Your browser doesn't support javascript.
Mostrar: 20 | 50 | 100
Resultados 1 - 19 de 19
Filtrar
Mais filtros










Base de dados
Intervalo de ano de publicação
1.
Menopause ; 27(2): 134-142, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31688416

RESUMO

OBJECTIVE: To quantify the association between vulvovaginal atrophy and depression, major depressive disorder, and anxiety. METHODS: Women with vulvovaginal atrophy from the Truven Health MarketScan Commercial and Medicare Supplemental Databases (01/2010-09/2016) with ≥365 days of continuous insurance coverage before and after the first vulvovaginal atrophy/dyspareunia diagnosis (index date) were selected. Women with vulvovaginal atrophy were matched 1:3 to women without (controls) according to age, calendar year, health plan, and region. The study period spanned from 12 months before to 12 months after index date. The ratios of diagnosed depression, major depressive disorder, and anxiety among women with vulvovaginal atrophy and the controls were calculated. Logistic regressions adjusting for proxies of menopause were used to compare prevalence. RESULTS: In all, 125,889 women with vulvovaginal atrophy and 376,057 controls were included (mean age 60.7 [45-101]). The prevalence of depression, major depressive disorder, and anxiety was higher among women with vulvovaginal atrophy compared with controls (23.9% vs 18.9%, 6.3% vs 4.7%, 16.6% vs 11.3%), with prevalence ratios of 1.26, 1.33, and 1.47, respectively (all P < 0.0001). Highest prevalences and differences were observed in younger women. Findings were consistent when analyzing newly diagnosed conditions. When adjusting for proxies of menopause (insomnia, vasomotor symptoms, dysuria, and estrogen therapy), vulvovaginal atrophy remained significant (prevalence odds ratios; depression 1.23, major depressive disorder 1.22, anxiety 1.39; all P < 0.0001). CONCLUSIONS: Vulvovaginal atrophy is associated with a significantly higher prevalence/incidence of depression, major depressive disorder, and anxiety. The higher prevalence/incidence and greater differences in younger women highlight the need for a multidisciplinary approach and early diagnosis/management of vulvovaginal atrophy.

2.
Pediatr Res ; 2019 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-31578038

RESUMO

BACKGROUND: Privacy-protecting analytic approaches without centralized pooling of individual-level data, such as distributed regression, are particularly important for vulnerable populations, such as children, but these methods have not yet been tested in multi-center pediatric studies. METHODS: Using the electronic health data from 34 healthcare institutions in the National Patient-Centered Clinical Research Network (PCORnet), we fit 12 multivariable-adjusted linear regression models to assess the associations of antibiotic use <24 months of age with body mass index z-score at 48 to <72 months of age. We ran these models using pooled individual-level data and conventional multivariable-adjusted regression (reference method), as well as using the more privacy-protecting pooled summary-level intermediate statistics and distributed regression technique. We compared the results from these two methods. RESULTS: Pooled individual-level and distributed linear regression analyses produced virtually identical parameter estimates and standard errors. Across all 12 models, the maximum difference in any of the parameter estimates or standard errors was 4.4833 × 10-10. CONCLUSIONS: We demonstrated empirically the feasibility and validity of distributed linear regression analysis using only summary-level information within a large multi-center study of children. This approach could enable expanded opportunities for multi-center pediatric research, especially when sharing of granular individual-level data is challenging.

3.
Am J Epidemiol ; 188(4): 709-723, 2019 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-30535131

RESUMO

Distributed data networks enable large-scale epidemiologic studies, but protecting privacy while adequately adjusting for a large number of covariates continues to pose methodological challenges. Using 2 empirical examples within a 3-site distributed data network, we tested combinations of 3 aggregate-level data-sharing approaches (risk-set, summary-table, and effect-estimate), 4 confounding adjustment methods (matching, stratification, inverse probability weighting, and matching weighting), and 2 summary scores (propensity score and disease risk score) for binary and time-to-event outcomes. We assessed the performance of combinations of these data-sharing and adjustment methods by comparing their results with results from the corresponding pooled individual-level data analysis (reference analysis). For both types of outcomes, the method combinations examined yielded results identical or comparable to the reference results in most scenarios. Within each data-sharing approach, comparability between aggregate- and individual-level data analysis depended on adjustment method; for example, risk-set data-sharing with matched or stratified analysis of summary scores produced identical results, while weighted analysis showed some discrepancies. Across the adjustment methods examined, risk-set data-sharing generally performed better, while summary-table and effect-estimate data-sharing more often produced discrepancies in settings with rare outcomes and small sample sizes. Valid multivariable-adjusted analysis can be performed in distributed data networks without sharing of individual-level data.


Assuntos
Confidencialidade/normas , Agregação de Dados , Projetos de Pesquisa Epidemiológica , Disseminação de Informação/métodos , Serviços de Informação , Humanos , Análise Multivariada , Privacidade , Pontuação de Propensão
4.
Clin Epidemiol ; 10: 1773-1786, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30568510

RESUMO

Purpose: Sharing of detailed individual-level data continues to pose challenges in multi-center studies. This issue can be addressed in part by using analytic methods that require only summary-level information to perform the desired multivariable-adjusted analysis. We examined the feasibility and empirical validity of 1) conducting multivariable-adjusted distributed linear regression and 2) combining distributed linear regression with propensity scores, in a large distributed data network. Patients and methods: We compared percent total weight loss 1-year postsurgery between Roux-en-Y gastric bypass and sleeve gastrectomy procedure among 43,110 patients from 36 health systems in the National Patient-Centered Clinical Research Network. We adjusted for baseline demographic and clinical variables as individual covariates, deciles of propensity scores, or both, in three separate outcome regression models. We used distributed linear regression, a method that requires only summary-level information (specifically, sums of squares and cross products matrix) from sites, to fit the three ordinary least squares linear regression models. A comparison set of analyses that used pooled deidentified individual-level data from sites served as the reference. Results: Distributed linear regression produced results identical to those from the corresponding pooled individual-level data analysis for all variables in all three models. The maximum numerical difference in the parameter estimate or standard error for all the variables was 3×10-11 across three models. Conclusion: Distributed linear regression analysis is a feasible and valid analytic method in multicenter studies for one-time continuous outcomes. Combining distributed regression with propensity scores via modeling offers more privacy protection and analytic flexibility.

5.
Menopause ; 25(11): 1339-1353, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30358731

RESUMO

OBJECTIVE: The aim of this study is to confirm the local beneficial effects of intravaginal dehydroepiandrosterone (DHEA, Prasterone) on moderate to severe dyspareunia or pain at sexual activity, the most frequent symptom of vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause (GSM). METHODS: In a prospective, randomized, double-blind, and placebo-controlled phase III clinical trial, the effect of daily intravaginal 0.50% DHEA (6.5 mg) (Prasterone, EndoCeutics) was examined on four coprimary objectives, namely percentage of parabasal cells, percentage or superficial cells, vaginal pH, and moderate to severe pain at sexual activity (dyspareunia) identified by the women as their most bothersome vulvovaginal atrophy symptom. The intent-to-treat population included 157 and 325 women in the placebo and DHEA-treated groups, respectively. RESULTS: After daily intravaginal administration of 0.50% DHEA for 12 weeks, when compared to baseline by the analysis of covariance test, the percentage of parabasal cells decreased by 27.7% over placebo (P < 0.0001), whereas the percentage of superficial cells increased by 8.44% over placebo (P < 0.0001), vaginal pH decreased by 0.66 pH unit over placebo (P < 0.0001), and pain at sexual activity decreased by 1.42 severity score unit from baseline or 0.36 unit over placebo (P = 0.0002). On the other hand, moderate to severe vaginal dryness present in 84.0% of women improved at 12 weeks by 1.44 severity score unit compared to baseline, or 0.27 unit over placebo (P = 0.004). At gynecological evaluation, vaginal secretions, epithelial integrity, epithelial surface thickness, and color all improved by 86% to 121% over the placebo effect (P < 0.0001 for all comparisons with placebo). Serum steroid levels remained well within the normal postmenopausal values according to the involved mechanisms of intracrinology. The only side effect reasonably related to treatment is vaginal discharge due to melting of the vehicle at body temperature and this was reported in about 6% of the participants. CONCLUSIONS: The daily intravaginal administration of 0.50% (6.5 mg) DHEA (Prasterone) has shown clinically and highly statistically significant effects on the four coprimary parameters suggested by the US Food and Drug Administration. The strictly local action of Prasterone is in line with the absence of significant drug-related adverse events, thus showing the high benefit-to-risk ratio of this treatment based upon the novel understanding of the physiology of sex steroids in women.


Assuntos
Adjuvantes Imunológicos/uso terapêutico , Desidroepiandrosterona/uso terapêutico , Dispareunia/tratamento farmacológico , Menopausa , Vagina/patologia , Doenças Vaginais/tratamento farmacológico , Vulva/patologia , Adjuvantes Imunológicos/administração & dosagem , Adjuvantes Imunológicos/efeitos adversos , Administração Intravaginal , Adulto , Idoso , Idoso de 80 Anos ou mais , Atrofia/tratamento farmacológico , Desidroepiandrosterona/administração & dosagem , Desidroepiandrosterona/efeitos adversos , Método Duplo-Cego , Dispareunia/patologia , Feminino , Humanos , Concentração de Íons de Hidrogênio/efeitos dos fármacos , Pessoa de Meia-Idade , Estudos Prospectivos , Inquéritos e Questionários , Síndrome , Resultado do Tratamento , Sistema Urogenital/patologia , Vagina/química
6.
J Steroid Biochem Mol Biol ; 159: 142-53, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-26972555

RESUMO

This study integrates all data obtained in women aged 40-80years enrolled with moderate to severe symptoms of vulvovaginal atrophy (VVA) who received daily intravaginal administration of 0.50% (6.5mg) dehydroepiandrosterone (DHEA; prasterone) for 12weeks (n=723; ITT-S population) as compared with placebo (n=266; ITT-S population). To this end, serum steroid levels (DHEA, DHEA-sulfate (DHEA-S), androst-5-ene-3ß, 17ß-diol (5-diol), testosterone, dihydrotestosterone (DHT), androstenedione (4-dione), estrone (E1), estradiol (E2), estrone sulfate (E1-S), androsterone glucuronide (ADT-G), and androstane-3α, 17ß-diol 17-glucuronide (3α-diol-17G)) were measured at Day 1 and Week 12 by liquid chromatography-tandem mass spectrometry (LC-MS/MS) following validation performed according to the FDA guidelines [1-6]. In agreement with the mechanisms of intracrinology where DHEA is exclusively transformed intracellularly into active sex steroids which act and are inactivated locally before being released as glucuronided or sulfated metabolites for elimination by the kidneys and liver, all sex steroids remained well within normal postmenopausal values following administration of intravaginal DHEA. Serum estradiol, the most relevant sex steroid, was measured after 12weeks of treatment at 3.36pg/ml (cITT-S population) or 19% below the normal postmenopausal value of 4.17pg/ml. On the other hand, serum E1-S, the best recognized marker of global estrogenic activity, shows an average value of 209pg/ml at 12 weeks compared to 220pg/ml in normal postmenopausal women. Moreover, serum ADT-G, the main metabolite of androgens, also remains well within normal postmenopausal values. The present data shows that a low daily intravaginal dose (6.5mg) of DHEA (prasterone) which is efficacious on the symptoms and signs of VVA, permits to achieve the desired local efficacy without systemic exposure, in agreement with the stringent mechanisms of menopause established after 500 million years of evolution where each cell in each tissue is the master of its sex steroid exposure.


Assuntos
Desidroepiandrosterona/administração & dosagem , Estradiol/sangue , Pós-Menopausa/sangue , Testosterona/sangue , Doenças Vaginais/tratamento farmacológico , Administração Intravaginal , Adulto , Idoso , Idoso de 80 Anos ou mais , Atrofia/tratamento farmacológico , Desidroepiandrosterona/farmacocinética , Feminino , Terapia de Reposição Hormonal , Humanos , Pessoa de Meia-Idade
7.
Menopause ; 23(3): 243-56, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26731686

RESUMO

OBJECTIVE: The aim of this study is to confirm the local beneficial effects of intravaginal dehydroepiandrosterone (DHEA, Prasterone) on moderate to severe dyspareunia or pain at sexual activity, the most frequent symptom of vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause (GSM). METHODS: In a prospective, randomized, double-blind, and placebo-controlled phase III clinical trial, the effect of daily intravaginal 0.50% DHEA (6.5 mg) (Prasterone, EndoCeutics) was examined on four coprimary objectives, namely percentage of parabasal cells, percentage or superficial cells, vaginal pH, and moderate to severe pain at sexual activity (dyspareunia) identified by the women as their most bothersome vulvovaginal atrophy symptom. The intent-to-treat population included 157 and 325 women in the placebo and DHEA-treated groups, respectively. RESULTS: After daily intravaginal administration of 0.50% DHEA for 12 weeks, when compared to baseline by the analysis of covariance test, the percentage of parabasal cells decreased by 27.7% over placebo (P < 0.0001), whereas the percentage of superficial cells increased by 8.44% over placebo (P < 0.0001), vaginal pH decreased by 0.66 pH unit over placebo (P < 0.0001), and pain at sexual activity decreased by 1.42 severity score unit from baseline or 0.36 unit over placebo (P = 0.0002). On the other hand, moderate to severe vaginal dryness present in 84.0% of women improved at 12 weeks by 1.44 severity score unit compared to baseline, or 0.27 unit over placebo (P = 0.004). At gynecological evaluation, vaginal secretions, epithelial integrity, epithelial surface thickness, and color all improved by 86% to 121% over the placebo effect (P < 0.0001 for all comparisons with placebo). Serum steroid levels remained well within the normal postmenopausal values according to the involved mechanisms of intracrinology. The only side effect reasonably related to treatment is vaginal discharge due to melting of the vehicle at body temperature and this was reported in about 6% of the participants. CONCLUSIONS: The daily intravaginal administration of 0.50% (6.5 mg) DHEA (Prasterone) has shown clinically and highly statistically significant effects on the four coprimary parameters suggested by the US Food and Drug Administration. The strictly local action of Prasterone is in line with the absence of significant drug-related adverse events, thus showing the high benefit-to-risk ratio of this treatment based upon the novel understanding of the physiology of sex steroids in women.


Assuntos
Desidroepiandrosterona/uso terapêutico , Dispareunia/tratamento farmacológico , Terapia de Reposição Hormonal , Menopausa , Doenças Vaginais/tratamento farmacológico , Vulva/efeitos dos fármacos , Doenças da Vulva/tratamento farmacológico , Administração Intravaginal , Idoso , Método Duplo-Cego , Feminino , Humanos , Pessoa de Meia-Idade , Pós-Menopausa , Síndrome , Vagina/efeitos dos fármacos , Vagina/patologia , Vulva/patologia , Doenças da Vulva/patologia
8.
Horm Mol Biol Clin Investig ; 25(3): 181-90, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26725467

RESUMO

OBJECTIVE: Intravaginal DHEA (dehydroepiandrosterone, prasterone), the exclusive precursor of androgens and estrogens in postmenopausal women, has previously been shown to improve all the domains of sexual function by a strictly local action in the vagina. The well recognized female sexual function index (FSFI) questionnaire was used in the present study. DESIGN: The long-term effect of 52-week treatment with daily intravaginal 0.50% (6.5 mg) DHEA was evaluated on the various domains of female sexual function using the FSFI questionnaire at baseline, Week 26 and Week 52. SUBJECTS: One hundred and fifty-four postmenopausal women with at least one mild to severe symptom of vulvovaginal atrophy (VVA) and who have completed the FSFI questionnaire at baseline and at least one post-baseline timepoint were included in the analysis. RESULTS: The FSFI domains desire, arousal, lubrication, orgasm, satisfaction and pain were increased by 28%, 49%, 115%, 51%, 41% and 108%, respectively (p<0.0001 for all parameters) at 52 weeks vs. baseline, while the total score was increased from 13.4±0.62 at baseline to 21.5±0.82 (+60%, p<0.0001) at 52 weeks. CONCLUSION: As the serum levels of DHEA and all its metabolites, including estradiol and testosterone, show no meaningful change, the present clinical data indicate a stimulatory effect of intravaginal DHEA through a strictly local action in agreement with the preclinical data showing that the androgens made locally from DHEA in the vagina induce an increase in local nerve density.


Assuntos
Desidroepiandrosterona/uso terapêutico , Pós-Menopausa/efeitos dos fármacos , Disfunções Sexuais Fisiológicas/tratamento farmacológico , Administração Intravaginal , Adulto , Idoso , Desidroepiandrosterona/administração & dosagem , Desidroepiandrosterona/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Pessoa de Meia-Idade , Orgasmo/efeitos dos fármacos , Efeito Placebo , Inquéritos e Questionários
9.
Gynecol Endocrinol ; 32(3): 240-5, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26634942

RESUMO

The objective of the study is to evaluate the acceptability of the intravaginal administration of ovules/suppositories of DHEA (dehydroepiandrosterone, prasterone) for the treatment of vulvovaginal atrophy (VVA) in women with moderate to severe dyspareunia who were administered daily for 12 weeks intravaginal 0.50% (6.5 mg) DHEA or placebo. There were a total of 373 women in the per-protocol population who responded to the questionnaire for both treatment groups. While it was planned that the applicator would be evaluated as suitable if at least 80% of participants have a global score ≤ 2 units, 99% and 100% of participants had a score ≤ 2 units in the placebo and DHEA groups, respectively, for the global score (mean of 5 questions). When asked about like and dislike the technique of drug administration, 284 comments were positive, while 114 women gave no comment. About 92-94% of women indicated that they were very confident to be able use the applicator successfully in the future. The survey shows a high degree of satisfaction and of confidence to use the applicator successfully in the future.


Assuntos
Desidroepiandrosterona/administração & dosagem , Dispareunia/tratamento farmacológico , Doenças Vaginais/tratamento farmacológico , Administração Intravaginal , Atrofia/tratamento farmacológico , Método Duplo-Cego , Feminino , Humanos , Aceitação pelo Paciente de Cuidados de Saúde , Estudos Prospectivos , Vagina/patologia
10.
J Sex Med ; 12(12): 2401-12, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26597311

RESUMO

INTRODUCTION: Previous data have shown that intravaginal dehydroepiandrosterone (DHEA, prasterone) improved all the domains of sexual function, an effect most likely related to the local formation of androgens from DHEA. AIMS: To confirm in a placebo-controlled, prospective, double-blind and randomized study the benefits of daily intravaginal DHEA for 12 weeks on sexual function using the Female Sexual Function Index (FSFI) questionnaire. METHODS: Placebo was administered daily to 157 women while 325 women received 0.50% (6.5 mg) DHEA daily for 12 weeks. All women were postmenopausal meeting the criteria of vulvovaginal atrophy (VVA), namely moderate to severe dyspareunia as their most bothersome symptom of VVA in addition to having ≤5% of vaginal superficial cells and vaginal pH > 5.0. The FSFI questionnaire was filled at baseline (screening and day 1), 6 weeks and 12 weeks. Comparison between DHEA and placebo of the changes from baseline to 12 weeks was made using the analysis of covariance test, with treatment group as the main factor and baseline value as the covariate. MAIN OUTCOME MEASURES: The six domains and total score of the FSFI questionnaire were evaluated. RESULTS: The FSFI domain desire increased over placebo by 0.24 unit (+49.0%, P = 0.0105), arousal by 0.42 unit (+56.8%, P = 0.0022), lubrication by 0.57 unit (+36.1%, P = 0.0005), orgasm by 0.32 unit (+33.0%, P = 0.047), satisfaction by 0.44 unit (+48.3%, P = 0.0012), and pain at sexual activity by 0.62 unit (+39.2%, P = 0.001). The total FSFI score, on the other hand, has shown a superiority of 2.59 units in the DHEA group over placebo or a 41.3% greater change than placebo (P = 0.0006 over placebo). CONCLUSION: The present data show that all the six domains of the FSFI are improved over placebo (from P = 0.047 to 0.0005), thus confirming the previously observed benefits of intravaginal DHEA on female sexual dysfunction by an action exerted exclusively at the level of the vagina, in the absence of biologically significant changes of serum steroids levels.


Assuntos
Desidroepiandrosterona/administração & dosagem , Dispareunia/tratamento farmacológico , Vagina/efeitos dos fármacos , Vagina/patologia , Vulva/efeitos dos fármacos , Vulva/patologia , Administração Intravaginal , Adulto , Idoso , Atrofia , Método Duplo-Cego , Dispareunia/etiologia , Dispareunia/psicologia , Feminino , Humanos , Pessoa de Meia-Idade , Orgasmo , Satisfação Pessoal , Pós-Menopausa/efeitos dos fármacos , Estudos Prospectivos , Inquéritos e Questionários
11.
J Steroid Biochem Mol Biol ; 154: 186-96, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26291918

RESUMO

The objective of the present phase III, placebo-controlled, double-blind, prospective and randomized study was to confirm the efficacy of daily intravaginal administration of 0.50% dehydroepiandrosterone (DHEA; prasterone) ovules for 12 weeks on moderate to severe dyspareunia (or pain at sexual activity) as most bothersome symptom of vulvovaginal atrophy (VVA) while having serum steroid concentrations within normal postmenopausal values. To this end, serum levels of DHEA, DHEA-sulfate (DHEA-S), Androst-5-ene-diol-3ß, 17ß-diol (5-diol), testosterone, dihydrotestosterone (DHT), androstenedione (4-dione), estrone (E1), estradiol (E2), estrone sulfate (E1-S), androsterone glucuronide (ADT-G), and androstane-3α, 17ß-diol 17-glucuronide (3α-diol-17G) were measured by validated liquid chromatography-tandem mass spectrometry (LC-MS/MS). In agreement with the mechanisms of intracrinology, all serum sex steroids and metabolites concentrations after 12 weeks of daily intravaginal administration of 0.50% DHEA remain well within the limits of normal postmenopausal women. More specifically, the 12-week serum E2 concentration was measured at 22% below the average normal postmenopausal value (3.26 versus 4.17 pg/ml), thus eliminating any fear of E2 exposure outside the vagina. In addition, serum E1-S, a particularly reliable indicator of global estrogenic activity, shows serum levels practically superimposable to the value observed in normal postmenopausal women (219 versus 220 pg/ml). Similarly, serum ADT-G, the major metabolite of androgens, remains within normal postmenopausal values. The present data confirm the intracellular transformation of DHEA in the vagina resulting in local efficacy without any systemic exposure to sex steroids, observations which are in agreement with the physiological mechanisms of menopause.


Assuntos
Desidroepiandrosterona/administração & dosagem , Hormônios Esteroides Gonadais/sangue , Vagina , Idoso , Método Duplo-Cego , Vias de Administração de Medicamentos , Feminino , Humanos , Pessoa de Meia-Idade , Placebos , Pós-Menopausa , Estudos Prospectivos
12.
Maturitas ; 81(1): 46-56, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25771041

RESUMO

OBJECTIVE: An objective was to analyze the time course of efficacy of daily intravaginal administration of 0.5% (6.5mg) DHEA (prasterone) for 52 weeks on the moderate to severe (MS) symptoms and signs of vulvovaginal atrophy (VVA). METHOD: Five hundred twenty-one postmenopausal women were enrolled and received daily intravaginal administration of 0.5% DHEA in an open-label phase III study. The severity of the VVA symptoms examined in detail in the different groups. RESULTS: A parallel improvement of pain at sexual activity was observed in women who had moderate to severe (MS) dyspareunia as their most bothersome symptom (MBS) (n=183) or not MBS (n=240) and MS without being MBS (n=57) with a 1.70 severity unit change in the MBS group for a decrease of 66.1% from baseline (p<0.0001 versus baseline) over 52 weeks. A further improvement of dyspareunia, namely 0.33 severity unit (19.4%), was observed with continuing treatment from 12 weeks to 52 weeks. Similar results were observed on vaginal dryness and irritation/itching. Highly significant beneficial effects (p<0.0001 versus baseline for all) were observed at gynecological examination on vaginal secretions, color, epithelial integrity and epithelial surface thickness. CONCLUSION: The present study shows, in addition to the parallel benefits on the three symptoms of VVA, that the choice of any of the MS symptoms as being or not being MBS by women has no influence on the observed therapeutic effect (NCT01256671).


Assuntos
Desidroepiandrosterona/administração & dosagem , Hormônios/administração & dosagem , Vagina/patologia , Doenças Vaginais/tratamento farmacológico , Vulva/patologia , Doenças da Vulva/tratamento farmacológico , Administração Intravaginal , Adulto , Idoso , Atrofia/complicações , Atrofia/tratamento farmacológico , Método Duplo-Cego , Dispareunia/tratamento farmacológico , Dispareunia/etiologia , Feminino , Humanos , Pessoa de Meia-Idade , Pós-Menopausa , Prurido/tratamento farmacológico , Índice de Gravidade de Doença , Comportamento Sexual , Doenças Vaginais/complicações , Doenças da Vulva/complicações
13.
Pharmacoepidemiol Drug Saf ; 22(11): 1171-7, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-23878013

RESUMO

PURPOSE: It is increasingly necessary to analyze data from multiple sources when conducting public health safety surveillance or comparative effectiveness research. However, security, privacy, proprietary, and legal concerns often reduce data holders' willingness to share highly granular information. We describe and compare two approaches that do not require sharing of patient-level information to adjust for confounding in multi-site studies. METHODS: We estimated the risks of angioedema associated with angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), and aliskiren in comparison with beta-blockers within Mini-Sentinel, which has created a distributed data system of 18 health plans. To obtain the adjusted hazard ratios (HRs) and 95% confidence intervals (CIs), we performed (i) a propensity score-stratified case-centered logistic regression analysis, a method identical to a stratified Cox regression analysis but needing only aggregated risk set data, and (ii) an inverse variance-weighted meta-analysis, which requires only the site-specific HR and variance. We also performed simulations to further compare the two methods. RESULTS: Compared with beta-blockers, the adjusted HR was 3.04 (95% CI: 2.81, 3.27) for ACEIs, 1.16 (1.00, 1.34) for ARBs, and 2.85 (1.34, 6.04) for aliskiren in the case-centered analysis. The corresponding HRs were 2.98 (2.76, 3.21), 1.15 (1.00, 1.33), and 2.86 (1.35, 6.04) in the meta-analysis. Simulations suggested that the two methods may produce different results under certain analytic scenarios. CONCLUSION: The case-centered analysis and the meta-analysis produced similar results without the need to share patient-level data across sites in our empirical study, but may provide different results in other study settings.


Assuntos
Angioedema/induzido quimicamente , Pesquisa Comparativa da Efetividade/métodos , Farmacoepidemiologia/métodos , Antagonistas Adrenérgicos beta/efeitos adversos , Amidas/efeitos adversos , Angioedema/epidemiologia , Antagonistas de Receptores de Angiotensina/efeitos adversos , Inibidores da Enzima Conversora de Angiotensina/efeitos adversos , Simulação por Computador , Bases de Dados Factuais , Fumaratos/efeitos adversos , Humanos , Modelos Logísticos , Análise Multivariada , Pontuação de Propensão
14.
J Am Soc Hypertens ; 3(6): 403-15, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-20409983

RESUMO

Study quantified incremental cost of cardiovascular (CV) events in 6 high-risk and compelling indication subgroups: post-myocardial infarction (MI), diabetes, diabetic nephropathy, elderly, chronic kidney disease, and prior stroke. Based on claims data from privately insured individuals with 2+ hypertension (HTN) diagnoses in 2004-2006, we estimated regression-adjusted per-member-per-month healthcare costs after CVE. Costs were compared between patients with and without a CV events, and before and after CV events in each subgroup. The following CVevents were studied: acute MI, acute coronary syndrome, angina, ventricular arrhythmia, atrial arrhythmia, heart failure, coronary artery disease, left ventricular hypertrophy, stroke, and sinus tachycardia. Of 1,598,890 HTN patients, 510,118 had >/=1 CV event. Compared with controls, healthcare costs among patients with events were significantly greater across all cost components (inpatient, outpatient, and prescription drug). Acute MI and congestive heart failure generally had the largest incremental total healthcare costs. First-quarter post-event costs were attributable to inpatient costs. CV events are costly sequelae of hypertension in high-risk and CI subgroups.

15.
Dis Manag ; 11(1): 49-58, 2008 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-18279115

RESUMO

The objective of the study was to quantify the direct and indirect incremental costs of epoetin alpha (EPO) therapy for anemia in pre-dialysis chronic kidney disease (CKD). Using employer claims data from January 1998 to January 2005, direct (medical and pharmacy) and indirect (sick leave and disability) costs were compared between CKD-anemic patients treated with EPO before dialysis (n = 199) and those not treated with an erythropoiesis-stimulating therapy (EST) (n = 196). Among the results, incremental direct and indirect cost savings for EPO-treated patients were $1443 and $328 per member per month (PMPM) (p < 0.001), respectively, compared to non-EST-treated patients with anemia. After multivariate adjustments, direct and indirect costs remained significantly lower by $852 and $308 PMPM (p < 0.001), respectively, for the EPO-treated group. Direct costs during the first 6 months of dialysis also were significantly lower for the EPO-treated group (who received EPO before dialysis), by $1515 PMPM (p = 0.0267, in multivariate regression). In conclusion, anemic CKD patients treated with EPO before dialysis had significantly lower direct and indirect costs compared to non-EST-treated patients.


Assuntos
Anemia/economia , Avaliação da Deficiência , Eritropoetina/uso terapêutico , Falência Renal Crônica/terapia , Diálise Renal/métodos , Idoso , Anemia/prevenção & controle , Anemia/reabilitação , Custos e Análise de Custo , Eritropoetina/economia , Feminino , Seguimentos , Humanos , Revisão da Utilização de Seguros , Falência Renal Crônica/complicações , Masculino , Pessoa de Meia-Idade , Proteínas Recombinantes , Estudos Retrospectivos , Resultado do Tratamento , Estados Unidos
16.
Curr Med Res Opin ; 23(12): 3215-22, 2007 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-18021497

RESUMO

OBJECTIVE: To characterize first-year utilization patterns of teriparatide derived from a claims database analysis versus predictions from an economic model. RESEARCH DESIGN AND METHODS: Claims data for actual teriparatide utilization were obtained from an integrated administrative database of approximately 3.4 million beneficiaries. A control group included patients with osteoporosis but without the use of teriparatide. An economic model, which relied on first-year market share projections, predicted the utilization of teriparatide from the demographic characteristics of the plan. Predictions were compared to actual utilization for eight health plans within the database. MAIN OUTCOME MEASURES: Demographic and clinical characteristics, number of teriparatide patients, and days of teriparatide therapy. RESULTS: Less than 1% of patients diagnosed with osteoporosis received teriparatide. Teriparatide-treated patients, compared to other patients with osteoporosis, were older and more likely to have experienced a previous fracture or to have received previous osteoporosis pharmacotherapy. For the combined 505 300 lives in the eight plans used for the comparative analysis, there were 134 teriparatide patients; the model predicted 131. For individual plans, the predictions varied in their accuracy. The greatest under-prediction for one plan was 17 patients (40 predicted vs. 57 actual), while the greatest over-prediction was 18 patients (34 predicted vs. 16 actual). For the other 6 plans, the predictions were within four patients of the actual number of teriparatide users. A similar pattern of differences was observed by comparing actual versus predicted days of teriparatide therapy across the eight plans. LIMITATIONS: Some clinical details of the actual patient cohorts, such as bone mineral density results, were not available in the database. The comparisons made between the teriparatide model predictions and actual utilization were based on analyses of a single model and do not speak to the broader issue of the accuracy of predictive economic models in general. CONCLUSIONS: Overall, first-year teriparatide utilization was relatively limited, consistent with model predictions. Predictions for individual plans varied in their accuracy.


Assuntos
Seguro Saúde , Modelos Econômicos , Osteoporose/tratamento farmacológico , Teriparatida/administração & dosagem , Teriparatida/economia , Idoso , Idoso de 80 Anos ou mais , Densidade Óssea , Esquema de Medicação , Uso de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico
17.
Clin Breast Cancer ; 7(2): 127-32, 2006 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-16800971

RESUMO

BACKGROUND: Aromatase inhibitors (AIs) are a novel hormonal therapy for patients with breast cancer. However, AIs can cause bone loss by blocking estrogen production. This study aims to assess the association between AIs and treatment-related bone loss in a large managed-care population of women with breast cancer. PATIENTS AND METHODS: With use of medical and pharmacy claims, data from > 5 million beneficiaries between January 1, 1998, and January 31, 2005, we identified 12,368 patients with > or = 2 breast cancer claims in a 6-month period who also had no bone metastases and no previous osteoporosis or fracture claims. Patients who had received antiestrogen (eg, tamoxifen) therapy were also excluded. One thousand three hundred fifty-four patients receiving an AI (anastrozole, exemestane, or letrozole) were compared with 11,014 controls who did not receive an AI with respect to their risk of bone loss. The observation start date for the AI and control groups was defined as the service date of the first AI claim and breast cancer claim, respectively. The endpoints include (1) bone loss, consisting of osteoporosis or osteopenia, and (2) clinical fractures. RESULTS: The univariate analysis found that the prevalence of bone loss was 8.7% in the AI group versus 7.1% in the control group, resulting in a significant relative risk of 1.3 (95% confidence interval [CI], 1.1-1.6; P = 0.01). The prevalence of bone fracture was also significantly increased in the AI group compared with the controls (13.5% vs. 10.3%) with a relative risk of 1.4 (95% CI, 1.2-1.6, P = 0.001). Multivariate Cox proportional hazards regressions showed that after adjusting for age and comorbidities, the risk of bone loss remained significantly higher in the AI group than in the non-AI group, with a 27% (95% CI, 4%-55%; P = 0.02) and 21% (95% CI, 3%-43%; P = 0.02) increase in the risk of bone loss and fractures, respectively. CONCLUSION: This retrospective longitudinal analysis of a large cohort of patients with breast cancer corroborates previous findings from smaller clinical trials and demonstrates that AI therapies carry an increased risk of bone loss. Monitoring and treatment management strategies to reduce bone loss risk are warranted in women receiving an AI for breast cancer.


Assuntos
Inibidores da Aromatase/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Fraturas Ósseas/epidemiologia , Osteoporose/epidemiologia , Idoso , Estudos de Coortes , Feminino , Fraturas Ósseas/induzido quimicamente , Humanos , Incidência , Formulário de Reclamação de Seguro , Pessoa de Meia-Idade , Osteoporose/induzido quimicamente , Prevalência , Estudos Retrospectivos , Medição de Risco
18.
J Urol ; 175(1): 136-9; discussion 139, 2006 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-16406890

RESUMO

PURPOSE: We assessed the relationship between GnRH agonists and the risk of clinical fractures in men with prostate cancer. MATERIALS AND METHODS: Using a database of medical claims from 16 large American companies we identified a study group of 3,779 men with prostate cancer who received treatment with a GnRH agonist and a control group of 8,341 with prostate cancer who were not treated with a GnRH agonist. Men with 1 or more medical claims for bone metastases were excluded. The rates of any clinical fracture, hip fracture and vertebral fracture were compared between the groups. RESULTS: The rate of any fracture was 7.91/100 vs 6.55/100 person-years at risk in men who received vs did not receive a GnRH agonist (relative risk 1.21, 95% CI 1.09 to 1.34). The rates of hip fracture (relative risk 1.76, 95% CI 1.33 to 2.33) and vertebral fracture (relative risk 1.18, 95% CI 0.94 to 1.48) were also higher in men who received a GnRH agonist. GnRH agonist treatment was independently associated with fracture risk on multivariate analyses. CONCLUSIONS: GnRH agonists increase the risk of clinical fracture in men with prostate cancer.


Assuntos
Fraturas Espontâneas/induzido quimicamente , Fraturas Espontâneas/epidemiologia , Hormônio Liberador de Gonadotropina/efeitos adversos , Hormônio Liberador de Gonadotropina/agonistas , Gosserrelina/efeitos adversos , Leuprolida/efeitos adversos , Neoplasias da Próstata/tratamento farmacológico , Pamoato de Triptorrelina/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Hormônio Liberador de Gonadotropina/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco
19.
Health Aff (Millwood) ; Suppl Web Exclusives: W3-537-51, 2003.
Artigo em Inglês | MEDLINE | ID: mdl-15506158

RESUMO

We analyze the relationship between the supply of new technologies and health care utilization and spending, focusing on diagnostic imaging, cardiac, cancer, and newborn care technologies. As anticipated by previous research, increases in the supply of technology tend to be related to higher utilization and spending on the service in question. In some cases, notably diagnostic imaging, increases in availability appear associated with incremental utilization rather than substitution for other services. Policy efforts to assess and manage the availability of new technologies could benefit society where the additional spending produced by new services is not associated with strong quality improvements.


Assuntos
Gastos em Saúde , Tecnologia , Política de Saúde , Qualidade da Assistência à Saúde , Tecnologia/economia , Avaliação da Tecnologia Biomédica , Estados Unidos
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA