Ospemifene's effects on lipids and coagulation factors: a post hoc analysis of phase 2 and 3 clinical trial data

Menopause : the Journal of the North American Menopause Society
David F ArcherSusannah Cort

Abstract

To evaluate the effect of ospemifene 60 mg on the lipid and coagulation parameters of postmenopausal women using data from five phase 2 and 3 clinical trials. Data for lipids and coagulation factors for 2,166 postmenopausal women were pooled from five randomized, placebo-controlled studies. Lipid and coagulation parameters included in this analysis were total cholesterol, high-density lipoproteins (HDL), low-density lipoproteins (LDL), triglycerides, activated partial thromboplastin time (aPTT), fibrinogen, antithrombin antigen, protein C Ag, and protein S Ag free. Mean percent changes in HDL and LDL were significantly greater with ospemifene versus placebo at month 3 (HDL: 4.4% vs 0.2%; LDL: -5.2% vs 2.4%), month 6 (HDL: 5.1% vs 1.5%; LDL: -6.7% vs 2.4%), and month 12 (HDL: 2.3% vs -1.9%; LDL: -7.0% vs -2.1%; P < 0.05, for all comparisons). Ospemifene significantly reduced total cholesterol at 6 months (-1.8% vs 1.6%; P = 0.0345 versus placebo), and changes in triglycerides with ospemifene were similar to placebo at all three time points. In subgroup analyses based on age, body mass index, and baseline triglyceride level, ospemifene increased HDL and decreased LDL, but had no significant effect on total cholesterol and triglyc...Continue Reading

References

May 26, 1998·JAMA : the Journal of the American Medical Association·B W WalshP W Anderson
Jul 18, 2001·The Journal of Steroid Biochemistry and Molecular Biology·T L TarasM W DeGregorio
Feb 20, 2002·JAMA : the Journal of the American Medical Association·Elizabeth Barrett-ConnorUNKNOWN MORE Investigators (Multiple Outcomes of Raloxifene Evaluation)
Apr 29, 2003·British Journal of Haematology·Ian J MackieUNKNOWN Haemostasis and Thrombosis Task Force of the British Committee for Standards in Haematology
Aug 21, 2003·Lancet·Pierre-Yves ScarabinUNKNOWN EStrogen and THromboEmbolism Risk Study Group
Sep 23, 2003·Menopause : the Journal of the North American Menopause Society·Eeva-Marja RutanenOlavi Ylikorkala
Sep 23, 2003·Menopause : the Journal of the North American Menopause Society·Olavi YlikorkalaJanne Komi
Apr 15, 2004·JAMA : the Journal of the American Medical Association·Garnet L AndersonUNKNOWN Women's Health Initiative Steering Committee
Jul 17, 2004·Gynecological Endocrinology : the Official Journal of the International Society of Gynecological Endocrinology·J KomiO Ylikorkala
Sep 4, 2004·The Journals of Gerontology. Series A, Biological Sciences and Medical Sciences·Karen M PrestwoodMary Cushman
Mar 18, 2005·Menopause : the Journal of the North American Menopause Society·Janne KomiRisto Erkkola
May 3, 2005·Obstetrics and Gynecology·David A Grimes, Kenneth F Schulz
Nov 10, 2005·Menopause : the Journal of the North American Menopause Society·David F ArcherRichard L Kempson
Jul 4, 2006·Journal of Bone and Mineral Metabolism·Janne KomiRisto Erkkola
Feb 21, 2007·Circulation·Marianne CanonicoUNKNOWN Estrogen and Thromboembolism Risk (ESTHER) Study Group
Dec 13, 2007·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Paul D MillerPierre D Delmas
Dec 25, 2009·Menopause : the Journal of the North American Menopause Society·Gloria A BachmannUNKNOWN Ospemifene Study Group
Oct 26, 2012·Menopause : the Journal of the North American Menopause Society·James A SimonUNKNOWN Ospemifene Study Group
Nov 10, 2012·Journal of Thrombosis and Haemostasis : JTH·R E J RoachA van Hylckama Vlieg
Jan 31, 2013·Menopause : the Journal of the North American Menopause Society·David J PortmanUNKNOWN Ospemifene Study Group
Jul 16, 2013·Maturitas·Sebastian Mirkin, Barry S Komm
Aug 30, 2013·Climacteric : the Journal of the International Menopause Society·S R GoldsteinUNKNOWN Ospemifene Study Group
Feb 15, 2014·Hormone and Metabolic Research = Hormon- Und Stoffwechselforschung = Hormones Et Métabolisme·L KangasN Eigéliené
Apr 23, 2014·International Journal of Laboratory Hematology·R A Marlar, J N Gausman
Aug 28, 2014·Menopause : the Journal of the North American Menopause Society·David J PortmanUNKNOWN Vulvovaginal Atrophy Terminology Consensus Conference Panel
Aug 15, 2015·Thrombosis and Haemostasis·Massimo FranchiniPier Mannuccio Mannucci
Jul 13, 2016·Menopause : the Journal of the North American Menopause Society·Ginger D ConstantineJoAnn V Pinkerton

❮ Previous
Next ❯

Citations

Oct 25, 2017·Journal of Women's Health·James A SimonJoAnn V Pinkerton
Mar 22, 2019·Climacteric : the Journal of the International Menopause Society·J V Pinkerton, E A Conner
Mar 22, 2019·Expert Opinion on Pharmacotherapy·Gilbert G G DondersSvitrigaile Grinceviciene
Apr 25, 2020·Gynecological Endocrinology : the Official Journal of the International Society of Gynecological Endocrinology·Lino Del Pup, Rafael Sánchez-Borrego
Sep 28, 2017·Journal of Menopausal Medicine·Jae Jun ShinChang Suk Suh
Jun 25, 2020·Menopause : the Journal of the North American Menopause Society·David F Archer
Apr 3, 2020·Clinical and Applied Thrombosis/hemostasis : Official Journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis·Yan ZhangYue Teng
Sep 19, 2019·Expert Review of Endocrinology & Metabolism·David F ArcherIrwin Goldstein
Nov 24, 2020·Biomedicine & Pharmacotherapy = Biomédecine & Pharmacothérapie·Jiaqi BaoLili Chen
Mar 27, 2020·Maturitas·Panagiotis AnagnostisMargaret Rees

❮ Previous
Next ❯

Software Mentioned

SAS

Related Concepts

Related Feeds

Blood Clotting Disorders

Thrombophilia includes conditions with increased tendency for excessive blood clotting. Blood clotting occurs when the body has insufficient amounts of specialized proteins that make blood clot and stop bleeding. Here is the latest research on blood clotting disorders.

ApoE, Lipids & Cholesterol

Serum cholesterol, triglycerides, apolipoprotein B (APOB)-containing lipoproteins (very low-density lipoprotein (VLDL), immediate-density lipoprotein (IDL), and low-density lipoprotein (LDL), lipoprotein A (LPA)) and the total cholesterol/high-density lipoprotein (HDL) cholesterol ratio are all connected in diseases. Here is the latest research.