Durability of Glucose-Lowering Effect of the First Administration of Dulaglutide: A Retrospective, Single-Center, Single-Arm Study.
Ontology highlight
ABSTRACT: Introduction
Dulaglutide (Dula) is a once-weekly glucagon-like peptide-1 receptor agonist that efficiently reduces the level of glycated hemoglobin (HbA1c) in patients with type 2 diabetes (T2D). However, the durability of the glucose-lowering effect of the first injection of Dula (1st Dula) remains unclear.Methods
This study had a retrospective, single-center, and single-arm design in a clinical setting and was conducted between April 2016 and March 2017. We investigated the changes and fluctuations in glucose level in 15 patients with T2D using a continuous glucose monitor, from 1 day before the first administration of Dula to 6 days thereafter.Results
The mean glucose levels decreased significantly from 1 day before 1st Dula up to 5 days thereafter, whereas the standard deviation, mean amplitude of glucose excursion, and percentage of the glucose levels > 180 mg/dL were significantly improved only up to 3, 2, and 3 days after the 1st Dula, respectively, compared to those before administration.Conclusion
The effect of blood glucose regulation after the 1st Dula did not continue for a whole week. These effects should be considered when adjusting for other hypoglycemic agents.
SUBMITTER: Matsushita M
PROVIDER: S-EPMC6167306 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BackgroundRecent studies on perioperative fluid administration in patients undergoing major abdominal surgery have suggested that increased fluid loads are associated with worse perioperative outcomes. However, results of retrospective analyses of the relationship between intraoperative fluid (IOF) administration and perioperative outcomes in patients undergoing pancreaticoduodenectomy (PD) are conflicted. We sought to investigate this relationship in patients undergoing PD at our academic center.MethodsA retrospective analysis of 124 patients undergoing PD from 2007 to 2012 was performed. IOF administration rate (ml/kg/hr) was correlated with perioperative outcomes. Outcomes were also stratified by preoperative serum albumin level.ResultsRegression analyses were performed comparing independent perioperative variables, including IOF rate, to four outcomes variables: length of stay, severity of complications, number of complications per patient, and 30-day mortality. Both univariate and multivariate regression analyses showed IOF rate correlated with one or more perioperative outcomes. Patients with an albumin ≤ 3.0 g/dl who received more than the median IOF rate experienced more severe complications, while patients with an albumin >3.0 g/dl did not.ConclusionIncreased IOF administration is associated with worse perioperative outcomes in patients undergoing PD. Patients with low preoperative serum albumin levels (≤ 3.0 g/dl) may be a group particularly sensitive to volume overload.
| S-EPMC5481842 | biostudies-literature
Project description:IntroductionFrequent self-monitoring of blood glucose (SMBG) is usually required in patients with type 1 diabetes (T1D). However, the fear of self-testing, hygiene, and social obstacles may deter some patients from SMBG. Flash glucose monitoring (FGM), a less-invasive glucose monitoring method, was launched in Japan in September 2017. The aim of this study was to evaluate patient satisfaction and the clinical efficacy of FGM in Japanese patients with T1D.MethodsPatient satisfaction with FGM was assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Diabetes Therapy-Related Quality of Life (DTR-QOL) questionnaire before (baseline) and 4 and 12 weeks after initiating FGM use in 20 Japanese patients with T1D. Clinical parameters related to glucose metabolism, such as glycated hemoglobin (HbA1c) levels, were assessed, and glucose fluctuations were evaluated using the FGM data. Values at 4 and 12 weeks after initiating FGM were compared with baseline data using the Wilcoxon signed-rank test. The mean absolute relative difference (MARD) between glucose values detected using the FGM device and by SMBG was also calculated.ResultsThe DTSQ scores significantly improved 12 weeks after initiating FGM (P < 0.001). The DTR-QOL scores related to "burden in social activities" and "treatment satisfaction" also significantly improved 12 weeks after initiating FGM (P = 0.024 and 0.007, respectively). The HbA1c values and the percentage of time within the target glucose range (3.9-7.8 mmol/L) at the 12-week time point also improved, from 58 ± 5 (baseline) to 54 ± 4 mmol/mol (P = 0.002) and from 36% (interquartile range [IQR] 25-44.5%) (baseline) to 43% (IQR 39-50%) (P = 0.016), respectively. The MARD between glucose values detected using FGM and those detected using SMBG was 12.2% throughout the study period.ConclusionsFlash glucose monitoring contributed to improved patient satisfaction and the adjustment of blood glucose levels in patients with T1D.Trial registrationUniversity Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR): UMIN000029673.
| S-EPMC7376612 | biostudies-literature
Project description:BackgroundWide-spectrum antibiotics have been favored to treat acute uncomplicated cystitis (AUC) for a long time, leading to the emergence of multi-drug resistant bacteria. We hypothesize that narrow-spectrum antibiotics might mitigate the issue and aim to investigate the clinical efficacy of cefaclor in patients with AUC.MethodsWe retrospectively reviewed the clinical data of female outpatients with AUC treated with cefaclor and evaluated the safety and clinical efficacy. Clinical cure was defined as the elimination of clinical symptom under 4 white blood cells (WBCs) per high power field on microscopy.ResultsOverall, 223 women with AUC were enrolled. Escherichia coli was the dominant pathogen (n = 160; 68.6%), followed by Klebsiella species and E. coli-extended spectrum β-lactamase (ESBL) (n = 19; 8.1% and n = 18; 7.7%). Overall success rate was 94.0% (n = 219) and susceptibility rate of cefazolin was 84.1%, which was close to that of levofloxacin (82.9%). Ampicillin showed the lowest rate of 63.7% with a significantly greater resistance rate of 35.3% among all antibiotics (P < 0.001). In the subgroup analysis, the success rate in patients with resistance to levofloxacin or cefazolin was 100% (n = 24) or 93.3% (n = 14). The rate in patients with resistance to both antibiotics was 60.0% (n = 9), and the pathogens in the other 40.0% (n = 6) of patients with treatment failure were E. coli-ESBL.ConclusionCefaclor showed excellent efficacy in AUC patients, even in those with in vitro resistance to cefazolin or levofloxacin. Cefaclor may be considered as a first-line option in patients with AUC and a second-line option for those with levofloxacin treatment failure.
| S-EPMC7137291 | biostudies-literature
Project description:AIM:To evaluate the pharmacokinetic and pharmacodynamic properties of a novel glycosylated Fc-fused glucagon-like peptide-1(GLP-1-gFc) receptor agonist with distinctive receptor binding affinity, designed to improve in vivo stability and safety relative to the commercial GLP-1 analogue dulaglutide, and assess its safety profile and pharmacokinetics in healthy humans. MATERIALS AND METHODS:We constructed GLP-1-gFc and determined its binding affinity and potency using in vitro instrumental and cell-based analyses followed by in vivo comparison of the glucose-lowering and gastrointestinal side effects between GLP-1-gFc and dulaglutide. A phase 1 clinical trial was conducted to confirm the efficacy and safety profile of GLP-1-gFc. RESULTS:GLP-1-gFc showed 10-fold less binding affinity and 4-fold less potency than dulaglutide in in vitro. A potency-adjusted dose delayed HbA1c increase comparable with that of dulaglutide (Change for 6?weeks: 2.4?mg/kg GLP-1-gFc, 4.34?±?0.40 vs. 0.6?mg/kg dulaglutide, 4.26?±?0.22; n.s.). However, the equivalent efficacy dose and higher dose did not induce malaise-related responses (blueberry bar consumption, g/mouse: 2.4?mg/kg GLP-1-gFc, 0.15%?±?0.03% vs. 0.6?mg/kg dulaglutide, 0.04%?±?0.01%; P?<?.01) or QT interval changes (mean at 14-20?hours, mSc: 0.28?mg/kg GLP-1-gFc, 0.0-8.0 vs. 0.07?mg/kg dulaglutide, 8.0-27.7; n.s.), observed as safety variables in rats and monkeys, compared with those of dulaglutide. Glucose reductions in an oral glucose tolerance test were significant at day 3 postdose without severe gastrointestinal adverse events and pulse rate changes in healthy subjects. CONCLUSIONS:These results suggest that GLP-1-gFc could be used as a novel GLP-1 receptor agonist with better safety than dulaglutide to maximize therapeutic benefits in subjects with type 2 diabetes.
| S-EPMC7383507 | biostudies-literature
Project description:Medication complexity/burden can be associated with nonadherence in patients with type 2 diabetes mellitus (T2DM). Patients' satisfaction with their treatment is an important consideration for physicians. Strategies like using longer acting efficacious agents with less frequent dosing may help adherence.To explore the mode of administration of dulaglutide and its implications for treatment adherence in T2DM.PubMed search using the term "Dulaglutide" through October 31, 2015 was conducted. Published articles, press releases, and abstracts presented at national/international meetings were considered.Dulaglutide is a once-weekly glucagon like peptide-1 analog with a low intraindividual variability. Phase III trials demonstrated significant improvements in glycemia and weight, with a low hypoglycemia risk similar to liraglutide/exenatide, but with substantially fewer injections. A significant improvement was observed in the total Diabetes Treatment Satisfaction Questionnaire score, Impact of Weight on Self-Perception, and perceived frequency of hyperglycemia with dulaglutide when compared with placebo, exenatide, liraglutide, or metformin. Treatment satisfaction scores showed an improvement with dulaglutide (34%-39%) when compared with exenatide (31%). A positive experience with a high initial (97.2%) and final (99.1%) injection success rate along with a significant reduction in patients' fear of self-injecting, as measured by the modified self-injecting subscale of the Diabetes Fear of Injecting and Self-Testing Questionnaire and Medication Delivery Device Assessment Battery, was found. Its acceptance was high (>96%) among a variety of patients including patients who fear injections and injection-naïve users. Dulaglutide is available as a single-dose automatic self-injecting device, which has a low volume, does not need reconstitution, and avoids patient handling of the needle. Dose adjustment based on weight, sex, age, race, ethnicity, or injection-site is not necessary. In chronic diseases like diabetes where patients need lifelong medications, the efficacy, safety, and convenience of a once-weekly, easy-to-use, self-injecting device should encourage patient adherence to dulaglutide therapy.
| S-EPMC4898439 | biostudies-other
Project description:BackgroundCentral retinal artery occlusion ((C)RAO) is known to be associated with stroke and/or atrial fibrillation (AF). Nevertheless, patients often present at the ophthalmologist initially and it is unknown how many of these receive an adequate cardiological/neurological work-up (CWU/NWU), including a 24 h-Holter-ECG.HypothesisHypothesis of this study was that patients with (C)RAO do not undergo CWU on regular basis and that new-onset AF is more often detected in patients with CWU.Methods and resultsWe performed a retrospective analysis of n = 292 consecutive patients who presented at an ophthalmology department with the diagnosis of (C)RAO during a 3-year period. After excluding patients with known AF, meeting exclusion criteria, inability to comply with the protocol, missed land phoneline, or death during follow-up a total of 174 patients were enrolled; mean follow-up was 20 ± 12 months. The CHA2 DS2 -VASc score of the cohort was 5.3 ± 1.4. Our analysis revealed that only 50.6% of patients received a CWU including a single Holter-ECG after the index-event. In 12.6% cases new-onset AF was diagnosed, while the rate was higher in patients with CWU compared to patients without CWU (18.2 vs. 7.0%; p = 0.26). Evaluation of oral anticoagulation (OAC) therapy showed that only 66% of patients with AF were treated according to guidelines.ConclusionOnly half of patients with (C)RAO underwent CWU. Despite minimal monitoring, rate of new diagnosed AF was high. Our results confirm that (C)RAO identifies a high-risk population for AF. These results illustrate the importance to implement standardized CWU in (C)RAO patients presenting at the ophthalmologist.
| S-EPMC8715400 | biostudies-literature
Project description:BackgroundGlucocorticoid (GC)-induced hyperglycemia is a frequent adverse effect in hospitalized patients. Guidelines recommend insulin treatment to a target range of 6-10 mmol/L (108-180 mg/dl), but efficacies of particular regimes have not been well-studied.MethodsIn this retrospective cohort study, hospitalized patients receiving GCs at the medical ward were analyzed by treatment (basal-bolus vs. bolus-only vs. pre-mixed insulin) and compared to a non-insulin-therapy reference group. Coefficients of glucose variation (CV), percentage of glucose readings in range (4-10 mmol/L (72-180 mg/dl)) and hypoglycemia (< 4 mmol/L (< 72 mg/dl)) were evaluated.ResultsOf 2424 hospitalized patients receiving systemic GCs, 875 (36%) developed GC-induced hyperglycemia. 427 patients (17%) had a previous diagnosis of diabetes. Adjusted relative risk ratios (RRR) for the top tertile of CV (> 29%) were 1.47 (95% Cl 1.01-2.15) for bolus-only insulin, 4.77 (95% CI 2.67-8.51) for basal-bolus insulin, and 4.98 (95% CI 2.02-12.31) for premixed insulin, respectively. Adjusted RRR for percentages of glucose readings in range were 0.98 (95% Cl 0.97-0.99) for basal-bolus insulin, 0.99 (95% Cl 0.98-1.00) for premixed insulin, and 1.01 (95% Cl 1.00-1.01) for bolus-only insulin, respectively. Adjusted RRR for hypoglycemia was 13.17 (95% Cl 4.35-39.90) for basal-bolus insulin, 8.92 (95% Cl 2.60-30.63) for premixed insulin, and 2.99 (95% Cl 1.01-8.87) for bolus-only insulin, respectively.ConclusionsCurrent guidelines recommend a basal-bolus regimen for treatment of GC-induced hyperglycemia, but we found similar outcomes with pre-mixed and bolus-only insulin regimens. As GC-induced hyperglycemia is a frequent issue in hospitalized patients, it might be reasonable to prospectively study the ideal regimen.
| S-EPMC8734262 | biostudies-literature
Project description:IntroductionConcomitant experimental/compassionate drug administration has been all-pervasive in the treatment of COVID-19 patients. The objective of this study was to study the relationship between patient severity, the number of experimental/compassionate medications received (main outcome measure), and patient outcomes [survival to hospital discharge and length of hospital stay (LOS)].MethodsRetrospective analysis of data collected in real time during the first pandemic wave in a tertiary care hospital. Data included patient demographics, comorbidities, admission vital signs, laboratory values, most extreme respiratory intervention during hospitalization, and data regarding treatment with compassionate/experimental drugs during their stay.ResultsOverall, 292 PCR-confirmed patients with symptoms of COVID-19 were studied (March/April, 2020). Increasing respiratory support correlated with both LOS and mortality. Patients were more likely to receive more than 1 experimental/compassionate drugs as respiratory support escalated, ranging from 3% (n = 4/136) among patients on room air to 77.3% (n = 17/22) of mechanically ventilated/ECMO patients (P < 0.001, linear by linear association). The mean number of experimental/compassionate drugs received also increased with escalating respiratory support (P < 0.001, one-way ANOVA). After adjustment for severity of patient condition, administration of more experimental/compassionate drugs was unrelated to survival (P = 0.24), but was related to increased LOS (P < 0.001).ConclusionPatients that were hospitalized in worse condition were more likely to receive more experimental/compassionate drugs. Treatment was unrelated to survival but may have been related to LOS. This finding raises questions regarding the results of studies on medication effects that adjusted for multiple drug administration.
| S-EPMC8381349 | biostudies-literature
Project description:Synopsis: Lymphovascular space invasion is an independent risk factor for disease progression and presence of tumor stalk an independent protective factor. Fertility sparing surgery may be acceptable in cases whose tumors present with stalks and without high risk factors. Objectives: The aim of the present study was to investigate the potential prognostic factors of uterine adenosarcoma. Methods: A total of 49 cases of uterine adenosarcoma were retrospectively reviewed at our institution between April 2006 and October 2018. Results: Median follow-up time was 34 months (range: 1-148). Median age was 47.50 years (19-75). Nineteen (38.9%) patients were uterine cervical adenosarcoma and 30 (61.22%) patients were uterine corpus adenosarcoma. Twenty-nine (59.2%) patients were polypoid with a stalk to the uterine cervix or corpus. Twenty-six (38.8%) patients were stage IA. Fifteen (30.6%) patients showed sarcomatous overgrowth. Six (12.2%) patients displayed lymphovascular space invasion (LVSI). Four (8.16%) patients had heterologous elements. In univariate analysis, Disease-free-survival (DFS) was associated with tumor location, presence of tumor stalk, heterologous elements, LVSI. In multivariate analysis, presence of tumor stalk remained an independently protective factor for recurrence (HR = 0.088, P = 0.005), and LVSI a risk factor for recurrence (HR = 11.953, P = 0.002). Fertility-sparing surgery (FSS) was performed in seven stage IA patients. When patients of stage IA analyzed separately, FSS was not significant with the DFS or OS. Conclusions: Presence of tumor stalk remained an independently protective factor for recurrence. Along with adequate counseling, FSS may be acceptable in cases whose tumors present with stalks and without high risk factors.
| S-EPMC6527837 | biostudies-literature
Project description:Introduction: COVID-19 induces a pro-thrombotic state as evidenced by microvascular thrombi in the renal and pulmonary vasculature. Therapeutic anticoagulation in COVID-19 has been debated and data remain anecdotal. Hypothesis: We hypothesize that therapeutic anticoagulation is associated with a reduction in in-hospital mortality, upgrade to intensive care unit, invasive mechanical ventilation, and acute renal failure necessitating dialysis by decreasing the over-all clot burden. Methods: A retrospective cohort study was done to determine the impact of therapeutic anticoagulation in hospitalized COVID-19 patients. Independent t-test and multivariate logistic regression analysis were performed to calculate mean differences and adjusted odds ratios (aOR) with its 95% confidence interval (CI) respectively. Results: A total of 176 hospitalized COVID-19 patients were divided into two groups, therapeutic anticoagulation and prophylactic anticoagulation. The mean age, baseline comorbidities and other medications used during hospitalization were similar in both groups. The aOR for in-hospital mortality (OR 3.05, 95% CI 1.15-8.10, p = 0.04), upgrade to intensive care (OR 3.08, 95% CI 1.43-6.64, p = 0.006) and invasive mechanical ventilation (OR 4.27, 95% CI 1.95-9.34, p = 0.00) were significantly lower while there was no statistically significant difference in the rate of developing acute renal failure (OR 1.87 95% CI 0.46-7.63, p = 0.64) between two groups. Conclusions: In patients with COVID-19, therapeutic anticoagulation offers a significant reduction in the rate of in-hospital mortality, upgrade to intensive medical care, and invasive mechanical ventilation. It should be preferred over prophylactic anticoagulation in COVID-19 patients unless randomized controlled trials prove otherwise.
| S-EPMC7850331 | biostudies-literature