44 results on '"G. Stemer"'
Search Results
2. PB2153: SURGICAL SPECIMENS OF INDOLENT AND AGGRESSIVE B-NHLS SHOW DIFFERENCES IN THEIR FLOW-CYTOMETRY PROFILE OF PLOIDY, PROLIFERATING FRACTION AND PROPORTION OF TUMOR-ASSOCIATED MYELOID AND T-CELL SUBSETS
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D. Azoulay, T. Tapuchi, H. I. Cohen, L. Akria, G. Stemer, and O. Ronen
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Diseases of the blood and blood-forming organs ,RC633-647.5 - Published
- 2022
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3. Topic: AS06-Prognosis/AS06a-Prognostic factors of outcome and risk assessment: INCREASED DNA-CELL-CYCLE S-PHASE FRACTION IS RELATED TO INCREASED INCIDENCES OF IMMATURE MYELOID CELLS AND HIGH IPSS-R RISK ASSESSMENT IN PATIENTS WITH MYELODYSPLASTIC SYNDROME
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D. Azoulay, A. Paz-Frydman, and G. Stemer
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Cancer Research ,Oncology ,Hematology - Published
- 2023
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4. 5PSQ-010 Identification of incorrect dosing of direct oral anticoagulants: an important intervention to improve patient safety
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F Nagele, E Tudela-Lopez, M Hana, M Holbik, S Zotter, M Amtmann, B Datterl, P Pölzleitner, K Jadrna, G Stemer, and M Anditsch
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- 2022
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5. 4CPS-207 Improving the safety of pharmacotherapy in paediatric haemato-oncology by clinical pharmacy services
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C Gradwohl, H Pichler, G Engstler, F Nagele, M Anditsch, and G Stemer
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- 2022
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6. PB1869 PERSISTENT COMPLEMENT ACTIVATION IS PROVOKED BY IGG-AGGREGATES IN A SUB-POPULATION OF CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS
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Tamar Tadmor, Ariel Aviv, Lev Shvidel, G. Stemer, M. Shehadeh, Andrei Braester, M. Yuklea, N. Rahimi-Levene, R. Michelis, M. Barhoum, and Najib Dally
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education.field_of_study ,business.industry ,Chronic lymphocytic leukemia ,Population ,Immunology ,medicine ,Hematology ,education ,medicine.disease ,business ,Complement system - Published
- 2019
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7. CP-084 The clinical pharmacist resolves medication related problems in cardiosurgery patients
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P Pölzleitner, K Jadrna, T Mitteregger, E Tudela-Lopez, and G Stemer
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General Pharmacology, Toxicology and Pharmaceutics - Published
- 2016
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8. Pill Burden, Age or Education - What Impacts On Medication Knowledge and Adherence to Immunosuppressive Therapy in Kidney Transplant Recipients (KTRs)?
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B. Watschinger, M. Groß, G. Stemer, R. Lemmens-Gruber, B. Gnam, and R. Ristl
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Transplantation ,medicine.medical_specialty ,business.industry ,Pill ,medicine ,Or education ,Intensive care medicine ,business ,Kidney transplant - Published
- 2014
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9. Clinical pharmacy services and solid organ transplantation: a literature review.
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G. Stemer and R. Lemmens-Gruber
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Abstract Aim of the review Organ transplantation represents the therapy of choice for most types of end-stage organ failure, and post-transplant patient care warrants great attention. The aim of this study was to summarise the available evidence regarding the role and impact of clinical pharmacy services in the care of solid organ transplant patients. Methods A search of the literature was conducted using the MEDLINE, EMBASE and IPA databases to identify studies relevant to our investigation of the impact of clinical pharmacists’ interventions. Results Only five out of nineteen of the included studies were randomised controlled trials; eleven studies were descriptive, and three were before-after studies. Interventions performed in these studies consisted of routine clinical pharmacy services with a focus on identifying, resolving and preventing drug-related problems; clinical pharmacy services with a focus on therapeutic drug monitoring; and those with a focus on compliance enhancement and educational interventions. The number and type of interventions and the physicians’ acceptance rates were assessed in the majority of the included studies. Acceptance rates were generally above 95%, and most studies reported that clinical pharmacy services had a positive impact on the care of solid organ transplant patients. Positive perceptions of patients and health care professionals are also reported. In two of the studies, patients’ compliance rates and drug knowledge were assessed following counselling by a pharmacist. Dosing-related interventions were the most common interventions proposed. Immunosuppressants, cardiovascular drugs and antimicrobials were the drug classes most affected by the clinical pharmacists’ interventions. Conclusions High quality evidence that supports the benefit of clinical pharmacy services in the care of solid organ transplant patients is rare. Nevertheless, all of the included studies showed that clinical pharmacy services had a positive impact. Furthermore, all included studies showed that patients and physicians appreciated clinical pharmacists. The various outcome measures used in these studies were improved by interactions with clinical pharmacists. More randomised controlled trials are needed to contribute to the paucity of the existing evidence. [ABSTRACT FROM AUTHOR]
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- 2010
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10. Flow-cytometry Assessment of DNA content and Immunophenotyping of Immune-cells in Lymph-node-specimens as a Potential Diagnostic Signature of Aggressiveness in B-Non-Hodgkin Lymphomas.
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Azoulay D, Tapuchi T, Ronen O, Akria L, Cohen HI, Surio C, Chepa SR, Eshel E, Zarfati M, Stemer G, and Horowitz NA
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- Humans, Male, Female, Middle Aged, Aged, Adult, Retrospective Studies, Lymphoma, B-Cell diagnosis, Lymphoma, B-Cell pathology, Lymphoma, B-Cell immunology, Lymphoma, B-Cell classification, Aged, 80 and over, DNA, Neoplasm analysis, Lymph Nodes pathology, Flow Cytometry methods, Immunophenotyping methods
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Flow-cytometry (FC) is a powerful tool that can assist in lymphoma diagnosis in lymph node (LN) specimens. Although lymphoma diagnosis and classification are mainly based on tumor cell characteristics, surrounding cells are less employed in this process. We retrospectively investigated alterations in the ploidy status, proliferative cell fraction (PF) and the percentages of surrounding immune cells in 62 consecutive LN specimens with B-Cell Non-Hodgkin Lymphoma (B-NHL) that were submitted for FC evaluation between 2019-2022. Compared with indolent B-NHLs, aggressive B-NHLs show increased DNA aneuploidy and PF, increased monocytes, immature-granulocytes, mature granulocytes, CD8
+ T-cells, Double-Negative-T-cells and Double-Positive-T-cells, and decreased total CD45+ cells, total lymphocytes, CD4+ T-cells and CD4/CD8 ratio. Receiver operating characteristic analysis determined PF > 6.8% and immature-granulocytes > 0.9% as optimal cutoffs with highest specificity and sensitivity in differentiating aggressive and indolent B-NHLs. These findings further strength the diagnostic value of DNA content analysis by FC and suggest the utilization of tumor surrounding immune cells in NHL diagnosis and classification., (© 2024. The Author(s).)- Published
- 2024
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11. Outcomes of Fedratinib in Routine Treatment of Ruxolitinib-Resistant or -Refractory Patients with Primary and Post-Polycythemia Vera or Essential Thrombocythemia Myelofibrosis: A Nationwide Retrospective Study.
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Duek A, Tzinman A, Maziuk K, Levy A, Ellis M, Stemer G, Shacham Abulafia A, Cohen A, Lavi N, Ronson A, Braester A, Shapira S, Canaani J, Volchek Y, Leiba R, and Leiba M
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Introduction: In recent years, fedratinib, a selective JAK2 inhibitor, has emerged as a potential therapeutic option for patients who have failed or are intolerant to ruxolitinib. Despite the promising results observed in clinical studies, real-world evidence from the USA and Europe suggests that the efficacy of fedratinib may be less conclusive. We report the characteristics, treatment patterns, and clinical outcomes of patients with myelofibrosis (MF) treated with fedratinib following ruxolitinib failure in Israel's clinical practice., Methods: This retrospective patient chart review included adults with a physician-reported diagnosis of MF, who initiated fedratinib after discontinuing ruxolitinib. Descriptive analyses characterized patient characteristics, clinical outcomes, and treatment patterns from MF diagnosis through ruxolitinib and fedratinib treatment., Results: We extracted data for 16 eligible patients. Approximately 62.5% of the patients were female, and the median age was 77 (range: 63-85) years. The median duration of ruxolitinib therapy was 17 months (range: 3-84) months. Before the initiation of fedratinib, the median spleen size by palpation was 15.5 cm below the costal margin (range: 4-22 cm). After 3 months the median spleen size was 13 cm below the costal margin (range: 2-21 cm). Only 2 patients showed minimal improvement after 6 months, while 3 patients progressed, and 2 patients showed no change in the spleen size. The spleen response did not improve after 12 months of treatment. At this point, the median spleen size was 19 cm below the costal margin (range: 2-30 cm). Regarding the MF-related symptoms, 43.75% (n = 7) of patients reported some improvement, 37.5% (n = 6) showed no changes, whereas 18.75% (n = 3) of the population complained of worsening. Gastrointestinal toxicity was the most frequent adverse effect of the drug, while 31% of patients died., Conclusion: Our observations showed that in MF patients who have failed to ruxolitinib, the therapeutic value from fedratinib may be modest, especially when exposure time to ruxolitinib was more than 12 months. Early switching from ruxolitinib to fedratinib may yield a better result., (© 2024 S. Karger AG, Basel.)
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- 2024
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12. Costs, challenges and opportunities of decentralised chimeric antigen receptor T-cell production: a literature review and clinical experts' interviews.
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Stemer G, Mittermayr T, Schnell-Inderst P, and Wild C
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The objectives were to summarise the evidence and clinical experts' views comparing the use of decentralised produced chimeric antigen receptor (CAR) T-cell therapies versus commercially available products, regarding drug costs, time to finalised product and other reported advantages, disadvantages, challenges and facilitators. A literature review according to the PRISMA guidelines was conducted in Medline, Embase and Trip databases. Publications were included if they reported information on cost estimates, time to finalised products and other outcomes of interest of a decentralised CAR T-cell production strategy. A structured interview guide was developed and used for qualitative expert interviews. Five experts were purposively selected, and interviews were either conducted face-to-face or online, and recorded for the purpose of transcription. Transcripts were analysed and categories and codes extracted. Reporting is based on the COREQ checklist for reporting qualitative research. Costs of decentralised produced CAR T-cells appear to be lower by a factor two to 14, compared with commercial products. But there is high uncertainty about this estimate, because it is unclear whether cost components included are comparable and due to the heterogeneity of the studies. The most commonly reported advantages were proximity to patients and decreased product risks and costs, whereas the continuing dependency on centrally manufactured reagents and specific characteristics of 'fresh' CAR T-cells are reported as disadvantages. Compliance with regulatory requirements is mentioned as the biggest challenge. The availability of closed-system production devices is reported as one main facilitator, as are clear commitment, secured financing and knowledge transfer from already experienced centres. Apparent cost differences open a field for healthcare decision-makers to discuss and justify investment costs for implementation of a complementing decentralised production programme and to realise other associated benefits of such a strategy, such as flexibility, patient proximity and expanding patient access., Competing Interests: Competing interests: The first author is associate editor at EJHP. The authors declare having no conflict of interest., (© European Association of Hospital Pharmacists 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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13. The threatened medicines information pharmacist!
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Stemer G and Williams SD
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- Humans, Professional Role, Drug Information Services standards, Pharmacists trends
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Competing Interests: Competing interests: Both authors are editors of EJHP.
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- 2024
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14. Liquid antimicrobials: a national analysis of critical shortages.
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Riesenhuber N, Krauss M, Moßburger K, Gradwohl C, and Stemer G
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Medicine shortages, especially those involving antibiotics, pose a global public health dilemma that can lead to adverse health outcomes. The aim of this study was to assess the supply situation of various antimicrobials in liquid dosage forms, which represent the mainstay of therapy for paediatric infections. The availability was examined over a period of 27 weeks in Austria. During the time period investigated, 34 products (81.0%) were not available for over 50% of the time; eight of those (19.0%) experienced complete unavailability. Only four products (9.5%) demonstrated continuous availability. Regarding penicillin antibiotics, amoxicillin was not available for 77.8% of the time (21 weeks) and amoxicillin/clavulanic acid for 59.3% (16 weeks). Regular monitoring of availability status can help mitigate this issue; however, cross-national strategies are urgently needed to guarantee a constant supply in the future., Competing Interests: Competing interests: GS is Associate Editor of the European Journal of Hospital Pharmacy. The other authors have no relevant financial or non-financial interests to disclose., (© European Association of Hospital Pharmacists 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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15. MDS-Related Anemia Is Associated with Impaired Quality of Life but Improvement Is Not Always Achieved by Increased Hemoglobin Level.
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Haring Y, Goldschmidt N, Taha S, Stemer G, Filanovsky K, Hellman I, Okasha D, Krayem B, Levi I, Rosenbaum H, Koren-Michowitz M, Yagna S, Nemets A, Gino-Moor S, Saban R, Cohen J, Halperin E, Wolach O, Dally N, Merkel D, Oster HS, and Mittelman M
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Quality of life is impaired in MDS, but the role of hemoglobin level is unclear. To study the Hb-QoL correlation at diagnosis and 1 year later, patients filled out the EQ-5D questionnaire, assessing their mobility, self care, daily activities, pain/discomfort, and anxiety/depression, using scores of 0 (normal), 1 (mild/moderate), or 2 (poor). They also evaluated their health using a visual analogue scale, scoring from 0 (poor) to 100 (excellent). The anemia subgroups were: none/normal (Hb ≥ 12.5 g/dL), mild (10 ≤ Hb < 12.5), moderate (9 ≤ Hb < 10), severe (8 ≤ Hb < 9), or very severe (Hb < 8). LR-MDS patients (n = 127) and inpatient controls (n = 141) participated. The anemic patients had a poor QoL and the MDS patients had a lower QoL with a lower Hb. The controls had no QoL difference among the various anemia subgroups. In addition, the MDS QoL sharply decreased with an Hb of < 9. The MDS patients showed a wide QoL variability, i.e., different QoL scores in the same Hb subgroup, suggesting that other factors affect QoL (e.g., age and comorbidities). After 1 year (n = 61), the QoL was still poor for most MDS patients (including 27 patients with an increased Hb). In summary: (1) a poor QoL in MDS-anemia is non-linear, suggesting other influencing factors on QoL. (2) The sharp QoL drop with Hb < 9 g/dL challenges the transfusion Hb threshold. (3) The QoL in anemic MDS patients might differ from that in non-MDS patients. (4) Raising Hb, while recommended, does not guarantee an improved QoL.
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- 2023
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16. Lymphoid aggregates in the bone marrow biopsies of patients with myelodysplastic syndromes - A potential prognostic marker?
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Book R, Ben-Ezra J, Glait Santar C, Kay S, Stemer G, Oster HS, and Mittelman M
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Background: Lymphoid aggregates (LA) are occasionally seen in bone marrow biopsies (BMB) of myelodysplastic syndromes (MDS) patients. Our aim was to evaluate their incidence and association with prognosis., Methods: We compared BMB reports of MDS patients treated at the Tel Aviv Sourasky Medical Center (2011-2018), and controls (2015-2017, normal BMB), and examined the charts of the MDS patients (LA+ and LA-). Categorical, normally and non-normally distributed continuous variables were compared using Fisher's exact, independent t and Mann-Whitney tests respectively. Adjusted [age, gender, lymphocytes, white blood cells (WBC) and diabetes mellitus (DM)] Cox proportional hazard model examined survival at 12 and 24 months., Results: MDS patients (N=140) were older than controls (N=38; 74.1 vs 69.2 years, p=0.005); 34 MDS (24.3%) and 5 controls (13.2%) had LA+ (P=0.141). CD20/CD3 staining suggested LA polyclonality. MDS/LA+ (vs MDS/LA-) patients were younger, with a trend (not statistically significant) towards poor prognostic parameters: lower Hb, WBC, and platelets, higher LDH, BM cellularity, and IPSS-R score. The incidence of cardiovascular disease was similar, but MDS/LA+ had twice the incidence of DM (38.2% vs 19.0%, p=0.022). Similar trend for cancer (26.5% vs 14.3%, p=0.102). Twelve-month survival: 24/34 (70.6%) MDS/LA+; 88/106 (83.0%) MDS/LA- (p=0.140). This trend, seen in Kaplan-Meier curves, disappeared at 24 months. The hazard ratio for LA was 2.283 (p=0.055) for 12 months., Conclusion: These preliminary data suggest LA are relatively common (24%) in MDS BMB, and might indicate poor prognosis. This may reflect involvement of the immune system in MDS. Future studies will examine larger groups, to clarify the incidence, significance and the pathophysiology., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Book, Ben-Ezra, Glait Santar, Kay, Stemer, Oster and Mittelman.)
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- 2023
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17. Brain-Derived Neurotrophic Factor (BDNF) Is Associated with Platelet Activity and Bleeding Tendency in Patients with Gaucher Disease.
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Azoulay D, Naamad M, Frydman D, Broide E, Zimran A, Stemer G, and Revel-Vilk S
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- Humans, Blood Platelets metabolism, Brain-Derived Neurotrophic Factor metabolism, P-Selectin metabolism, Hemorrhage metabolism, Gaucher Disease complications, Gaucher Disease metabolism, Blood Coagulation Disorders metabolism
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Bleeding tendency, a prominent feature of patients with Gaucher disease (GD), is associated with abnormal platelet function. Brain-derived neurotrophic factor (BDNF) is a protein with neuroprotective potential stored in alpha granules of circulating platelets. Here we studied BDNF levels in 50 patients with type I GD (GD1) and their correlation with platelet activity and bleeding tendency. Flow cytometry was used to test unstimulated and stimulated measurement of platelet surface-activated expression of αIIbβ3 integrin, P-selectin and lysosomal-associated membrane protein (LAMP3/CD63). Serum and plasma BDNF levels were quantified using ELISA. The bleeding history was recorded by a bleeding questionnaire. Serum BDNF levels were positively correlated with platelet count and moderately correlated with unstimulated and stimulated platelet P-selectin expression. Patients with more than one bleeding manifestation were shown to have lower serum BDNF levels, albeit similar platelet count. Plasma BDNF levels were significantly elevated in splenectomized patients and showed a moderate positive correlation with stimulated platelet CD63 expression. These observations demonstrate the first association between BDNF levels in the peripheral blood with platelet dysfunction and increased bleeding manifestation. The role of measuring serum BDNF for assessing platelet alpha degranulation defects and bleeding risk in patients with GD and the general population needs further study.
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- 2022
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18. Increased serum level of alpha-2 macroglobulin and its production by B-lymphocytes in chronic lymphocytic leukemia.
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Michelis R, Milhem L, Galouk E, Stemer G, Aviv A, Tadmor T, Shehadeh M, Shvidel L, Barhoum M, and Braester A
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- Adult, B-Lymphocytes metabolism, Female, Humans, Immunoglobulin G metabolism, Lymphocyte Count, Pregnancy, Transcription Factors metabolism, Leukemia, Lymphocytic, Chronic, B-Cell metabolism, Pregnancy-Associated alpha 2-Macroglobulins metabolism
- Abstract
Chronic lymphocytic leukemia (CLL), the most common adult's leukemia in the western world, is caused in 95% of the cases by uncontrolled proliferation of monoclonal B-lymphocytes. The complement system in CLL is chronically activated at a low level via the classical pathway (CP). This chronic activation is induced by IgG-hexamers, which are formed after binding to alpha-2-macroglobulin (A2M). The study investigated for the first time the serum levels of A2M in CLL patients, their association with the disease severity, and A2M production by the malignant B-lymphocytes. Blood samples were collected from 65 CLL patients and 30 normal controls (NC) subjects, and used for quantifications of the A2M levels, the complement activation marker (sC5b-9), the complement components C2, C3 and C4, and clinical biochemistry and hematology parameters. The production of A2M was studied in B-lymphocytes isolated from blood samples as well as in CLL and non-CLL cell lines.The serum A2M levels were significantly higher in CLL patients vs NCs, showing values of 3.62 ± 0.22 and 1.97 ± 0.10 mg/ml, respectively. Within the CLL group, A2M levels correlated significantly with the disease stage, with sC5b-9, and with clinical indicators of the disease severity. Increased A2M production was showed in three out of four CLL B-lymphocytic lines that were studied, as compared to non-CLL lines, to a non-lymphocytic line, and to blood-derived primary B-lymphocytes. A2M production was further increased both in primary cells and in the CLL cell-line after incubation with CLL sera, compared to NC sera. This study shows for the first time that serum A2M levels in CLL are significantly increased, likely due to A2M production by the malignant B-lymphocytes, and are correlated with the disease severity and with chronic complement activation. The moderate change in A2M production after incubation with NC sera in-vitro supports the hypothesis that inhibition of excess A2M production can be achieved, and that this may potentially down-regulate the IgG-hexamerization and the resulting chronic CP activation. This may also help restore complement system activity, and eventually improve complement activity and immunotherapy outcomes in CLL., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Michelis, Milhem, Galouk, Stemer, Aviv, Tadmor, Shehadeh, Shvidel, Barhoum and Braester.)
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- 2022
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19. The Impact of Clinical Pharmacy Services in a Tertiary Care Center Specialized in Pediatric Hemato-Oncology.
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Gradwohl C, Engstler G, Anditsch M, Pichler H, and Stemer G
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Clinical pharmacy services (CPS) have shown beneficial effects on several outcome measures in hospital patients, including the reduction of drug-related problems (DRP) and of therapy costs. Less is known about the impact of CPS in pediatric haemato-oncology, even though this patient population is highly susceptible to DRP. CPS were implemented in a tertiary care children's hospital specialized in hemato-oncology and hematopoietic stem cell transplantation. The main outcome measures were type and number of DRP, type and number of pharmaceutical interventions (PI), their acceptance rate, and their clinical significance and economic benefit. During 6 months and 32 ward rounds, 275 DRP were identified and addressed by PI. The acceptance of PI was high (73.4%), and up to 80% of PI were rated as very significant or significant by independent external raters. The estimated therapy cost reductions were substantial, approaching at least EUR 54,600 for avoided follow-up costs. Conclusion: CPS improve medication safety in pediatric hemato-oncology and may reduce therapy costs.
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- 2022
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20. Eculizumab use in a tertiary care nephrology center: data from the Vienna TMA cohort.
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Aigner C, Gaggl M, Stemer G, Eder M, Böhmig G, Kain R, Prohászka Z, Garam N, Csuka D, Sunder-Plassmann R, Piggott LC, Haninger-Vacariu N, Schmidt A, and Sunder-Plassmann G
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- Antibodies, Monoclonal, Humanized adverse effects, Female, Humans, Tertiary Healthcare, Nephrology, Thrombotic Microangiopathies etiology
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Background: Practice patterns of eculizumab use are not well described. We examined indications for, and outcomes of, eculizumab therapy in a tertiary care nephrology center., Methods: We used the "Vienna TMA cohort" and the hospital pharmacy database at the Medical University of Vienna to identify patients that received eculizumab treatment between 2012 and 2019. We describe clinical characteristics, details of eculizumab use, and outcomes of patients with complement gene-variant mediated TMA (cTMA), secondary TMA (sTMA) and C3 glomerulopathy (C3G)., Results: As of December 2019, 23 patients received complement blockade at the Division of Nephrology and Dialysis: 15 patients were diagnosed with cTMA, 6 patients with sTMA and 2 patients with C3G. Causes of sTMA were bone marrow transplantation (n = 2), malignant hypertension, malignant tumor, systemic lupus erythematosus, antiphospholipid syndrome and lung transplantation (each n = 1). Across all indications, patients had a median age of 31 and were predominantly female (78%) and the median duration of treatment was 227 days. Hematological recovery was seen in most patients, while renal response was best in patients with cTMA. Adverse events were recorded in 26%., Conclusions: In summary, eculizumab is the treatment of choice for cTMA patients that do not respond to plasma therapy. In patients with sTMA and C3G, the response rates to therapy are much lower and therefore, the decision to start therapy needs to be considered carefully., (© 2021. The Author(s).)
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- 2022
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21. Is There a Predictive Value of High Mean Platelet Volume in Early Diagnosis of Venous Thromboembolism?
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Braester A, Stemer G, Khouri S, Raviv B, and Barhoum M
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- Case-Control Studies, Diagnosis, Differential, Emergency Service, Hospital statistics & numerical data, Female, Humans, Israel epidemiology, Male, Middle Aged, Negative Results, Predictive Value of Tests, Reproducibility of Results, Retrospective Studies, Time-to-Treatment, Early Diagnosis, Mean Platelet Volume methods, Venous Thromboembolism blood, Venous Thromboembolism diagnosis, Venous Thromboembolism epidemiology
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Background: Venous thromboembolism (VTE) is a serious disease, which demands a fast accurate diagnosis to begin suitable treatment. It presents a major problem in the emergency department (ED), and its confirmation requires adequate evaluation., Objectives: To evaluate a potential role of mean platelet volume (MPV) in differentiating VTE from other potential diagnosis in patients with suspected VTE., Methods: We conducted a retrospective case-controlled study of 440 consecutive patients who presented to the ED of our hospital with clinical VTE, but only 316 with proven VTE. A control group was composed of patients (124) who presented with clinical VTE but without proven VTE. We checked the MPV value in all 440 patients and the correlation with VTE occurrence in the study group vs. control group., Results: Statistical analysis of the acquired results indicated that MPV value could not aid in determining the difference of real VTE vs. patients with VTE-like clinical picture presenting to the ED. We found an inverse correlation between MPV value and proven VTE, in contrast to most researchers who have studied the same issue., Conclusions: Although MPV can be a useful diagnostic marker in many diseases, we found no definite association between low MPV and VTE.
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- 2021
22. Venetoclax combinations induce high response rates in newly diagnosed acute myeloid leukemia patients ineligible for intensive chemotherapy in routine practice.
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Apel A, Moshe Y, Ofran Y, Gural A, Wolach O, Ganzel C, Canaani J, Zektser M, Duek A, Stemer G, Hellman I, Basood M, Frisch A, Leibovitch C, and Koren-Michowitz M
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- Aged, Aged, 80 and over, Female, Humans, Leukemia, Myeloid, Acute diagnosis, Male, Middle Aged, Treatment Outcome, Antineoplastic Agents therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Bridged Bicyclo Compounds, Heterocyclic therapeutic use, Cytarabine therapeutic use, Leukemia, Myeloid, Acute drug therapy, Sulfonamides therapeutic use
- Abstract
Combinations of the BCL-2 inhibitor, venetoclax, with either hypomethylating agents (HMA) or low dose cytarabine (LDAC), have shown promising results in clinical trials of AML patients unfit for intensive therapy. We report on the efficacy and safety of venetoclax combinations in AML patients treated outside of clinical trials. Complete remission (CR) + CR with incomplete count recovery (CRi) were achieved in 61% of patients, with similar CR+CRi rates in with secondary AML, and in patients who were previously treated with HMA (61% and 43%, respectively). Relapse occurred in 25% of patients, with a median event-free survival (EFS) of 11.7 months (95% CI, 10.09-13.35) in responding patients. At a median follow up of 8.7 months, the median overall survival (OS) was 9.8 months (95% CI 6.42-13.3) in the entire cohort. In multivariate analysis adverse karyotype was the only negative predictor of CR/CRi (p = .03), while both ECOG performance status (PS) and adverse karyotype were significantly associated with shorter OS (p = .023 and .038, respectively). Median OS was higher in patients achieving CR/CRi and in patients proceeding to allogeneic stem cell transplantation (allo-SCT). Treatment was well tolerated, with side effects similar to those described in the randomized clinical trials. Tumor lysis syndrome (TLS) occurred in 12% of patients. Our data support the efficacy and safety of venetoclax combinations in newly diagnosed AML patients not eligible for intensive therapy. According to our data, secondary AML patients could benefit from venetoclax combinations similarly to de-novo AML patients, and allo-SCT could be offered to selected patients achieving CR/CRi., (© 2021 Wiley Periodicals LLC.)
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- 2021
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23. Efficacy and Safety Profile of Ivosidenib in the Management of Patients with Acute Myeloid Leukemia (AML): An Update on the Emerging Evidence.
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Stemer G, Rowe JM, and Ofran Y
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The isocitrate dehydrogenase enzyme, catalyzing isocitrate conversion to α-ketoglutarate (αKG) in both the cell cytoplasm and mitochondria, contributes to the production of dihydronicotinamide-adenine dinucleotide phosphate (NADPH) as a reductive potential in various cellular processes. IDH1 gene mutations are revealed in up to 20% of the patients with acute myeloid leukemia (AML). A mutant IDH enzyme, existing in the cell cytoplasm and possessing neomorphic activity, converts αKG into oncometabolite R-2-hydroxyglutarate (R-2-HG) that accumulates in high amounts in the cell and inhibits αKG-dependent enzymes, including epigenetic regulators. The resultant alteration in gene expression and blockade of differentiation ultimately lead to leukemia development. Myeloid differentiation capacity can be restored by obstruction of the mutant enzyme, inducing substantial reduction in R-2-HG levels. Ivosidenib, a potent selective inhibitor of mutant IDH1 , is a differentiating agent shown to be clinically effective in newly diagnosed AML (ND-AML) and relapsed/refractory (R/R) AML harboring this mutation. The drug is approved by the Food and Drug Administration (FDA) as a single-agent treatment for R/R AML. Significance of mutated IDH1 targeting and a potential role of ivosidenib in AML management, when used either as a single agent or as part of combination therapies, will be reviewed herein., Competing Interests: The authors declare no potential conflicts of interest., (© 2021 Stemer et al.)
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- 2021
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24. Tackling the challenges of nanomedicines: are we ready?
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Hertig JB, Shah VP, Flühmann B, Mühlebach S, Stemer G, Surugue J, Moss R, and Di Francesco T
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- Humans, Therapeutic Equivalency, Nanomedicine
- Abstract
Purpose: This review provides an overview of the proceedings of the symposium "Tackling the Challenges of Nanomedicines: Are We Ready?" organized by the International Pharmaceutical Federation (FIP) Hospital Pharmacy Section and Non-Biological Complex Drugs (NBCDs) Working Group at the 2019 FIP World Congress of Pharmacy and Pharmaceutical Sciences. Debate centered on reasons underlying the current complex regulatory landscape for nanomedicines and their follow-on products (referred to as nanosimilars) and the pivotal role of hospital pharmacists in selecting, handling, and guiding usage of nanomedicines and nanosimilars., Summary: The evaluation and use of nanomedicines are recognized among scientific, pharmaceutical, and regulatory bodies as complex. Interchangeability and substitutability of nanomedicines and nanosimilars are confounded by a lack of pharmaceutical and pharmacological equivalence, reflecting the inherent complex nature of these drug products and manufacturing processes. Consequences include implications for clinical safety and efficacy and, ultimately, comparability. Local regulatory approvals of some nanomedicines have occurred, but there is no standard to ensure streamlined evaluation and use of consistent measures of therapeutic equivalence of reference products and their nanosimilars. Hospital pharmacists are expected to be experts in the selection, handling, and substitution of nanomedicines and familiarize themselves with the limitations of current methods of assessing pharmaceutical and clinical equivalence of nanosimilars in order to ensure informed formulary decision-making and eventual patient benefit., Conclusion: Supportive guidance for pharmacists focusing on the substitutability and/or interchangeability of nanomedicines and their nanosimilars is needed. Current FIP guidance for pharmacists on therapeutic interchange and substitution should be extended to include nanomedicines and nanosimilars., (© American Society of Health-System Pharmacists 2021. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2021
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25. The Role of Alpha 2 Macroglobulin in IgG-Aggregation and Chronic Activation of the Complement System in Patients With Chronic Lymphocytic Leukemia.
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Naseraldeen N, Michelis R, Barhoum M, Chezar J, Tadmor T, Aviv A, Shvidel L, Litmanovich A, Shehadeh M, Stemer G, Shaoul E, and Braester A
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- Aged, Aged, 80 and over, Antigens, B-Lymphocytes immunology, Case-Control Studies, Cell Membrane immunology, Endoplasmic Reticulum Chaperone BiP, Female, Heat-Shock Proteins metabolism, Humans, Immunoglobulin G blood, Leukemia, Lymphocytic, Chronic, B-Cell blood, Leukemia, Lymphocytic, Chronic, B-Cell immunology, Male, Middle Aged, Protein Aggregates, B-Lymphocytes metabolism, Cell Membrane metabolism, Complement Activation, Immunoglobulin G metabolism, Leukemia, Lymphocytic, Chronic, B-Cell metabolism, alpha-Macroglobulins metabolism
- Abstract
Chronic lymphocytic leukemia (CLL) is the most common leukemia in adults in the western world. One of the treatments offered for CLL is immunotherapy. These treatments activate various cellular and biochemical mechanisms, using the complement system. Recently it was shown that the complement system in CLL patients is persistently activated at a low level through the classical pathway (CP). The mechanism of chronic CP activation involves the formation of IgG-hexamers (IgG-aggregates). According to recent studies, formation of ordered IgG-hexamers occurs on cell surfaces via specific interactions between Fc regions of the IgG monomers, which occur after antigen binding. The present study investigated the formation of IgG-hexamers in CLL patients and normal (non-malignant) controls (NC), their ability to activate complement, their incidence as cell-free and cell-bound forms and the identity of the antigen causing their formation. Sera from 30 patients and 12 NC were used for separation of IgG- aggregates. The obtained IgG- aggregates were measured and used for assessment of CP activation. For evaluation of the presence of IgG- aggregates on blood cells, whole blood samples were stained and assessed by flow cytometry. Serum levels of IgG- aggregates were higher in CLL and they activated the complement system to a higher extent than in NC. Alpha 2 macroglobulin (A2M) was identified as the antigen causing the hexamerization/aggregation of IgG, and was found to be part of the hexamer structure by mass spectrometry, Western blot and flow cytometry analysis. The presence of A2M-IgG-hexamers on B-cells suggests that it may be formed on B cells surface and then be detached to become cell-free. Alternatively, it may form in the plasma and then attach to the cell surface. The exact time course of A2M-IgG-hexamers formation in CLL should be further studied. The results in this study may be useful for improvement of current immunotherapy regimens., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Naseraldeen, Michelis, Barhoum, Chezar, Tadmor, Aviv, Shvidel, Litmanovich, Shehadeh, Stemer, Shaoul and Braester.)
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- 2021
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26. The Contribution of MicroRNAs to the Inflammatory and Neoplastic Characteristics of Erdheim-Chester Disease.
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Weissman R, Diamond EL, Haroche J, Pillar N, Shapira G, Durham BH, Buthorn J, Cohen F, Ki M, Stemer G, Ulaner GA, Amoura Z, Emile JF, Mazor RD, Shomron N, Abdel-Wahab OI, Shpilberg O, and Hershkovitz-Rokah O
- Abstract
The pathogenesis of histiocytic neoplasms is driven by mutations activating the MAPK/ERK pathway, but little is known about the transcriptional and post-transcriptional alterations involved in these neoplasms. We analyzed microRNA (miRNA) expression in plasma samples and tissue biopsies of Erdheim-Chester disease (ECD) and Langerhans cell histiocytosis (LCH) patients. In silico analysis revealed a potential role of miRNAs in regulating gene expression in these neoplasms as compared with healthy controls (HC). NanoString analysis revealed 101 differentially expressed plasma miRNAs in 16 ECD patients as compared with 11 HC, 95% of which were downregulated. MiRNAs-15a-5p, -15b-5p, -21-5p, -107, -221-3p, -320e, -630, and let-7 family miRNAs were further evaluated by qRT-PCR in an extended cohort of 32 ECD patients, seven LCH and 15 HC. Six miRNAs (let-7a, let-7c, miR-15a-5p, miR-15b-5p, miR-107 and miR-630) were highly expressed in LCH plasma and tissue samples as compared with ECD. Pathway enrichment analysis indicated the miRNA contribution to inflammatory and pro-survival signaling pathways. Moreover, the let-7 family members were downregulated in untreated ECD patients as compared with HC, while treatment with MAPK/ERK signaling inhibitors for 16 weeks resulted in their upregulation, which was in parallel with the radiologic response seen by PET-CT. The study highlights the potential contribution of miRNA to the inflammatory and neoplastic characteristics of ECD and LCH.
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- 2020
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27. Reassessment of Venous Thromboembolism Risk and Prophylaxis in Postdelivery Period of Healthy Women.
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Braester A, Bornstein J, Zverev A, Kukuyev Y, Stemer G, and Barhoum M
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- Adolescent, Adult, Anticoagulants administration & dosage, Anticoagulants adverse effects, Female, Humans, Middle Aged, Post-Exposure Prophylaxis methods, Postnatal Care methods, Prospective Studies, Risk Assessment, Risk Factors, Young Adult, Post-Exposure Prophylaxis trends, Postnatal Care trends, Venous Thromboembolism diagnosis, Venous Thromboembolism prevention & control
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- 2020
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28. Self-reported clinical pharmacy service provision in Austria: an analysis of both the community and hospital pharmacy sector-a national study.
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Deibl S, Mueller D, Kirchdorfer K, Stemer G, Hoppel M, and Weidmann AE
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- Austria, Education, Pharmacy statistics & numerical data, Humans, Pilot Projects, Professional Role, Self Report, Surveys and Questionnaires, Community Pharmacy Services organization & administration, Pharmacists organization & administration, Pharmacy Service, Hospital organization & administration
- Abstract
Background With expansion of more advanced clinical roles for pharmacists we need to be mindful that the extent to which clinical pharmacy services are implemented varies from one country to another. To date no comprehensive assessment of number and types of services provided by either community or hospital pharmacies in Austria exists. Objective To analyse and describe the number and types of clinical pharmacy services provided in both community and hospital pharmacies, as well as the level of clinical pharmacy education of pharmacists across Austria. Setting Austrian community and hospital pharmacies. Method An electronic questionnaire to determine number and types of clinical pharmacy services provided was send to all chief pharmacists at all community (n = 1365) and hospital pharmacies (n = 40) across Austria. Besides current and future services provision, education and training provision were also assessed. Main outcome measure Extent of and attitude towards CPS in Austria. Results Response rates to the surveys were 19.1% (n = 261/1365) in community and 92.5% (n = 37/40) in hospital pharmacies. 59.0% and 89.2% of community and hospital pharmacies, respectively, indicated that the provision of clinical pharmacy services in Austria has increased substantially over the past 10 years. Fifty-one percent of community pharmacies reported to provide a medication review service, while 97.3% of hospitals provide a range of services. Only 18.0% of community pharmacies offer services other than medication review services at dispensing. Binary regressions show that provision of already established medication management is a predictor for the willingness of community pharmacists to extend the range of CPS (p < 0.01), while completed training in the area of clinical pharmacy is not (p > 0.05). More hospital than community pharmacists have postgraduate education in clinical pharmacy (17.4% vs 6.5%). A desire to complete postgraduate education was shown by 28.3% of community and 14.7% of hospital pharmacists. Lack of time, inadequate remuneration, lack of resources and poor relationship between pharmacists and physicians were highlighted as barriers. Conclusion Both community and hospital pharmacists show strong willingness to expand their service provision and will need continued support, such as improved legislative structures, more supportive resources and practice focused training opportunities, to further these services.
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- 2020
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29. Risks in Antibiotic Substitution Following Medicine Shortage: A Health-Care Failure Mode and Effect Analysis of Six European Hospitals.
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Miljković N, Godman B, van Overbeeke E, Kovačević M, Tsiakitzis K, Apatsidou A, Nikopoulou A, Yubero CG, Portillo Horcajada L, Stemer G, Kuruc-Poje D, De Rijdt T, Bochenek T, Huys I, and Miljković B
- Abstract
Introduction: Medicine shortages result in great risk for the continuity of patient care especially for antimicrobial treatment, potentially enhancing resistance rates and having a higher economic impact. This study aims to identify, describe, assess, and assign risk priority levels to potential failures following substitution of antimicrobial treatment due to shortages among European hospitals. Furthermore, the study investigated the impact of corrective actions on risk reduction so as to provide guidance and improve future patient care. Methods: Health-care failure mode and effect analysis (HFMEA) was applied to hospitals in Austria (H-AT), Belgium (H-BE), Croatia (H-CR), Greece (H-GR), Spain (H-SP), and Serbia (H-SR). Multidisciplinary teams identified processes, failure modes, causes, and corrective actions related to antibiotic substitution following medicine shortages. Characteristics of study hospitals as well as severity, probability, and hazard scores (HSs) of failure modes/causes were analyzed using Microsoft Office Excel 2010 and IBM SPSS Statistics® via descriptive and inferential statistics. Results: Through HFMEA, 74 failure modes were identified, with 53 of these scoring 8 or above on the basis of assigned severity and probability for a failure. Severity of failure modes differed before and after corrective actions in H-CR, H-GR, and H-SR ( p < 0.005). Their probability differed in all study hospitals ( p < 0.005) when compared before and after corrective actions aimed to be implemented. The highest number of failure-mode causes was detected in H-CR (46) and the lowest in H-SP (16). Corrective actions can address failure modes and lower HSs; therein, all teams proposed the following: structuring communication among stakeholders, introducing electronic prescribing, strengthening pharmacists' involvement, and increasing effectiveness of the ward stock assessment. These proposed actions led to HS reductions up to 83%. Conclusion: There is a lack of structure in addressing risks associated with antibiotic substitution following shortages. Furthermore, lack of communication, data scarcity on availability of antibiotics, non-supportive information technology (IT) systems, and lack of internal substitution protocols hinder quick assessment of alternatives addressing patient needs. Nevertheless, the study shows that health-care professionals manage to secure optimal antimicrobial treatment for patients using available IT and human resources., (Copyright © 2020 Miljković, Godman, van Overbeeke, Kovačević, Tsiakitzis, Apatsidou, Nikopoulou, Yubero, Portillo Horcajada, Stemer, Kuruc-Poje, De Rijdt, Bochenek, Huys and Miljković.)
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- 2020
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30. Cell-free IgG-aggregates in plasma of patients with chronic lymphocytic leukemia cause chronic activation of the classical complement pathway.
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Michelis R, Tadmor T, Aviv A, Stemer G, Majdob R, Shvidel L, Shehadeh M, Barhoum M, and Braester A
- Subjects
- Aged, Female, Humans, Immunoglobulin G chemistry, Male, Middle Aged, Molecular Weight, Complement Pathway, Classical, Immunoglobulin G blood, Leukemia, Lymphocytic, Chronic, B-Cell blood, Leukemia, Lymphocytic, Chronic, B-Cell immunology
- Abstract
Therapy regimens for Chronic lymphocytic leukemia (CLL) commonly include chemotherapy and immunotherapy, which act through complement-mediated-cytotoxicity (CDC) and other mechanisms. CDC depends on several factors, including the availability and activity of the complement classical pathway (CP). Recently, a significant decrease in CP activity was shown to be associated with an immunoglobulin-C5a complex (Ig-C5a) and other markers of chronic CP activation in 40% of the patients. The study focused on the involvement of IgG-hexamers, an established CP activator, in the mechanism of chronic CP activation in CLL. Sera from 51 naïve CLL patients and 20 normal controls were collected. CP and alternative pathway (AP) activities were followed by the complement activity marker sC5b-9. Serum high molecular weight (HMW) proteins were collected by gel-filtration chromatography and their complement activation capacity was assessed. The levels of IgM, another established CP activator, were measured. Data were associated with the presence of Ig-C5a. Baseline levels of activation markers negatively correlated with CP and the AP activities, supporting chronic complement activation. In patients with Ig-C5a, HMW proteins that are not IgM, activated the complement. HMW proteins were identified as IgG-aggregates by affinity binding assays and Western blot analysis. The data indicate chronic CP activation, mediated by cell-free IgG-hexamers as a cause of decreased CP activity in part of the CLL population. This mechanism may affect immunotherapy outcomes due to compromised CP activity and CDC., Competing Interests: The authors have declared that no competing interests exist.
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- 2020
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31. A C5a-Immunoglobulin complex in chronic lymphocytic leukemia patients is associated with decreased complement activity.
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Michelis R, Tadmor T, Barhoum M, Shehadeh M, Shvidel L, Aviv A, Stemer G, Dally N, Rahimi-Levene N, Yuklea M, and Braester A
- Subjects
- Blotting, Western, Complement Activation genetics, Complement Activation physiology, Complement C5a genetics, Complement C5a physiology, Complement Membrane Attack Complex genetics, Complement Membrane Attack Complex metabolism, Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell blood, Leukemia, Lymphoid blood, Male, Middle Aged, Complement C3-C5 Convertases metabolism, Leukemia, Lymphocytic, Chronic, B-Cell metabolism, Leukemia, Lymphoid metabolism
- Abstract
Chronic lymphocytic leukemia (CLL) is the most common adult leukemia in the Western world. The therapeutic approach to CLL includes chemotherapeutic regimens and immunotherapy. Complement-mediated cytotoxicity, which is one of the mechanisms activated by the therapeutic monoclonal antibodies, depends on the availability and activity of the complement (C) system. The aim was to study the structure of circulating C components and evaluate the importance of C5 structural integrity for C activity in CLL patients. Blood samples were collected from 40 naïve CLL patients and 15 normal controls (NC). The Western blot analysis showed abnormal C5 pattern in some CLL patients, while patterns of C3 and C4 were similar in all subjects. Levels of the C activation markers sC5b-9 and C5a were quantified before and after activation via the classical (CP) and alternative (AP) pathways. In patients with abnormal C5, basal levels of sC5b-9 and C5a were increased while activities of the CP and of the CP C5-convertase, the immediate C5-upstream complex, were decreased compared to NC and to patients with normal C5. The data indicate a link between CP activation and apparent C5 alterations in CLL. This provides a potential prognostic tool that may personalize therapy by identifying a sub-group of CLL patients who display an abnormal C5 pattern, high basal levels of sC5b-9 and C5a, and impaired CP activity, and are likely to be less responsive to immunotherapy due to compromised CP activity., Competing Interests: The authors have declared that no competing interests exist.
- Published
- 2019
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32. Pharmacy Practice and Education in Austria.
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Langer T, Spreitzer H, Ditfurth T, Stemer G, and Atkinson J
- Abstract
The PHARMINE (“Pharmacy Education in Europe”) project studied pharmacy practice and education in the European Union (EU) member states. The work was carried out using an electronic survey sent to chosen pharmacy representatives. The surveys of the individual member states are now being published as reference documents for students and staff interested in research on pharmacy education in the EU and in mobility. This paper presents the results of the PHARMINE survey on pharmacy practice and education in Austria. In the light of this, we examine the harmonisation of practice and education in Austria with EU norms.
- Published
- 2018
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33. Anemia and bleeding in patients receiving anticoagulant therapy for venous thromboembolism.
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Kuperman A, López-Reyes R, Bosco LJ, Lorenzo A, José B, Farge Bancel D, Alfonso M, Lumbierres M, Stemer G, Monreal Bosch M, and Braester A
- Subjects
- Anticoagulants therapeutic use, Humans, Registries, Risk, Venous Thromboembolism drug therapy, Anemia complications, Anticoagulants adverse effects, Hemorrhage chemically induced, Neoplasms complications, Venous Thromboembolism complications
- Abstract
In patients receiving anticoagulant therapy for venous thromboembolism (VTE), the important issue of anemia influence on the risk of bleeding has not been consistently studied. We used the large registry data RIETE (Registro Informatizado Enfermedad Tromboembólica) to compare the rate of major bleeding in patients receiving anticoagulant therapy for VTE according to the presence or absence of anemia at baseline. Patients with or without cancer were separately studied. Until August 2016, 63492 patients had been enrolled. Of these, 21652 (34%) had anemia and 14312 (23%) had cancer. Anemia was found in 57% of the patients with cancer and in 28% without (odds ratio 3.46; 95% CI 3.33-3.60). During the course of anticoagulant therapy, 680 patients with cancer had a major bleeding event (gastrointestinal tract 43%, intracranial 14%, hematoma 12%). Cancer patients with anemia had a higher rate of major bleeding (rate ratio [RR]: 2.52; 95% CI 2.14-2.97) and fatal bleeding (RR 2.73; 95% CI 1.95-3.86) than those without anemia. During the course of anticoagulation, 1133 patients without cancer had major bleeding (gastrointestinal tract 32%, hematoma 24%, intracranial 21%). Patients with anemia had a higher rate of major bleeding (RR 2.84; 95% CI 2.52-2.39) and fatal bleeding (RR 2.76; 95% CI 2.07-3.67) than those without. On a multivariable analysis, anemia independently predicted the risk for major bleeding in patients with and without cancer (hazard ratios: 1.66; 95% CI 1.40-1.96 and 1.95; 95% CI 1.72-2.20, respectively). During anticoagulation for VTE, both cancer- and non-cancer anemic patients had a higher risk for major bleeding than those without anemia. In anemic patients (with or without cancer), the rate of major bleeding during the course of anticoagulant therapy exceeded the rate of VTE recurrences. In patients without anemia the rate of major bleeding was lower than the rate of VTE recurrences.
- Published
- 2018
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34. Dalteparin or vitamin K antagonists to prevent recurrent venous thromboembolism in cancer patients: a patient-level economic analysis for France and Austria.
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Dranitsaris G, Shane LG, Galanaud JP, Stemer G, Debourdeau P, and Woodruff S
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- Austria, Cost-Benefit Analysis, Dalteparin administration & dosage, Dalteparin pharmacology, Female, France, Humans, Male, Middle Aged, Neoplasms drug therapy, Recurrence, Anticoagulants therapeutic use, Dalteparin therapeutic use, Neoplasms complications, Quality of Life psychology, Venous Thromboembolism economics, Venous Thromboembolism prevention & control, Vitamin K antagonists & inhibitors
- Abstract
Background: International guidelines recommend extended duration secondary prophylaxis in cancer patients who develop primary venous thromboembolism (VTE). Agent selection is guided in part by one large randomized trial (i.e., CLOT; Lee et al., N Engl J Med 349:146-53, 2003) which demonstrated that dalteparin reduced the relative risk of recurrence by 52% compared with oral vitamin K antagonists (VKA; HR = 0.48, 95% CI, 0.30 to 0.77). In a subgroup analysis from that same trial, patients with renal impairment also derived benefit with dalteparin (VTE rates = 3% vs. 17%; p = 0.011). To measure the economic value of secondary VTE prophylaxis with dalteparin, a patient-level pharmacoeconomic analysis was conducted from the Austrian and French healthcare system perspectives., Methods: Chapter 1 Healthcare resource use collected during the CLOT trial was extracted and converted into direct cost estimates. Incremental cost differences between the dalteparin and VKA groups were then combined with health state utilities to measure the cost per quality-adjusted life year (QALY) gained., Results: The dalteparin group had significantly higher costs than the VKA group in both countries (Austria: dalteparin = €2687 vs. VKA = €2012; France: dalteparin = €2053 vs. VKA = €1352: p < 0.001). However, when the incremental costs were combined with the utility gain, dalteparin had a cost of €6600 and €4900 per QALY gained in Austria and France, respectively. The analyses in patients with renal impairment suggested an even better economic profile, with the cost per QALY gained being less than €4000 in both countries., Conclusions: Secondary prophylaxis with dalteparin is a cost-effective alternative to VKA for the prevention of recurrent VTE in patients with cancer.
- Published
- 2017
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35. Experiences in a family with the Upshaw-Schulman syndrome over a 44-year period.
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Bennett M, Chubar Y, Gavish I, Aviv A, Stemer G, and Chap-Marshak D
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- ADAM Proteins blood, ADAM Proteins genetics, ADAMTS13 Protein, Adolescent, Adult, Female, Heterozygote, Humans, Male, Pedigree, Purpura, Thrombotic Thrombocytopenic blood, Purpura, Thrombotic Thrombocytopenic genetics, Purpura, Thrombotic Thrombocytopenic therapy, Young Adult, Purpura, Thrombotic Thrombocytopenic pathology
- Abstract
A family with a novel c.717_del frameshift and a c.3655C > T missense mutation of a disintegrin and metalloproteinase with thrombospondin type I motif, member 13 protein (ADAMTS13) is described. Family members have been under observation for 44 years. Two double heterozygotes have severe early-onset Upshaw-Schulman syndrome and require prophylactic plasma infusions. Analysis reveals that 2 weekly plasma infusions are not sufficient in preventing laboratory evidence of a thrombotic thrombocytopenic purpura (TTP) attack. Both the double heterozygotes also have a heterozygous factor V Leiden G1291A mutation. One underwent splenectomy, which did not reduce the frequency of TTP episodes but resulted in a recurrent pulmonary embolism and has necessitated lifelong anticoagulant therapy. The other has mild chronic renal failure and has had episodes of atrial fibrillation and cerebral infarction. Of the 3 heterozygotes in the family, 1 has had episodes of mild thrombocytopenia.
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- 2014
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36. Efficacy and safety of vildagliptin in new-onset diabetes after kidney transplantation--a randomized, double-blind, placebo-controlled trial.
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Haidinger M, Werzowa J, Hecking M, Antlanger M, Stemer G, Pleiner J, Kopecky C, Kovarik JJ, Döller D, Pacini G, and Säemann MD
- Subjects
- Adamantane adverse effects, Adamantane therapeutic use, Aged, Blood Glucose metabolism, Diabetes Mellitus, Type 2 drug therapy, Dipeptidyl-Peptidase IV Inhibitors adverse effects, Double-Blind Method, Female, Glucose Tolerance Test, Glycated Hemoglobin metabolism, Humans, Kidney Transplantation, Male, Middle Aged, Nitriles adverse effects, Pyrrolidines adverse effects, Vildagliptin, Adamantane analogs & derivatives, Dipeptidyl-Peptidase IV Inhibitors therapeutic use, Nitriles therapeutic use, Pyrrolidines therapeutic use
- Abstract
New-onset diabetes after transplantation (NODAT) is a serious complication after kidney transplantation, but therapeutic strategies remain underexplored. Dipeptidyl peptidase-4 (DPP-4) inhibitors selectively foster insulin secretion without inducing hypoglycemia, which might be advantageous in kidney transplant recipients (KTRs) with NODAT. We conducted a randomized, double-blind, placebo-controlled, phase II trial to assess safety and efficacy of the DPP-4 inhibitor vildagliptin. Intraindividual differences in oral glucose tolerance test (OGTT)-derived 2-h plasma glucose (2HPG) from baseline to 3 months after treatment served as primary endpoint. Among secondary outcomes, we evaluated HbA1c, metabolic and safety parameters, as well as OGTTs at 1 month after drug discontinuation. Of 509 stable KTRs who were screened in our outpatient clinic, 63 (12.4%) had 2HPG ≥ 200 mg/dL, 33 of them were randomized and 32 completed the study. In the vildagliptin group 2HPG and HbA1c were profoundly reduced in comparison to placebo (vildagliptin: 2HPG = 182.7 mg/dL, HbA1c = 6.1%; placebo: 2HPG = 231.2 mg/dL, HbA1c = 6.5%; both p ≤ 0.05), and statistical significance was achieved for the primary endpoint (vildagliptin: 2HPG-difference -73.7 ± 51.3 mg/dL; placebo: -5.7 ± 41.4 mg/dL; p < 0.01). Adverse events were generally mild and occurred at similar rates in both groups. In conclusion, DPP-4 inhibition in KTRs with overt NODAT was safe and efficient, providing a novel treatment alternative for this specific form of diabetes., (© Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.)
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- 2014
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37. Alloimmune platelet transfusion refractoriness circumvented by allogeneic stem cell transplantation.
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Bonstein L, Stemer G, Dann EJ, Zuckerman T, Fineman R, and Haddad N
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- Adult, Biomarkers blood, Blood Group Incompatibility diagnosis, Blood Group Incompatibility immunology, Female, Granulocytes transplantation, Humans, Leukemia, Myeloid, Acute complications, Leukemia, Myeloid, Acute immunology, Sepsis etiology, Sepsis therapy, Transplantation, Homologous, Blood Group Incompatibility therapy, HLA Antigens immunology, Hematopoietic Stem Cell Transplantation, Isoantibodies blood, Leukemia, Myeloid, Acute therapy, Platelet Transfusion
- Abstract
Background: Administration of intensive chemotherapy used in the management of malignancies is accompanied with marrow suppression. Patients undergoing such treatments and especially those with acute leukemia need prolonged blood component support and are at risk for platelet (PLT) refractoriness. Irradiated and filtered blood, although effective, does not eliminate the risk for refractoriness and consequent fatal hemorrhage., Study Design and Methods: The current report presents a case of an acute myeloid leukemia patient who became alloimmunized to multiple HLA antigens after complicated autologous stem cell transplantation and to whom granulocytes were transfused as part of treatment for overwhelming sepsis. Poor engraftment necessitated prolonged transfusion dependency with rare HLA-compatible donors detected according to the indirect PLT immunofluorescence test. During the proceeding weeks the patient suffered from recurrent severe attacks of gastrointestinal bleeding. When several conservative treatments failed, a fully HLA-matched, bidirectionally ABO-incompatible allogeneic transplantation from a sibling donor was performed., Results: Allogeneic transplantation was uneventful, with stable full donor-derived lymphohematopoietic engraftment., Conclusion: Immune PLT refractoriness can appear at later stages of treatment even in severely immunocompromised patients. Granulocyte transfusions could lead to alloimmunization and should therefore be cautiously considered in this patient population., (© 2012 American Association of Blood Banks.)
- Published
- 2013
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38. Vildagliptin and pioglitazone in patients with impaired glucose tolerance after kidney transplantation: a randomized, placebo-controlled clinical trial.
- Author
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Werzowa J, Hecking M, Haidinger M, Lechner F, Döller D, Pacini G, Stemer G, Pleiner J, Frantal S, and Säemann MD
- Subjects
- Adamantane therapeutic use, Aged, Blood Glucose metabolism, Dipeptidyl-Peptidase IV Inhibitors therapeutic use, Double-Blind Method, Female, Glucose Intolerance blood, Glycated Hemoglobin metabolism, Humans, Hypoglycemic Agents therapeutic use, Male, Middle Aged, Outcome Assessment, Health Care, Pioglitazone, Risk Factors, Treatment Outcome, Vildagliptin, Adamantane analogs & derivatives, Diabetes Mellitus prevention & control, Glucose Intolerance drug therapy, Kidney Transplantation, Nitriles therapeutic use, Pyrrolidines therapeutic use, Thiazolidinediones therapeutic use
- Abstract
Background: New-onset diabetes after transplantation (NODAT) is a serious complication after kidney transplantation affecting graft and patient survival. Currently, no guidelines exist for the management of renal transplant patients with impaired glucose tolerance (IGT), a risk factor for the development of NODAT and an independent predictor of death., Methods: In a population of 48 stable renal transplant recipients at least 6 months from time of transplantation with newly diagnosed IGT, we tested the dipeptidylpeptidase-4 inhibitor vildagliptin, the thiazolidinedione pioglitazone, or placebo for 3 months in addition to lifestyle counseling. Outcome measures were difference in change in oral glucose tolerance test between the groups and between baseline and end of study as well as change in HbA1c, serum lipids, and renal and hepatic function., Results: In both treatment groups, 2-hr plasma glucose at 3 months was significantly reduced compared with baseline (vildagliptin: -20±24 mg/dL; P=0.002 and pioglitazone: -23±29 mg/dL; P=0.004), and pioglitazone also significantly improved fasting plasma glucose (-11±14 mg/dL; P=0.003), although the primary outcome (difference in change in 2-hr plasma glucose among the three groups) did not reach statistical significance. Furthermore, HbA1c was decreased in both treatment arms (vildagliptin: -0.1%±0.3%; P=0.046 and pioglitazone: -0.2%±0.3%; P=0.029). In the placebo group, no significant changes in these parameters were observed. Only mild adverse events occurred and at a similar rate in all three groups., Conclusions: These data demonstrate that both vildagliptin and pioglitazone are of potential benefit in patients with IGT after renal transplantation in addition to lifestyle modification.
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- 2013
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39. The clinical pharmacist's contributions within the multidisciplinary patient care team of an intern nephrology ward.
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Stemer G and Lemmens-Gruber R
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- Humans, Medication Errors prevention & control, Patient Care Team organization & administration, Pharmacy Service, Hospital organization & administration, Program Evaluation methods, Program Evaluation statistics & numerical data, Medication Errors statistics & numerical data, Nephrology statistics & numerical data, Patient Care Team statistics & numerical data, Pharmacy Service, Hospital statistics & numerical data, Program Development statistics & numerical data
- Abstract
Objective: To describe and evaluate newly implemented clinical pharmacy services and ward round participation on a specialized nephrology ward in a large tertiary care hospital., Method: All issues addressed by the clinical pharmacist were systematically collected, and the contributions were classified by type. Where applicable, physicians' acceptance rates were recorded. The drugs most commonly affected by the clinical pharmacist's contributions are described., Results: A total of 158 clinical pharmacist's contributions were recorded. Approximately 90% (n = 104) of applicable suggestions (117 out of 158; 74%) were accepted by the treating physicians. Most issues were discussed with physicians (85%); the remaining issues were discussed with nurses and medical students. Antimicrobials, drugs affecting the alimentary system and metabolism, and cardiovascular drugs were among the most commonly affected drugs. Issues concerning dosage and drug-therapy selection were common. The clinical pharmacist was also involved in developing dosing guidelines and performing literature searches., Conclusion: The observed effects of a newly implemented clinical pharmacy service on an internal nephrology ward are encouraging; acceptance rates of suggestions and the multidisciplinary appreciation of clinical pharmacy services are high.
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- 2011
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40. Clinical pharmacy activities in chronic kidney disease and end-stage renal disease patients: a systematic literature review.
- Author
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Stemer G and Lemmens-Gruber R
- Subjects
- Humans, Kidney Failure, Chronic epidemiology, Kidney Failure, Chronic etiology, Randomized Controlled Trials as Topic methods, Renal Insufficiency, Chronic complications, Renal Insufficiency, Chronic drug therapy, Renal Insufficiency, Chronic epidemiology, Disease Progression, Kidney Failure, Chronic drug therapy, Pharmacists, Pharmacy Service, Hospital methods
- Abstract
Background: Chronic kidney disease (CKD) and end-stage renal disease (ESRD) represent worldwide health problems with an epidemic extent. Therefore, attention must be given to the optimisation of patient care, as gaps in the care of CKD and ESRD patients are well documented. As part of a multidisciplinary patient care strategy, clinical pharmacy services have led to improvements in patient care. The purpose of this study was to summarise the available evidence regarding the role and impact of clinical pharmacy services for these patient populations., Methods: A literature search was conducted using the Medline, Embase and International Pharmaceutical Abstracts databases to identify relevant studies on the impact of clinical pharmacists on CKD and ESRD patients, regarding disease-oriented and patient-oriented outcomes, and clinical pharmacist interventions on drug-related problems., Results: Among a total of 21 studies, only four (19%) were controlled trials. The majority of studies were descriptive (67%) and before-after studies (14%). Interventions comprised general clinical pharmacy services with a focus on detecting, resolving and preventing drug-related problems, clinical pharmacy services with a focus on disease management, or clinical pharmacy services with a focus on patient education in order to increase medication knowledge. Anaemia was the most common comorbidity managed by clinical pharmacists, and their involvement led to significant improvement in investigated disease-oriented outcomes, for example, haemoglobin levels. Only four of the studies (including three controlled trials) presented data on patient-oriented outcomes, for example, quality of life and length of hospitalisation. Studies investigating the number and type of clinical pharmacist interventions and physician acceptance rates reported a mean acceptance rate of 79%. The most common reported drug-related problems were incorrect dosing, the need for additional pharmacotherapy, and medical record discrepancies., Conclusions: Few high-quality trials addressing the benefit and impact of clinical pharmacy services in CKD and ESRD patients have been published. However, all available studies reported some positive impact resulting from clinical pharmacist involvement, including various investigated outcome measures that could be improved. Additional randomised controlled trials investigating patient-oriented outcomes are needed to further determine the role of clinical pharmacists and the benefits of clinical pharmacy services to CKD and ESRD patients.
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- 2011
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41. Sex-specific differences in metabolic control, cardiovascular risk, and interventions in patients with type 2 diabetes mellitus.
- Author
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Kautzky-Willer A, Kamyar MR, Gerhat D, Handisurya A, Stemer G, Hudson S, Luger A, and Lemmens-Gruber R
- Subjects
- Aged, Angina Pectoris prevention & control, Angioplasty, Balloon, Coronary, Antihypertensive Agents therapeutic use, Aspirin therapeutic use, Blood Glucose metabolism, Blood Pressure physiology, Brain Ischemia complications, Brain Ischemia epidemiology, Coronary Artery Bypass, Coronary Disease complications, Coronary Disease physiopathology, Coronary Disease surgery, Cross-Sectional Studies, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 physiopathology, Diabetic Angiopathies physiopathology, Diabetic Angiopathies therapy, Female, Glycated Hemoglobin metabolism, Humans, Hypoglycemic Agents therapeutic use, Lipids blood, Male, Metabolic Syndrome complications, Metabolic Syndrome metabolism, Metabolic Syndrome physiopathology, Middle Aged, Myocardial Infarction prevention & control, Patient Compliance, Primary Prevention, Secondary Prevention, Sex Factors, Coronary Disease metabolism, Coronary Disease therapy, Diabetes Mellitus, Type 2 blood, Diabetic Angiopathies metabolism
- Abstract
Background: Sex-specific differences appear particularly relevant in the management of type 2 diabetes mellitus (T2DM), with women experiencing greater increases in cardiovascular morbidity and mortality than do men., Objective: The aim of this article was to investigate the influence of biological sex on clinical care and microvascular and macrovascular complications in patients with T2DM in a Central European university diabetes clinic., Methods: In a cross-sectional study, sex-specific disparities in metabolic control, cardiovascular risk factors, and diabetic complications, as well as concomitant medication use and adherence to treatment recommendations, were evaluated in 350 consecutive patients who were comparable for age, diabetes duration, and body mass index. Study inclusion criteria included age ≤75 years, T2DM, a documented history of presence or absence of coronary heart disease (CHD), and informed consent. Patients were followed in the diabetes outpatient clinic between November 2007 and March 2008., Results: Two hundred and one patients with T2DM met inclusion criteria (93 [46.3%] women, 108 [53.7%] men). Women with T2DM had higher mean (SE) systolic blood pressure (155.4 [22.5] vs 141.0 [19.8] mm Hg for men; P < 0.001) and total cholesterol (TC) (5.28 [1.34] vs 4.86 [1.29] mmol/L for men; P < 0.05), but a lower TC:HDL-C ratio (4.1 [1.19] vs 4.5 [1.2] for men; P < 0.05). Slightly more men (32.4%) than women (26.9%) reached the therapeutic goal of <7.0% for glycosylated hemoglobin. Women with shorter diabetes duration (<10 years) received oral antihyperglycemic therapy less frequently (P < 0.05). Women with longer disease duration had hypertension more frequently than did their male counterparts (100% vs 86.0%, respectively; P < 0.01). Despite a similar rate of CHD, men were twice as likely as women to have had coronary interventions (percutaneous transluminal coronary angioplasty/coronary artery bypass graft, 25.0% vs 12.9%, respectively; P < 0.05). Women with CHD also had a higher rate of cerebral ischemia than did men (27.6% vs 5.4%, respectively; P < 0.05) and received aspirin less frequently for secondary prevention (P < 0.001). Men had greater overall adherence to diabetes and cardiovascular risk guidelines than did women (66.4% vs 58.9%, respectively; P < 0.01)., Conclusions: In this study of diabetes clinic outpatients, women with T2DM had a worse cardiovascular risk profile and achieved therapeutic goals less frequently than did men. Treatment strategies should be improved in both sexes, but women with diabetes may be in need of more aggressive treatment, especially when cardiovascular disease is present., (Copyright © 2010. Published by EM Inc USA.)
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- 2010
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42. A randomized, placebo-controlled, double-blind, prospective trial to evaluate the effect of vildagliptin in new-onset diabetes mellitus after kidney transplantation.
- Author
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Haidinger M, Werzowa J, Voigt HC, Pleiner J, Stemer G, Hecking M, Döller D, Hörl WH, Weichhart T, and Säemann MD
- Subjects
- Adamantane adverse effects, Adamantane therapeutic use, Austria, Biomarkers blood, Blood Glucose drug effects, Blood Glucose metabolism, Clinical Protocols, Diabetes Mellitus blood, Diabetes Mellitus diagnosis, Dipeptidyl-Peptidase IV Inhibitors adverse effects, Double-Blind Method, Glucose Tolerance Test, Glycated Hemoglobin metabolism, Humans, Hypoglycemia chemically induced, Hypoglycemic Agents adverse effects, Nitriles adverse effects, Placebo Effect, Prospective Studies, Pyrrolidines adverse effects, Research Design, Time Factors, Treatment Outcome, Vildagliptin, Adamantane analogs & derivatives, Diabetes Mellitus drug therapy, Dipeptidyl-Peptidase IV Inhibitors therapeutic use, Hypoglycemic Agents therapeutic use, Kidney Transplantation adverse effects, Nitriles therapeutic use, Pyrrolidines therapeutic use
- Abstract
Background: New-onset diabetes mellitus after transplantation (NODAT), a frequent and serious complication after transplantation, is associated with decreased graft and patient survival. Currently, it is diagnosed and treated primarily according to existing guidelines for type II diabetes. To date, only a few trials have studied antidiabetic drugs in patients with NODAT. Vildagliptin is a novel dipeptidyl peptidase-4 (DPP-4) inhibitor that improves pancreatic islet function by enhancing both α- and β-cell responsiveness to increased blood glucose. Experimental data show potential protective effects of DPP-4 inhibitors on islet function after exogenous stress stimuli including immunosuppressants. Therefore, the therapy of NODAT with this class of compounds seems attractive. At present, vildagliptin is used to treat type II diabetes as monotherapy or in combination with other antidiabetic drugs, since that it efficiently decreases glycated hemoglobin (HbA1c) values. Additionally, vildagliptin has been shown to be safe in patients with moderately impaired kidney function. This study will evaluate the safety and efficacy of vildagliptin monotherapy in renal transplant recipients with recently diagnosed NODAT., Methods/design: This study is a randomized, placebo-controlled, double-blind, prospective phase II trial. Using the results of routinely performed oral glucose tolerance tests (OGTT) in stable renal transplant patients at our center, we will recruit patients without a history of diabetes and a 2 h glucose value surpassing 200 mg/dl (11.1 mmol/l). They are randomized to receive either 50 mg vildagliptin or placebo once daily. A total of 32 patients with newly diagnosed NODAT will be included. The primary endpoint is the difference in the 2 h glucose value between baseline and the repeated OGTT performed 3 months after treatment start, compared between the vildagliptin- and the placebo-group. Secondary endpoints include changes in HbA1c and fasting plasma glucose (FPG). The safety of vildagliptin in renal transplant patients will be assessed by the number of symptomatic hypoglycemic episodes (glucose <72 mg/dl or 4 mmol/l), the number of adverse events, and possible medication-associated side-effects., Discussion: NODAT is a severe complication after kidney transplantation. Few trials have assessed the safety and efficacy of antidiabetic drugs for these patients. The purpose of this study is to assess the safety and efficacy of vildagliptin in renal transplant patients with NODAT., Trial Registration: ClinicalTrials.gov NCT00980356.
- Published
- 2010
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43. Clinical pharmacy services and solid organ transplantation: a literature review.
- Author
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Stemer G and Lemmens-Gruber R
- Subjects
- Clinical Trials as Topic, Drug Monitoring, Drug-Related Side Effects and Adverse Reactions prevention & control, Humans, Immunosuppressive Agents therapeutic use, Patient Compliance, Patient Education as Topic, Organ Transplantation, Pharmacists psychology, Pharmacy Service, Hospital, Professional Role psychology
- Abstract
Aim of the Review: Organ transplantation represents the therapy of choice for most types of end-stage organ failure, and post-transplant patient care warrants great attention. The aim of this study was to summarise the available evidence regarding the role and impact of clinical pharmacy services in the care of solid organ transplant patients., Methods: A search of the literature was conducted using the MEDLINE, EMBASE and IPA databases to identify studies relevant to our investigation of the impact of clinical pharmacists' interventions., Results: Only five out of nineteen of the included studies were randomised controlled trials; eleven studies were descriptive, and three were before-after studies. Interventions performed in these studies consisted of routine clinical pharmacy services with a focus on identifying, resolving and preventing drug-related problems; clinical pharmacy services with a focus on therapeutic drug monitoring; and those with a focus on compliance enhancement and educational interventions. The number and type of interventions and the physicians' acceptance rates were assessed in the majority of the included studies. Acceptance rates were generally above 95%, and most studies reported that clinical pharmacy services had a positive impact on the care of solid organ transplant patients. Positive perceptions of patients and health care professionals are also reported. In two of the studies, patients' compliance rates and drug knowledge were assessed following counselling by a pharmacist. Dosing-related interventions were the most common interventions proposed. Immunosuppressants, cardiovascular drugs and antimicrobials were the drug classes most affected by the clinical pharmacists' interventions., Conclusions: High quality evidence that supports the benefit of clinical pharmacy services in the care of solid organ transplant patients is rare. Nevertheless, all of the included studies showed that clinical pharmacy services had a positive impact. Furthermore, all included studies showed that patients and physicians appreciated clinical pharmacists. The various outcome measures used in these studies were improved by interactions with clinical pharmacists. More randomised controlled trials are needed to contribute to the paucity of the existing evidence.
- Published
- 2010
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44. Evaluation of risk factor management of patients treated on an internal nephrology ward: a pilot study.
- Author
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Stemer G, Zehetmayer S, and Lemmens-Gruber R
- Subjects
- Adult, Aged, Aged, 80 and over, Austria, Confidence Intervals, Diabetes Mellitus therapy, Drug Interactions, Drug Monitoring statistics & numerical data, Drug Therapy statistics & numerical data, Female, Glomerular Filtration Rate, Humans, Hyperlipidemias therapy, Hypertension therapy, Kidney Diseases classification, Kidney Failure, Chronic therapy, Kidney Transplantation rehabilitation, Kidney Transplantation statistics & numerical data, Male, Medical Records, Middle Aged, Odds Ratio, Patient Care classification, Pilot Projects, Regression Analysis, Retrospective Studies, Risk Factors, Treatment Outcome, Young Adult, Diabetes Mellitus prevention & control, Hospital Units statistics & numerical data, Hyperlipidemias prevention & control, Hypertension prevention & control, Kidney Diseases therapy, Medication Therapy Management statistics & numerical data, Nephrology statistics & numerical data, Patient Care statistics & numerical data
- Abstract
Background: The objectives of this pilot study were to evaluate treatment quality for the risk factors of hypertension, diabetes and hyperlipidemia as well as the overall treatment quality for patients on an internal nephrology ward. This evaluation included the collection of data concerning the quality of therapeutic drug monitoring, drug use and potential drug-drug interactions. Establishing such baseline information highlights areas that have a need for further therapeutic intervention and creates a foundation for improving patient care, a subject that could be addressed in future clinical pharmacy research projects., Methods: Medical charts of patients treated on a single internal nephrology ward were retrospectively evaluated using a predefined data collection form. Assessment of further need for therapeutic intervention was performed., Results: For 76.5% (n = 78) of the total study population (n = 102), there was either a possibility (39.2%, n = 40) or a need (37.3%, n = 38) for further intervention based on the overall assessment. For the risk factors of hypertension, diabetes and hyperlipidemia, the proportions of patients that require further intervention were 78.8% (n = 71), 90.6% (n = 58) and 87.9% (n = 58), respectively. Patients with diabetes or hyperlipidemia were less likely to have optimal risk factor control. The number of drugs prescribed and the number of potential drug-drug interactions were significantly higher after in-hospital treatment., Conclusion: Risk factor treatment needs optimisation. Risk factor management, systematic medication reviews, and screening for and management of potential drug-drug interactions deserve great attention. Clinical pharmacy services could help in the achievement of treatment goals.
- Published
- 2009
- Full Text
- View/download PDF
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