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  1. Article ; Online: Comprehensive response criteria for myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions: a proposal from the MLN International Working Group.

    Shomali, William / Colucci, Philomena / George, Tracy I / Kiladjian, Jean-Jacques / Langford, Cheryl / Patel, Jay L / Reiter, Andreas / Vannucchi, Alessandro M / Gotlib, Jason

    Leukemia

    2023  Volume 37, Issue 5, Page(s) 981–987

    MeSH term(s) Humans ; Protein-Tyrosine Kinases/genetics ; Eosinophilia/genetics ; Myeloproliferative Disorders/genetics ; Lymphoma/genetics ; Gene Fusion ; Oncogene Proteins, Fusion/genetics
    Chemical Substances Protein-Tyrosine Kinases (EC 2.7.10.1) ; Oncogene Proteins, Fusion
    Language English
    Publishing date 2023-04-19
    Publishing country England
    Document type Journal Article ; Review ; Research Support, Non-U.S. Gov't
    ZDB-ID 807030-1
    ISSN 1476-5551 ; 0887-6924
    ISSN (online) 1476-5551
    ISSN 0887-6924
    DOI 10.1038/s41375-023-01859-3
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  2. Article ; Online: Hemorrhage in patients with polycythemia vera receiving aspirin with an anticoagulant: a prospective, observational study.

    Zwicker, Jeffrey I / Paranagama, Dilan / Lessen, David S / Colucci, Philomena M / Grunwald, Michael R

    Haematologica

    2022  Volume 107, Issue 5, Page(s) 1106–1110

    Abstract: Polycythemia vera (PV) is associated with increased risk of thrombosis and hemorrhage. Aspirin, recommended for primary thromboprophylaxis, is often combined with anticoagulants during management of acute thrombotic events. The safety of dual ... ...

    Abstract Polycythemia vera (PV) is associated with increased risk of thrombosis and hemorrhage. Aspirin, recommended for primary thromboprophylaxis, is often combined with anticoagulants during management of acute thrombotic events. The safety of dual antiplatelet and anticoagulant therapy is not established in PV. In a prospective, observational study, 2,510 patients with PV were enrolled at 227 sites in the United States. Patients were monitored for the development of hemorrhage and thrombosis after enrollment. A total of 1,602 patients with PV received aspirin with median follow-up of 2.4 years (range, 0-3.6 years). The exposure-adjusted rate of all hemorrhages in patients receiving aspirin alone was 1.40 per 100 patient-years (95% confidence interval [CI]: 0.99-1.82). The combination of aspirin plus anticoagulant was associated with an incidence of hemorrhage of 6.75 per 100 patient-years (95% CI: 3.04-10.46). The risk of hemorrhage was significantly greater in patients receiving the combination of aspirin and anticoagulant compared with aspirin alone (total hemorrhages, hazard ratio [HR]: 5.83; 95% CI: 3.36-10.11; P<0.001; severe hemorrhage, HR: 7.49; 95% CI: 3.02-18.62; P<0.001). Periods of thrombocytosis (>600×109/L) were associated with an increased risk of hemorrhage (HR: 2.25; 95% CI: 1.16- 4.38; P=0.02). Rates of hemorrhage were similar for aspirin in combination with warfarin or direct-acting oral anticoagulants. We conclude that the combination of aspirin and anticoagulants is associated with significantly increased risk of hemorrhage in patients with PV (clinicaltrials gov. Identifier: NCT02252159).
    MeSH term(s) Anticoagulants/adverse effects ; Aspirin/adverse effects ; Hemorrhage/chemically induced ; Hemorrhage/epidemiology ; Humans ; Platelet Aggregation Inhibitors/adverse effects ; Polycythemia Vera/complications ; Polycythemia Vera/drug therapy ; Prospective Studies ; Risk Factors ; Thrombosis/etiology ; United States ; Venous Thromboembolism/complications
    Chemical Substances Anticoagulants ; Platelet Aggregation Inhibitors ; Aspirin (R16CO5Y76E)
    Language English
    Publishing date 2022-05-01
    Publishing country Italy
    Document type Journal Article ; Observational Study
    ZDB-ID 2333-4
    ISSN 1592-8721 ; 0017-6567 ; 0390-6078
    ISSN (online) 1592-8721
    ISSN 0017-6567 ; 0390-6078
    DOI 10.3324/haematol.2021.279032
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  3. Article ; Online: Disease and Clinical Characteristics of Patients With a Clinical Diagnosis of Myelofibrosis Enrolled in the MOST Study.

    Gerds, Aaron T / Lyons, Roger M / Colucci, Philomena / Kalafut, Patricia / Paranagama, Dilan / Verstovsek, Srdan

    Clinical lymphoma, myeloma & leukemia

    2022  Volume 22, Issue 7, Page(s) e532–e540

    Abstract: Background: Clinical characteristics and treatment patterns of patients with lower-risk myelofibrosis (MF) are not well described. This analysis from the MOST (NCT02953704) assessed the demographic and clinical characteristics and treatment patterns of ... ...

    Abstract Background: Clinical characteristics and treatment patterns of patients with lower-risk myelofibrosis (MF) are not well described. This analysis from the MOST (NCT02953704) assessed the demographic and clinical characteristics and treatment patterns of patients with the clinical diagnosis of lower-risk MF at enrollment.
    Patients and methods: MOST is an ongoing, prospective, observational study in patients with clinical diagnoses of MF or essential thrombocythemia enrolled at clinical practices throughout the United States. Patients included in the MF cohort (≥18 years of age) had low-risk MF by the Dynamic International Prognostic Scoring System or intermediate-1 (INT-1) risk MF (by age >65 years only) at enrollment. Patient data were entered into an electronic case report form during usual-care visits over a planned 36 month observation period.
    Results: Two hundred five patients were eligible for this analysis (low risk, n = 85; INT-1 risk, n = 120; median age, 68 years [range, 35-88]); 166 patients (81.0%) had mutation testing results available. The median time from MF diagnosis to enrollment was 1.8 years. Hemoglobin and hematocrit levels were below the normal range in 50.5% and 48.7% of patients, respectively. Nearly all (98.0%) patients had comorbid conditions, most commonly hypertension (49.8%). Fatigue was the most common physician-reported MF symptom (30.7%). At enrollment, 55.6% of patients were receiving MF-directed monotherapy, most frequently hydroxyurea (46.5%) or ruxolitinib (40.4%).
    Conclusion: Future longitudinal analyses of data from MOST will help identify unmet needs and characterize how patients with lower-risk MF are managed throughout the disease course.
    MeSH term(s) Aged ; Cohort Studies ; Humans ; Hydroxyurea/therapeutic use ; Primary Myelofibrosis/diagnosis ; Primary Myelofibrosis/drug therapy ; Prospective Studies ; Thrombocythemia, Essential/drug therapy ; United States/epidemiology
    Chemical Substances Hydroxyurea (X6Q56QN5QC)
    Language English
    Publishing date 2022-02-08
    Publishing country United States
    Document type Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 2540992-X
    ISSN 2152-2669 ; 2152-2650
    ISSN (online) 2152-2669
    ISSN 2152-2650
    DOI 10.1016/j.clml.2022.02.001
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  4. Article ; Online: Treatment Patterns and Blood Counts in Patients With Polycythemia Vera Treated With Hydroxyurea in the United States: An Analysis From the REVEAL Study.

    Grunwald, Michael R / Kuter, David J / Altomare, Ivy / Burke, John M / Gerds, Aaron T / Walshauser, Mark A / Savona, Michael R / Stein, Brady / Oh, Stephen T / Colucci, Philomena / Parasuraman, Shreekant / Paranagama, Dilan / Mesa, Ruben

    Clinical lymphoma, myeloma & leukemia

    2019  Volume 20, Issue 4, Page(s) 219–225

    Abstract: Background: Polycythemia vera (PV) is associated with increased blood cell counts, risk of thrombosis, and symptoms including fatigue and pruritus. National guidelines support the use of hydroxyurea (HU) in high-risk patients or those with some other ... ...

    Abstract Background: Polycythemia vera (PV) is associated with increased blood cell counts, risk of thrombosis, and symptoms including fatigue and pruritus. National guidelines support the use of hydroxyurea (HU) in high-risk patients or those with some other clinical indication for cytoreduction.
    Patients and methods: REVEAL is a prospective, observational study designed to collect data pertaining to demographics, disease burden, clinical management, patient-reported outcomes, and health care resource utilization of patients with PV in the United States. In this analysis, HU treatment patterns and outcomes were assessed from 6 months prior to enrollment to the time of discontinuation, death, or data cutoff.
    Results: Of the 1381 patients who received HU for ≥ 3 months, the median HU exposure was 23.6 months (range, 3.1-38.5 months). The most common maximum daily HU doses were 1000 mg (30.6%) and 500 mg (30.1%); only 6.4% received ≥ 2 g/d HU. Approximately one-third (32.3%) of patients had dose adjustments, 23.8% had dose interruptions, and 257 (18.6%) discontinued HU. The most common reasons for HU discontinuations and interruptions were adverse events/intolerance (37.1% and 54.5%, respectively) and lack of efficacy (35.5% and 22.1%, respectively). Of those who received HU for ≥ 3 months, 57.1% had hematocrit values > 45% on ≥ 1 occasion, 33.1% continued to receive phlebotomies, and 27.4% had uncontrolled myeloproliferation.
    Conclusion: The results of this analysis emphasize the need for active management of patients with PV with appropriate HU dose titration to maintain blood count control while monitoring for signs and symptoms of HU intolerance.
    MeSH term(s) Adult ; Aged ; Aged, 80 and over ; Blood Cell Count ; Female ; Humans ; Hydroxyurea/administration & dosage ; Longitudinal Studies ; Male ; Middle Aged ; Polycythemia Vera/blood ; Polycythemia Vera/drug therapy ; Prospective Studies ; United States
    Chemical Substances Hydroxyurea (X6Q56QN5QC)
    Language English
    Publishing date 2019-09-30
    Publishing country United States
    Document type Clinical Trial ; Journal Article ; Multicenter Study ; Observational Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 2540992-X
    ISSN 2152-2669 ; 2152-2650
    ISSN (online) 2152-2669
    ISSN 2152-2650
    DOI 10.1016/j.clml.2019.09.601
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  5. Article ; Online: Symptom Burden and Blood Counts in Patients With Polycythemia Vera in the United States: An Analysis From the REVEAL Study.

    Grunwald, Michael R / Burke, John M / Kuter, David J / Gerds, Aaron T / Stein, Brady / Walshauser, Mark A / Parasuraman, Shreekant / Colucci, Philomena / Paranagama, Dilan / Savona, Michael R / Mesa, Ruben

    Clinical lymphoma, myeloma & leukemia

    2019  Volume 19, Issue 9, Page(s) 579–584.e1

    Abstract: Background: Approximately 50% of patients with polycythemia vera (PV) have PV-related symptoms at diagnosis; these symptoms might develop or worsen with time. Symptoms have been shown to negatively affect quality of life and interfere with daily ... ...

    Abstract Background: Approximately 50% of patients with polycythemia vera (PV) have PV-related symptoms at diagnosis; these symptoms might develop or worsen with time. Symptoms have been shown to negatively affect quality of life and interfere with daily activities. To our knowledge, an analysis to evaluate the relationship between blood count control and symptoms has not been published.
    Patients and methods: The Prospective Observational Study of Patients with Polycythemia Vera in US Clinical Practices (REVEAL; NCT02252159) is a multicenter, noninterventional, nonrandomized prospective observational study of patients with PV in the United States. Patients included were required to have a complete blood count result within 30 days before completing the at-enrollment Myeloproliferative Neoplasm Self-Assessment Form Total Symptom Score (MPN-SAF TSS). Symptom severity was compared between those who had blood count control versus those who did not.
    Results: At the time of enrollment, 1714 patients (94.5%) were being managed with cytoreductive therapy; 468 patients (25.8%) had complete hematologic remission (CHR), 1614 patients (89.0%) had ≥1 controlled blood count, and 1122 patients (61.9%) had ≥2 controlled blood counts. Mean MPN-SAF TSSs were similar across patients in different blood count control groups. Fatigue was the most frequently reported symptom. The severity of individual symptoms, except those of pruritus and night sweats, was not affected by CHR or the number of blood counts that were controlled.
    Conclusion: Symptom burden in patients with PV can persist despite control of blood counts, which suggests some discordance between laboratory values and symptom burden. Consequently, regular monitoring of symptom burden should be factored into the assessment of disease control.
    MeSH term(s) Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/therapeutic use ; Blood Cell Count ; Disease Management ; Female ; Humans ; Male ; Middle Aged ; Polycythemia Vera/blood ; Polycythemia Vera/complications ; Polycythemia Vera/diagnosis ; Polycythemia Vera/therapy ; Prospective Studies ; Severity of Illness Index ; Symptom Assessment ; Treatment Outcome ; United States ; Young Adult
    Chemical Substances Antineoplastic Agents
    Language English
    Publishing date 2019-06-13
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2540992-X
    ISSN 2152-2669 ; 2152-2650
    ISSN (online) 2152-2669
    ISSN 2152-2650
    DOI 10.1016/j.clml.2019.06.001
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  6. Article ; Online: Safety and Efficacy of Ruxolitinib in Patients with Myelofibrosis and Low Platelet Counts (50 - 100 × 10

    Talpaz, Moshe / Prchal, Josef / Afrin, Lawrence / Arcasoy, Murat / Hamburg, Solomon / Clark, Jason / Kornacki, Deanna / Colucci, Philomena / Verstovsek, Srdan

    Clinical lymphoma, myeloma & leukemia

    2021  Volume 22, Issue 5, Page(s) 336–346

    Abstract: Introduction: Treatment options in patients with myelofibrosis (MF) presenting with thrombocytopenia are limited. Final results of the phase 2 study (NCT01348490) of ruxolitinib in patients with MF and low baseline platelet counts (50 - 100 × 10: ... ...

    Abstract Introduction: Treatment options in patients with myelofibrosis (MF) presenting with thrombocytopenia are limited. Final results of the phase 2 study (NCT01348490) of ruxolitinib in patients with MF and low baseline platelet counts (50 - 100 × 10
    Patients and methods: Patients received ruxolitinib 5 mg twice daily (BID), with optional up-titration to a maximum of 15 mg BID, provided platelet count remained ≥40 × 10
    Results: Of 66 patients, 52 (78.8%) completed the first 24 weeks of treatment. Median (range) percentage change from baseline in spleen volume and TSS (coprimary endpoints) were -20.5% (-55.8% to 38.5%, n=51) and -39.8% (-98.6% to 226.4%, n=53), respectively; greatest median reductions were in the 10 mg BID final titrated dose group. Of patients achieving ≥35% or ≥10% reduction in spleen volume, 8/11 (72.7%) and 21/34 (61.8%), respectively, were in the 10 mg BID final titrated dose group. Thirty-seven of 65 patients (56.9%) had ≥20% improvement in TSS, and 35/66 patients (53.0%) were Patient Global Impression of Change responders. Treatment-emergent adverse events led to dose interruption in 17/66 patients (25.8%), most commonly thrombocytopenia (n=3).
    Conclusion: A starting dose of ruxolitinib 5 mg BID with gradual up-titration and dose optimization based on hematologic parameters and response was efficacious and generally well-tolerated in patients with MF and low platelet counts. Median improvement in spleen volume and symptoms was greatest for patients receiving ruxolitinib 10 mg BID.
    MeSH term(s) Anemia ; Humans ; Nitriles ; Platelet Count ; Primary Myelofibrosis/diagnosis ; Primary Myelofibrosis/drug therapy ; Pyrazoles ; Pyrimidines ; Quality of Life ; Thrombocytopenia
    Chemical Substances Nitriles ; Pyrazoles ; Pyrimidines ; ruxolitinib (82S8X8XX8H)
    Language English
    Publishing date 2021-11-02
    Publishing country United States
    Document type Clinical Trial, Phase II ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2540992-X
    ISSN 2152-2669 ; 2152-2650
    ISSN (online) 2152-2669
    ISSN 2152-2650
    DOI 10.1016/j.clml.2021.10.016
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  7. Article: Colorectal polyps.

    Colucci, Philomena M / Yale, Steven H / Rall, Christopher J

    Clinical medicine & research

    2005  Volume 1, Issue 3, Page(s) 261–262

    MeSH term(s) Adenoma/classification ; Adenoma/pathology ; Adenoma/surgery ; Colon/pathology ; Colonic Polyps/classification ; Colonic Polyps/pathology ; Colonic Polyps/surgery ; Humans ; Precancerous Conditions/classification ; Precancerous Conditions/pathology ; Precancerous Conditions/surgery ; Rectum/pathology
    Language English
    Publishing date 2005-05-25
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2303793-3
    ISSN 1539-4182
    ISSN 1539-4182
    DOI 10.3121/cmr.1.3.261
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  8. Article ; Online: Management of paclitaxel-induced neurotoxicity

    Manisha Bhutani / Philomena M. Colucci / Heather Laird-Fick / Barbara A. Conley

    Oncology Reviews, Vol 4, Iss

    2011  Volume 2

    Abstract: Paclitaxel exerts its antitumor activity by promoting microtubule assembly and stabilizing microtubules. Microtubules are important for the development and maintenance of neurons. As a consequence, neurotoxicity is one of the drug’s major side effects. ... ...

    Abstract Paclitaxel exerts its antitumor activity by promoting microtubule assembly and stabilizing microtubules. Microtubules are important for the development and maintenance of neurons. As a consequence, neurotoxicity is one of the drug’s major side effects. The risk of neurotoxicity depends on dose, duration and schedule of paclitaxel. Risk increases for patients with pre-existing conditions that may cause neuropathy (such as alcohol consumption, diabetes, or renal disease) or with simultaneous or prior exposure to other neurotoxic chemotherapy such as platinum-based drugs, vinca alkaloids, immunomodulators, proteasome inhibitors, and epothilones. Patients with paclitaxel-induced neurotoxicity (PINT) experience a constellation of symptoms over the course of treatment and beyond, ranging from mild to severe. Typically, the clinical presentation reflects an axonal peripheral neuropathy with glove-and-stocking distribution sensory loss, combined with features suggestive of nerve hyperexcitability including paresthesia, dysesthesia, and pain. Proprioceptive and motor effects become apparent as neuropathy becomes more advanced. These symptoms may be prolonged, severe, disabling, relatively resistant to intervention and adversely affect activities of daily living and thereby quality of life. Management is mainly symptomatic and supportive. Despite attempts to minimize PINT with changes in dose, vehicle, delivery systems, infusion schedule and premedication or co-treatment with neuroprotective agents, PINT remains dose-limiting in many instances and is a barrier to achieving the desired clinical response.
    Keywords Paclitaxel - Neuropathy - Taxane - Supportive care ; Other systems of medicine ; RZ201-999 ; Internal medicine ; RC31-1245
    Subject code 610
    Language English
    Publishing date 2011-12-01T00:00:00Z
    Publisher PAGEPress Publications
    Document type Article ; Online
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  9. Article: Are patients with high-risk polycythemia vera receiving cytoreductive medications? A retrospective analysis of real-world data.

    Paranagama, Dilan / Colucci, Philomena / Evans, Kristin A / Bonafede, Machaon / Parasuraman, Shreekant

    Experimental hematology & oncology

    2018  Volume 7, Page(s) 16

    Abstract: Background: Patients with polycythemia vera (PV) have a higher mortality risk compared with the general population, primarily driven by cardiovascular disease, thrombotic events (TEs), and hematologic transformations. The goal of risk-adapted therapy in ...

    Abstract Background: Patients with polycythemia vera (PV) have a higher mortality risk compared with the general population, primarily driven by cardiovascular disease, thrombotic events (TEs), and hematologic transformations. The goal of risk-adapted therapy in PV is prevention of TEs. Current treatment recommendations indicate that high-risk patients (aged ≥ 60 years and/or with history of TEs) should be managed with cytoreductive medications, phlebotomy, and low-dose aspirin. This noninterventional study was conducted to describe real-world cytoreductive medication treatment in adult patients with PV, stratified by risk, in the United States.
    Methods: This retrospective analysis used claims data from the Truven Health MarketScan
    Results: A total of 2856 patients were identified for this analysis, including 1823 with high-risk PV and 1033 with low-risk PV. Mean (SD) age was 62.5 (13.5) years, and 65.9% of patients were male. Preindex comorbid conditions of interest were more common in high-risk than low-risk patients, including hypertension (65.0% vs 43.1%), type 2 diabetes (21.7% vs 10.1%), and congestive heart failure (6.6% vs 0.6%). Among patients who received preindex cytoreductive therapy, the most commonly used medications in high-risk (n = 666) and low-risk (n = 160) patients were hydroxyurea (94.7 and 87.5%, respectively), anagrelide (7.4 and 11.9%), and interferon (1.7 and 4.4%). Among patients who initiated cytoreductive therapy postindex, the most commonly used medications in high-risk (n = 100) and low-risk (n = 35) patients were hydroxyurea (97.0 and 91.4%, respectively), anagrelide (4.0 and 2.9%), and interferon (2.0 and 8.6%). Overall, 42.0% of high-risk and 18.9% of low-risk patients received cytoreductive medication during the preindex or postindex periods.
    Conclusions: Despite consistent guideline recommendations for cytoreductive therapy in patients with high-risk PV, this analysis revealed that only a minority of these patients received cytoreductive medication. A notable proportion of high-risk patients with PV would likely benefit from a revised treatment plan that aligns with current guidelines.
    Language English
    Publishing date 2018-07-09
    Publishing country England
    Document type Journal Article
    ZDB-ID 2669066-4
    ISSN 2162-3619
    ISSN 2162-3619
    DOI 10.1186/s40164-018-0107-8
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  10. Article: Comparison of healthcare utilization and direct costs in three degenerative dementias.

    Murman, Daniel L / Chen, Qin / Colucci, Philomena M / Colenda, Christopher C / Gelb, Douglas J / Liang, Jersey

    The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry

    2002  Volume 10, Issue 3, Page(s) 328–336

    Abstract: The authors conducted a survey of healthcare utilization in three dementia syndromes to determine whether type of dementia influenced utilization or resulting direct costs. Patients with Alzheimer disease (n=131), dementia with parkinsonism (n=85), and ... ...

    Abstract The authors conducted a survey of healthcare utilization in three dementia syndromes to determine whether type of dementia influenced utilization or resulting direct costs. Patients with Alzheimer disease (n=131), dementia with parkinsonism (n=85), and Huntington disease (n=51) were identified from a registry and enrolled. Caregivers completed the mailed survey, and direct costs were estimated. The presence of dementia with parkinsonism resulted in significantly greater utilization of long-term care services and higher total direct costs. In all three groups, long-term care costs accounted for the majority of direct costs. Unique patterns of utilization and costs are seen in specific neurodegenerative dementias.
    MeSH term(s) Aged ; Analysis of Variance ; Cross-Sectional Studies ; Dementia/economics ; Dementia/therapy ; Female ; Health Expenditures/statistics & numerical data ; Health Services/economics ; Health Services/utilization ; Humans ; Male ; Middle Aged ; Time Factors
    Language English
    Publishing date 2002-05
    Publishing country England
    Document type Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 1278145-9
    ISSN 1545-7214 ; 1064-7481
    ISSN (online) 1545-7214
    ISSN 1064-7481
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