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1. Efficacy and safety of erenumab in women with a history of menstrual migraine

Author

Pavlovic, Jelena M, Paemeleire, Koen, Göbel, Hartmut, Bonner, Jo, Rapoport, Alan, Kagan, Risa, Zhang, Feng, Picard, Hernan, and Mikol, Daniel D

Subjects
Headaches, Pain Research, Chronic Pain, Neurosciences, Clinical Trials and Supportive Activities, Clinical Research, Migraines, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Antibodies, Monoclonal, Humanized, Calcitonin Gene-Related Peptide Receptor Antagonists, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Menstrual Cycle, Middle Aged, Migraine Disorders, Self Report, Treatment Outcome, Young Adult, Erenumab, Headache, Episodic migraine, Migraine prevention, Pure menstrual migraine, Menstrually related migraine, Perimenstrual attacks, Genetics, Clinical Sciences, Neurology & Neurosurgery
Abstract

BackgroundWe performed a post hoc, subgroup analysis of a phase 3, randomized, double-blind, placebo-controlled study of erenumab for prevention of episodic migraine (STRIVE) to determine the efficacy and safety of erenumab in women with self-reported menstrual migraine.MethodsPatients received placebo, erenumab 70 mg, or erenumab 140 mg subcutaneously once monthly during the 6-month double-blind treatment phase of STRIVE. Women who reported history of menstrual migraine and who were ≤ 50 years old were included in the analysis. Endpoints were change from baseline in monthly migraine days (MMD) and monthly acute migraine-specific medication days (MSMD; among patients who took acute migraine-specific medications at baseline), proportion of patients achieving ≥ 50% reduction from baseline in MMD, and incidence of adverse events.ResultsAmong 814 women enrolled in STRIVE, 232 (28.5%) reported a history of menstrual migraine and were ≤ 50 years old. Of the 232 patients, 214 (92%) had a baseline MMD > 5, suggesting a high proportion of women with attacks outside of the 5-day perimenstrual window (2 days before and 3 days after the start of menstruation). Information on "migraine days" includes (and does not discriminate between) perimenstrual and intermenstrual migraine attacks. Between-group differences from placebo over months 4-6 for erenumab 70 mg and 140 mg were - 1.8 (P = 0.001) and - 2.1 (P

Published
2020

6. Oral estradiol/micronized progesterone may be associated with lower risk of venous thromboembolism compared with conjugated equine estrogens/medroxyprogesterone acetate in real-world practice

Author

Panay, Nick, Nappi, Rossella E, Stute, Petra, Palacios, Santiago, Paszkowski, Tomasz, Kagan, Risa, Archer, David F, Héroux, Julie, and Boolell, Mitra

Subjects
Obstetrics and Gynecology, 610 Medicine & health, 610 Medizin und Gesundheit, General Biochemistry, Genetics and Molecular Biology
Abstract

OBJECTIVES The Women's Health Initiative study reported an increased risk of venous thromboembolism among menopausal women treated with conjugated equine estrogens/medroxyprogesterone acetate (CEE/MPA) versus placebo. Newer hormone therapies may have a lower venous thromboembolism risk. The study compared the risk of venous thromboembolism between women treated with the combined oral product 17β-estradiol/micronized progesterone (E2/P4) and those treated with oral CEE/MPA regimens. STUDY DESIGN In a retrospective longitudinal study using real-world claims data from April 2019 to June 2021, women aged 40 years or more treated with oral E2/P4 or oral CEE/MPA who did not have a venous thromboembolism diagnosis before first dispensing claim of CEE/MPA or E2/P4 identified on or after May 1st 2019 (index date) were observed for 6 months or more after the index date. Oral E2/P4 and oral CEE/MPA had been prescribed by the treating physician in real-world practice and were observed through pharmacy dispensing records. MAIN OUTCOME MEASURES Venous thromboembolism risk was compared between women receiving oral E2/P4 versus oral CEE/MPA. RESULTS The study included 36,061 women treated with oral E2/P4 or oral CEE/MPA. In the analyses weighted by the inverse probability of treatment for control of potential confounding factors, the incidence of venous thromboembolism was significantly lower for oral E2/P4 compared with oral CEE/MPA (37/10,000 women-years for oral E2/P4 vs 53/10,000 women-years for oral CEE/MPA; incidence rate ratio 0.70, 95 % confidence interval: 0.53-0.92). CONCLUSIONS Real-world evidence suggests that the risk of venous thromboembolism is significantly lower among women treated with oral E2/P4 compared with oral CEE/MPA.

Published
2023

8. List of contributors

Author

Abrahamsen, Bo, primary, Adler, Robert A., additional, Ajjour, Sara, additional, Alemi, Mohammad Mehdi, additional, Anderson, Dennis E., additional, Arnett, Timothy R., additional, Assaad, Mariam A., additional, Ballane, Ghada T., additional, Baron, Roland, additional, Bassett, J.H. Duncan, additional, Bauer, Douglas C., additional, Bauman, William A., additional, Beavers, Kristen M., additional, Berry, Sarah D., additional, Bilezikian, John P., additional, Biver, Emmanuel, additional, Bliuc, Dana, additional, Bonewald, Lynda F., additional, Boskey, Adele L., additional, Bouxsein, Mary L., additional, Bravenboer, Nathalie, additional, Brown, Todd T., additional, Bukata, Susan V., additional, Burkhart, Katelyn, additional, Canalis, Ernesto, additional, Cardozo, Christopher, additional, Castillo, Alesha B., additional, Cauley, Jane A., additional, Center, Jacqueline R., additional, Chen, Julia C., additional, Civitelli, Roberto, additional, Cohen, Adi, additional, Cosman, Felicia, additional, Crandall, Carolyn J., additional, Crawford, Brooke M., additional, Cusano, Natalie E., additional, de Paula, Francisco J.A., additional, Delbaere, Kim, additional, Dempster, David W., additional, Diab, Dima L., additional, Dick-de-Paula, Ingrid, additional, DiMeglio, Linda A., additional, Drake, Matthew T., additional, Dubrovsky, Alanna M.K., additional, D’Onofrio, Luca, additional, Eastell, Richard, additional, Elder, Grahame J., additional, El-Hajj Fuleihan, Ghada A., additional, Ensrud, Kristine E., additional, Ferrari, Serge, additional, Freudenthal, Bernard, additional, Genant, Harry K., additional, Gerstenfeld, Louis C., additional, Giangregorio, Lora, additional, Gielen, Evelien, additional, Gold, Deborah T., additional, Goldring, Steven R., additional, Gordon, Catherine M., additional, Gori, Francesca, additional, Greendale, Gail A., additional, Griffith, James F., additional, Hadji, Peyman, additional, Hernandez, Christopher J., additional, Hoggatt, Jonathan, additional, Houston, Denise K., additional, Hussein, Amira I., additional, Jacobs, Christopher R., additional, Jiang, Xuezhi, additional, Johnston, James D., additional, Kagan, Risa, additional, Karim, Lamya, additional, Karvonen-Gutierrez, Carrie, additional, Katzman, Wendy B., additional, Kawai, Masanobu, additional, Khosla, Sundeep, additional, Kiel, Douglas P., additional, Kontulainen, Saija A., additional, Kostenuik, Paul, additional, Krez, Alexandra, additional, Kronenberg, Henry, additional, Kumar, Rajiv, additional, Lane, Nancy E., additional, Langsetmo, Lisa, additional, Laurent, Michaël R., additional, Lawenius, L., additional, Leikin, Sergey, additional, Leslie, William D., additional, Lewiecki, E. Michael, additional, Liu, Minghao, additional, Liu, Yi, additional, Lord, Stephen R., additional, Lorenzo, Joseph, additional, Ma, Nina S., additional, Maalouf, Naim M., additional, Marcus, Robert, additional, McClung, Michael R., additional, Mendes, Marcela Moraes, additional, Miller, Paul D., additional, Misra, Madhusmita, additional, Mohseni, Mahshid, additional, Morgan, Elise F., additional, Morin, Suzanne N., additional, Mukaddam, Mona Al, additional, Mulder, Chris J.J., additional, Nair, Nandini, additional, Napoli, Nicola, additional, Nasomyont, Nat, additional, Nelson, Dorothy A., additional, Nieves, Jeri W., additional, Nissenson, Robert, additional, Ohlsson, Claes, additional, Oleson, Christina V., additional, Ortinau, Laura, additional, Orwoll, Eric, additional, Ott, Susan M., additional, Pacifici, Roberto, additional, Palermo, Andrea, additional, Parfitt, A.M., additional, Park, Dongsu, additional, Provot, Sylvain, additional, Randhawa, Sonia Bhandari, additional, Randolph, John F., additional, Rivadeneira, Fernando, additional, Robey, Pamela Gehron, additional, Robinson, Lauren, additional, Rogers-Soeder, Tara, additional, Roodman, G. David, additional, Rosen, Clifford J., additional, Saag, Kenneth G., additional, Sahni, Shivani, additional, Sakhaee, Khashayar, additional, Scadden, David T., additional, Schafer, Anne L., additional, Schipani, Ernestina, additional, Serra, Monica C., additional, Shapiro, Jay R., additional, Sherrington, Catherine, additional, Shikany, James M., additional, Silverberg, Shonni J., additional, Singer, Andrea J., additional, Sjögren, K., additional, Snyder, Peter J., additional, Stein, Emily M., additional, Swanson, Christine M., additional, Szulc, Pawel, additional, Taxel, Pamela, additional, Tebben, Peter J., additional, Twardowski, Sarah E., additional, Uitterlinden, André G., additional, Vaidya, Rachana, additional, Vallera, Cristianna, additional, van Bodegraven, Adriaan A., additional, van der Eerden, Bram C.J., additional, van der Meulen, Marjolein C.H., additional, van Wijnen, André J., additional, Vanderschueren, Dirk, additional, Wactawski-Wende, Jean, additional, Watts, Laura, additional, Watts, Nelson B., additional, Weaver, Ashley A., additional, Weinstein, Robert S., additional, Williams, Graham R., additional, Wu, Joy, additional, Wu, Karin C., additional, Yin, Michael T., additional, Yu, Elaine W., additional, and Zhou, Hua, additional

Published
2021
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18. Management of genitourinary syndrome of menopause in women with or at high risk for breast cancer: consensus recommendations from The North American Menopause Society and The International Society for the Study of Womenʼs Sexual Health

Author

Faubion, Stephanie S., Larkin, Lisa C., Stuenkel, Cynthia A., Bachmann, Gloria A., Chism, Lisa A., Kagan, Risa, Kaunitz, Andrew M., Krychman, Michael L., Parish, Sharon J., Partridge, Ann H., Pinkerton, JoAnn V., Rowen, Tami S., Shapiro, Marla, Simon, James A., Goldfarb, Shari B., and Kingsberg, Sheryl A.

Published
2018
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34. Patient considerations in the management of menopausal symptoms: role of conjugated estrogens with bazedoxifene

Author

Kagan, Risa, Goldstein,Steven R., Pickar,James H., and Komm,Barry S.

Subjects
Therapeutics and Clinical Risk Management
Abstract

Risa Kagan,1,2 Steven R Goldstein,3 James H Pickar,4 Barry S Komm5 1Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, 2East Bay Physicians Medical Group, Berkeley, CA, 3Department of Obstetrics and Gynecology, New York University School of Medicine, 4Department of Obstetrics and Gynecology, Columbia University Medical Center, New York, NY, 5Global Medical Affairs, Pfizer Inc., Collegeville, PA, USA Abstract: Menopausal symptoms (eg, hot flushes and vaginal symptoms) are common, often bothersome, and can adversely impact women’s sexual functioning, relationships, and quality of life. Estrogen–progestin therapy was previously considered the standard care for hormone therapy (HT) for managing these symptoms in nonhysterectomized women, but has a number of safety and tolerability concerns (eg, breast cancer, stroke, pulmonary embolism, breast pain/tenderness, and vaginal bleeding) and its use has declined dramatically in the past decade since the release of the Women’s Health Initiative trial results. Conjugated estrogens paired with bazedoxifene (CE/BZA) represent a newer progestin-free alternative to traditional HT for nonhysterectomized women. CE/BZA has demonstrated efficacy in reducing the frequency and severity of vasomotor symptoms and preventing loss of bone mineral density in postmenopausal women. CE/BZA provides an acceptable level of protection against endometrial hyperplasia and does not increase mammographic breast density. Compared with traditional estrogen–progestin therapy, it is associated with lower rates of breast pain/tenderness and vaginal bleeding. Patient-reported outcomes indicate that CE/BZA improves menopause-specific quality of life, sleep, some measures of sexual function (especially ease of lubrication), and treatment satisfaction. This review looks at the rationale for selection and combination of CE with BZA at the dose ratio in the approved product and provides a detailed look at the efficacy, safety, tolerability, and patient-reported outcomes from the five Phase III trials. Patient considerations in the choice between CE/BZA and traditional HT (eg, tolerability, individual symptoms, and preferences for route of administration) are also considered. Keywords: menopause, conjugated estrogens/bazedoxifene, hormone therapy, hot flashes, osteoporosis, safety

Published
2016

36. Goal‐Directed Treatment for Osteoporosis: A Progress Report From the ASBMR‐NOF Working Group on Goal‐Directed Treatment for Osteoporosis

Author

Cummings, Steven R, primary, Cosman, Felicia, additional, Lewiecki, E Michael, additional, Schousboe, John T, additional, Bauer, Douglas C, additional, Black, Dennis M, additional, Brown, Thomas D, additional, Cheung, Angela M, additional, Cody, Kathleen, additional, Cooper, Cyrus, additional, Diez‐Perez, Adolfo, additional, Eastell, Richard, additional, Hadji, Peyman, additional, Hosoi, Takayuki, additional, Jan De Beur, Suzanne, additional, Kagan, Risa, additional, Kiel, Douglas P, additional, Reid, Ian R, additional, Solomon, Daniel H, additional, and Randall, Susan, additional

Published
2016
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39. Patient considerations in the management of menopausal symptoms: role of conjugated estrogens with bazedoxifene

Author

Kagan,Risa, Goldstein,Steven R, Pickar,James H, Komm,Barry S, Kagan,Risa, Goldstein,Steven R, Pickar,James H, and Komm,Barry S

Abstract

Risa Kagan,1,2 Steven R Goldstein,3 James H Pickar,4 Barry S Komm5 1Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, 2East Bay Physicians Medical Group, Berkeley, CA, 3Department of Obstetrics and Gynecology, New York University School of Medicine, 4Department of Obstetrics and Gynecology, Columbia University Medical Center, New York, NY, 5Global Medical Affairs, Pfizer Inc., Collegeville, PA, USA Abstract: Menopausal symptoms (eg, hot flushes and vaginal symptoms) are common, often bothersome, and can adversely impact women’s sexual functioning, relationships, and quality of life. Estrogen–progestin therapy was previously considered the standard care for hormone therapy (HT) for managing these symptoms in nonhysterectomized women, but has a number of safety and tolerability concerns (eg, breast cancer, stroke, pulmonary embolism, breast pain/tenderness, and vaginal bleeding) and its use has declined dramatically in the past decade since the release of the Women’s Health Initiative trial results. Conjugated estrogens paired with bazedoxifene (CE/BZA) represent a newer progestin-free alternative to traditional HT for nonhysterectomized women. CE/BZA has demonstrated efficacy in reducing the frequency and severity of vasomotor symptoms and preventing loss of bone mineral density in postmenopausal women. CE/BZA provides an acceptable level of protection against endometrial hyperplasia and does not increase mammographic breast density. Compared with traditional estrogen–progestin therapy, it is associated with lower rates of breast pain/tenderness and vaginal bleeding. Patient-reported outcomes indicate that CE/BZA improves menopause-specific quality of life, sleep, some measures of sexual function (especially ease of lubrication), and treatment satisfaction. This review looks at the rationale for selection and combination of CE with BZA at the dose ratio in the approved prod

Published
2016

45. Algorithm and mobile app for menopausal symptom management and hormonal/non-hormonal therapy decision making

Author

Manson, JoAnn E., primary, Ames, Jeffrey M., additional, Shapiro, Marla, additional, Gass, Margery L.S., additional, Shifren, Jan L., additional, Stuenkel, Cynthia A., additional, Pinkerton, JoAnn V., additional, Kaunitz, Andrew M., additional, Pace, Diane T., additional, Kagan, Risa, additional, Schnatz, Peter F., additional, Kingsberg, Sheryl A., additional, Liu, James H., additional, Joffe, Hadine, additional, Richard-Davis, Gloria, additional, Goldstein, Steven R., additional, Schiff, Isaac, additional, and Utian, Wulf H., additional

Published
2015
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46. Goal-Directed Treatment for Osteoporosis: A Progress Report From the ASBMR-NOF Working Group on Goal-Directed Treatment for Osteoporosis.

Author

Cummings, Steven R, Cosman, Felicia, Lewiecki, E Michael, Schousboe, John T, Bauer, Douglas C, Black, Dennis M, Brown, Thomas D, Cheung, Angela M, Cody, Kathleen, Cooper, Cyrus, Diez-Perez, Adolfo, Eastell, Richard, Hadji, Peyman, Hosoi, Takayuki, Jan De Beur, Suzanne, Kagan, Risa, Kiel, Douglas P, Reid, Ian R, Solomon, Daniel H, and Randall, Susan

Abstract

ABSTRACT The American Society for Bone and Mineral Research and the United States National Osteoporosis Foundation (NOF) formed a working group to develop principles of goal-directed treatment and identify gaps that need to be filled to implement this approach. With goal-directed treatment, a treatment goal would first be established and choice of treatment determined by the probability of achieving that goal. Goals of treatment would be freedom from fracture, a T-score > -2.5, which is above the NOF threshold for initiating treatment, or achievement of an estimated risk level below the threshold for initiating treatment. Progress toward reaching the patient's goal would be periodically and systematically assessed by estimating the patient's compliance with treatment, reviewing fracture history, repeating vertebral imaging when indicated, and repeating measurement of bone mineral density (BMD). Using these data, a decision would be made to stop, continue, or change therapy. Some of these approaches can now be applied to clinical practice. However, the application of goal-directed treatment cannot be fully achieved until medications are available that provide greater increases in BMD and greater reduction in fracture risk than those that are currently approved; only then can patients with very high fracture risk and very low BMD achieve such goals. Furthermore, assessing future fracture risk in patients on treatment requires a new assessment tool that accurately captures the change in fracture risk associated with treatment and should also be sensitive to the importance of recent fractures as predictors of imminent fracture risk. Lastly, evidence is needed to confirm that selecting and switching treatments to achieve goals reduces fracture risk more effectively than current standard care. © 2016 American Society for Bone and Mineral Research. [ABSTRACT FROM AUTHOR]

Published
2017
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47. Why the product labeling for low-dose vaginal estrogen should be changed

Author

Manson, JoAnn E., primary, Goldstein, Steven R., additional, Kagan, Risa, additional, Kaunitz, Andrew M., additional, Liu, James H., additional, Pinkerton, JoAnn V., additional, Rebar, Robert W., additional, Schnatz, Peter F., additional, Shifren, Jan L., additional, Stuenkel, Cynthia A., additional, Gass, Margery L.S., additional, and Utian, Wulf H., additional

Published
2014
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