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36 results on '"Malec, Lynn M."'

8. Hemophilia Natural History Study (ATHN 7): Baseline Characteristics, Adverse Events, and Self-Reported Health Status of Individuals with Hemophilia a and B

Author

Buckner, Tyler W., primary, Carpenter, Shannon L, additional, Croteau, Stacy E., additional, Cuker, Adam, additional, Daoud, Nabil, additional, Kempton, Christine L, additional, Malec, Lynn M, additional, McLean, Thomas W., additional, Raffini, Leslie J., additional, Staber, Janice M, additional, Wang, Michael, additional, Watson, Crystal, additional, Zia, Ayesha, additional, and Recht, Michael, additional

Published
2020
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9. Inhibit Clinical Trials Platform to Prevent and Eradicate Inhibitors: Feasibility Survey of Current Prophylaxis and Immune Tolerance Practices

Author

Ragni, Margaret V., primary, Xavier, Frederico, additional, Seaman, Craig D., additional, Acharya, Suchitra, additional, McGuinn, Catherine E., additional, Werner, Eric J., additional, Lawrence, Courtney Elizabeth, additional, Wheeler, Allison P., additional, Reiss, Ulrike, additional, Ayala, Irmel, additional, Cockrell, Erin, additional, Tarango, Cristina, additional, Dunn, Amy, additional, Kulkarni, Roshni, additional, Ahuja, Sanjay P, additional, Chitlur, Meera B., additional, Pipe, Steven W., additional, Malec, Lynn M, additional, Rodriguez, Vilmarie, additional, Crary, Shelley, additional, Brown, Deborah, additional, Diaz, Rosa, additional, Velez, Maria, additional, Leissinger, Cindy A., additional, Carpenter, Shannon L, additional, Knoll, Christine M., additional, Wang, Michael, additional, Young, Guy, additional, Thornburg, Courtney D, additional, Lasky, Joseph L, additional, Lucas, Tiffany Lin, additional, Hwang, Nina, additional, Vehec, Deborah, additional, Ivanco, Dana, additional, Haller, Tamara L., additional, Bertolet, Marnie, additional, and Brooks, Maria M, additional

Published
2020
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10. U.S. Cohort Study of Previously Untreated Patients with Congenital Hemophilia (ATHN 8: PUPs Study): Association between Family History and Age of Diagnosis

Author

Thornburg, Courtney D, primary, Friedman, Kenneth D, additional, Guerrera, Michael F, additional, He, Chunla, additional, Malec, Lynn M, additional, Simpson, Mindy L, additional, Tarantino, Michael D, additional, Van Den Berg, H. Marijke, additional, Watson, Crystal, additional, and Carpenter, Shannon L, additional

Published
2020
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12. Bleeding patterns in patients before and after diagnosis of von Willebrand disease: Analysis of a US medical claims database.

Author

Roberts, Jonathan C., Malec, Lynn M., Halari, Imrran, Hale, Sarah A., Oladapo, Abiola, and Sidonio, Robert F.

Subjects
*VON Willebrand disease, *MEDICAL databases, *MENORRHAGIA, *GASTROINTESTINAL hemorrhage, *HEMORRHAGE, *ORAL contraceptives
Abstract

Introduction: Von Willebrand disease (VWD) is the most common inherited bleeding disorder. The bleeding phenotype is variable, and some individuals have persistent symptoms post‐diagnosis. Aim: To characterize bleeding patterns in patients with VWD before and after diagnosis. Methods: De‐identified claims data for commercially insured patients in the IQVIA PharMetrics® Plus US database (Jan‐2006 to Jun‐2015) were extracted. Eligible patients had ≥2 claims for VWD (ICD‐9 code 286.4), and continuous health‐plan enrolment for ≥2 years before and after diagnosis. Bleeding event, treatment and treating‐physician type were analysed for 18 months before and 7‐24 months after diagnosis, according to pre‐diagnosis bleeding phenotype (claims from one vs multiple bleed sites) and post‐diagnosis bleeding status (resolved [no post‐diagnosis bleed claims] vs continued [≥1 claim]). Results: Data for 3756 eligible patients (72.6% female; 71.0% aged ≥18 years at diagnosis) were analysed. Overall, 642 (17.1%) and 805 (21.4%) patients had single‐ and multiple‐site bleed claims pre‐diagnosis, respectively, and 1263 (33.6%) patients (38.5% of women, 20.8% of men) continued to bleed post‐diagnosis. Multiple‐site bleeding was associated with pre‐diagnosis heavy menstrual bleeding (HMB), oral contraceptive (OC) use and nasal cauterization. Continued bleeding post‐diagnosis was associated with pre‐diagnosis gastrointestinal bleeding, HMB and epistaxis; pre‐diagnosis use of OCs, aminocaproic acid and nasal cauterization; and younger age at diagnosis. Few patients consulted a haematologist for bleed management. Conclusion: Many patients with VWD have persistent bleeding from multiple sites and continue to bleed post‐diagnosis. Our findings suggest a need to optimize management to reduce the symptomatic burden of VWD following diagnosis. [ABSTRACT FROM AUTHOR]

Published
2022
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13. The impact of extended half‐life factor concentrates on prophylaxis for severe hemophilia in the United States

Author

Malec, Lynn M., primary, Cheng, Dunlei, additional, Witmer, Char M., additional, Jaffray, Julie, additional, Kouides, Peter A., additional, Haley, Kristina M., additional, Sidonio, Robert F., additional, Johnson, Kelsey, additional, Recht, Michael, additional, White, Gilbert, additional, Croteau, Stacy E., additional, and Ragni, Margaret V., additional

Published
2020
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17. Von Willebrand Disease Minimize Menorrhagia (VWDMin) Trial

Author

Ragni, Margaret V., primary, Seaman, Craig D., additional, Gilligan, Diana, additional, Philipp, Claire S., additional, Neff, Anne T., additional, Sidonio, Robert F., additional, Kuriakose, Philip, additional, Wang, Tzu-Fei, additional, Malec, Lynn M., additional, Pruthi, Rajiv K., additional, Majerus, Elaine, additional, Rodgers, George M., additional, Nance, Danielle, additional, Hwang, Nina, additional, Konkle, Barbara A., additional, Leavitt, Andrew D., additional, Lasky, Joseph, additional, Wheeler, Allison P., additional, Kulkarni, Roshni, additional, Singleton, Tammuella, additional, Ivanco, Dana, additional, Youm, Elynna, additional, Koerbel, Glory, additional, Rothenberger, Scott, additional, and Rubio, Doris M., additional

Published
2019
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18. Regional variation and cost implications of prescribed extended half‐life factor concentrates among U.S. Haemophilia Treatment Centres for patients with moderate and severe haemophilia

Author

Croteau, Stacy E., primary, Cheng, Dunlei, additional, Cohen, Alice J., additional, Holmes, Chris E., additional, Malec, Lynn M., additional, Silvey, Michael, additional, Thornburg, Courtney D., additional, Wheeler, Allison P., additional, Kouides, Peter A., additional, Raffini, Leslie J., additional, and Neufeld, Ellis J., additional

Published
2019
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22. Feasibility of the Von Willebrand disease PREVENT trial

Author

Ragni, Margaret V., primary, Machin, Nicoletta, additional, James, Andra H., additional, Seaman, Craig D., additional, Malec, Lynn M., additional, Kessler, Craig M., additional, Konkle, Barbara A., additional, Kouides, Peter A., additional, Neff, Anne T., additional, Philipp, Claire S., additional, and Brooks, Maria M., additional

Published
2017
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24. Von Willebrand Factor to Prevent Postpartum Hemorrhage

Author

Machin, Nicoletta, primary, Ragni, Margaret V., additional, James, Andra H., additional, Seaman, Craig D., additional, Malec, Lynn M., additional, Kessler, Craig M., additional, Konkle, Barbara, additional, Kouides, Peter, additional, Neff, Anne T., additional, Philipp, Claire S., additional, and Brooks, Maria M., additional

Published
2016
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28. Von Willebrand Factor for Menorrhagia: A Survey and Literature Review

Author

Machin, Nicoletta, primary, Ragni, Margaret V., additional, Malec, Lynn M., additional, Brambilla, Donald, additional, Coyle, Thomas, additional, Davis, Joanna A., additional, Drygalski, Annette, additional, James, Andra H, additional, Jobe, Shawn M, additional, Konkle, Barbara A., additional, Kouides, Peter, additional, Kuriakose, Philip, additional, Ma, Alice D., additional, Majerus, Elaine M., additional, Nance, Danielle, additional, Neff, Anne T., additional, Philipp, Claire S., additional, Wang, Tzu-Fei, additional, and Yaish, Hassan M., additional

Published
2015
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33. Validation Study Of The Composite Score To Identify Von Willebrand Disease in Children

Author

Malec, Lynn M., primary, Moore, Charity G., additional, Bennett, Carolyn M., additional, Yee, Donald L, additional, Kerlin, Bryce A., additional, Witmer, Char, additional, Gunawardena, Sriya, additional, Kulkarni, Roshni, additional, Gupta, Sweta, additional, Kouides, Peter A., additional, Brown, Deborah, additional, Bujnicki, Heather L., additional, and Ragni, Margaret V., additional

Published
2013
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34. Observational Study of Recombinant Factor-VIII-Fc, Eloctate, in Hemophilia Patients with and without Inhibitors

Author

Ebbert, Patrick T., Ragni, Margaret V., Xavier, Frederico, Malec, Lynn M., and Seaman, Craig D.

Abstract

Background:Inhibitor formation is a serious complication of hemophilia A, occurring in up to 30% with severe disease. It is associated with a T-cell response to infused factor VIII which neutralizes and renders it ineffective. Bypass therapy (rVIIa, FEIBA) is less effective, resulting in high morbidity and mortality. While immune tolerance (ITI) with high-dose FVIII neutralizes the inhibitor, it is costly, invasive, and unsuccessful in 30%. Basic studies suggest rFVIIIFc, Eloctate,is less immunogenic than standard recombinant FVIII, rFVIII, as the Fc portion contains regulatory T cells that promote tolerance. In the hemophilia mouse model, rFVIIIFc reduces inhibitor frequency, lowers titer, and shortens ITI, but little is known of its impact on inhibitor patients, as they were excluded from clinical trials.

Published
2017
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35. Copper Deficiency

Author

Close, Allison and Malec, Lynn M.

Abstract

BACKGROUND:Acquired copper deficiency in the pediatric population is a rare event but given the hematologic and potentially irreversible neurologic consequences, prompt recognition and treatment is important. Copper is an essential cofactor in enzymatic reactions essential to proper hematologic, skeletal, neurologic and vascular function. Copper is found in a variety of foods including meats, nuts, legumes, and whole grains while lacking in highly processed foods. Copper requirements in children over the age of 4 is 15 mg/day, which is readily acquired in a typical diet. Copper deficiency is known to occur in patients with the rare X-linked mutation in the ATP7A copper transport protein, known as Menkes Syndrome, and in older individuals with gastrointestinal bypass surgery who lose the ability to absorb copper through the duodenum and proximal jejunum, however, it is rarely reported in other conditions. Pediatric patients with autism spectrum disorders or developmental delay with a limited dietary repertoire are at risk for copper deficiency thus a high index of suspicion must exist in order to diagnose the disorder.

Published
2017
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36. Feasibility of the Von Willebrand disease PREVENT trial.

Author

Machin, Nicoletta, Ragni, Margaret V., Seaman, Craig D., Malec, Lynn M., James, Andra H., Kessler, Craig M., Konkle, Barbara A., Kouides, Peter A., Neff, Anne T., Philipp, Claire S., and Brooks, Maria M.

Subjects
*VON Willebrand disease, *CLINICAL trials, *FEASIBILITY studies, *VON Willebrand factor, *PREVENTION of diseases in women, *MENORRHAGIA, *THROMBOSIS risk factors, *BLOOD volume determination, *PREVENTION
Abstract

Background Despite treatment, women with von Willebrand disease (VWD) have lower von Willebrand factor (VWF) levels and greater blood loss at delivery than controls. Current weight-based dosing does not account for the ~ 1.5-fold increase in blood volume in pregnancy. Methods To evaluate the feasibility of a trial to prevent postpartum hemorrhage (PPH), we reviewed pre-pregnancy and 8th month VWF levels in women with VWD with and without PPH following vaginal delivery, assessed VWF concentrate use at delivery by U.S. hemophilia treatment center physician survey, and reviewed thrombosis risk with VWF concentrate by literature review. We determined trial interest and acceptability by structured interviews of physicians and patients. Analysis was by Student's t -test for continuous data, and chi-square or Fisher's exact test for discrete data. Results PPH was associated with lower pre-pregnancy VWF:RCo, p < 0.005; higher pre-pregnancy, 8th and 9th-month weight, each p < 0.001; a family bleeding history, p = 0.036; and VWF concentrate treatment, p = 0.005. Surveyed physicians reported first-line therapy at delivery was VWF concentrate, at a mean dose 50 IU/kg. A trial of a 1.5-fold volume-based dose increase was acceptable to physicians and patients, if it is safe and if costs and visits are minimized. A literature review determined thrombosis risk with VWF concentrate is low, 0.4%. Conclusions This study suggests pre-pregnancy VWF:RCo may predict PPH, but 50–80 IU/kg VWF concentrate dosing may not prevent PPH. If pharmacokinetic modeling confirms volume-based dosing achieves VWF levels comparable to pregnant controls, it may be possible to determine if volume-modified VWF concentrate dosing will reduce PPH in VWD. [ABSTRACT FROM AUTHOR]

Published
2017
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