Purpose: This study was conducted to update the practice guidelines for intravenous infusion therapy published in 2017, focusing on the most recent evidence for peripheral intravenous infusion therapy. Methods: The guideline update was conducted using the 22-step methodology. Results: The updated guidelines consist of 17 domains and 235 recommendations (including 284 sub-recommendations). The domains are as follows: general instructions (5 items), peripheral catheter selection (7), catheter insertion site selection (11), management during peripheral catheter insertion (10), post-insertion management (30), perfusion and locking (17), blood sampling via peripheral catheters(6), exchange and removal of peripheral catheters (6), infusion set management (14), add-on devices (32), complications (25), chemotherapy infusions (10), PCA infusions (7), parenteral nutrition (20), transfusion therapy (23), education (5), and documentation and reporting (7). The evidence levels for these recommendations are as follows: 27(9.5%) at level I, 3 (1.1%) at level I A/P, 118 (41.5%) at level II, and 136 (47.9%) at level III.Recommendation grades are categorized as follows: 30 (10.6%) at level A, 118 (41.5%) at level B, and 136(47.9%) at level C. Of these, 73 (25.7%) recommendations were newly developed, 49 (17.3%) underwent major revisions, and 147 (51.7%) underwent minor revisions. Conclusion The updated practice guideline, based on the latest evidence, is anticipated to enhance nursing practice related to peripheral intravenous infusion therapy.

Purpose: This study was conducted to update the practice guidelines for intravenous infusion therapy published in 2017, focusing on the most recent evidence for peripheral intravenous infusion therapy. Methods: The guideline update was conducted using the 22-step methodology. Results: The updated guidelines consist of 17 domains and 235 recommendations (including 284 sub-recommendations). The domains are as follows: general instructions (5 items), peripheral catheter selection (7), catheter insertion site selection (11), management during peripheral catheter insertion (10), post-insertion management (30), perfusion and locking (17), blood sampling via peripheral catheters(6), exchange and removal of peripheral catheters (6), infusion set management (14), add-on devices (32), complications (25), chemotherapy infusions (10), PCA infusions (7), parenteral nutrition (20), transfusion therapy (23), education (5), and documentation and reporting (7). The evidence levels for these recommendations are as follows: 27(9.5%) at level I, 3 (1.1%) at level I A/P, 118 (41.5%) at level II, and 136 (47.9%) at level III.Recommendation grades are categorized as follows: 30 (10.6%) at level A, 118 (41.5%) at level B, and 136(47.9%) at level C. Of these, 73 (25.7%) recommendations were newly developed, 49 (17.3%) underwent major revisions, and 147 (51.7%) underwent minor revisions. Conclusion The updated practice guideline, based on the latest evidence, is anticipated to enhance nursing practice related to peripheral intravenous infusion therapy.

Purpose: This study was conducted to update the practice guidelines for intravenous infusion therapy published in 2017, focusing on the most recent evidence for peripheral intravenous infusion therapy. Methods: The guideline update was conducted using the 22-step methodology. Results: The updated guidelines consist of 17 domains and 235 recommendations (including 284 sub-recommendations). The domains are as follows: general instructions (5 items), peripheral catheter selection (7), catheter insertion site selection (11), management during peripheral catheter insertion (10), post-insertion management (30), perfusion and locking (17), blood sampling via peripheral catheters(6), exchange and removal of peripheral catheters (6), infusion set management (14), add-on devices (32), complications (25), chemotherapy infusions (10), PCA infusions (7), parenteral nutrition (20), transfusion therapy (23), education (5), and documentation and reporting (7). The evidence levels for these recommendations are as follows: 27(9.5%) at level I, 3 (1.1%) at level I A/P, 118 (41.5%) at level II, and 136 (47.9%) at level III.Recommendation grades are categorized as follows: 30 (10.6%) at level A, 118 (41.5%) at level B, and 136(47.9%) at level C. Of these, 73 (25.7%) recommendations were newly developed, 49 (17.3%) underwent major revisions, and 147 (51.7%) underwent minor revisions. Conclusion The updated practice guideline, based on the latest evidence, is anticipated to enhance nursing practice related to peripheral intravenous infusion therapy.

Purpose: This study was conducted to update the practice guidelines for intravenous infusion therapy published in 2017, focusing on the most recent evidence for peripheral intravenous infusion therapy. Methods: The guideline update was conducted using the 22-step methodology. Results: The updated guidelines consist of 17 domains and 235 recommendations (including 284 sub-recommendations). The domains are as follows: general instructions (5 items), peripheral catheter selection (7), catheter insertion site selection (11), management during peripheral catheter insertion (10), post-insertion management (30), perfusion and locking (17), blood sampling via peripheral catheters(6), exchange and removal of peripheral catheters (6), infusion set management (14), add-on devices (32), complications (25), chemotherapy infusions (10), PCA infusions (7), parenteral nutrition (20), transfusion therapy (23), education (5), and documentation and reporting (7). The evidence levels for these recommendations are as follows: 27(9.5%) at level I, 3 (1.1%) at level I A/P, 118 (41.5%) at level II, and 136 (47.9%) at level III.Recommendation grades are categorized as follows: 30 (10.6%) at level A, 118 (41.5%) at level B, and 136(47.9%) at level C. Of these, 73 (25.7%) recommendations were newly developed, 49 (17.3%) underwent major revisions, and 147 (51.7%) underwent minor revisions. Conclusion The updated practice guideline, based on the latest evidence, is anticipated to enhance nursing practice related to peripheral intravenous infusion therapy.

Concomitant administration of lobeglitazone, empagliflozin, and metformin is expected to enhance blood glucose-lowering effects and improve medication compliance in patients with diabetes mellitus. In this study, we investigated the pharmacokinetic (PK) interactions and safety of lobeglitazone and co-administered empagliflozin and metformin, which are approved agents used in clinical settings. Two randomized, open-label, multiple-dose, 2-treatment, 2-period, 2-sequence crossover clinical trials (parts 1 and 2) were conducted independently. In part 1, lobeglitazone monotherapy or lobeglitazone, empagliflozin, and metformin triple therapy was administered for 5 days. In part 2, empagliflozin and metformin dual therapy or the abovementioned triple therapy were administered for 5 days. Serial blood samples were collected up to 24 hours after the last dose in each period for PK evaluation.The primary PK parameters (AUC tau,ss , C max,ss ) of treatment regimens in each study part were calculated and compared. For lobeglitazone, the geometric mean ratios (GMRs) with 90% confidence intervals (CI) for triple therapy over monotherapy were 1.08 (1.03–1.14) for C max,ss and 0.98 (0.90–1.07) for AUC tau,ss . For empagliflozin, the GMRs and 90% CIs for triple therapy over dual therapy were 0.87 (0.78–0.97) for C max,ss and 0.97 (0.93–1.00) for AUC tau,ss.For metformin, the GMRs and 90% CIs for triple therapy over dual therapy were 1.06 (0.95– 1.17) for C max,ss and 1.04 (0.97–1.12) for AUCtau,ss . All reported adverse events were mild. The triple therapy consisting of lobeglitazone, empagliflozin, and metformin did not show any clinically relevant drug interactions in relation to the PKs and safety of each drug substance.

YH4808 is a novel potassium-competitive acid blocker developed for gastric acid-related disorders. Previous studies indicate its potential to improve symptoms of gastric acid-related disorders. The current study was aimed to find the optimal regimen of YH4808 for night time pH control. This study was performed in two parts. Each was a randomized, open-label, active-controlled, multiple-doses, two-treatment, two-period crossover study conducted in 20 healthy Korean volunteers. Subjects were randomly assigned to one of the four groups.The three groups received different dosage regimens of YH4808 (100 mg twice a day, 200 mg once a day, or 200 mg twice a day), and the fourth group received esomeprazole 40 mg twice a day. The pharmacokinetic parameters demonstrated that the systemic exposure of YH4808 increased in a dose-proportional manner. The difference in the proportion of time above pH 4 over 24 h from the baseline was the greatest in the group receiving YH4808 200 mg twice a day. The values of the area under the effect curve at night time (12 A.M.–7 A.M.) were higher in all YH4808 groups than in the esomeprazole group. However, the differences among the YH4808 groups were not statistically significant (p > 0.05). YH4808 exhibited potential for better pH control during the night in comparison to esomeprazole. The optimal regimen for night time pH control among all the YH4808 regimens was 200 mg twice a day.

YH4808 is a novel potassium-competitive acid blocker that was developed as a therapeutic agent for gastric acid-related diseases; it may replace proton pump inhibitors, which are widely used in combination with amoxicillin and clarithromycin for Helicobacter pylori eradication. We compared the pharmacokinetic (PK) profiles and safety of amoxicillin, clarithromycin, and YH4808 used as monotherapies or in combination for evaluating potential drug interactions. An open-label, randomized, single-dose, Latin-square (4 × 4) crossover study was conducted in 32 healthy Korean volunteers. Subjects were randomly assigned to one of the 4 treatment sequences that consisted of 4 periods separated by 21-day washout intervals. PK parameters of YH4808, amoxicillin and clarithromycin administered in combination were compared with those of the respective monotherapies. The geometric mean ratios of the maximum concentration (Cmax) and the area under the time-concentration curve from time zero to time of the last quantifiable concentration (AUClast) of YH4808 increased during the triple therapy by 48.6% and 29.1%, respectively. Similarly, the Cmax and AUClast of M3 (active metabolite of YH4808) increased by 23.3% and 16.0%, respectively. The Cmax and AUClast of clarithromycin increased by 27.4% and 30.5%, and those of 14-hydroxyclarithromycin were increased by 23.1% and 32.4%, respectively. The corresponding amoxicillin values decreased during the triple therapy by 21.5% and 15.6%, respectively. There was no clinically significant change in safety assessment related to either monotherapies or triple therapy. In conclusion, amoxicillin, clarithromycin and YH4808 administered as triple therapy did not exhibit significant PK interactions and were not associated with safety issues.

YH4808 is a novel selective potassium-competitive acid blocker demonstrated to be safe and to have inhibitory effects against gastric acid secretion in previous studies. A randomized, open-label, multiple-dose, 3-treatment, 1-period, parallel design study was conducted to compare the Helicobacter pylori eradication rates and acid suppression capacities of three regimens in 60 healthy subjects with H. pylori-positive, and the potential of YH4808 to replace proton-pump inhibitors (PPIs) in standard regimens for H. pylori eradication. Group 1 received YH4808, amoxicillin, and clarithromycin as a novel triple regimen, while Group 2 received YH4808 and amoxicillin only, and Group 3 received esomeprazole, amoxicillin, and clarithromycin, as the standard triple regimen. H. pylori eradication rates were 85.0% for Group 1, 25.0% for Group 2, and 83.3% for Group 3. Relative response rate between Group 1 and 3 was 1.02 (0.50–2.07; 95% CI, χ2 test p = 0.8881). Furthermore, the novel triple regimen, YH4808, amoxicillin, and clarithromycin, stably inhibited acid secretion and maintained a gastric pH greater than 4 or 5 for 24 hours, which was comparable to the pH range in the standard triple regimen. However, the onset times of the YH4808 regimens were earlier than that for the regimens using esomeprazole. There were no differences in the incidences or severity of adverse events among the three groups. Overall, the novel triple regimen was safe and well-tolerated. YH4808 could replace PPIs in standard triple regimens used for H. pylori eradication.

YH4808 is a novel selective potassium-competitive acid blocker demonstrated to be safe and to have inhibitory effects against gastric acid secretion in previous studies. A randomized, open-label, multiple-dose, 3-treatment, 1-period, parallel design study was conducted to compare the Helicobacter pylori eradication rates and acid suppression capacities of three regimens in 60 healthy subjects with H. pylori-positive, and the potential of YH4808 to replace proton-pump inhibitors (PPIs) in standard regimens for H. pylori eradication. Group 1 received YH4808, amoxicillin, and clarithromycin as a novel triple regimen, while Group 2 received YH4808 and amoxicillin only, and Group 3 received esomeprazole, amoxicillin, and clarithromycin, as the standard triple regimen. H. pylori eradication rates were 85.0% for Group 1, 25.0% for Group 2, and 83.3% for Group 3. Relative response rate between Group 1 and 3 was 1.02 (0.50–2.07; 95% CI, χ2 test p = 0.8881). Furthermore, the novel triple regimen, YH4808, amoxicillin, and clarithromycin, stably inhibited acid secretion and maintained a gastric pH greater than 4 or 5 for 24 hours, which was comparable to the pH range in the standard triple regimen. However, the onset times of the YH4808 regimens were earlier than that for the regimens using esomeprazole. There were no differences in the incidences or severity of adverse events among the three groups. Overall, the novel triple regimen was safe and well-tolerated. YH4808 could replace PPIs in standard triple regimens used for H. pylori eradication.

Fimasartan is a nonpeptide angiotensin II receptor blocker. In a previous study that compared the pharmacokinetics (PK) of fimasartan between patients with hepatic impairment (cirrhosis) and healthy subjects, the exposure to fimasartan was found to be higher in patients, but the decrease of blood pressure (BP) was not clinically significant in those with moderate hepatic impairment. The aims of this study were to develop a population PK-pharmacodynamic (PD) model of fimasartan and to evaluate the effect of hepatic function on BP reduction by fimasartan using previously published data. A 2-compartment linear model with mixed zero-order absorption followed by first-order absorption with a lag time adequately described fimasartan PK, and the effect of fimasartan on BP changes was well explained by the inhibitory sigmoid function in the turnover PK-PD model overlaid with a model of circadian rhythm (NONMEM version 7.2). According to our PD model, the lower BP responses in hepatic impairment were the result of the increased fimasartan EC₅₀ in patients, rather than from a saturation of effect. This is congruent with the reported pathophysiological change of increased plasma ACE and renin activity in hepatic cirrhosis.
Absorption ; Blood Pressure ; Circadian Rhythm ; Colon, Sigmoid ; Healthy Volunteers ; Humans ; Linear Models ; Liver Cirrhosis* ; Liver* ; Pharmacokinetics ; Plasma ; Receptors, Angiotensin ; Renin