Real-World Clinical Outcomes Associated with Canagliflozin in Patients Aged 65 Years and Older with Type 2 Diabetes Mellitus in Spain: The Old Real-Wecan Study

The observational Real-Wecan study showed that canagliflozin 100 mg (CANA100) as an add-on therapy, and canagliflozin 300 (CANA300), switching from prior SGLT-2i therapy, significantly improved several cardiometabolic parameters in patients with T2DM. The aim of this sub-analysis was to assess the effectiveness and safety of canagliflozin in patients aged ≥65 years. The primary outcome of the study was the mean change in HbA1c over the follow-up period. A total of 583 patients met the inclusion criteria (39.5% ≥65 years), 279 in the cohort of CANA100 (36.9% ≥65 years; mean HbA1c 8.05%) and 304 in the cohort of CANA300 (mean age 61.1 years; 41.8% ≥65 years; mean HbA1c 7.51%). In the CANA100 cohort, older patients showed significant reductions in HbA1c (−0.78%) and weight (−4.5 kg). Patients aged ≥65 years switching to CANA300 experienced a significant decrease in HbA1c (−0.27%) and weight (−2.1 kg). There were no significant differences in HbA1c and weight reductions when the cohorts of patients <65 and ≥65 years were compared in a multiple linear regression model. The safety profile of canagliflozin was similar in both age groups. These findings support canagliflozin as an effective therapeutic option for older adults with T2DM.

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REAL-WORLD CLINICAL OUTCOMES ASSOCIATED WITH CANAGLIFLOZIN IN PATIENTS AGED 65 YEARS AND OLDER WITH TYPE 2 DIABETES MELLITUS IN SPAIN: THE OLD REAL-WECAN STUDY.

10.22541/au.161012555.53454416/v1 ◽

2021 ◽

Author(s):

MANUEL GARGALLO-FERNANDEZ ◽

Alba Galdón Sanz-Pastor ◽

Teresa Antón-Bravo ◽

MIGUEL BRITO-SANFIEL ◽

Jaime Wong-Cruz ◽

...

Keyword(s):

Older Patients ◽

Primary Outcome ◽

Therapeutic Option ◽

Age Groups ◽

Multiple Linear Regression Model ◽

Inclusion Criteria ◽

Effective Therapeutic Option ◽

The Mean

Abstract Objectives The observational REAL WECAN study showed that canagliflozin 100 mg (CANA100) as add-on therapy, and canagliflozin 300 mg (CANA300), switching from prior SGLT-2i therapy, significantly improved several cardiometabolic parameters in patients with T2DM. The aim of this sub-analysis was to assess the effectiveness and safety of canagliflozin in patients aged >65 years. The primary outcome of the study was the mean change in HbA1c over the follow-up time. Materials and Methods 583 patients met the inclusion criteria (39.5% > 65 years), 279 in the CANA100 cohort (36.9 % > 65 years, mean HbA1c 8.05%) and 304 in the CANA300 cohort (41.8 % > 65 years, mean HbA1c 7.51%). Results In the CANA100 cohort, older patients showed significant reductions in HbA1c (-0.78%) and weight (-4.5 kg). Patients aged >65 years switching to CANA300 experienced a significant decrease in HbA1c (-0.27%) and weight (-2.1 kg). There were no significant differences in HbA1c and weight reductions when the cohorts of patients <65 and >65 years were compared in a multiple linear regression model. The safety proﬁle of canagliﬂozin was similar in both age groups. Conclusion These ﬁndings support canagliﬂozin as an effective therapeutic option for older adults with T2DM

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Real-World Clinical Outcomes Associated with Canagliflozin in Patients with Type 2 Diabetes Mellitus in Spain: The Real-Wecan Study

Journal of Clinical Medicine ◽

10.3390/jcm9072275 ◽

2020 ◽

Vol 9 (7) ◽

pp. 2275

Author(s):

Juan J. Gorgojo-Martínez ◽

Manuel A. Gargallo-Fernández ◽

Alba Galdón Sanz-Pastor ◽

Teresa Antón-Bravo ◽

Miguel Brito-Sanfiel ◽

...

Keyword(s):

Diabetes Mellitus ◽

Real World ◽

Primary Outcome ◽

Baseline Hba1c ◽

Real World Setting ◽

Antihyperglycemic Therapy ◽

The Mean ◽

Hba1c Levels

The aims of this multicentric retrospective study were to assess in a real-world setting the effectiveness and safety of canagliflozin 100 mg/d (CANA100) as an add-on to the background antihyperglycemic therapy, and to evaluate the intensification of prior sodium–glucose co-transporter type 2 inhibitor (SGLT-2i) therapy by switching to canagliflozin 300 mg/d (CANA300) in patients with T2DM. One cohort of SGLT2i-naïve patients with T2DM who were initiated on CANA100 and a second cohort of patients with prior background SGLT-2i therapy who switched to CANA300 were included in the study. The primary outcome of the study was the mean change in HbA1c over the follow-up time. In total, 583 patients were included—279 in the cohort of CANA100 (HbA1c 8.05%, weight 94.9 kg) and 304 in the cohort of CANA300 (HbA1c 7.51%, weight 92.0 kg). Median follow-up periods in both cohorts were 9.1 and 15.4 months respectively. CANA100 was associated to significant reductions in HbA1c (−0.90%) and weight (−4.1 kg) at the end of the follow-up. In those patients with baseline HbA1c > 8% (mean 9.25%), CANA100 lowered HbA1c levels by 1.51%. In the second cohort, patients switching to CANA300 experienced a significant decrease in HbA1c (−0.35%) and weight (−2.1 kg). In those patients with baseline HbA1c > 8% (mean 8.94%), CANA300 lowered HbA1c levels by 1.12%. There were significant improvements in blood pressure in both cohorts. No unexpected adverse events were reported. In summary, CANA100 (as an add-on therapy) and CANA300 (switching from prior SGLT-2i therapy) significantly improved several cardiometabolic parameters in patients with T2DM.

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Dissecting spinal aneurysms: conservative management as a therapeutic option

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2017-013566 ◽

2017 ◽

Vol 10 (5) ◽

pp. 451-454 ◽

Cited By ~ 8

Author(s):

Guilherme Dabus ◽

Renato Tavares Tosello ◽

Benedito J A Pereira ◽

Italo Linfante ◽

Ronie L Piske

Keyword(s):

Conservative Management ◽

Therapeutic Option ◽

Anterior Spinal Artery ◽

Inclusion Criteria ◽

Posterior Spinal Artery ◽

Institutional Review Board Approval ◽

Institutional Review ◽

The Mean ◽

Dissecting Aneurysms

ObjectiveIsolated dissecting spinal aneurysms are rare lesions that pose a therapeutic challenge. We report our experience in the management of four patients with dissecting spinal aneurysms.MethodsAfter institutional review board approval was obtained, the neurointerventional databases of the two participating institutions were retrospectively reviewed. Aneurysms in the anterior spinal artery, posterior spinal artery, or in a radiculomedullary artery were included in the analysis. Flow-related aneurysms were excluded. Data on clinical presentation, hemorrhage location, aneurysm size, location, angiographic follow-up, re-hemorrhage, and clinical outcome were obtained and analyzed.ResultsFour patients with five spinal dissecting aneurysms met the inclusion criteria. There were two women and the mean age was 63 years (range 36–64). All patients presented with hemorrhage. Three radiculomedullary arteries in two different patients had one lesion each; the other two involved the anterior spinal artery and a posterior spinal artery in different patients. All four patients were managed conservatively. Follow-up angiography (5.5 months) demonstrated occlusion of all five aneurysms. There was no re-hemorrhage and all patients had a good outcome at the last follow-up (modified Rankin Scale score 0–2).ConclusionsConservative management of ruptured spontaneous dissecting spinal aneurysms is a reasonable therapeutic option capable of achieving favorable angiographic and clinical outcomes.

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666 Complete vs. culprit-only strategy in older MI patients with multi-vessel disease

European Heart Journal Supplements ◽

10.1093/eurheartj/suab140.011 ◽

2021 ◽

Vol 23 (Supplement_G) ◽

Author(s):

Serena Caglioni ◽

Daniela Mele ◽

Filippo Maria Verardi ◽

Roberta Campana ◽

Andrea Erriquez ◽

...

Keyword(s):

Primary Outcome ◽

Propensity Scores ◽

Target Population ◽

Complete Revascularization ◽

Inclusion Criteria ◽

Kaplan Meier ◽

All Cause Mortality ◽

The Mean ◽

Multivariable Adjustment

Abstract Aims The revascularization strategy to pursue in older myocardial infarction (MI) patients with multivessel disease (MVD) is currently unknown. For this reason, while waiting for the results of dedicated trials, we sought to compare a complete vs. a culprit-only strategy in older MI patients by merging data from four registries. Methods and results The inclusion criteria for the target population of the present study were: (i) age ≥75 years; (ii) MI (STE or NSTE); (iii) MVD; and (iv) successful treatment of culprit lesion. Propensity scores (PS) were derived using logistic regression (backwards stepwise selection, P < 0.2. The primary outcome was all-cause mortality. Secondary outcomes were cardiovascular (CV) death, MI, major bleeding. Multivariable adjustment included the PS and inverse probability of treatment weighting (IPTW). The Kaplan–Meier plots were weighted for IPT. Among 2087 patients included, 1362 (65%) received culprit-only treatment whereas 725 (35%) complete revascularization. The mean age was 81.5 years, while mean Follow-up was 419 ± 284 days. Seventy-four patients (10%) died in the complete group and 223 in the culprit-only one (16%). The adjusted cumulative 1-year mortality was 9.7% in the complete and 12.9% in the culprit-only group (adjusted HR: 0.67, 95% CI: 0.50–0.89). Complete revascularization was associated with lower incidence of CV death (adjusted HR: 0.68, 95% CI: 0.48–0.95) and MI (adjusted HR: 0.67, 95% CI: 0.48–0.95). Conclusions Culprit-only is the default strategy in older MI patients with MVD. In our analysis, complete revascularization was associated with lower all-cause and CV mortality and with a lower MI rate.

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Muscle strength, an independent determinant of glycemic control in older adults with long-standing type 2 diabetes: a prospective cohort study

BMC Geriatrics ◽

10.1186/s12877-021-02629-5 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Bo Kyung Koo ◽

Seoil Moon ◽

Min Kyong Moon

Keyword(s):

Insulin Resistance ◽

Type 2 Diabetes ◽

Older Adults ◽

Glycemic Control ◽

Muscle Mass ◽

Older Patients ◽

Primary Outcome ◽

Muscle Quality

Abstract Background Although the proportion of older patients with type 2 diabetes mellitus (T2DM) has increased, few studies have reported the factors affecting glucose levels in older patients with long-standing T2DM. This study assessed the determinants of glycemic control in older adults with T2DM of a duration of ≥10 years, including muscle mass, muscle quality, and β-cell function. Methods This was a prospective study of older patients aged ≥60 years with a T2DM duration of ≥10 years. The Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index, handgrip strength (HGS), and body composition through bioelectrical impedance analysis were assessed. The primary outcome was a composite of: (i) increment of glycated hemoglobin (HbA1c) from the baseline ≥0.6% and (ii) HbA1c ≥ 9% at any time point during the follow-up period. To find the predicting determinants of the outcome, we performed the Cox proportional hazard analysis. Results Among 100 patients (mean age, 64.0 ± 8.6 years; median duration of diabetes, 20 [interquartile range (IQR), 17–23] years; median HbA1c at baseline, 7.1 [IQR, 6.7–7.4] %), the primary outcome was observed in 40 (40.0%) patients during 4.0 (IQR 2.3–5.0) years of follow-up. A Cox proportional hazards model adjusted for age, sex, baseline HbA1c, obesity, duration of DM and anti-diabetic medication at baseline showed that low HGS and insulin resistance at the baseline were independent determinants of the primary outcome (hazard ratio [HR] = 2.23 [95% confidence interval (CI), 1.06–4.72] and 2.39 [95% CI, 1.18–4.83], respectively). Sex stratification confirmed that HGS and muscle mass were independent determinants of the primary outcome only in women (HR per quartile, 0.58 [95% CI, 0.37–0.93] and 0.46 [95% CI, 0.25–0.85], respectively). `. Conclusions Low HGS and insulin resistance were independent risk factors for aggravated glycemic control among older patients with long standing T2DM.

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Hybrid Endovascular Repair of Thoracoabdominal Aorta: Early Results

The Heart Surgery Forum ◽

10.1532/hsf98.2014315 ◽

2014 ◽

Vol 17 (3) ◽

pp. 146

Author(s):

Osman Tansel Darcin ◽

Mehmet Kalender ◽

Ayse Gul Kunt ◽

Okay Guven Karaca ◽

Ata Niyazi Ecevit ◽

...

Keyword(s):

Endovascular Repair ◽

Therapeutic Option ◽

Complete Recovery ◽

Aortic Aneurysms ◽

Thoracoabdominal Aorta ◽

Mortality And Morbidity ◽

Early Results ◽

The Mean ◽

Procedural Success

Background: Thoracoabdominal aortic aneurysms (TAAA) present a significant clinical challenge, as they are complex and require invasive surgery. In an attempt to prevent considerably high mortality and morbidity in open repair, hybrid endovascular repair has been developed by many authors. In this study, we evaluated the early-term results obtained from this procedure.Methods: From November 2010 to February 2013, we performed thoracoabdominal hybrid aortic repair in 18 patients. The mean age was 68 years (12 men, 6 women). All of the patients had significant comorbidities. Follow-up computed tomography (CT) scans were performed at 1 week, 3 months, 6 months, and annually thereafter.Results: All patients were operated on in a staged procedure and stent graft deployment was achieved. Procedural success was achieved in all cases. All patients were discharged with complete recovery. No endoleaks weres detected in further CT examination.Conclusion: Our results suggests that hybrid debranching and endovascular repair of extensive thoracoabdominal aneurysms represents a suitable therapeutic option to reduce the morbidity and mortality of TAAA repair, particularly in those typically considered at high risk for standard repair.

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Impact of comprehensive management on clinical outcomes in hypertensive patients with coronary artery disease: HIJ-CREATE sub-study

European Heart Journal ◽

10.1093/ehjci/ehaa946.2796 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

H Ogawa ◽

H Sekiguchi ◽

K Jujo ◽

E Kawada-Watanabe ◽

H Arashi ◽

...

Keyword(s):

Coronary Artery Disease ◽

Primary Outcome ◽

Ldl Cholesterol ◽

Lipid Lowering ◽

Hypertensive Patients ◽

Mean Values ◽

Comprehensive Management ◽

The Mean ◽

Artery Disease

Abstract Background There are limited data on the effects of blood pressure (BP) control and lipid lowering in secondary prevention of coronary artery disease (CAD) patients. We report a secondary analysis of the effects of BP control and lipid management in participants of the HIJ-CREATE, a prospective randomized trial. Methods HIJ-CREATE was a multicenter, prospective, randomized, controlled trial that compared the effects of candesartan-based therapy with those of non-ARB-based standard therapy on major adverse cardiac events (MACE; a composite of cardiovascular death, non-fatal myocardial infarction, unstable angina, heart failure, stroke, and other cardiovascular events requiring hospitalization) in 2,049 hypertensive patients with angiographically documented CAD. In both groups, titration of antihypertensive agents was performed to reach the target BP of <130/85 mmHg. The primary endpoint was the time to first MACE. Incidence of endpoint events in addition to biochemistry tests and office BP was determined during the scheduled 6, 12, 24, 36, 48, and 60-month visits. Achieved systolic BP and LDL-Cholesterol (LDL-C) level were defined as the mean values of these measurements in patients who did not develop MACEs and as the mean values of them prior to MACEs in those who developed MACEs during follow-up. Results During a median follow-up of 4.2 years (follow-up rate of 99.6%), the primary outcome occurred in 304 patients (30.3%). Among HIJ-CREATE participants, 905 (44.2%) were prescribed statins on enrollment. Kaplan–Meier curves for the primary outcome revealed that there was no relationship between statin therapy and MACEs in hypertensive patients with CAD. The original HIJ-CREATE population was divided into 9 groups based on equal tertiles based on mean achieved BP and LDL-C during follow-up. For the analysis of subgroups, estimates of relative risk and the associated 95% CIs were generated with a Cox proportional-hazards model (Figure 1). The relation between LDL cholesterol level and hazard ratios for MACEs was nonlinear, with a significant increase of MACEs only in the patients with inadequate controlled LDL-C level even in the patients with tightly controlled BP. Conclusions The results of the post-hoc analysis of the HIJ-CREATE suggest that clinicians should pay careful attention to conduct comprehensive management of lipid lowering even in the contemporary BP lowering for the secondary prevention in hypertensive patients with CAD. Figure 1 Funding Acknowledgement Type of funding source: None

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Partial pulpotomy without age restriction: a retrospective assessment of permanent teeth with carious pulp exposure

Clinical Oral Investigations ◽

10.1007/s00784-021-04007-2 ◽

2021 ◽

Author(s):

Florin Eggmann ◽

Thomas J. W. Gasser ◽

Hanjo Hecker ◽

Mauro Amato ◽

Roland Weiger ◽

...

Keyword(s):

Survival Rates ◽

Age Groups ◽

Permanent Teeth ◽

Eligibility Criteria ◽

Presumptive Diagnosis ◽

Tooth Discoloration ◽

Significant Difference ◽

Pulp Exposure ◽

The Mean

Abstract Objectives This study aimed to retrospectively evaluate clinical and radiographic outcomes of partial pulpotomy performed in permanent teeth with carious pulp exposure. Materials and methods Records of patients undergoing treatment at an undergraduate dental clinic between 2010 and 2019 were screened for partial pulpotomies in teeth with a presumptive diagnosis of normal pulp or reversible pulpitis. The follow-up had to be ≥ 1 year. Patient data were retrieved and analyzed using Mantel-Cox chi square tests and Kaplan–Meier statistics. The level of significance was set at α = 0.05. Results Partial pulpotomy was performed in 111 cases, of which 64 (58%) fulfilled the eligibility criteria. At the time of partial pulpotomy, the mean age was 37.3 (± 13.5) years (age range 18–85). The mean observation period was 3.1 (± 2.0) years. Two early failures (3.1%) and five late failures (7.7%) were recorded. The overall success rate of maintaining pulp vitality was 89.1%, with 98.4% tooth survival. The cumulative pulp survival rates of partial pulpotomy in patients aged < 30 years, between 30 and 40 years, and > 40 years were 100%, 75.5%, and 90.5%, respectively, with no significant difference between the age groups (p = 0.225). At follow-up, narrowing of the pulp canal space and tooth discoloration were observed in 10.9% and 3.1% of cases, respectively. Conclusions Across age groups, partial pulpotomy achieved favorable short and medium-term outcomes in teeth with carious pulp exposure. Clinical relevance Adequate case selection provided, partial pulpotomy is a viable operative approach to treat permanent teeth with deep carious lesions irrespective of patients’ age.

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Minimum 2-Year Outcomes of All-Arthroscopic Capsular Autograft Labral Reconstruction

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967121s00242 ◽

2021 ◽

Vol 9 (7_suppl4) ◽

pp. 2325967121S0024

Author(s):

Michael Kucharik ◽

Paul Abraham ◽

Mark Nazal ◽

Nathan Varady ◽

Wendy Meek ◽

...

Keyword(s):

Body Mass Index ◽

Body Mass ◽

Donor Site ◽

Donor Site Morbidity ◽

Labral Tear ◽

Labral Repair ◽

Inclusion Criteria ◽

The Mean ◽

Tönnis Grade

Objectives: Acetabular labral tears distort the architecture of the hip and result in accelerated osteoarthritis and increases in femoroacetabular stress. Uncomplicated tears with preserved, native fibers can be fixed to acetabular bone using labral repair techniques, which have shown improved outcomes when compared to the previous gold standard, labral debridement and resection. If the tear is complex or the labrum is hypoplastic, labral reconstruction techniques can be utilized to add grafted tissue to existing, structurally intact tissue or completely replace a deficient labrum. The ultimate goal is to reconstruct the labrum to restore the labral seal and hip biomechanics. Clinical outcomes using autografts and allografts from multiple sources for segmental and whole labral reconstruction have been reported as successful. However, reconstruction using autografts has been associated with substantial donor-site morbidity. More recently, all-arthroscopic capsular autograft labral reconstruction has been proposed as a way to repair complex or irreparable tears without the downside of donor-site morbidity. Since all-arthroscopic capsular autograft labral reconstruction is a novel technique, there is limited data in the literature on patient outcomes. The purpose of this study is to report outcomes in patients who have undergone this procedure at a minimum 2-year follow-up. Methods: This is a retrospective case series of prospectively collected data on patients who underwent arthroscopic acetabular labral repair by a senior surgeon between December 2013 and May 2017. Patients who failed at least 3 months of conservative therapy and had a symptomatic labral tear on magnetic resonance angiography (MRA) were designated for hip arthroscopy. The inclusion criteria for this study were adult patients age 18 or older who underwent arthroscopic labral repair with capsular autograft labral reconstruction and completion of a minimum 2-year follow-up. Intraoperatively, these patients were found to have a labrum with hypoplastic tissue (width < 5 mm), complex tearing, or frank degeneration of native tissue. Patients with lateral center edge angle (LCEA) ≤ 20° were excluded from analysis. Using the patients’ clinical visit notes with detailed history and physical exam findings, demographic and descriptive data were collected, including age, sex, laterality, body mass index (BMI), and Tönnis grade to evaluate osteoarthritis. Patients completed patient-reported outcome measures and postoperatively at 3 months, 6 months, 12 months, and annually thereafter. Results: A total of 72 hips (69 patients) met inclusion criteria. No patients were excluded. The cohort consisted of 37 (51.4%) male and 35 (48.6%) female patients. The minimum follow-up was 24 months, with an average follow-up of 30.3 ± 13.2 months (range, 24-60). The mean patient age was 44.0 ± 10.4 years (range 21-64), with mean body mass index of 26.3 ± 4.3. The cohort consisted of 6 (8.3%) Tönnis grade 0, 48 (66.7%) Tönnis grade 1, and 18 (25.0%) Tönnis grade 2. Two (2.8%) progressed to total hip arthroplasty. Intraoperatively, 5 (6.9%) patients were classified as Outerbridge I, 14 (19.4%) Outerbridge II, 45 (62.5%) Outerbridge III, and 8 (11.1%) Outerbridge IV. Seventy-two (100.0%) patients had a confirmed labral tear, 34 (47.2%) isolated pincer lesion, 4 (5.6%) isolated CAM lesion, and 27 (37.5%) had both a pincer and CAM lesion. The mean of differences between preoperative and 24-month postoperative follow-up PROMs was 22.5 for mHHS, 17.4 for HOS-ADL, 32.7 for HOS-Sport, 22.9 for NAHS, 33.9 for iHOT-33. (Figure 1) The mean of differences between preoperative and final post-operative follow-up PROMs was 22.1 for mHHS, 17.6 for HOS-ADL, 33.2 for HOS-Sport, 23.3 for NAHS, and 34.2 for iHOT-33. (Table 1) Patient age and presence of femoroacetabular impingement were independently predictive of higher postoperative PROM improvements at final follow-up, whereas Tönnis grade was not. (Table 2) The proportion of patients to achieve the minimally clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptom state (PASS) thresholds were also calculated. (Table 3) Conclusions: In this study of 72 hips undergoing arthroscopic labral repair with capsular autograft labral reconstruction, we found excellent outcomes that exceeded the MCID thresholds in the majority of patients at an average 30.3 months follow-up. When compared to capsular reconstruction from autografts and allografts, this technique offers the potential advantages of minimized donor-site morbidity and fewer complications, respectively. [Table: see text][Table: see text][Table: see text]

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FXa Inhibition and Coagulation Changes During DVT Prophylaxis by Enoxaparin Over the Course of a 15-Day Follow-Up in Septic Patients

Clinical and Applied Thrombosis/Hemostasis ◽

10.1177/1076029609345686 ◽

2009 ◽

Vol 16 (5) ◽

pp. 584-590 ◽

Cited By ~ 7

Author(s):

Zuzana Zenáhlíková ◽

Jan Kvasnička ◽

Zuzana Kudrnová ◽

Magda Sudrová ◽

Radka Brzežková ◽

...

Keyword(s):

Severe Sepsis ◽

Protein C ◽

Factor Xa ◽

Inclusion Criteria ◽

C Reactive Protein ◽

Once Daily ◽

Reactive Protein ◽

Factor Xa Inhibition ◽

The Mean

The objective of our study was to examine the changes in coagulation parameters and inflammatory reaction over the course of 15 days in patients with severe sepsis. We tried to identify mechanisms by which sepsis-induced pathophysiological changes may influence the effectiveness of subcutaneously (SC) administered enoxaparin 40 mg once daily. A total of 16 patients (8 men, 8 women; age 35-83 years) meeting the inclusion criteria of severe sepsis were enrolled in this study. The follow-up was performed on days 1, 2, 3, 6, 9, 12, and 15 of hospitalization at the intensive care unit (ICU). Blood coagulation (activated partial thromboplastin time [aPTT], prothrombin time [PT], fibrinogen, antithrombin (AT), protein C [PC], D-dimer, fragment 1.2 [F1.2], factor Xa [FXa] inhibition) and inflammatory reactants (interleukin 6 [IL-6], C-reactive protein [CRP], orosomucoid, α-1-antitrypsin) were tested. The mean FXa inhibition was 0.17 (±0.17) IU/mL. The arbitrarily established range of FXa inhibition for prophylaxis, 0.2 to 0.4 IU/mL, was reached in 22 cases (20%), while in 74 cases (68%), it was below and in 13 cases (12%) above the aforementioned range. Factor Xa inhibition positively correlated with AT (r = .42; P < .001) and PC (r = .45; P < .001) activities. A negative correlation was found between the FXa inhibition and α-1-antitrypsin concentrations (r = —.33; P = .01) but only in the subgroup with α-1-antitrypsin concentrations ≥2.2 g/L. We confirmed that in most patients with sepsis, the prophylaxis with enoxaparin did not lead to the required FXa inhibition. The inhibition of FXa by enoxaparin depends mainly on the AT and PC activities.

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