[Evaluation the efficacy and safety of estradiol and drospirenone tablets in the
treatment of menopausal symptoms among postmenopausal Chinese healthy women:a
randomized, multi-center, double-blind, placebo-controlled clinical study]. [Article in Chinese]
Author(s): Zhou YZ, Sun LZ, Lin JF, Yang X, Zhang LJ, Qiao J, Wang ZH, Xu YX, Xiong ZA, Lin
SQ.
Affiliation(s): Department of Obstetrics and Gynecology, Peking Union Medical College Hospital,
Chinese Academy of Medical Sciences, Beijing 100730, China.
Publication date & source: 2011, Zhonghua Fu Chan Ke Za Zhi. , 46(5):345-9
OBJECTIVE: To study the efficacy and safety of estradiol and drospirenone tablets
(Angeliq) in treatment of menopausal symptoms among postmenopausal Chinese
healthy women.
METHODS: Total 244 postmenopausal Chinese healthy women who had moderate to
severe hot flushes were randomly assigned into estradiol and drospirenone
(observation group, n = 183) or placebo group (n = 61) by the ratio of 3:1 for 16
weeks in this randomized multi-center double-blind placebo-controlled study.
During the trial, the follow-up visits were conducted at week 4, 8, 12, 16 of
treatment and 2 weeks after treatment respectively. Height, weight, vital signs,
hot flushes, other relevant menopausal symptoms and vaginal bleeding were
observed in each follow-up visit, while the clinical global impression scale was
assessed at 16 weeks as well.
RESULTS: It showed that hot flushes were reduced significantly more in
observation group than that in placebo group (P < 0.01), although both treatments
were effective. The absolute values of mean severity index of total hot flushes
decreased by -0.6 ± 0.5 in observation group and -0.4 ± 0.4 in placebo group from
baseline respectively, which reached significant difference (P < 0.05). However,
the absolute values of mean severity index of moderate to severe hot flushes
decreased by -0.6 ± 0.8 in observation group and -0.3 ± 0.6 in placebo group from
baseline respectively, which had no significant difference (P > 0.05). After 16
weeks treatment, it also showed that estradiol and drospirenone had significant
better efficacy than placebo on moderate to severe sweating, vaginal dryness and
clinical global impression scale (P < 0.01). During the trial, blood pressure in
observation group was stable. The rate of vaginal bleeding in observation group
was higher than that in the placebo group, especially during the week 4 to week 8
when 48.9% (87/178) in observation group and 10.7% (6/56) in placebo group of
patients bled. Although the cumulative amenorrhea rate of observation group was
lower than that of placebo group in each cycle (28 days), it increased gradually
along with duration of the treatment. The commonest adverse event in observation
group was breast tenderness which accounted for 12.0% (22/183). The level of
serum potassium was in the normal range in observation group mostly.Meanwhile,
the other adverse events rate was low. Serious adverse events reported in this
trial were assessed as not study drug related or as unlikely study drug related.
CONCLUSION: Estradiol and drospirenone tablets which could effectively alleviate
menopausal symptoms in postmenopausal Chinese healthy women is a novel hormone
replacement therapy regimen with high safety and efficacy.
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