Real-world comparison of elobixibat and lubiprostone treatment in patients with chronic constipation: A propensity score matched analysis

2020 ◽  
Author(s):  
Takaaki Eguchi ◽  
Tetsuya Yoshizaki ◽  
Seitaro Ikeoka ◽  
Megumi Takagi ◽  
Maho Fujinami ◽  
...  
Keyword(s):  
Propensity Score ◽  
Chronic Constipation ◽  
Nearest Neighbor ◽  
Japanese Patients ◽  
Treatment Groups ◽  
Bowel Movements ◽  
Nearest Neighbor Matching ◽  
Stool Form ◽  
Group 2 ◽  
The Individual

Introduction: Elobixibat is a new laxative, but its efficacy and adverse events (AEs) are insufficiently examined compared with those of other laxatives. Hence, by propensity score (PS) matching, we compared the effects and AEs between elobixibat and lubiprostone. Methods: We retrospectively analyzed 1887 Japanese patients with chronic constipation (CC) treated at our hospital between October 2013 and April 2020. Enrolled patients were divided into three treatment groups, namely, elobixibat (10 mg daily) (E10 group, n = 293), lubiprostone (24 mcg daily) (L24 group, n = 772), and lubiprostone (48 mcg daily) (L48 group, n = 822), as their first treatment. We then investigated the changes on the weekly average number of spontaneous bowel movements (SBMs), Stool Consistency Scores (SCSs), and AEs starting from the baseline until the end of the 2-week treatment. To adjust for patient background, we performed one-to-one nearest neighbor matching without replacement between elobixibat- and lubiprostone-treated patients according to the individual estimated PSs. Results: After treatment, for SCSs, both the L24 and L48 groups significantly improved compared with the E10 group (p < 0.05), but their stools were soft (Bristol stool form scale: 4.8). Notably, the E10 group had less frequent AEs than the L24 group (26 [9.0%] vs. 43 [14.8%], p = 0.03). Particularly, nausea was significantly less in the E10 group than in the L48 group (2 [0.7%] vs. 7 [2.4%], p = 0.01). Conclusion: Elobixibat is a beneficial drug for patients with mildly symptomatic CC and is safe to use, given its few AEs.

scholarly journals IMPACTO DEL PROGRAMA JUNTOS SOBRE EL GASTO EN ALIMENTOS EN LOS HOGARES RURALES, 2015

2016 ◽  
Vol 5 (2) ◽  
pp. 68-83
Author(s):  
Alfredo Pelayo Calatayud Mendoza ◽  
Edson Apaza Mamani
Keyword(s):  
Propensity Score ◽  
Propensity Score Matching ◽  
Nearest Neighbor ◽  
Nearest Neighbor Matching ◽  
Per Capita

El objetivo del presente estudio es estimar el impacto del programa Juntos sobre el gasto per cápita en alimentos en los hogares rurales, como fuente de información se utiliza la base de datos de la Encuesta Nacional de Hogares – 2015, la metodología es la técnica de diseño cuasi-experimental Propensity Score Matching – PSM con la técnica de emparejamiento de vecino más cercano (Nearest Neighbor Matching), este método consiste en comparar el gasto per cápita en alimentos que obtiene cada beneficiario tratado con el grupo de control que tenga el propensity score más cercano, luego se calcula la diferencia entre cada par de hogares emparejadas en el gasto per cápita en alimentos y luego se promedian todas las diferencias para calcular el ATT. La unidad de análisis son los hogares rurales de la sierra y selva del Perú en condición de pobreza y extrema pobreza. Los resultados reportan que la probabilidad de participar en el programa Juntos depende de las características del hogar, de la vivienda y del jefe de hogar. Asimismo, los resultados sugieren que el programa Juntos si tiene un impacto positivo sobre el gasto per cápita en alimentos, para aquellos hogares rurales en pobreza y extrema pobreza el programa Juntos ha incrementado el gasto per cápita en 8.9% (ATT=0.089) a un nivel de significancia de 10%.

scholarly journals EFFECT OF MICROFINANCE ON SMALLHOLDER FARMERS’ LIVELIHOOD IN RWANDA: A CASE STUDY OF NYAMAGABE DISTRICT

AGROFOR ◽  
2020 ◽  
Vol 5 (1) ◽  
Author(s):  
Eularie MUTAMULIZA ◽  
Edouard MUSABANGANJI
Keyword(s):  
Propensity Score ◽  
Propensity Score Matching ◽  
Rural Areas ◽  
Nearest Neighbor ◽  
Smallholder Farmers ◽  
Descriptive Statistics ◽  
Primary Data ◽  
Microfinance Institutions ◽  
Nearest Neighbor Matching ◽  
The Government

Microfinance in Rwanda is considered as one of the most crucial mechanisms in the implementation of the Government program to reduce poverty and to increase economic growth. However, despite the effort made by the Government of Rwanda to put in place microfinance institutions in rural areas, little is known about the effects of microfinance on smallholder farmers’ income in Nyamagabe District of Rwanda. This study aimed at examining the contribution of microfinance services to the income of smallholder farmers in Nyamagabe District. Primary data were collected from 240 respondents randomly selected in 3 sectors of Nyamagabe District using structured questionnaires. Data were analyzed using descriptive statistics to describe the socio-economic characteristics of the respondents and Propensity Score Matching was used to assess the effect of microfinance on smallholder farmers’ livelihood. The results from descriptive statistics showing that 117 respondents were participants in microfinance services and 123 were nonparticipants and more men were committed to participate and to access microfinance services than women. Results from Propensity Score Matching Model using both Kernel Based Matching and Nearest Neighbor Matching showed that the households participating in microfinance services increased their total annual income by 256,674 Rwandan francs and 228,246 Rwandan francs more than non-participants, respectively. The study recommended that smallholder farmers should be encouraged to participate in microfinance services to increase their income and agricultural productivity. The use of SACCOs and microfinance services needs to be promoted in order to provide an instrument for mobilizing savings and extending credit.

scholarly journals IMPACTO DEL PROGRAMA JUNTOS SOBRE LA VIOLENCIA DOMÉSTICA

2016 ◽  
Vol 5 (1) ◽  
pp. 108-126
Author(s):  
Alfredo Pelayo Calatayud Mendoza ◽  
María Del Pilar Blanco Espesua
Keyword(s):  
Propensity Score ◽  
Propensity Score Matching ◽  
Nearest Neighbor ◽  
Nearest Neighbor Matching ◽  
Salud Mental ◽  
Violencia Domestica

El objetivo del presente estudio, es estimar el impacto del programa Juntos sobre los niveles de violencia doméstica contra la mujer. Ciertamente, la violencia es un fenómeno complejo y está determinado por múltiples causas;  si bien es cierto, dentro de los objetivos del programa Juntos no está prevista directamente la disminución de la violencia doméstica. Sin embargo, un grupo de estudios advierten que una de las causas de la violencia contra la mujer es por razones de carácter económico y existen tres tipos de violencia doméstica: física, psicológica y sexual. Específicamente, el programa Juntos, es un programa social dirigido a la población de mayor vulnerabilidad, en situación de extrema pobreza, riesgo y exclusión; el subsidio consiste en la entrega mensual de dinero de 100 soles. El estudio sigue una metodología cuantitativa por la necesidad de evidenciar empíricamente el impacto del programa, concretamente es la técnica de Propensity Score Matching : Nearest Neighbor Matching y la fuente de datos utilizada para el análisis es la Encuesta Nacional de Demografía y de Salud Familiar - ENDES de los años 2014 y 2015. Los resultados señalan que el programa Juntos no ha logrado reducir los niveles de violencia doméstica a un nivel de significancia de 5%, no se reporta impacto favorable del programa en la reducción de la violencia física, psicológica y sexual ya sea en forma severa o algunas veces; no obstante que el número de hogares beneficiarios se ha incrementado exponencialmente, durante los 10 años de funcionamiento. Los resultados sugieren incorporar en el componente de salud del programa Juntos la salud mental de los hogares beneficiarios para ello es importante la participación de la mujer y de su pareja, la condición o el compromiso es modificar el comportamiento de la pareja en actos o actitudes de violencia.

Abstract TMP83: Propensity Score Matching to Estimate Supported Outcomes in Intracerebral Hemorrhage Patients with Withdrawal of Life Support

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
David L Tirschwell ◽  
Kyra J Becker ◽  
Claire J Creutzfeldt ◽  
Marisa Gallo ◽  
W. T Longstreth
Keyword(s):  
Propensity Score ◽  
Intraventricular Hemorrhage ◽  
Primary Outcome ◽  
Nearest Neighbor ◽  
Life Support ◽  
Absolute Difference ◽  
Multivariate Modeling ◽  
Nearest Neighbor Matching ◽  
Intracerebral Hemorrhages ◽  
Acceptable Outcome

Background: Observational reports suggest that a self-fulfilling prognostic pessimism may lead to withdrawal of life support (WOLS) in patients with more severe intracerebral hemorrhages (ICHs) who might otherwise have acceptable clinical outcomes. Our objective was to estimate what outcomes in a cohort of ICH patients might have been if they did not have WOLS. Methods: Multivariate modeling was used to create a propensity score (PS) for WOLS in a Seattle single center cohort of ICH patients with hospital discharge modified Rankin Scale (mRS) as the primary outcome. Using nearest neighbor matching, individual ICH patients with WOLS were matched to individual ICH patients without WOLS and baseline variables and outcome were compared. Results: The cohort comprised 590 ICH patients with mean age of 67 years, 42% women, 76% white and 18% WOLS. Factors used to create the PS for WOLS included age, pre-ICH mRS, GCS, ICH volume, intraventricular hemorrhage, pre-existing hypertension, diabetes and atrial fibrillation, first temperature and intubation. Matches were possible for 78 WOLS/non-WOLS pairs. Groups were well matched on all PS factors, mean age (67 years), GCS (6.4), ICH volume (59cc) and % intubation (59). Discharge mRS in the both groups varied from 3-6 and was for the WOLS group 1.3%, 2.6%, 6.4% and 90% respectively; in the matched non-WOLS group discharge mRS was 6.4%, 32%, 24% and 37% respectively (difference p<0.0005). Using mRS <= 4 at discharge as an acceptable outcome, % in WOLS/non-WOLS were 4%/38% (difference p<0.0005). Conclusions: The proportion of ICH patients with WOLS that might have had an acceptable outcome without WOLS was ~38%. This discharge “acceptable outcome” of mRS <= 4 assumes eventual recovery to better function in many. The 34% absolute difference in WOLS/non-WOLS outcomes suggests that for every 3 fewer ICH patients with WOLS, one more patient might have an acceptable clinical outcome. This proportion would vary depending on an individual patient’s interpretation of what constitutes an acceptable outcome.

scholarly journals 560. Evaluation of Optimal Methylprednisolone Dose in Patients with Covid 19

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S382-S382
Author(s):  
Jose Luis Lamas Ferreiro ◽  
Judith Álvarez Otero ◽  
Fernando Maroto Piñeiro ◽  
Iolanda Abalde Ortega ◽  
Marta Rodríguez Villar ◽  
...  
Keyword(s):  
Propensity Score ◽  
Primary Outcome ◽  
Cox Regression ◽  
Bivariate Analysis ◽  
High Dose ◽  
Male Mortality ◽  
Treatment Groups ◽  
Group 2 ◽  
The Impact ◽  
Group 1

Abstract Background Optimal dose of methylprednisolone in patients with moderate or severe COVID-19 is unclear. In our hospital, the use of 250-500 mg/day of methylprednisolone was frequent in the first wave of the pandemic. Lower dose were recommended in our protocol since September 2020. The aim was to evaluate the impact of methylprednisolone dose in the outcome of patients with moderate or severe COVID-19. Methods This is a retrospective and observational study. Inclusion criteria: SARS-CoV-2 infection diagnosed by PCR, admission to our hospital between March 2020 and February 2021, SatO2 &lt; 94% or SatO2/FiO2 &lt; 447. Two treatment groups were compared: patients treated with 0.5-1.5 mg/kg/day (group 1) and patients treated with more than 1.5 mg/kg/day (group 2). The primary outcome analyzed was orotracheal intubation (OTI) or death from any cause at 28 days after admission. Differences in demographic, clinical and laboratory characteristics between treatment groups were analyzed. Variables with P &lt; 0.1 were included in a binary logistic regression model, calculating a propensity score for assigning each patient to group 1 treatment. Bivariate analysis was performed to identify variables associated with worst outcome. Finally, Cox regression was performed including treatment group, propensity score as covariate and all the variables with P&lt; 0.05 in the bivariate analysis. Results 285 patients were included, 197 in group 1 and 88 in group 2. The median age was 73 years, 52,3% were male. Mortality or OTI at 28 days was 24,9%. There was a higher proportion of patients in group 1 with COPD (9,6% vs 1.1%, P&lt; 0.01), dyspnea (60.4% vs 45.5%, P=0.01), sepsis (22.8% vs 13.6%, P=0.07). Patients in group 2 had more impaired consciousness (18.2% vs 8.6%, P=0.02). The median of lymphocytes count was lower in group 1 (900 vs 1025, P=0.01). There were no differences in the primary outcome between treatment groups (26.1% in the group 2 vs 24.4% in the group 1, P=0.7). Conclusion The use of high dose of methylprednisolone compared with intermediate dose is not associated with a better outcome in patients with moderate or severe COVID-19. Disclosures All Authors: No reported disclosures

scholarly journals Can the cytokine adsorber CytoSorb® help to mitigate cytokine storm and reduce mortality in critically ill patients? A propensity score matching analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Christina Scharf ◽  
Ines Schroeder ◽  
Michael Paal ◽  
Martin Winkels ◽  
Michael Irlbeck ◽  
...  
Keyword(s):  
Propensity Score ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Wilcoxon Test ◽  
Relative Reduction ◽  
Cytokine Storm ◽  
Saps Ii ◽  
Significant Difference ◽  
Group 2 ◽  
Group 1

Abstract Background A cytokine storm is life threatening for critically ill patients and is mainly caused by sepsis or severe trauma. In combination with supportive therapy, the cytokine adsorber Cytosorb® (CS) is increasingly used for the treatment of cytokine storm. However, it is questionable whether its use is actually beneficial in these patients. Methods Patients with an interleukin-6 (IL-6) > 10,000 pg/ml were retrospectively included between October 2014 and May 2020 and were divided into two groups (group 1: CS therapy; group 2: no CS therapy). Inclusion criteria were a regularly measured IL-6 and, for patients allocated to group 1, CS therapy for at least 90 min. A propensity score (PS) matching analysis with significant baseline differences as predictors (Simplified Acute Physiology Score (SAPS) II, extracorporeal membrane oxygenation, renal replacement therapy, IL-6, lactate and norepinephrine demand) was performed to compare both groups (adjustment tolerance: < 0.05; standardization tolerance: < 10%). U-test and Fisher’s-test were used for independent variables and the Wilcoxon test was used for dependent variables. Results In total, 143 patients were included in the initial evaluation (group 1: 38; group 2: 105). Nineteen comparable pairings could be formed (mean initial IL-6: 58,385 vs. 59,812 pg/ml; mean SAPS II: 77 vs. 75). There was a significant reduction in IL-6 in patients with (p < 0.001) and without CS treatment (p = 0.005). However, there was no significant difference (p = 0.708) in the median relative reduction in both groups (89% vs. 80%). Furthermore, there was no significant difference in the relative change in C-reactive protein, lactate, or norepinephrine demand in either group and the in-hospital mortality was similar between groups (73.7%). Conclusion Our study showed no difference in IL-6 reduction, hemodynamic stabilization, or mortality in patients with Cytosorb® treatment compared to a matched patient population.

scholarly journals Responsiveness of the Scripps Neurologic Rating Scale During a Multiple Sclerosis Clinical Trial

1999 ◽  
Vol 26 (4) ◽  
pp. 283-289 ◽  
Author(s):  
James A. Koziol ◽  
Adriana Lucero ◽  
Jack C. Sipe ◽  
John S. Romine ◽  
Ernest Beutler
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Rating Scale ◽  
Effect Sizes ◽  
Active Therapy ◽  
Double Blind ◽  
Treatment Groups ◽  
Negative Effect ◽  
The Individual ◽  
Positive Effect

Objective:The Scripps neurologic rating scale (SNRS) is a summary measure of individual components comprising a neurological examination, designed for use in multiple sclerosis (MS). Our objective is to evaluate the responsiveness of the SNRS, within the context of a 2-year, randomized, double-blind crossover study of the efficacy of cladribine for treatment of secondary progressive MS.Methods:Effect sizes were determined for the SNRS and its components, separately for each treatment group (initial placebo, and initial cladribine) over both years of the clinical trial, using a standard random effects model.Results:Individual components tended to show positive effect sizes (improvement) during periods of active therapy in both treatment groups, and negative effect sizes (deterioration) during periods of no active therapy. Summation indices derived from the individual components of the SNRS seemed somewhat more stable than the individual components. The two components mentation and mood, and bladder, bowel, or sexual dysfunction, were rather unresponsive in our clinical trial.Conclusion:Changes in the components of the SNRS over the course of our clinical trial were consistent between the two treatment groups. Most components were moderately responsive; and, the summary SNRS score appropriately summarized the moderate magnitudes of change evinced in the individual components.

scholarly journals Can the Ceftriaxone Breakpoints Be Increased Without Compromising Patient Outcomes?

2018 ◽  
Vol 5 (6) ◽  
Author(s):  
Pranita D Tamma ◽  
Virginia M Pierce ◽  
Sara E Cosgrove ◽  
Ebbing Lautenbach ◽  
Anthony Harris ◽  
...  
Keyword(s):  
Propensity Score ◽  
Propensity Score Matching ◽  
Patient Outcomes ◽  
Nearest Neighbor ◽  
Clinical Laboratory ◽  
Severity Of Illness ◽  
Bloodstream Infections ◽  
Source Control ◽  
Exact Matching ◽  
Extended Spectrum

Abstract Background In 2010, the Clinical Laboratory and Standards Institute recommended a 3-fold lowering of ceftriaxone breakpoints to 1 mcg/mL for Enterobacteriaceae. Supportive clinical data at the time were from fewer than 50 patients. We compared the clinical outcomes of adults with Enterobacteriaceae bloodstream infections treated with ceftriaxone compared with matched patients (with exact matching on ceftriaxone minimum inhibitory concentrations [MICs]) treated with extended-spectrum agents to determine if ceftriaxone breakpoints could be increased without negatively impacting patient outcomes. Methods A retrospective cohort study was conducted at 3 large academic medical centers and included patients with Enterobacteriaceae bacteremia with ceftriaxone MICs of 2 mcg/mL treated with ceftriaxone or extended-spectrum β-lactams (ie, cefepime, piperacillin/tazobactam, meropenem, or imipenem/cilastatin) between 2008 and 2014; 1:2 nearest neighbor propensity score matching was performed to estimate the odds of recurrent bacteremia and mortality within 30 days. Results Propensity score matching yielded 108 patients in the ceftriaxone group and 216 patients in the extended-spectrum β-lactam group, with both groups well-balanced on demographics, preexisting medical conditions, severity of illness, source of bacteremia, and source control interventions. No difference in recurrent bacteremia (odds ratio [OR], 1.16; 95% confidence interval [CI], 0.49–2.73) or mortality (OR, 1.27; 95% CI, 0.56–2.91) between the treatment groups was observed for patients with isolates with ceftriaxone MICs of 2 mcg/mL. Only 6 isolates (1.6%) with ceftriaxone MICs of 2 mcg/mL were extended-spectrum β-lactamase (ESBL)–producing. Conclusions Our findings suggest that patient outcomes are similar when receiving ceftriaxone vs extended-spectrum agents for the treatment of Enterobacteriaceae bloodstream infections with ceftriaxone MICs of 2 mcg/mL. This warrants consideration of adjusting the ceftriaxone susceptibility breakpoint from 1 to 2 mcg/mL, as a relatively small increase in the antibiotic breakpoint could have the potential to limit the use of large numbers of extended-spectrum antibiotic agents.

scholarly journals Thromboelastometric evaluation of horses submitted to experimental thrombosis and jugular thrombectomy

2016 ◽  
Vol 36 (8) ◽  
pp. 677-686 ◽  
Author(s):  
Dietrich Pizzigatti ◽  
Daniele S. Gonçalves ◽  
Thays C. Trentin ◽  
Regina K. Takahira ◽  
Ana L.G. Alves ◽  
...  
Keyword(s):  
Platelet Count ◽  
Surgical Treatment ◽  
Alpha Angle ◽  
Fogarty Catheter ◽  
Significance Level ◽  
Treatment Groups ◽  
Significant Difference ◽  
Group 2 ◽  
The Moment ◽  
Α Angle

Abstract: Jugular thrombosis in horses occurs commonly in iatrogenic situations, secondary to endotoxemic clinical condition and disseminated vascular coagulation, potentially leading to death. Thus, hemostatic evaluation becomes necessary and extremely important for monitoring the risks of systemic hypercoagulability and for the efficiency of allopathic and surgical treatment. This paper describes the hemostatic behavior in experimental jugular thrombosis of ten healthy equines, subsequently submitted to two thrombectomy techniques and receiving heparin sodium as anti-rethrombosis therapy. These animals were evaluated for 20 days by thromboelastometry (TEM), platelet count, hematocrit and fibrinogen, at four moments: pre-induction to phlebitis (D0-MPF); three days after thrombophlebitis induction (D3-MFM); 6 days after, - moment of thrombophlebitis - (D9-MT); and 54 (D16) and 126 (D19) hours after thrombectomies (PTM). Thrombectomy was performed via a Vollmar Ring (group 1, n=5) and Fogarty catheter (group 2, n=5). All the animals received heparin (150 UI/kg, SC) every 12 hours, for ten days after the respective thrombectomies. Through the blood samples were evaluated TEM, activated partial thromboplastin time (aPTT) and prothrombin time (PT), dosing of fibrinogen, hematocrit and platelet count at the abovementioned moments. For comparison between groups and moments the t test was applied at 5% significance level. No significant difference was verified between treatment groups at any of the moments. There were reductions in clotting time (CT) and clot formation time (CFT), with increase in maximum lysis (ML) until the moment D9-MT. Evaluation through INTEM® reagent presented prolongations of CT and CFT with reduction of α angle and ML starting from D16 and D19. Similarly, aPTT presented significant differences between moments pre- (D0, 3 and 9) and post- (D16 and 19) anticoagulant and surgical treatment. The platelet numbers were diminished at moments D16 and D19. In evaluation with EXTEM® reagent, prolongation of CT and CFT occurred only between the moments D0 vs. D3 and vs. D9. O PT did not present significant differences. The results obtained demonstrate that experimental jugular thrombophlebitis leads to local clinical alterations, with impairment of tissue and of the extrinsic coagulation pathway (EXTEM® ), but without evidence of systemic hypercoagulability status, since there was no increase of the alpha angle or maximum clot firmness (MCF). Furthermore, TEM was shown useful and more sensitive than conventional coagulation tests (PT, aPTT and fibrinogen) for the monitoring of anticoagulant therapy, as demonstrated in other works.

scholarly journals Effects of food and sucralfate on a single oral dose of 500 milligrams of levofloxacin in healthy subjects.

1997 ◽  
Vol 41 (10) ◽  
pp. 2196-2200 ◽  
Author(s):  
L J Lee ◽  
B Hafkin ◽  
I D Lee ◽  
J Hoh ◽  
R Dix
Keyword(s):  
Oral Dose ◽  
Healthy Subjects ◽  
High Fat ◽  
Time Curve ◽  
Mean Values ◽  
Treatment Groups ◽  
The Mean ◽  
The Individual ◽  
Individual Profiles ◽  
Fat Meal

The effects of food and sucralfate on the pharmacokinetics of levofloxacin following the administration of a single 500-mg oral dose were investigated in a randomized, three-way crossover study with young healthy subjects (12 males and 12 females). Levofloxacin was administered under three conditions: fasting, fed (immediately after a standardized high-fat breakfast), and fasting with sucralfate given 2 h following the administration of levofloxacin. The concentrations of levofloxacin in plasma and urine were determined by high-pressure liquid chromatography. By noncompartmental methods, the maximum concentration of drug in serum (Cmax), the time to Cmax (Tmax), the area under the concentration-time curve (AUC), half-life (t1/2), clearance (CL/F), renal clearance (CLR), and cumulative amount of levofloxacin in urine (Ae) were estimated. The individual profiles of the drug concentration in plasma showed little difference among the three treatments. The only consistent effect of the coadministration of levofloxacin with a high-fat meal for most subjects was that levofloxacin absorption was delayed and Cmax was slightly reduced (Tmax, 1.0 and 2.0 h for fasting and fed conditions, respectively [P = 0.002]; Cmax, 5.9 +/- 1.3 and 5.1 +/- 0.9 microg/ml [90% confidence interval = 0.79 to 0.94] for fasting and fed conditions, respectively). Sucralfate, which was administered 2 h after the administration of levofloxacin, appeared to have no effect on levofloxacin's disposition compared with that under the fasting condition. Mean values of Cmax and AUC from time zero to infinity were 6.7 +/- 3.2 microg/ml and 47.9 +/- 8.4 microg x h/ml, respectively, following the administration of sucralfate compared to values of 5.9 +/- 1.3 microg/ml and 50.5 +/- 8.1 microg x h/ml, respectively, under fasting conditions. The mean t1/2, CL/F, CLR, and Ae values were similar among all three treatment groups. In conclusion, the absorption of levofloxacin was slightly delayed by food, although the overall bioavailability of levofloxacin following a high-fat meal was not altered. Finally, sucralfate did not alter the disposition of levofloxacin when sucralfate was given 2 h after the administration of the antibacterial agent, thus preventing a potential drug-drug interaction.

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