PubMed · 12792561
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R Isaac. 2003. Patching up pain.. https://doi.org/10.1097/00152193-200305000-00003
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BACKGROUND: Oral estrogen therapy has activity in patients with hormone-naive and androgen-independent prostate carcinoma (AIPC), but its utility is limited by the associated risk of thromboembolic toxicity. Parenteral administration may be safer as it avoids "first pass" liver exposure to estrogen. The authors tested the safety and efficacy of transdermal estradiol (TDE), as well as the effect of therapy on hot flashes, sex hormones, the procoagulant cascade, and bone turnover in patients with AIPC. METHODS: Patients with prostate carcinoma progressing after primary hormonal therapy received TDE 0.6 mg per 24 hours (administered as six 0.1 mg per 24-hour patches replaced every 7 days). Serum prostate-specific antigen (PSA) and hormone levels, coagulation factors, markers of bone turnover, bone density measurements, and a hot flash diary were collected at regular intervals. RESULTS: Three of 24 patients (12.5%; 95% confidence interval [CI], 0-26%) had a confirmed PSA reduction >50%. The Kaplan-Meier estimate of median time to disease progression was 12 weeks (95% CI, 4.6-19.4 weeks). Toxicity was modest and no thromboembolic complications occurred. The mean (+/-95% CI) serum estradiol level increased from 17.2 pg.mL (range, 14.8-19.6 pg/mL) to 460.7 pg/mL (range, 334.6-586.7 pg/mL). The total testosterone level remained stable in the anorchid range during treatment, but the free testosterone level decreased as a result of increased sex hormone binding globulin. No change in factor VIII activity, F 1.2, or resistance to activated protein C was observed, whereas a modest decrease in the protein S level was observed. CONCLUSIONS: In patients with APIC, TDE was well tolerated and produced a modest response rate, but was not associated with thromboembolic complications or clinically important changes in several coagulation factors.
AIM: To evaluate the efficacy and safety of a new transdermal continuous combined hormone replacement therapy (HRT) for the prevention of postmenopausal osteoporosis. METHODS: 212 osteopenic (lumbar spine and/or hip (femoral neck) bone mineral density (BMD) between -1.0 and -2.5 S.D. of the premenopausal mean value) postmenopausal women aged 45-65 years participated in a 2-year prospective study. Treatments were 45 microg 17beta-estradiol combined with 30 (n = 69) or 40 microg (n = 72) levonorgestrel daily or placebo (n = 71) given as a 7-day patch. All received a daily supplement of 500 mg calcium. BMD at lumbar spine (L2-L4), hip and total body, as well as blood and urinary biochemical markers of bone turnover (serum osteocalcin (sOC), serum bone-specific alkaline phosphatase (sBSAP), urinary calcium (uCa) and urinary CrossLaps (uCTX)) were measured regularly. RESULTS: BMD at the lumbar spine, hip and total body increased by 8, 6 and 3% (P < 0.001), respectively, in the hormone groups versus placebo. The bone markers all decreased accordingly (sOC: 37%, sBSAP: 34% and uCTX: 65% from baseline (all P < 0.001)), except for uCa that did not change significantly. No significant dose-related effect of levonorgestrel was found. Vaginal bleeding/spotting decreased from 48 to 25% of the HRT-treated women during the study period. Skin tolerance was good in 84% of the women with no difference between the study groups. No incidences of endometrial hyperplasia, uterine or mammary cancer occurred. CONCLUSION: The transdermal combination of 17beta-estradiol and levonorgestrel has a positive effect on BMD in an osteopenic postmenopausal population. Furthermore, a high safety profile was observed.
BACKGROUND: When genital atrophy exists, systemic hormone therapy (HT) has a timing until to induce vaginal proliferation and symptomatic relieve. Thus, in order to obtain a prompt improvement, the association of local therapy acting on the genital epithelium to the systemic treatment should be considered. OBJECTIVE: To evaluate the effects of a combined therapy consisting of vaginal estriol with transdermal 17-beta-estradiol (50 microg/day) plus medroxyprogesterone acetate (5 mg/day) per os in shortening the period of uro-genital symptoms. SUBJECTS AND METHODS: In a randomized, double blind, controlled with placebo study, 27 women with climacteric symptoms and atrophic vaginitis were treated for 4 months with HT plus vaginal estriol 0.5 mg/day (group E) or placebo (group P). Patients use the local medication daily for the first 3 weeks and twice-weekly thereafter. Before entering in the study, patients were asked about HT and selected for inclusion. In the first visit, electible patients after written informed consent were randomized to receive HT plus local estriol or placebo. All the subjects had baseline studies, including medical history, physical examination, blood and urine analysis. In order to evaluate the effect of local treatment on urinary and genital symptoms, a score for genital, urinary and colposcopic complaints (0 minimum-100 maximum) was developed. This score and Blatt-Kuperman were recorded and performed in every control. RESULTS: There were no differences on climacteric symptoms relief between the two groups. Additionally, the improvement in urinary symptoms at the end of the study was similar for both groups (from 16.5 +/- 6.1 to 8.5 +/- 2.4 for E group and from 15.8 +/- 7.8 to 8.8 +/- 2.7 for P group; P < 0.01 versus basal); however, those women in group E reached significant improvement on urinary complaints since the first month of treatment. Additionally, a significant difference between E and P was observed at months 2 and 3, although no differences were detected at the end of the study. Papanicolaou smear showed reactive or reparative changes and karyopyknotic index exhibited a significant increase in superficial cells in both groups and at the end of the study. CONCLUSIONS: Adding vaginal estriol to HRT may shorten the latency period for urinary symptoms.