Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0600142 (hot flushes)
 1,242 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

A double blind, crossover study was used to test the effect of transdermal oestrogen therapy (Estraderm) in 22 women with climacteric complaints. The number and intensity of hot flushes were both reduced by approximately 80% (p less than 0.0025). Some improvement was also seen as regards general wellbeing, disturbed sleep and tiredness. We noted a significant increase in serum oestradiol to premenopausal follicular phase levels, and a decrease in FSH values. Systolic blood pressure was lowered during active treatment (p less than 0.025), a smaller reduction of diastolic pressure was not significant. Body weight remained unchanged. Some patients reported tender breasts, and some reported slight irritation of the skin. Neither condition necessitated withdrawal of treatment. It is concluded that Estraderm is effective and suitable for treatment of climacteric complaints.
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PMID:[Transdermal estrogen treatment. A placebo controlled study]. 194 34

Results of clinical studies have revealed that the transdermal therapeutic system of estrogen administration (Estraderm, Ciba Pharmaceutical Co., Summit, New Jersey) is both effective and well tolerated. Relief of hot flushes and vaginal atrophy has been shown to equal oral administration of conjugated equine estrogens and early experience suggests that the bone sparing effect is maintained. The patch has no effect on certain liver proteins; safety variables have shown no adverse biochemical changes. Moderate bleeding has occurred in some patients with an intact uterus but can be controlled by the addition of a progestogen. The incidence of endometrial hyperplasia and breast tenderness has been relatively low, and minor side effects (such as fluid retention) have been limited. Several investigators have evaluated skin irritation resulting from the systems. Some erythema has been reported but serious ulcerations or sloughing did not occur. A survey of patient attitudes comparing oral administration and transdermal systems indicated a preference for the transdermal method.
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PMID:Clinical experience with transdermal estradiol in the treatment of the climacteric. 254 95

Two-hundred and fourteen (214) menopausal women with moderate to severe vasomotor symptoms, aged 40-65 years, were randomised. After a 4-week treatment-free period, each women received a continuous regimen of Menorest 50 twice weekly or Premarin 0.625 mg daily, for 12 weeks. Didrogesterone 10 mg was also given to all women for 12 days of every 28-day cycle. The objectives were to compare the efficacy and safety profiles of Menorest and an oral estrogen. A statistically significant reduction in the mean number of hot flushes occurred in each group compared to baseline with a decrease from 7.1 at baseline to 0.9 at 12 weeks in the Menorest group, and from 6.7 to 0.5 in the oral estrogen group; there was no statistically significant difference between the two groups (P = 0.36). With each successive treatment cycle, there was a continuous improvement in the number of hot flushes. The incidence and severity of menopausal symptoms were reduced in the same manner in both groups. There were no statistically significant differences in the mean plasma estradiol and estrone concentrations between the two treatment groups after 10 weeks of therapy. The mean estradiol to estrone ratio was similar in both groups, as was the number of adverse events observed. In summary, Menorest was as effective as an oral estrogen in alleviating menopausal symptoms.
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PMID:Efficacy and tolerance of Menorest compared to Premarin in the treatment of postmenopausal women. A randomised, multicentre, double-blind, double-dummy study. 853 78

Two-hundred and five (205) menopausal women with moderate to severe vasomotor symptoms, aged 39-64 years, were randomized from 20 clinical centers. After a 4-week treatment-free period, each woman received a cyclical regimen (25 days of a 4-week cycle) of Menorest 50, a new matrix-type transdermal estradiol system or Estraderm TTS 50, a marketed reservoir-type transdermal estradiol system twice weekly for 12 weeks. An oral progestin was also given for 10 days each cycle. The objectives were to compare local and systemic tolerability and efficacy in the treatment of menopausal symptoms. One-hundred and ninety-four [194] patients (96 and 98 patients in the Menorest 50 and the reservoir transdermal patch groups, respectively) were considered in the intent-to-treat population and 204 (102 in each group) in the safety population. The two treatment groups were comparable with regard to the demographic data and menopausal status. The primary efficacy criteria were the comparison between Menorest 50 and the reservoir transdermal patch in erythema and pruritus at application sites and the difference between the treatment groups in the mean number of hot flushes per day at week 12, adjusted for baseline. A statistically significant reduction in the mean number of hot flushes was observed in each group compared with baseline, with a decrease from 6.5 at baseline to 0.3 at 12 weeks and 6.4 to 0.4 in the Menorest 50 and reservoir transdermal patch groups respectively; there was no statistically significant difference between the two groups during the 12-week treatment. The severity score of menopausal symptoms was also dramatically improved in each of the two treatment groups. There were no statistically significant differences in the mean plasma estradiol concentrations and mean estradiol to estrone ratio (> 1.0) in both groups after 10 weeks of therapy. A similar number of adverse events was observed in both groups. Menorest 50 showed better local tolerability than the reservoir transdermal patch with a lower incidence of topical adverse events, erythema and pruritus. In summary, Menorest 50 was as effective as the reservoir transdermal patch in reducing the mean number of hot flushes, and improving the severity of other menopausal symptoms, including vasomotor, psychiatric and urogenital symptoms.
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PMID:Efficacy and tolerability of Menorest 50 compared with Estraderm TTS 50 in the treatment of postmenopausal symptoms. A randomized, multicenter, parallel group study. 874 78

Thirty-two (32) menopausal women were entered into the study (16 in each treatment group), of whom 24 completed the study. The objectives were to compare the long-term efficacy and the local and systemic tolerance of Menorest and Premarin in the control of menopausal symptoms, and the prevention of bone loss. After a 4-week treatment-free run-in period, patients were treated with continuous estrogen therapy (a twice weekly application with Menorest 50 or a daily oral administration of Premarin 0.625 mg) for one year. Patients were also given 20 mg oral Dydrogesterone per day for the last 12 days of each 28 day cycle of treatment. The main efficacy criterion was the reduction in the mean number of hot flushes per day at 12 months compared to baseline. This study was also considered as a pilot study to collect data on changes in the bone mineral density of the lumbar spine (L1-L4) assessments from baseline to week 30 and week 56. Menorest and Premarin were equally effective in the relief of menopausal symptoms over the 1-year period of treatment. The mean number of hot flushes per day decreased from 6.9 at baseline to 0.5 at 12 weeks and 0.1 at 12 months in the Menorest group, and from 7.0 to 0.3 and 0.0 in the Premarin group. Regarding the lumbar spine and hip densitometry results, Menorest prevented bone loss to the same extent as Premarin. This data confirms the positive action of estrogen, with oral in addition to transdermal administration on both trabecular and cortical BMD over 1 year of treatment. Tolerance was similar, with approximately the same number of patients with AEs, severe AEs and related to study drug AEs in both groups. There was one serious AE (breast carcinoma) diagnosed after 6-months of treatment. Chemotherapy and radiotherapy was initiated prior to surgery. According to the investigator it was not related to study drug and must have been present prior to study start. Menorest 50 and Premarin 0.625 were equally effective over the 1-year treatment period in reducing the mean number of hot flushes and the severity score of menopausal symptoms, including vasomotor, psychological and urogenital symptoms.
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PMID:Efficacy and safety of Menorest (50 mikrog/day) compared to Premarin 0.625 mg in the treatment of menopausal symptoms and the prevention of bone loss, in menopausal women. A single-center, comparative, randomized, double-blind, double-dummy study. 896 97

This 12-week, double-masked, double-dummy, randomized, parallel-group study compared the efficacy and safety of an estradiol matrix transdermal delivery system (Alora) in two strengths (50-microgram/d estradiol and 100-microgram/d estradiol) with placebo in postmenopausal women who were experiencing at least 60 moderate-to-severe hot flushes per week. In 273 postmenopausal women, the reduction in the frequency of moderate-to-severe hot flushes was significantly better than placebo within 2 weeks of initiating therapy in the 100-microgram/d group and within 3 weeks of initiating therapy in the 50-microgram/d group. The reduction in hot flushes for both active treatment groups remained significantly different from placebo throughout the 12-week trial. Improvement in vaginal cytology profile (maturation index) was observed in both active treatment groups. Serum estradiol concentrations were elevated to early-to mid-follicular levels, in proportion to dose, and the estradiol/estrone ratio remained within the expected premenopausal range. The incidence of estrogen-related side effects was modest but greater in the active treatment groups than in the placebo group: Breast pain was reported in 4.5% of the patients in the 50-microgram/d group, 5.3% of patients in the 100-microgram/d group, and none of the patients in the placebo group. Breakthrough bleeding occurred in 3.4% of women in the 50-microgram/d group, 20.2% of women in the 100-microgram/d group, and 4.4% of women in the placebo group. Only 3 (1.1%) patients terminated treatment because of skin reactions. This study demonstrates that this estradiol matrix transdermal delivery system is effective in the treatment of menopausal symptoms, while providing the skin tolerability desired by patients.
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PMID:Double-masked, multicenter study of an estradiol matrix transdermal delivery system (Alora) versus placebo in postmenopausal women experiencing menopausal symptoms. Alora Study Group. 900 26

This study was designed to compare the efficacy and safety of two sizes of Lyrelle, a new matrix design transdermal oestrogen patch, with Estraderm TTS 50, a reservoir system. Three hundred and ninety-four (394) hysterectomised postmenopausal women between 30 and 65 years of age participated in this open-label, randomised, multicentre clinical trial. The main efficacy criterion was the reduction in the mean number of hot flushes per day at six months. Secondary efficacy end points included other climacteric symptoms as well as various psychofunctional and genitourinary disorders. A significant decrease from baseline in the mean number of hot flushes/day was observed in all three groups from the end of cycle 1, reaching 90% at the end of cycle 7. there was no statistically significant difference between Lyrelle 50 and Estraderm at any time point for any parameter; however, between-group differences between Lyrelle 80 and Estraderm for various parameters were seen in the first three cycles in favour of Lyrelle 80. A similar impact on blood lipid levels was observed in all three groups, without significant between-group differences. We conclude that the new Lyrelle patch is a highly effective system for transdermal oestrogen replacement therapy that may enhance long-term patient compliance.
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PMID:A randomised study to compare the efficacy and safety of new 17 beta-oestradiol transdermal matrix patch with Estraderm TTS 50 in hysterectomised postmenopausal women. The Lyrelle Study Group. 915 67

Aerodiol with its new mode of action--pulsed estrogen therapy made possible by a unique pharmacokinetic profile and an innovative route of administration--acts on the full range of climacteric symptoms and on the long-term consequences of estrogen deprivation. Four well-designed, international studies investigating the efficacy of pulsed estrogen therapy on both the short- and long-term consequences of estrogen deprivation were conducted. Climacteric symptoms and their reduction were assessed individually and also using the Kupperman index, which is a weighted score. Aerodiol produced a significant reduction in the Kupperman index and in the occurrence of menopausal symptoms, such as hot flushes and night sweats. This reduction appeared to be significant as early as the second week of treatment. Moreover, Aerodiol remained effective even among highly symptomatic women with more than seven hot flushes per day, and also among smokers. Since it avoids hepatic first-pass metabolism, pulsed estrogen therapy also has a favorable action on the lipid profile, decreasing lipoprotein(a), apolipoprotein B, total cholesterol, and low-density lipoprotein cholesterol. Furthermore, Aerodiol is neutral with regard to clotting factors, angiotensinogen and insulin levels. The effect of pulsed estrogen therapy on bone has been assessed in both the short and the long term. Bone turnover, as measured by markers of resorption and formation, was normalized to premenopausal levels after 3 months of treatment at a dose of 300 microg/day. Aerodiol, again at the dose of 300 microg/day, is as effective as a 50-microg/day transdermal patch in increasing bone mineral density (p < 0.001 versus baseline) at the spine and hip after 56 weeks. Finally, data collected during the development of Aerodiol have shown that pulsed estrogen therapy is at least as effective as 2 mg of oral estrogen or 50 microg of transdermal estrogen in relieving climacteric symptoms and preventing postmenopausal bone loss.
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PMID:Pulsed estrogen therapy: relieving climacteric symptoms, preventing postmenopausal bone loss. 1248 9