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Metabolic, inflammatory and haemostatic effects of a low‐dose continuous combined HRT in women with type 2 diabetes: potentially safer with respect to vascular risk?
Author(s) -
McKenzie Joyce,
Jaap Alan J.,
Gallacher Stephen,
Kelly Anne,
Crawford Lynne,
Greer Ian A.,
Rumley Ann,
Petrie John R.,
Lowe Gordon D.,
Paterson Kenneth,
Sattar Naveed
Publication year - 2003
Publication title -
clinical endocrinology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.055
H-Index - 147
eISSN - 1365-2265
pISSN - 0300-0664
DOI - 10.1046/j.1365-2265.2003.01906.x
Subject(s) - medicine , endocrinology , norethisterone , norethisterone acetate , type 2 diabetes , hormone replacement therapy (female to male) , diabetes mellitus , placebo , metabolic syndrome , risk factor , triglyceride , cholesterol , estrogen , population , alternative medicine , environmental health , pathology , research methodology , testosterone (patch)
Summary background Conventional hormone replacement therapy (HRT) containing conjugated equine oestrogen (CEE) and medroxyprogesterone acetate (MPA) increases triglyceride, C‐reactive protein (CRP) and coagulation Factor VII concentrations, potentially explaining their increased coronary heart disease (CHD) and stroke risk. objective To assess the metabolic effects of a continuous combined HRT containing 1 mg oestradiol and 0·5 mg norethisterone or matching placebo. design Double‐blind, randomized placebo‐controlled trial. patients Fifty women with type 2 diabetes. measurements Classical and novel risk factors for vascular disease. results Triglyceride concentration was not altered ( P = 0·31, change in active arm relative to placebo) and low‐density lipoprotein (LDL) cholesterol concentration declined 13% ( P = 0·018). IL‐6 concentration (mean difference −1·42 pg/ml, 95% CI: −2·55 to –0·29 IU/dl, P = 0·015), Factor VII (−32 IU/dl, −43 to −21 IU/l, P < 0·001) and tissue plasminogen activator antigen (by 13%, P = 0·005) concentrations fell, but CRP was not significantly altered ( P = 0·62). Fasting glucose ( P = 0·026) also declined significantly, but there are no significant effects on HBA1c, Factor IX or APC resistance. conclusions HRT containing 1 mg oestradiol and 0·5 mg norethisterone may avoid the adverse metabolic effects potentially implicated in the elevated CHD and stroke risk induced by conventional higher dose HRT. This type of preparation may therefore be more suitable than conventional HRT for women at elevated CHD risk such as those with type 2 diabetes. Large randomized controlled trials of such low dose preparations, powered for cardiovascular end points, are now needed.