Optimizing continuous-combined hormone replacement therapy for postmenopausal women: A comparison of six different treatment regimens

Heikkinen, Jorma; Vaheri, Raija; Ahomäki, Satu M.; Kainulainen, Petri; Viitanen, Antti; Timonen, Ulla

doi:10.1067/mob.2000.104767

Cited by 43 publications

(41 citation statements)

References 15 publications

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“…Nearly half of all discontinuations (45%) occurred during the ®rst study year, mainly due to bleeding disturbances. Most discontinuations due to bleeding occurred in women who had received the combination 2 mg E 2 V with 2.5 mg MPA [24]. The highest continuation rate of 81% at 4 years was achieved in women receiving the 1 mg E 2 V dose combinations (1 mg E 2 V/2.5 mg MPA and 1 mg E 2 V/5 mg MPA) throughout the study (Table 3).…”

Section: Resultsmentioning

confidence: 83%

“…The results for the ®rst two study years concerning the bleeding pattern, climacteric symptoms and safety issues have been described elsewhere [24]. We report here the effects of the regimens on the vertebral and femoral BMD and endometrium after 4 study years.…”

Section: Introductionmentioning

confidence: 93%

“…The study was conducted double-masked for the ®rst 2 years [24], and single-masked thereafter (the subjects did not know their study treatment). The study protocol was approved by the local ethics committee of the study center and all women gave written informed consent before entry into the study and before the start of each subsequent study year.…”

Section: Study Subjectsmentioning

confidence: 99%

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Long-Term Continuous Combined Hormone Replacement Therapy in the Prevention of Postmenopausal Bone Loss: A Comparison of High- and Low-Dose Estrogen-Progestin Regimens

Heikkinen

Vaheri

Kainulainen

et al. 2000

Osteoporosis International

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We studied the effect of four continuous combined estradiol valerate (E2V) and medroxyprogesterone acetate (MPA) dose combinations in six treatment groups (n = 70 per group) receiving regimens containing 1 mg or 2 mg E2V combined to 2.5 mg or 5 mg MPA, on bone mineral density (BMD) and endometrium in 419 healthy postmenopausal women over 4 treatment years. In two groups the 1 mg dose of E2V was increased to 2 mg after the first 6 months, while the MPA doses remained constant (2.5 mg or 5 mg). The remaining four groups received 1 E2V + 2.5 mg MPA, 1 mg E2V + 5 mg MPA, 2 mg E2V + 2.5 mg MPA, or 2 mg E2V + 5 mg MPA throughout the study. BMD at the spine and hip was measured by dual-energy X-ray absorptiometry and endometrial biopsy samples were taken at 6, 12, 24, 36 and 48 month follow-ups. Combinations containing the low dose of 1 mg of E2V (with 2.5 mg or 5 mg MPA) resulted in a mean BMD increase of 6.2% at the spine and 2.9% at the femoral neck after 4 years of treatment. With 2 mg E2V the corresponding increases were 7.4% and 2.9%, respectively. The largest increases in BMD were seen in women for whom the E2V dose was doubled after the initial 6 months of treatment: 8.9% at the spine and 4.2% in the femoral neck. Both MPA doses (2.5 mg and 5 mg) effectively prevented estrogen-induced stimulation of the endometrium. No endometrial hyperplasia was observed in any of the treatment groups. Lower-dose combinations of continuous combined estrogen-progestin regimens are effective in increasing and maintaining BMD and provide a good endometrial safety profile for the long-term prevention of osteoporosis in postmenopausal women.

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Section: Resultsmentioning

confidence: 83%

Section: Introductionmentioning

confidence: 93%

Section: Study Subjectsmentioning

confidence: 99%

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Long-Term Continuous Combined Hormone Replacement Therapy in the Prevention of Postmenopausal Bone Loss: A Comparison of High- and Low-Dose Estrogen-Progestin Regimens

Heikkinen

Vaheri

Kainulainen

et al. 2000

Osteoporosis International

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“…This is a clinically relevant finding since low bleeding rates are associated with better patient adherence and considered to be a key factor in a woman's decision to initiate and continue treatment. [26][27][28] Of note is that the subgroup analyses concerning the vaginal bleeding pattern should be taken with caution, as this was not one of the primary study endpoints. Nevertheless, additional knowledge about this topic might contribute to an improved information delivery to the women, which in turn results in a better treatment adherence.…”

Section: Discussionmentioning

confidence: 99%

Tibolone and low‐dose continuous combined hormone treatment: vaginal bleeding pattern, efficacy and tolerability

Hammar

Weijer

et al. 2007

BJOG

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ObjectivesThe primary objective was to compare the vaginal bleeding pattern during administration of tibolone and low-dose continuous combined estradiol plus norethisterone acetate (E 2 / NETA). The secondary objectives were efficacy on vasomotor symptoms and vaginal atrophy.Design A randomised, double-blind, double-dummy, group comparative intervention trial.Setting Multicentre study executed in 32 centres in 7 European countries.Sample Five hundred and seventy-two healthy symptomatic postmenopausal women, aged 45-65 years.Methods Participants were randomised to receive 2.5 mg tibolone or 1 mg 17b estradiol plus 0.5 mg norethisterone acetate (E 2 / NETA) daily for 48 weeks.Main outcome measures Prevalence of vaginal bleeding, hot flushes and adverse events.Results The incidence of bleeding was significantly lower in the tibolone group during the first 3 months of treatment (18.3 versus 33.1%; P < 0.001) when compared with the E 2 /NETA group. This effect on the bleeding pattern was sustained throughout the study, although reaching statistical significance again only in 7-9 months of treatment (11 versus 19%; P < 0.05). In both treatment groups, vasomotor symptoms and vaginal atrophy were significantly reduced to a similar extent when compared with baseline. The prevalence of breast pain/tenderness was significantly lower with tibolone compared with E 2 /NETA (3.2 versus 9.8%; P < 0.001).Conclusion Tibolone reduces menopausal symptoms to a similar extent as conventional low-dose continuous combined hormone therapy but causes significant less vaginal bleeding in the first 3 months of treatment. This constitutes an important argument for woman adherence to therapy.

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“…20 Some bleeding may occur in up to 37% of menopausal women after starting continuous HRT, but this is often light and tends to decrease with time. 21 There are no data regarding the effect of GnRH analogues on BMD in adolescents with learning disabilities, however the data from the treatment of children with central precocious puberty suggest that although GnRH analogues may cause a reduction in BMD during treatment, this recovers once the treatment is stopped and peak BMD at final height is unaffected. 22 23 BMD seems to be improved in those children receiving calcium supplements 23 and so it would seem sensible to recommend calcium and vitamin D supplementation in children with learning disabilities treated with GnRH analogues.…”

Section: Gnrh Analoguesmentioning

confidence: 99%

Suppression of menstruation in adolescents with severe learning disabilities

Albanese

Hopper

2007

Archives of Disease in Childhood

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Optimizing continuous-combined hormone replacement therapy for postmenopausal women: A comparison of six different treatment regimens

Cited by 43 publications

References 15 publications

Long-Term Continuous Combined Hormone Replacement Therapy in the Prevention of Postmenopausal Bone Loss: A Comparison of High- and Low-Dose Estrogen-Progestin Regimens

Long-Term Continuous Combined Hormone Replacement Therapy in the Prevention of Postmenopausal Bone Loss: A Comparison of High- and Low-Dose Estrogen-Progestin Regimens

Tibolone and low‐dose continuous combined hormone treatment: vaginal bleeding pattern, efficacy and tolerability

Suppression of menstruation in adolescents with severe learning disabilities

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