The effects of 12 weeks of HMR 3339, a novel selective estrogen receptor modulator, on markers of coagulation and fibrinolysis: a randomized, placebo-controlled, double-blind, dose-ranging study in healthy postmenopausal women

Autor: Tatjana E. Vogelvang, Marius J. van der Mooren, Peter Kenemans, Jef J. Emeis, Johannes A. Heijst, Velja Mijatovic
Přispěvatelé: TNO Preventie en Gezondheid, VU University medical center
Jazyk: angličtina
Rok vydání: 2005
Předmět:
double blind procedure
Time Factors
medicine.medical_treatment
Estrogen receptor
Fibrinogen
protein C
raloxifene
tissue plasminogen activator
Estradiol
Fibrinolysis
adult
Antithrombin
drug effect
Obstetrics and Gynecology
clinical trial
Middle Aged
selective estrogen receptor modulator
HMR 3339
Postmenopause
antithrombin
aged
parameter
Selective estrogen receptor modulator
D dimer
Biological Markers
Female
Menopause
protein S
medicine.drug
Selective Estrogen Receptor Modulators
medicine.medical_specialty
blood clotting
statistical analysis
Double-Blind Method
Internal medicine
D-dimer
medicine
Humans
Raloxifene
controlled study
Blood Coagulation
Coagulation
controlled clinical trial
Dose-Response Relationship
Drug
business.industry
hmr 339
Endocrinology
multicenter study
Raloxifene Hydrochloride
protein blood level
randomized controlled trial
business
Plasminogen activator
Biomarkers
Zdroj: American Journal of Obstetrics and Gynecology, 4, 193, 1384-1394
Vogelvang, T E, Mijatovic, V, Kenemans, P, Emeis, J J, Heijst, J A & van der Mooren, M J 2005, ' The effects of 12 weeks of HMR 3339, a novel selective estrogen receptor modulator, on markers of coagulation and fibrinolysis: a randomized, placebo-controlled, double-blind, dose-ranging study in healthy postmenopausal women ', American Journal of Obstetrics and Gynecology, vol. 193, no. 4, pp. 1384-1394 . https://doi.org/10.1016/j.ajog.2005.02.083
American Journal of Obstetrics and Gynecology, 193(4), 1384-1394. Mosby Inc.
ISSN: 0002-9378
1384-1394
Popis: Objective: To investigate the short-term effects of HMR 3339, a novel selective estrogen receptor modulator, on markers of coagulation and fibrinolysis. Study design: In a multicenter, 14-week, randomized, placebo-controlled, double-blind, dose-ranging study, healthy postmenopausal women received daily placebo (n = 22), HMR 3339 2.5 mg (n = 25), HMR 3339 10 mg (n = 24), HMR 3339 50 mg (n = 24), or raloxifene 60 mg (n = 23). Statistical analysis was performed using standard parametric tests. Results: After 12 weeks, compared with placebo, HMR 3339 50 mg induced the largest mean percentage changes in antithrombin (-14.6%, P < .001), protein C (-12.9%, P = .029), and fibrinogen (-26.3%, P = .001). Decreases were observed in the HMR 3339 2.5 mg group, compared with placebo, in tissue-type plasminogen activator (-55.0%, P = .026 after 4 weeks), plasmin-α2-antiplasmin complex (-85%, P = .031 and -63.3%, P = .008, respectively, after 4 and 12 weeks), and D-dimer (-91.4%, P = .018 after 12 weeks). Compared with placebo, raloxifene 60 mg decreased total protein S (-8.2%, P = .009) after 4 weeks and antithrombin (-6.0%, P = .034) and fibrinogen (-18.1%, P = .007) after 12 weeks. Conclusion: HMR 3339 and raloxifene decreased fibrinogen levels. In the low dosage, HMR 3339 showed potentially beneficial effects on some markers of fibrinolysis. Both drugs impaired the anticoagulatory potential. © 2005 Mosby, Inc. All rights resrved. Chemicals / CAS: antithrombin, 9000-94-6; fibrinogen, 9001-32-5; protein C, 60202-16-6; raloxifene, 82640-04-8, 84449-90-1; tissue plasminogen activator, 105913-11-9; Biological Markers; Estradiol, 50-28-2; HMR 3339; Raloxifene, 84449-90-1; Selective Estrogen Receptor Modulators
Databáze: OpenAIRE
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