A randomized, open-label study of conjugated equine estrogens plus medroxyprogesterone acetate versus tibolone: effects on symptom control, bleeding pattern, lipid profile and tolerability.

OBJECTIVE: To compare the effects of continuous combined conjugated equine estrogens plus medroxyprogesterone acetate (CEE/MPA) with those of tibolone on symptom control, bleeding pattern, lipid profile and tolerability in postmenopausal women. METHODS: This was a randomized, open-label, parallel-group, multicenter study. Generally healthy postmenopausal women with an intact uterus and no contraindications to hormone replacement therapy (HRT) or tibolone were enrolled. Each subject was randomly assigned to receive CEE/MPA 0.625 mg-5.0 mg or tibolone 2.5 mg daily for 13 treatment cycles, each of 28 days. RESULTS: A total of 85 subjects were enrolled and received at least one dose of study medication, of which 76 (89.4%) subjects completed the study (n = 40, CEE/MPA; n = 36, tibolone). The incidence of postmenopausal symptoms decreased significantly over time in both treatment groups, compared with baseline, including significant decreases in the incidence of urogenital and sexual health symptoms. Significant differences in symptom control (other than hot flushes) were observed between treatment groups in a few different cycles for different symptoms, but no consistent or clinically significant trends were observed. No statistically significant differences in the incidence of bleeding were observed between treatment groups after cycle 4. Significant decreases in total cholesterol (5.6%) and low-density lipoprotein (LDL) cholesterol (7.5%) were observed at cycle 13, compared with baseline, in the CEE/MPA group, and significant decreases in high-density lipoprotein (HDL) cholesterol (8.5%) and triglycerides (13.7%) were observed at cycle 13, compared with baseline, in the tibolone group. Significant weight gain was observed at cycle 13 in the tibolone group (3.05 kg), compared with the CEE/MPA group (0.96 kg). The incidences of adverse events were similar in both treatment groups. CONCLUSIONS: Women treated with CEE/MPA or tibolone showed significant improvement of postmenopausal symptoms, including urogenital and sexual health symptoms, and had similar bleeding patterns after four cycles of therapy. CEE/MPA and tibolone each induced a different mix of changes in the lipid profile.

Morphometric dual-energy X-ray absorptiometry of the spine: report of a large series and correlation with axial bone mineral density.

We studied vertebral morphometry and its relation to bone mineral density (BMD) in normal Brazilian women (n = 605). All women (age 22-97 years) were ambulatory and healthy. A lateral spine scan was done for morphometric X-ray absorptiometry using an imaging densitometer. In 429 of these women, BMD of the spine and proximal femur also were measured using dual-energy X-ray absorptiometry. All women were white with mean (+/- 1 SD) age of 53.7 (+/- 9.5) years. About 21% of the women over 50 years had a T score for spine BMD lower than -2.5 SD, and 7% had a femoral neck BMD below this osteoporosis threshold. Vertebral heights (anterior, HA; middle, HM; and posterior, HP) and ratios (HA/HP and HM/HP) were assessed. There was no systematic difference between younger (20-49 years) and older (50+ years) women in heights or ratios. The vertebral heights were normalized for those observed in each individual case for the L2-L4 sequence. This normalization was adequate for all vertebral heights; the Z score averaged about +0.1. The average Z score for HA/HP was +0.01, but that for the HM/HP was -0.72, indicating that the latter ratio might differ from the reference population used (white American and European women). We observed a small positive correlation between vertebral heights and spine or femur BMD, but this was due entirely to the influence of body size on BMD. On a group basis, the HM/HP showed a significant association with axial BMD; the 1 SD difference between the lowest and highest quartile was associated with a difference of 8-15% (0.5-1.0 SD) in axial BMD.

Densidade mineral óssea vertebral e femoral de 724 mulheres brancas brasileiras: influência da idade e do peso corporal / Vertebral and femoral bone mineral sessity of 724 caucasian Brazilian woman: influence of age and body weight

Objetivo. Estudar a densidade mineral óssea (BMD) vertebral (L2-L4) e femoral (colo do fêmur) de mulheres brancas, normais. Material e Método. Mediu-se o BMD de 724 mulheres (40-79 Kg; 20-69 anos de idade) por dual-energy x-ray absorptiometry e analisaram-se os dados em funçao da idade e peso corporal (PC). Resultados. As mulheres mais leves (40-49 Kg) atingiram o BMD maximo (BMDm) vertebral e femoral aos 30-39 anos de idade, enquanto as mais pesadas (60-79 Kg) apresentaram BMDm aos 20 anos. No fêmur, houve uma correlaçao significativa entre BMDm e PC (r=0,97, p<0,001; slope=0,72 por cento/Kg). Em L2-L4, apenas as mulheres com 40-49Kg apresentaram BMDm menor do que as demais(p<0,001). A diminuiçao do BMD vertebral foi mais intensa (-8,3 vs. -5,7 por cento/década) e iniciou mais cedo (quarta vs. quinta década) nas mulheres pesando 40-59Kg do que nas pesando 60-79Kg. A diminuiçao do BMD femoral iniciou logo após o BMDm ser atingido e, até os 69 anos, as mulheres mais pesadas apresentaram um decréscimo 5,3 por cento menor do que aquelas pesando 40-49Kg. O BMD vertebral das mulheres brasileiras foi praticamente o mesmo de uma populaçao norte-americana previamente descrita. Conclusoes. 1) O BMD vertebral e femoral das brasileiras estudadas comportou-se, em funçao da idade, de forma semelhante a de outras populaçoes brancas; 2) havendo o cuidado de corrigir o PC, o BMD das mulheres brasileiras é comparavel ao de mulheres norte-americanas; e 3) o PC é importante na aquisiçao e diminuiçao da massa óssea, além de influenciar a relaçao BMD-idade.

[Vertebral and femoral bone mineral density of 724 caucasian Brazilian women: influence of age and body weight]. / Densidade mineral óssea vertebral e femoral de 724 mulheres brancas brasileiras: influência da idade e do peso corporal.

OBJECTIVE: To study the vertebral (L2-L4) and femoral (neck) bone mineral density (BMD) of normal white women. MATERIAL AND METHOD: We measured the BMD of 724 women (40-79 kg; 20-69 years-age) by dual-energy X-ray absorptiometry. Data were analysed as a function of age and body weight (BW). RESULTS: Thinner women (40-49 kg) attained maximal vertebral and femoral BMD (mBMD) at ages between 30-39 years, while heavier women (60-79 kg) already had the mBMD by the age of 20. At the femur, there was a significant mBMD-BW correlation (r = 0.97; p < 0.001; slope = 0.72%/kg). At the spine, only the 40-49 Kg women exhibited lower mBMD when compared to the others (p < 0.001). The decrease of the vertebral BMD was more intense (-8.3 vs. -5.7%/decade) and started earlier (fourth vs. fifth decade) in women weighting 40-59 kg, as compared to those weighting 60-79 kg. The decrease of the femoral BMD was initiated just after mBMD was achieved and, at the age of 69, heavier women showed a decrease that was 5.3% lower than those weighting 40-49 kg. The vertebral BMD of the Brazilian women was practically the same as reported for a North-American population. CONCLUSIONS: (i) Vertebral and femoral BMD of this Brazilian population varied with age similarly to other white female populations; (ii) provided that appropriate corrections are made for BW, the BMD of Brazilian women is comparable to the BMD of North-Americans; and (iii) the BW is important both in acquisition and decline of bone mass, as it influences the relation BMD-age.

Influence of body composition on the bone mass of postmenopausal women.

AIMS: To investigate the influence of body weight (BW), fat mass (FM) and lean mass (LM) on the bone mineral density (BMD) of several areas of the skeleton. PARTICIPANTS: Sixty one white postmenopausal women (50.1 +/- 4.8 years). MEASUREMENTS: Measurement of BMD by dual energy x-ray absorptiometry. The results were analyzed by linear regression and the slopes of each curve were compared. RESULTS: The results showed that the correlations between BW, FM and LM to BMD were positive, whilst the correlations between age and years since menopause to BMD were negative. LM was the main factor that influence BMD in almost all areas. CONCLUSIONS: FM and LM present a positive effect on BMD, although LM is the main determinant of bone mass. Moreover, higher values of LM and FM present a protective effect against the reduction of BMD combined with menopause. Therefore postmenopausal women with low BW, especially low LM, present serious risk for developing osteoporosis.

Eficácia e segurança de um novo sistema matricial para liberaçäo transdérmica de stradiol comparativamente ao sistema clássico de reservatório / An open, randomized assessment of the efficacy and safety of two transdermal estradiol patches for relief of climacteric symptoms

Estudo comparativo, aberto, randomizado, foi conduzido em 10 centros da América Latina (oito no Brasil, um na Argentina e um no Chile), para avaliar a eficácia e segurança de dois sistemas transdérmicos para liberação de estradiol. Um total de 182 pacientes foi aleatoriamente distribuído para receber o sistema matricial (Climaderm-Wyeth-Ayerst) ou sistema clássico do tipo reservatório (Estraderm TTS 50 - Ciba-Geigy). Os sistemas foram aplicados na região inferior do abdome em áreas alternadas, durante seis ciclos consecutivos de 28 dias. Os sistemas liberavam aproximadamente, 50gr de estradiol por dia. Em ambos os grupos houve, em relação ao pré-tratamento, decréscimo significativo do número diário de fogachos nos ciclos de um a seis, porém houve, em relação ao sistema matricial, melhora significativa nos ciclos 4 (p = 0,033) e 6 (p = 0,046). Houve também diferença significativa entre os grupos com relação à fraqueza nos ciclos 2 (p = 0,019) e 3 (p + 0,015), fadiga no ciclo 2 (p = 0,033), interrupções do sono no ciclo 6 (p + 0,048), nervosismo no ciclo 3 (p = 0,045) e escore total nos ciclos 2 (p = 0,030) e 3 (p = 0,041), a favor do sistema matricial e 18 ( 21,2 por cento) do grupo medicado com o sistema reservatório abandonaram o tratamento

Transvaginal ultrasonography assessment of ovarian volumes in postmenopausal women.

The authors evaluated ovarian volumes by transvaginal ultrasonography at different periods after menopause. Ninety-eight postmenopausal women with an average age of 51.9 years and a one- to eight-year postmenopausal period were studied. The control group consisted of 40 women during menacme with an average age of 31.8 years, who were also submitted to transvaginal ultrasonography to evaluate ovarian volume. There was no significant difference between right and left ovarian volumes in the study groups. There was a significant decrease in measure and standard deviations of the volumes after the first year of menopause (mean volume--2.2 +/- 0.9 cm3) when compared to the control group (mean volume--6.3 +/- 2.0 cm3), followed by a slow and gradual shrinking after this phase. Decrease in ovarian volume became significant after the fourth postmenopausal year. Transvaginal ultrasonography demonstrated great importance as an investigative method of ovarian diseases in postmenopausal women.

Uso do promestriene por via vaginal: avaliaçäo da colpocitologia hormonal, dos níveis plasmáticos de gonadotrofinas e estradiol em mulheres na menopausa: análise da eficácia e tolerabilidade / Use of promestrien by intravaginal route: evaluation of hormonal colpocytology, plasma levels of gonadotrophins and estradiol in menopausal women: analysis of effectiveness and tolerability

Os autores estudaram os efeitos da administraçäo do promestriene por via vaginal em mulheres na pós-menopausa. Um grupo de 14 pacientes recebeu a droga em regime de administraçäo diária, contínua, por 60 dias. Um segundo grupo, com 16 pacientes, foi tratado em regime de administraçäo diária, contínua, por 20 dias e, a seguir, três vezes por semana por mais 40 dias. Analisaram a evoluçäo da colpocitologia hormonal e dos níveis de gonadotrofinas, bem como a tolerabilidade e eficácia da medicaçao ao longo do estudo. Concluem ser o promestriene um agente antiatrófico vaginal efetivo, sem produzir alteraçöes dos níveis plasmáticos de gonadotrofinas e estradiol. Nao observaram diferenças estatísticas nos dois regimes de administraçäo estudados.

[Approach to urinary tract disorders in postmenopausal women]. / Abordagem dos distúrbios do trato urinário na mulher pós-menopausada.

Urinary disorders in the postmenopausal women are important due to their high incidence and to the negative influence on the quality of life of these women. The authors make a brief review of the pathophysiology of these disorders, emphasizing the significant effects of an estrogen fall on the urinary tract during this period of life. They present a modern approach to the current diagnostic and therapeutic aspects of urinary incontinence, urinary tract infections, and urethral syndrome. They also point out the importance of systemic and/or local estrogen therapy in these different aspects, observing the benefits and risks involved in these therapeutic procedures. They comment on the treatment with antibiotics, with adrenergic and/or anticholinergic drugs, surgical treatment, and the techniques of vesical reeducation in the case of detrusor instability. They recommend that physicians should inform and offer their patients the resources above which lead to the cure and/or improvement of the urinary symptoms of those women, given them an expectation of a longer and better life.