Thesis (Ph.D. in Epidemiology) -- University of Colorado Denver, 2007. / Typescript. Includes bibliographical references (leaves 100-117). Free to UCD affiliates. Online version available via ProQuest Digital Dissertations;

Analysis of spontaneous adverse drug reactions reporting hormonal contraception and hormone replacement therapy Author: Vendula Ryndová Supervisor: PharmDr. Kateřina Malá, Ph.D. Consultant: PharmDr. Eva Zimčíková, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction: Hormonal contraception (HC) is the most widely used method to prevent pregnancy worldwide. In addition to pregnancy planning and other non-contraceptional benefits, it also has certain risks. Hormone replacement therapy (HRT) is used primarily for treatment of estrogen deficiency in postmenopausal women. HRT is associated with a number of risks, in particularly for women 60+ of age. Analysis of spontaneous adverse drug reactions (ADRs) reporting contribute to detection of potential risks associated with pharmacotherapy, thereby increases the safety of the drugs. Aim: The aim of this thesis was to analyse spontaneous ADRs reports of HC and HRT registered in the Czech Central Database of ADRs of the State Institute for Drug Control (SÚKL). Methods: Retrospective analysis of the spontaneous ADRs reports of HC and HRT registered in the database of SÚKL from 10/2004 to 6/2017. Mainly, method of receiving the report, reporting person, patient information, seriousness, and...

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A pós-menopausa é marcada por alterações fisiológicas hemodinâmicas e metabólicas. A terapia de reposição estrogênica é uma forma de amenizar as conseqüências da deficiência hormonal e o exercício físico contribui significativamente para a redução do risco cardiovascular. O objetivo desse estudo foi avaliar em mulheres pós-menopausadas os efeitos isolados e associados da terapia oral estrogênica (TRH) e do treinamento físico aeróbio (TF) nas respostas hemodinâmicas e neurais basais e durante os exercícios com handgrip. Quarenta e cinco mulheres (51±3 anos), histerectomizadas, com e sem ovários, saudáveis, realizaram uma sessão experimental e, posteriormente foram divididas em 4 grupos SED-PLA (n=11), SED-TRH (n=14), TF-PLA (n=12) e TF-TRH (n=8). Os grupos TRH e receberam valerato de estradiol 1mg/dia; PLA receberam placebo; TF, realizaram exercício aeróbio em cicloergômetro por 50 minutos, 3 vezes por semana e SED permaneceram sedentárias. Todas as voluntárias participaram de uma segunda sessão experimental após 6 meses de acompanhamento. Nas sessões experimentais foram avaliadas a atividade nervosa simpática periférica (ANSP - microneurografia), pressão arterial, freqüência cardíaca (FC - método oscilométrico Dixtal no membro inferior), fluxo sangüíneo do antebraço (FSA - pletismografia) em um período basal e durante exercícios estático e dinâmico com handgrip a 30% da força de contração máxima. Para análise estatística foi utilizada ANOVA. O TF isoladamente diminuiu ANSP de 40±7 a 34±4 impulsos/min, (P=0,01) e aumentou FSA de 1,92±0,96 a 2,65±1,34 ml(min.100ml), P=0,03 no período basal. TRH e TF associados reduziram a FC no período basal de 65±8 para 62±7 bpm (P=0,01) e durante o exercício estático e dinâmico com handgrip. A TRH de maneira isolada ou associada ao TF diminuiu as respostas de FC durante os exercícios estático e dinâmico com handgrip. Em conclusão, as intervenções de maneira isolada ou associada promovem alterações hemodinâmicas e neurais que podem contribuir para redução do risco cardiovascular de mulheres pós-menopausadas saudáveis. / The post-menopause is marked by physiological hemodynamic and metabolic changes. The estrogen replacement therapy is a way to reduce the consequences of hormone deficiency and physical exercise contributes significantly to the reduction of cardiovascular risk. The aim of this study was to evaluate in post-menopausal women the isolated and associated effects of oral estrogen therapy (TRH) and physical training (TF) in the neural and hemodynamic responses during baseline and \"handgrip\" exercises. Forty-five women (51 ± 3 years), hysterectomized, with or without ovaries, healthy, participated of an initial session and then they were divided into 4 groups SEDPLA (n = 11), SED-TRH (n = 14), TF-PLA (n = 12) and TF-TRH (n = 8). The TRH groups received estradiol valerate 1 mg / day; PLA placebo; TF, performed aerobic exercise on a cycle ergometer for 50 minutes, 3 times a week and SED remained sedentary. All subjects participated in a second experimental session after 6 months of follow-up. In the experimental sessions peripheral sympathetic nerve activity (ANSP - microneurography), blood pressure, heart rate (FC - oscillometry - Dixtal lower limb), forearm blood flow (FSA - plethysmography) were evaluated at the baseline period and during static and dynamic \"handgrip\" exercises at 30% of the maximum force. ANOVA was used for the statistica analysis. The TF alone decreased ANSP from 40 ± 7 to 34 ± 4 bursts/min, P = 0.01 and increased FSA 1.92 ± 0.96 to 2.65 ± 1.34 ml (min.100ml), P = 0.03 at the baseline. The association of TRH and TF reduced HR at the baseline from 65 ± 8 to 62 ± 7 bpm (P=0.01) and during exercise with static and dynamic \"handgrip\". HRT alone or associated with TF decreased the HR responses during static and dynamic \"handgrip exercises. In conclusion, the interventions alone or in an associated way promote neural and hemodynamic changes that may contribute to cardiovascular risk reduction in healthy postmenopausal women.

A pós-menopausa é marcada por alterações fisiológicas hemodinâmicas e metabólicas. A terapia de reposição estrogênica é uma forma de amenizar as conseqüências da deficiência hormonal e o exercício físico contribui significativamente para a redução do risco cardiovascular. O objetivo desse estudo foi avaliar em mulheres pós-menopausadas os efeitos isolados e associados da terapia oral estrogênica (TRH) e do treinamento físico aeróbio (TF) nas respostas hemodinâmicas e neurais basais e durante os exercícios com handgrip. Quarenta e cinco mulheres (51±3 anos), histerectomizadas, com e sem ovários, saudáveis, realizaram uma sessão experimental e, posteriormente foram divididas em 4 grupos SED-PLA (n=11), SED-TRH (n=14), TF-PLA (n=12) e TF-TRH (n=8). Os grupos TRH e receberam valerato de estradiol 1mg/dia; PLA receberam placebo; TF, realizaram exercício aeróbio em cicloergômetro por 50 minutos, 3 vezes por semana e SED permaneceram sedentárias. Todas as voluntárias participaram de uma segunda sessão experimental após 6 meses de acompanhamento. Nas sessões experimentais foram avaliadas a atividade nervosa simpática periférica (ANSP - microneurografia), pressão arterial, freqüência cardíaca (FC - método oscilométrico Dixtal no membro inferior), fluxo sangüíneo do antebraço (FSA - pletismografia) em um período basal e durante exercícios estático e dinâmico com handgrip a 30% da força de contração máxima. Para análise estatística foi utilizada ANOVA. O TF isoladamente diminuiu ANSP de 40±7 a 34±4 impulsos/min, (P=0,01) e aumentou FSA de 1,92±0,96 a 2,65±1,34 ml(min.100ml), P=0,03 no período basal. TRH e TF associados reduziram a FC no período basal de 65±8 para 62±7 bpm (P=0,01) e durante o exercício estático e dinâmico com handgrip. A TRH de maneira isolada ou associada ao TF diminuiu as respostas de FC durante os exercícios estático e dinâmico com handgrip. Em conclusão, as intervenções de maneira isolada ou associada promovem alterações hemodinâmicas e neurais que podem contribuir para redução do risco cardiovascular de mulheres pós-menopausadas saudáveis. / The post-menopause is marked by physiological hemodynamic and metabolic changes. The estrogen replacement therapy is a way to reduce the consequences of hormone deficiency and physical exercise contributes significantly to the reduction of cardiovascular risk. The aim of this study was to evaluate in post-menopausal women the isolated and associated effects of oral estrogen therapy (TRH) and physical training (TF) in the neural and hemodynamic responses during baseline and \"handgrip\" exercises. Forty-five women (51 ± 3 years), hysterectomized, with or without ovaries, healthy, participated of an initial session and then they were divided into 4 groups SEDPLA (n = 11), SED-TRH (n = 14), TF-PLA (n = 12) and TF-TRH (n = 8). The TRH groups received estradiol valerate 1 mg / day; PLA placebo; TF, performed aerobic exercise on a cycle ergometer for 50 minutes, 3 times a week and SED remained sedentary. All subjects participated in a second experimental session after 6 months of follow-up. In the experimental sessions peripheral sympathetic nerve activity (ANSP - microneurography), blood pressure, heart rate (FC - oscillometry - Dixtal lower limb), forearm blood flow (FSA - plethysmography) were evaluated at the baseline period and during static and dynamic \"handgrip\" exercises at 30% of the maximum force. ANOVA was used for the statistica analysis. The TF alone decreased ANSP from 40 ± 7 to 34 ± 4 bursts/min, P = 0.01 and increased FSA 1.92 ± 0.96 to 2.65 ± 1.34 ml (min.100ml), P = 0.03 at the baseline. The association of TRH and TF reduced HR at the baseline from 65 ± 8 to 62 ± 7 bpm (P=0.01) and during exercise with static and dynamic \"handgrip\". HRT alone or associated with TF decreased the HR responses during static and dynamic \"handgrip exercises. In conclusion, the interventions alone or in an associated way promote neural and hemodynamic changes that may contribute to cardiovascular risk reduction in healthy postmenopausal women.

A deficiência androgênica acomete um percentual de homens idosos ainda não bem definido na literatura. São usados parâmetros séricos hormonais de homens jovens, e apesar disto, a terapia de reposição da testosterona vem sendo defendida e utilizada largamente por muitos autores. Várias vias de reposição são usadas tentando simular o ciclo fisiológico de produção das testosteronas. Parece que a transdérmica é a que mais se aproxima do ideal. A relação câncer de próstata e testosterona é pouco compreendida. O receio do estímulo de um câncer oculto pela terapia de reposição não foi devidamente afastado. O tratamento deve ser instituído quando o quadro clínico e laboratorial for evidente. / The androgenic deficiency attacks a percentage of elderly men not well defined in literature yet. Hormonal serum parameters of young men are used and, in spite of that, the testosterone replacement therapy has been widely supported and used by many authors. Various ways of replacement are used trying to simulate the physiological cycle of the testosterone production. It seems that the transdermic is the one closest to the ideal. The relation of prostate cancer and testosterone is little understood. The fear of the stimulation of a concealed cancer by the replacement therapy has not been properly eliminated. The treatment should be indicated when the clinical and laboratorial was defined.

Background: Estrogen has been reported to enhance well-being and quality of life during the climacteric phase. In women with an intact uterus estrogen treatment is always combined with progestins in order to protect the endometrium from hyperplasia and malignancies. However, in certain women the addition of progestins causes cyclicity in negative mood symptoms and physical symptoms similar to those encountered during ovulatory cycles in women with premenstrual dysphoric disorder (PMDD). The ovarian hormones estradiol and progesterone have profound effects on a number of neurotransmitter systems in the brain, such as the gamma aminobutyric acid (GABA) system and the serotonergic system. Progesterone metabolites, such as allopregnanolone and pregnanolone (also referred to as neurosteroids) modify the GABAA receptor in the central nervous system (CNS) and enhance GABAergic inhibitory transmission. Neurosteroid sensitivity in human studies can be studied by saccadic eye movement measurements using pharmacodynamic challenges with pregnanolone. Altered neurosteroid sensitivity has been suggested as a possible contributory factor to the progesterone/progestin-induced adverse mood effects of hormone replacement therapy (HRT). There is also evidence of estrogen treatment affecting the serotonergic system in postmenopausal women, although progestin addition has been less well studied. Aims and method: The aim was to investigate whether the negative mood symptoms experienced during the progestin or progesterone phase of HRT were associated with changes in neurosteroid sensitivity, or changes in platelet serotonin uptake site (transporter) and serotonin2A (5-HT2A) receptor binding. The intention was also to investigate whether hormonal changes during the normal menstrual cycle affect these peripheral serotonergic parameters. Postmenopausal women with climacteric symptoms were given HRT in two randomized, double-blinded, placebo-controlled crossover studies. The women received 2 mg estradiol (E2) continuously during 28- day cycles. Synthetic progestins or natural progesterone were added sequentially during the last 14 days, and compared to a placebo addition. Before treatment, as well as during the last week of each treatment cycle the pharmacodynamic response to pregnanolone was assessed using saccadic eye movement measurements. Throughout the studies daily symptom ratings were made. In the study regarding synthetic progestins, platelet serotonin transporter and 5-HT2A receptor binding were assayed before entering the study, as well as during the last week of each treatment cycle. In the study on reproductive women, blood samples were collected for analysis of platelet serotonin transporter and 5-HT2A receptor binding at six different points in time during the menstrual cycle. Results and conclusion: The addition of synthetic progestins to estrogen treatment increased negative mood symptoms and physical symptoms, whereas positive symptoms decreased. The addition of progestins also increased the sensitivity to pregnanolone. The addition of natural progesterone to estrogen treatment increased the sensitivity to pregnanolone. However, in this study the pregnanolone sensitivity was enhanced also during estrogen treatment. Women expressing cyclicity in negative mood symptoms were more sensitive to pregnanolone than women without symptom cyclicity. Thus, it is evident that mood deterioration during HRT is associated with altered neurosteroid sensitivity. Platelet serotonin transporter and 5-HT2A receptor binding did not change during the different treatment conditions in HRT. Thus, we were unable to explain the negative mood changes of HRT by use of these peripheral serotonergic parameters. In the study on reproductive women however, it was clear that the serotonergic variables did change during the menstrual cycle. Binding to the serotonin transporter was higher in the late follicular phase than in the ovulatory, early luteal or mid-luteal phases. Binding to the 5-HT2A receptor was higher in the early follicular phase and the early luteal phase than in the mid-luteal phase. These findings may provide a link between the ovarian steroids, and the GABAergic and serotonergic neurotransmitter systems, which in turn, could explain part of the specific vulnerability that women have for the development of adverse mood effects during HRT, mood and anxiety disorders and for the deterioration of mood so frequently seen during the luteal phase.

Im Rahmen des demographischen Wandels kommt es zu einem kontinuierlichen Anstieg des Anteils postmenopausaler Frauen an der Weltbevölkerung, so dass die Therapie postmenopausaler Erkrankungen zu einem wichtigen Thema der ärztlichen Behandlung geworden ist. Seit Beginn des 21. Jahrhunderts werden hinsichtlich der klinischen Wirksamkeit und der Sicherheit der Hormonersatztherapie vermehrt Bedenken im Hinblick auf das erhöhte Risiko für das kardiovaskuläre System und Brustkrebs geäußert. Aus diesem Grund rücken alternative Therapieansätze verstärkt in den Mittelpunkt der Forschung. In unterschiedlichen Projekten hat sich hierbei CR als effektives, in der klinischen Praxis anwendbares Medikament gezeigt. Die vorliegende Dissertation setzt sich mit der Wirkung von Subfraktionen der Testsubstanz CR auf die klimakterisch bedingten Veränderungen bzw. Erkrankungen der Skelett- und der Herzmuskulatur auseinander. Vor diesem Hintergrund wurden 100 weibliche, zuvor ovariektomierte Sprague-Dawley-Ratten in 10 Gruppen unterteilt und über einen Zeitraum von 4 Wochen die verschiedenen Substanzen von Cimicifuga racemosa (CR) (Saponin-, S1-, S2-, S3-Fraktion und Rest-, R1-, R2- und R3-Fraktion) oder Östradiolbenzoat (EB) verabreicht. Über denselben Zeitraum wurde eine Kontrollgruppe mit sojafreiem Futter versorgt. Mittels histologischer Untersuchung der Herz- und Skelettmuskulatur wurden die Auswirkungen von EB und den verschiedenen Fraktionen und Subfraktionen aus CR ermittelt und untereinander und mit den Ergebnissen der Kontrollgruppe verglichen. Die Skelettmuskelfaserfläche hat unter dem Einfluss der Saponinfraktion, der S1-Subfraktion, der Restfraktion, der R2-Subfraktion und der EB-Gruppe signifikant im Vergleich zur Kontrollgruppe zugenommen. Eine signifikante Zunahme des elastischen Faseranteils bezogen auf die Skelettmuskelfaserfläche bestand unter dem Einfluss der Saponinfraktion, ihrer S1- und S2-Subfraktion und der R1-Subfraktion als auch der EB-Gruppe im Vergleich zur Kontrollgruppe. Die Kardiomyozytenfläche zeigte einen signifikanten Größenzuwachs im Vergleich zur Kontrollgruppe unter dem Einfluss der Saponinfraktion und all ihrer 3 Subfraktionen als auch der Restfraktion und ihrer 3 Subfraktionen und der EB-Gruppe. Eine signifikante Zunahme des elastischen Faseranteils bezogen auf die Kardiomyozytenfläche bestand unter dem Einfluss der Saponinfraktion, ihrer S1-Subfraktion und der Restfraktion und ihrer R3-Subfraktion als auch der EB-Gruppe im Vergleich mit der Kontrollgruppe. Ableiten lässt sich, dass die Subfraktionen der Saponin- und Restfraktion keine gleichmäßige Wirkung auf die strukturellen Bestandteile von Herz- und Skelettmuskulatur zeigen. Die Ergebnisse sprechen dafür, dass bestimmte Subfraktionen von CR anabol auf die Skelettmuskelfaser- und Kardiomyozytenfläche und die EZM beider Gewebe wirken. Nahezu regelmäßig erweist sich die vor allem Actein und Deoxyactein enthaltende S1-Fraktion als wirksamste Substanzgruppe. Die Wirkungen von CR sind noch Gegenstand der aktuellen Forschung. Eines der Ziele weiterer Untersuchungen sollte die Ermittlung der Kombination der jeweiligen Fraktionen und Subfraktionen oder deren Subsubstanzen sein, um eine bestmögliche osteoprotektive und anabole Wirkung auf Herz- und Skelettmuskulatur und den Knochen zur Linderung oder Beseitigung klimakterischer Beschwerden zu entfalten.

INTRODUÇÃO. Mulheres pós-menopáusicas apresentam maior risco de desenvolvimento de doença arterial coronariana. Estudos observacionais demonstraram que a terapia de reposição hormonal produz efeitos benéficos no perfil lipídico e na modulação autonômica cardíaca. O aumento da variabilidade da freqüência cardíaca (VFC), até então atribuído à reposição hormonal, não foi testado em estudos randomizados, placebo-controlados, delineados para permitir a comparação entre as duas formas mais utilizadas de reposição hormonal. A VFC de 24 horas calculada pelo método não linear Mapa de Retorno Tridimensional permite avaliar tanto a modulação vagal como a simpática. OBJETIVOS Avaliar a modulação autonômica cardíaca de mulheres pósmenopáusicas através da análise da VFC no domínio do tempo e dos índices do Mapa de Retorno Tridimensional no ECG de 24 horas. Testar a hipótese de que a reposição hormonal contínua, seja com estradiol isolado (TRE), seja com estradiol associado à noretisterona (TRH), por um período de três meses, aumenta a VFC nessas mulheres. MÉTODOS Quarenta mulheres pós-menopáusicas (46 a 63 anos; média = 54,6 ± 4,2) foram randomizadas para um dos três tratamentos, de forma contínua: TRH, estrogenioterapia (TRE) ou placebo, por três meses consecutivos. Previamente, todas as mulheres foram submetidas a exames clínico, ginecológico e laboratorial (glicose, estradiol, HDL, LDL, triglicerídios; mamografia e ultrassonografia transvaginal). O ECG de 24 horas foi gravado em cada paciente, antes e após o tratamento, para calcular os índices da VFC. RESULTADOS Não houve diferença estatisticamente significativa entre os três grupos, após 3 meses de tratamento, nos índices da VFC e do Mapa de Retorno Tridimensional. A TRH diferiu da TRE apenas quanto ao perfil lipídico. A associação com a noretisterona provocou uma redução de 12,4 % no HDL (p = 0,008). CONCLUSÃO Em mulheres pós-menopáusicas, a terapia de reposição hormonal contínua com estradiol, ou com estradiol associado à noretisterona, por um período de 3 meses, não altera a modulação autonômica cardíaca avaliada pela VFC. / Background: Postmenopausal women are at greater risk of coronary heart disease. Observational studies have demonstrated that hormone replacement therapy (HRT) improves lipid profile and cardiac autonomic modulation. The cardioprotective effect attributed to HRT has not been tested in randomized, placebo-controlled trials to compare the two most frequently used regimens. This study evaluates cardiac autonomic modulation in postmenopausal women using time domain indices of heart rate variability (HRV) and indices derived from the three-dimensional return map, and investigates whether continuous HRT for three months, either with estradiol alone (ERT) or with estradiol and norethisterone (HRT), increases HRV in postmenopausal women. Methods: Forty postmenopausal women aged 46 to 63 years were consecutively and randomly assigned to one of three treatment groups: HRT, ERT, or placebo. For all women, clinical, gynecological and laboratory data (glucose, estradiol, HDL, LDL, triglycerides, mammography and transvaginal sonography) were collected. Patients underwent 24-h ECG before and after the treatment to evaluate HRV indices. Results: Time domain indices of HRV as well as indices derived from the threedimensional return map presented no significant changes after interventions. The only significant difference between HRT and ERT groups was in lipid profile. HDL cholesterol levels decreased 12.4% (p = 0.008) for women who used HRT. Conclusion: In postmenopausal women, continuous hormone replacement therapy with estradiol or estradiol with norethisterone for 3 months does not affect cardiac autonomic modulation evaluated by HRV.

Made available in DSpace on 2015-07-22T20:49:22Z (GMT). No. of bitstreams: 0 Previous issue date: 2012-02-01. Added 1 bitstream(s) on 2015-08-11T03:26:17Z : No. of bitstreams: 1 Publico-13210a.pdf: 2089186 bytes, checksum: 4bd9af1812c538db03b2120cffdc516f (MD5). Added 1 bitstream(s) on 2015-08-11T03:26:17Z : No. of bitstreams: 2 Publico-13210a.pdf: 2089186 bytes, checksum: 4bd9af1812c538db03b2120cffdc516f (MD5) Publico-13210b.pdf: 2054432 bytes, checksum: c717885187f0d071e0c0fb8d4bbfe281 (MD5). Added 1 bitstream(s) on 2015-08-11T03:26:17Z : No. of bitstreams: 3 Publico-13210a.pdf: 2089186 bytes, checksum: 4bd9af1812c538db03b2120cffdc516f (MD5) Publico-13210b.pdf: 2054432 bytes, checksum: c717885187f0d071e0c0fb8d4bbfe281 (MD5) Publico-13210c.pdf: 540730 bytes, checksum: fba8c62dcb0177a09d2fde3ef4bace9d (MD5) / A lípase hepática (HL) é uma enzima presente nos sinusoides hepáticos, responsável pela lipólise de lipoproteínas. Contém quatro sítios polimórficos: G-250A, T-710C, 763G-A, e C-514T single-nucleotide polymorphism (SNPs). O último polimorfismo é o foco do presente estudo. Os genótipos associados com o polimorfismo C-514T são CC (homozigoto normal - W), CT (heterozigoto - H) e TT (alelo homozigoto menor - M). A atividade da HL é, significativamente, diminuída nos indivíduos dos genótipos TT e CT. Um total de 58 mulheres pós-menopausas foi estudado. As participantes eram histerectomizadas e submetidas à terapia de reposição hormonal, consistindo de 0,625 mg de estrogênio equino conjugado, uma vez ao dia. Os critérios de inclusão foram: menopausa de até há três anos, resultados de exames de sangue, radiografias, citologia cérvico-vaginal e densitometria óssea normais. O DNA foi extraído a partir de células da mucosa bucal e de células de sangue periférico de todas as pacientes, utilizando-se um conjunto comercialmente disponível (GFX ® - Amersham-Pharmacia, EUA). Resultados: foram encontradas reduções estatisticamente significativas nos triglicérides (t = 2,16; n = 58, p = 0,03), mas não nos níveis de colesterol total (t = 0,14; n = 58, p = 0,89) após o tratamento. Este grupo de bons respondedores eram portadores do alelo T; os genótipos CT e TT estavam presentes com frequência significativamente maior do que no grupo de nãorespondedores (p = 0,02 ou p = 0,07, respectivamente). No entanto, nenhuma diferença significativa nos níveis de HDL-C (t = 0,94; n = 58, p = 0,35) ou LDL-C (t =- 0,83; n = 58, p = 0,41) foi encontrada nestas pacientes. Conclusões: as variações no perfil lipídico associadas ao polimorfismo C-514T são significativas e o alelo T é associado à melhor resposta à TRE. / Background: Hepatic lipase (HL), an enzyme present in the hepatic sinusoids, is responsible for the lipolysis of lipoproteins. Human HL contains four polymorphic sites: G-250A, T-710C, A-763G, and C-514T single-nucleotide polymorphism (SNPs). The last polymorphism is the focus of the current study. The genotypes associated with the C-514T polymorphism are CC (normal homozygous – W), CT (heterozygous – H), and TT (minor-allele homozygous – M). HL activity is significantly impaired in individuals of the TT and CT genotypes. A total of 58 postmenopausal women were studied. The subjects were hysterectomized women receiving hormone replacement therapy consisting of 0.625 mg of conjugated equine estrogen once a day. The inclusion criteria were menopause of up to three years and normal blood tests, radiographs, cervical-vaginal cytology, and densitometry. DNA was extracted from the buccal and blood cells of all 58 patients using a commercially available kit (GFX® - Amersham-Pharmacia, USA). Results: Statistically significant reductions in triglycerides (t=2.16; n=58; p=0.03) but not in total cholesterol (t=0.14; n=58; p=0.89) were found after treatment. This group of good responders were carriers of the T allele; the CT and TT genotypes were present significantly more frequently than in the group of non-responders (p=0.02 or p=0.07, respectively). However, no significant difference in HDL-C (t=0.94; n=58; p=0.35) or LDL-C (t=- 0.83; n=58; p=0.41) was found in these patients. Conclusions: The variation in lipid profile associated with the C-514T polymorphism is significant, and the T allele is associated with the best response to ERT. / TEDE