Transition from estrogen-progestin to raloxifene in postmenopausal women: effect on vasomotor symptoms.
OBJECTIVE
To compare vasomotor symptoms after transition from estrogen-progestin therapy to raloxifene 60 mg/d with and without a placebo washout.


METHODS
Postmenopausal women currently taking continuous combined estrogen-progestin therapy (conjugated equine estrogen, 0.625 mg/medroxyprogesterone acetate, 2.5 or 5 mg) daily for 5 or more months were enrolled. Women were randomized to 1 of 4 blinded regimens: 1) 12 weeks estrogen-progestin; 2) 12 weeks placebo; 3) 4 weeks placebo, then 8 weeks raloxifene; or 4) 12 weeks raloxifene. For the final 36 weeks, all subjects received raloxifene. Vasomotor symptoms were assessed by patient diaries.


RESULTS
A total of 266 women (mean age 57.5) were enrolled. Mean hot flush frequency at baseline was approximately 1 per week in the entire population, with 16% of women reporting hot flushes. Mean frequency and severity of hot flushes during the first 12 weeks of the study were statistically greater in the 3 groups transitioned off estrogen-progestin (range of hot flushes per week: 4 weeks, 11-12; 8 weeks, 18-24; 12 weeks, 13-16), as compared with those continuing estrogen-progestin, with no difference between these 3 groups (P> or =.1). Approximately 50-70% of these women reported hot flushes, generally rated as mild to moderate by participants, after estrogen-progestin discontinuation.


CONCLUSIONS
A large proportion of women discontinuing estrogen-progestin experience hot flushes. Raloxifene does not appear to increase the frequency or severity of vasomotor symptoms in women discontinuing estrogen-progestin more than that observed with placebo treatment after estrogen-progestin discontinuation. Transition from estrogen-progestin to raloxifene with no washout period therefore may be acceptable.


METHODS
I
Gordon
Stephen
S
Women's Health and Internal Medicine, Comprehensive NeuroScience, Inc, 6065 Roswell, Suite 820, Atlanta, GA 30328, USA. flashmd_4919@msn.com
Walsh
Brian W
BW
Ciaccia
Angelina V
AV
Siddhanti
Suresh
S
Rosen
Amy S
AS
Plouffe
Leo
L
D000284:Administration, Oral; D000368:Aged; D000704:Analysis of Variance; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D019584:Hot Flashes / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause / Q000187:drug effects / Q000502:physiology; D011336:Probability; D011372:Progestins / Q000008:administration & dosage*; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage*; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016896:Treatment Outcome; D014666:Vasomotor System / Q000187:drug effects*
D004338:Drug Combinations; D004966:Estrogens, Conjugated (USP); D011372:Progestins; D020849:Raloxifene Hydrochloride