effectively and easily for routine colonoscopies without risking significant mucosal injury.
Adult ; Ascorbic Acid/administration & dosage/*adverse effects ; Cathartics/administration & dosage/*adverse effects ; Colonoscopy/methods ; Drug Therapy, Combination ; Female ; Humans ; Intestinal Mucosa/drug effects/*injuries ; Male ; Middle Aged ; Patient Compliance ; Patient Satisfaction ; Polyethylene Glycols/administration & dosage/*adverse effects ; Preoperative Care/*adverse effects/methods ; Surveys and Questionnaires ; Vitamins/administration & dosage/adverse effects

BACKGROUND/AIMS: We investigated whether sodium picosulfate with magnesium citrate (SPMC) plus bisacodyl compares favorably with conventional polyethylene glycol (PEG) with respect to bowel cleansing adequacy, compliance, and safety. METHODS: We performed a multicenter, prospective, single-blinded study in outpatients undergoing daytime colonoscopies. Patients were randomized into a split preparation SPMC/bisacodyl group and a conventional split PEG group. We compared preparation adequacy using the Boston bowel preparation scale (BBPS), ease of use using a modified Likert scale (LS), compliance/satisfaction level using a visual analogue scale (VAS), and safety by monitoring adverse events during the colonoscopy between the two groups. RESULTS: A total of 365 patients were evaluated by intention to treat (ITT) analysis, and 319 were evaluated by per protocol (PP) population analysis (153 for SPMC/bisacodyl, 166 for PEG). The mean total BBPS score was not different between the two groups in both the ITT and PP analyses (p>0.05). The mean VAS score for satisfaction and LS score for the ease of use were higher in the SPMC/bisacodyl group (p<0.001). The adverse event rate was lower in the SPMC/bisacodyl group than in the PEG group (p<0.05). CONCLUSIONS: The SPMC/bisacodyl treatment was comparable to conventional PEG with respect to bowel preparation adequacy and superior with respect to compliance, satisfaction, and safety.
Adult ; Aged ; Cathartics/*administration & dosage ; Citrates/*administration & dosage ; Citric Acid/*administration & dosage ; Colon/*drug effects/surgery ; *Colonoscopy ; Drug Combinations ; Drug Therapy, Combination/methods ; Female ; Humans ; Intention to Treat Analysis ; Laxatives/*administration & dosage ; Male ; Middle Aged ; Organometallic Compounds/*administration & dosage ; Patient Compliance ; Patient Satisfaction ; Picolines/*administration & dosage ; Polyethylene Glycols/*administration & dosage ; Preoperative Care/methods/psychology ; Single-Blind Method ; Young Adult

BACKGROUND/AIMS: The aim of this study was to compare polyethylene glycol (PEG) 4 L, split method of PEG 4 L and PEG 2 L plus sodium phosphate (NaP) in the aspect of bowel preparation quality, safety, patients' compliance and preference. METHODS: Total 249 subjects were prospectively enrolled and received bowel preparation for colonoscopy from August to October in 2010; PEG 4 L (93 subjects), split method of 4 L PEG (74 subjects) and PEG 2 L plus NaP 90 mL group (82 subjects). To investigate the completion, preference for bowel preparation and safety, a questionnaire survey was conducted before colonoscopy. RESULTS: There were no significant intergroup differences in the aspect of completion of preparation, cecal intubation time and success rate. Satisfaction and preference were higher in PEG 2 L plus NaP 90 mL and split method of 4 L PEG compared with PEG 4 L. In the aspect of the bowel preparation quality PEG 4 L showed significantly higher quality in the morning colonoscopy (p<0.001). However, in the afternoon colonoscopy PEG 2 L plus NaP 90 mL showed better result than PEG 4 L (p=0.009). Hyperphosphatemia was most frequently observed in PEG 2 L plus NaP 90 mL, but no severe adverse events occurred (p<0.001). CONCLUSIONS: PEG 4 L showed better result than split method of 4 L PEG or PEG 2 L plus NaP 90 mL in the aspect of bowel preparation quality and safety.
Adult ; Aged ; Cathartics/adverse effects/*pharmacology ; Colon/anatomy & histology/*drug effects ; Colonoscopy ; Female ; Humans ; Hyperphosphatemia/etiology ; Male ; Middle Aged ; Patient Compliance ; Phosphates/adverse effects/*pharmacology ; Polyethylene Glycols/adverse effects/*pharmacology ; Prospective Studies ; Questionnaires ; Time Factors

BACKGROUND/AIMS: We assessed changes in hemodynamic and arterial stiffness parameters following reductions of dialysate calcium concentrations in patients undergoing hemodialysis. METHODS: In this prospective study, 20 patients on maintenance hemodialysis (10 females, 10 males) with dialysate calcium concentrations of 1.75 mmol/L were enrolled. At the start of the study, the dialysate calcium level was lowered to 1.50 mmol/L. Serial changes in biochemical, hemodynamic, and arterial stiffness parameters, including pulse wave velocity (PWV) and augmentation index (AIx), were assessed every 2 months for 6 months. We also examined changes in the calcification-inhibitory protein, serum fetuin-A. RESULTS: During the 6-month study period, serum total calcium and ionized calcium decreased consistently (9.5 +/- 1.0 to 9.0 +/- 0.7, p = 0.002 vs. 1.3 +/- 0.1 to 1.1 +/- 0.1, p = 0.035). Although no apparent changes in blood pressure were observed, heart-femoral PWW (hf-PWV) and AIx showed significant improvement (p = 0.012, 0.043, respectively). Repeated-measures ANOVA indicated a significant effect of lowering dialysate calcium on hf-PWV (F = 4.58, p = 0.004) and AIx (F = 2.55, p = 0.049). Accompanying the change in serum calcium, serum fetuin-A levels significantly increased (95.8 +/- 45.8 pmol/mL at baseline to 124.9 +/- 82.2 pmol/mL at 6 months, p = 0.043). CONCLUSIONS: Lowering dialysate calcium concentration significantly improved arterial stiffness parameters, which may have been associated with upregulation of serum fetuin-A.
Aged ; Analysis of Variance ; Ankle Brachial Index ; Arteries/*drug effects/physiopathology ; Biological Markers/blood ; Blood Pressure/drug effects ; Calcium/*administration & dosage/adverse effects ; Compliance ; Female ; Hemodialysis Solutions/*administration & dosage/adverse effects/chemistry ; Humans ; Male ; Middle Aged ; Prospective Studies ; Pulsatile Flow/*drug effects ; *Renal Dialysis ; Republic of Korea ; Time Factors ; Treatment Outcome ; alpha-2-HS-Glycoprotein/metabolism

OBJECTIVETo prevent the deterioration of osteopenia, a triple herb product Bo-gu Ling ( , ELP) was created for a clinical trial on post-menopausal women suffering from osteopenia.

METHODSThe design of the clinical trial was of randomized, double-blind, placebo-controlled nature. A total of 150 women aged 40-60 years, who were after menopause for at least 1 year and their lumbar spine bone mineral density (BMD) must be lower than 0.891 g/cm(2), were recruited and randomly divided into the ELP group treated with ELP and the placebo group, with 75 in each group. The primary endpoint was the BMD of the lumbar spine that was assessed at baseline, 6 and 12 months after treatment. Secondary endpoints included peripheral quantitative computed tomography (pQCT) measurements of distal tibia and the changes in the quality of life (QOL).

RESULTSThe spine BMD of the ELP group was increased by 0.69% in the subjects who were more than 10 years after menopause. In contrast, the placebo group of the same stratum decreased by 0.61% (P=0.067). In the subjects with more than 10 years duration of menopause, the hip BMD increased by 0.21% in the ELP group, compared with a decrease of 0.52% in the placebo group (P=0.159). The tibia strength-strain index was increased by 1.94% in the ELP group compared with 0.33% in the placebo group (P=0.047). Physical function of SF-36 QOL questionnaire was remarkably improved compared with the baseline, but did not show dominance over the placebo group.

CONCLUSIONELP showed potential benefit in improving BMD on the women who experienced over 10 years of menopause.

Bone Density ; drug effects ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Female ; Humans ; Middle Aged ; Osteoporosis ; diagnostic imaging ; drug therapy ; physiopathology ; prevention & control ; Patient Compliance ; Quality of Life ; Surveys and Questionnaires ; Tomography, X-Ray Computed