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1.
Expert Opin Drug Deliv ; 14(9): 1131-1140, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28696796

RESUMO

INTRODUCTION: Globally, intrauterine devices (IUDs) are the second most commonly used form of reversible contraception because of their high efficacy, safety, convenience and cost effectiveness. The levonorgestrel releasing intrauterine system with daily average release of 20 mcg (LNG-IUS 20) is the popular choice because of its favorable bleeding patterns and many noncontraceptive benefits. A three year (LNG-IUS 8) became available three years ago. More recently, the LNG-IUS 12 was added. This new IUD shares a smaller frame, narrow inserter and lower rate of amenorrhea with the LNG-IUS 8, but it offers the five years of contraceptive protection of the LNG-IUS 20. Areas covered: This article provides information on the contraceptive efficacy, safety and tolerability of this new IUS based on approximately 60,000 cycles of use. Where available, the impacts of subject age, parity and body mass index (BMI) on study outcomes are reported. Expert opinion: This new LNG-IUS 12 with mid-dose hormone levels, smaller frame and longer effective life fills a niche that may better meet the needs of women who might appreciate the narrow insertion tube and/or the lower rates of amenorrhea. Cost will ultimately help determine success.


Assuntos
Anticoncepcionais Femininos/administração & dosagem , Dispositivos Intrauterinos Medicados , Levanogestrel/administração & dosagem , Anticoncepção , Anticoncepcionais Femininos/efeitos adversos , Análise Custo-Benefício , Feminino , Humanos , Levanogestrel/efeitos adversos , Gravidez
2.
Drug Saf ; 40(7): 583-596, 2017 07.
Artigo em Inglês | MEDLINE | ID: mdl-28382493

RESUMO

INTRODUCTION: The effects of drospirenone-containing combined oral contraceptives (COCs) on the risk of venous thromboembolism (VTE) remain controversial due to the challenge in distinguishing between first-time users and restarters, and their different underlying VTE risks, in healthcare databases. OBJECTIVES: The aim of this study was to describe the challenge of studying the risk of VTE among first-time users of drospirenone-containing COCs in a healthcare database and assess the risk among first-time users and restarters. METHODS: We used data from the Clinical Practice Research Datalink to construct two cohorts. The first-time user cohort included all women aged 16-45 years who received a first ever prescription of drospirenone- or levonorgestrel-containing COCs between May 2002 and March 2015. The restarter cohort included those who were restarting a COC after a period of non-use of ≥6 months. Cox proportional hazards models adjusted for high dimensional propensity scores were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). RESULTS: The final cohorts included 55,139 first-time users (3582 drospirenone and 51,557 levonorgestrel) and 162,959 restarters (23,191 drospirenone and 139,768 levonorgestrel). The adjusted HR of VTE associated with drospirenone versus levonorgestrel was 3.19 (95% CI 1.12-9.08) for first-time users and 1.96 (95% CI 1.12-3.41) for restarters. CONCLUSIONS: We found an elevated risk of VTE associated with drospirenone-containing COCs in comparison with levonorgestrel-containing COCs in both cohorts. While left truncation of healthcare databases is a concern for the identification of first-time users, the use of a more explicit cohort of restarters suggests a doubling of VTE risk with drospirenone-containing COCs.


Assuntos
Androstenos/efeitos adversos , Anticoncepcionais Orais Combinados/efeitos adversos , Tromboembolia Venosa/induzido quimicamente , Adolescente , Adulto , Androstenos/administração & dosagem , Estudos de Coortes , Anticoncepcionais Orais Combinados/administração & dosagem , Esquema de Medicação , Feminino , Humanos , Levanogestrel/administração & dosagem , Levanogestrel/efeitos adversos , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Fatores de Risco , Adulto Jovem
3.
Trials ; 18(1): 121, 2017 03 11.
Artigo em Inglês | MEDLINE | ID: mdl-28283026

RESUMO

BACKGROUND: Endometriosis is associated with the growth of endometrium in ectopic sites mainly within the pelvis. This results in inflammation and scarring, causing pain and impaired quality of life. Endometriotic lesions can be excised or ablated surgically, but the risk of recurrence is high. A Heath Technology Assessment commissioning call in 2011 sought applications for trials aimed at evaluating long-term effectiveness of postoperative, long-acting, reversible contraceptives (LARCs) in preventing recurrence of endometriosis. A survey of gynaecologists indicated that there was no consensus about which LARC (Levonorgestrel Intrauterine System (LNG-IUS) or depot medroxyprogesterone acetate injection (DMPA)) or comparator (combined oral contraceptive pill (COCP) or no treatment) should be evaluated. Hence, we designed a 'flexible-entry' internal pilot to assess whether a four-arm trial was feasible including a possible design adaption based on pilot findings. METHODS: In this pilot, women could be randomised to two, three or four treatment options provided that one was a LARC and one was a non-LARC. An assessment of feasibility based on recruitment to these options and a revised substantive trial design was considered by an independent oversight committee. RESULTS: The study ran for 1 year from April 2014 and 77 women were randomised. Only 5 (6%) women accepted randomisation to all groups, with 63 (82%) having a LARC preference and 55 (71%) a non-LARC preference. Four-way and three-way designs were ruled out with a two-way LARC versus COCP design, stratified by prerandomisation choice of LARC and optional subrandomisation to LNG-IUS versus DMPA considered a feasible substantive study. CONCLUSIONS: Multi-arm studies are potentially efficient as they can answer multiple questions simultaneously but are difficult to recruit to if there are strong patient or clinician preferences. A flexible approach to randomisation in a pilot phase can be used to assess feasibility of such studies and modify a trial design based on chosen recruitment options, but trialists should consider carefully any practical arrangements should groups need to be dropped during a study. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number, ISRCTN97865475 . Registered on 20 March 2014.


Assuntos
Anticoncepcionais Orais Hormonais/administração & dosagem , Endometriose/tratamento farmacológico , Levanogestrel/administração & dosagem , Acetato de Medroxiprogesterona/administração & dosagem , Progestinas/administração & dosagem , Prevenção Secundária/métodos , Adolescente , Adulto , Protocolos Clínicos , Anticoncepcionais Orais Hormonais/efeitos adversos , Preparações de Ação Retardada , Endometriose/diagnóstico , Endometriose/cirurgia , Estudos de Viabilidade , Feminino , Humanos , Injeções , Dispositivos Intrauterinos , Laparoscopia , Levanogestrel/efeitos adversos , Acetato de Medroxiprogesterona/efeitos adversos , Pessoa de Meia-Idade , Seleção de Pacientes , Projetos Piloto , Progestinas/efeitos adversos , Recidiva , Projetos de Pesquisa , Fatores de Tempo , Resultado do Tratamento , Reino Unido , Adulto Jovem
4.
J Prim Health Care ; 8(1): 13-9, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27477370

RESUMO

INTRODUCTION Subsidisation of the levonorgestrel-releasing Jadelle® contraceptive implant in 2010 resulted in a rapid uptake. Clinicians had little prior experience of client satisfaction, side effect profile, and removal rate of this contraceptive method. AIM To obtain information on satisfaction, bleeding patterns, continuation rates and reasons for removal for New Zealand women during their first year of use of a subsidised contraceptive implant, Jadelle®. METHODS Women having a Jadelle® implant inserted in New Zealand Family Planning clinics were recruited to be followed up by phone, text or email at 1, 3, 6, 9 and 12 months. They were asked about their bleeding pattern, satisfaction and their views on benefits of, or problems with, implant use. RESULTS 252 women were recruited. The three common bleeding patterns in the cohort were regular periods, amenorrhoea and irregular bleeding. Eighteen percent had their implant removed within the first year with more than half of those being unhappy with their bleeding pattern. This was usually prolonged bleeding. Otherwise satisfaction rates were high throughout the year. DISCUSSION The majority of New Zealand women using Jadelle® were satisfied with this method of contraception during their first year of use. Implant removals were most likely to be related to prolonged bleeding. However the commonest bleeding pattern was regular periods. KEYWORDS Contraceptive implant; progestin; bleeding; satisfaction; continuation rate; reducing reproductive health inequalities.


Assuntos
Anticoncepcionais Femininos/uso terapêutico , Levanogestrel/uso terapêutico , Satisfação do Paciente , Adolescente , Adulto , Anticoncepcionais Femininos/administração & dosagem , Anticoncepcionais Femininos/efeitos adversos , Implantes de Medicamento , Etnicidade/estatística & dados numéricos , Feminino , Humanos , Levanogestrel/administração & dosagem , Levanogestrel/efeitos adversos , Assistência Médica , Pessoa de Meia-Idade , Nova Zelândia , Hemorragia Uterina/induzido quimicamente , Adulto Jovem
5.
Mayo Clin Proc ; 91(6): 802-7, 2016 06.
Artigo em Inglês | MEDLINE | ID: mdl-27261868

RESUMO

Emergency contraception (EC) may help prevent pregnancy in various circumstances, such as contraceptive method failure, unprotected sexual intercourse, or sexual assault, yet it remains underused. There are 4 approved EC options in the United States. Although ulipristal acetate requires a provider's prescription, oral levonorgestrel (LNG) is available over the counter for women of all ages. The most effective method of EC is the copper intrauterine device, which can be left in place for up to 10 years for efficacious, cost-effective, hormone-free, and convenient long-term primary contraception. Ulipristal acetate tends to be more efficacious in pregnancy prevention than is LNG, especially when taken later than 72 hours postcoitus. The mechanism of action of oral EC is delay of ovulation, and current evidence reveals that it is ineffective postovulation. Women who weigh more than 75 kg or have a body mass index greater than 25 kg/m(2) may have a higher risk of unintended pregnancy when using oral LNG EC; therefore, ulipristal acetate or copper intrauterine devices are preferable in this setting. Providers are often unaware of the range of EC options or are unsure of how to counsel patients regarding the access and use of EC. This article critically reviews current EC literature, summarizes recommendations, and provides guidance for counseling women about EC. Useful tips for health care providers are provided, with a focus on special populations, including breast-feeding women and those transitioning to long-term contraception after EC use. When treating women of reproductive age, clinicians should be prepared to counsel them about EC options, provide EC appropriately, and, if needed, refer for EC in a timely manner.


Assuntos
Anticoncepção Pós-Coito/métodos , Conhecimentos, Atitudes e Prática em Saúde , Dispositivos Intrauterinos de Cobre , Levanogestrel , Norpregnadienos , Ovulação/efeitos dos fármacos , Administração Oral , Atitude do Pessoal de Saúde , Índice de Massa Corporal , Aleitamento Materno , Anticoncepção Pós-Coito/efeitos adversos , Anticoncepção Pós-Coito/economia , Anticoncepcionais Femininos/administração & dosagem , Anticoncepcionais Femininos/efeitos adversos , Anticoncepcionais Femininos/economia , Anticoncepcionais Femininos/provisão & distribuição , Anticoncepcionais Pós-Coito/administração & dosagem , Anticoncepcionais Pós-Coito/efeitos adversos , Anticoncepcionais Pós-Coito/economia , Anticoncepcionais Pós-Coito/provisão & distribuição , Feminino , Humanos , Dispositivos Intrauterinos de Cobre/efeitos adversos , Dispositivos Intrauterinos de Cobre/economia , Dispositivos Intrauterinos de Cobre/provisão & distribuição , Levanogestrel/administração & dosagem , Levanogestrel/efeitos adversos , Levanogestrel/economia , Levanogestrel/provisão & distribuição , Medicamentos sem Prescrição/economia , Medicamentos sem Prescrição/normas , Medicamentos sem Prescrição/provisão & distribuição , Norpregnadienos/administração & dosagem , Norpregnadienos/efeitos adversos , Norpregnadienos/economia , Norpregnadienos/provisão & distribuição , Educação de Pacientes como Assunto/métodos , Gravidez , Medicamentos sob Prescrição/economia , Medicamentos sob Prescrição/normas
6.
Contraception ; 89(6): 578-83, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24656553

RESUMO

OBJECTIVES: Long-acting reversible contraception (LARC) - the copper and levonorgestrel intrauterine devices (IUDs) and the single-rod implant - are safe and effective but account for a small proportion of contraceptive use by US women. This study examined obstetrician-gynecologists' knowledge, training, practice and beliefs regarding LARC methods. DESIGN: A survey questionnaire was mailed to 3000 Fellows of the American College of Obstetricians and Gynecologists. After exclusions, 1221 eligible questionnaires were analyzed (45.8% response rate, accounting for exclusions). RESULTS: Almost all obstetrician-gynecologists reported providing IUDs (95.8%). Most obstetrician-gynecologists reported requiring two or more visits for IUD insertion (86.9%). Respondents that reported IUD insertion in a single visit reported inserting a greater number of IUDs in the last year. About half reported offering the single-rod implant (51.3%). A total of 92.0% reported residency training on IUDs, and 50.8% reported residency training on implants. Residency training and physician age correlated with the number of IUDs inserted in the past year. A total of 59.6% indicated receiving continuing education on at least one LARC method in the past 2years. Recent continuing education was most strongly associated with implant insertion, and 31.7% of respondents cited lack of insertion training as a barrier. CONCLUSIONS: Barriers to LARC provision could be reduced if more obstetrician-gynecologists received implant training and provided same-day IUD insertion. Continuing education will likely increase implant provision. IMPLICATIONS: This study shows that obstetrician-gynecologists generally offer IUDs, but fewer offer the single-rod contraceptive implant. Recent continuing education strongly predicted whether obstetrician-gynecologists inserted implants and was also associated with other practices that encourage LARC use.


Assuntos
Atitude do Pessoal de Saúde , Anticoncepção/efeitos adversos , Educação Médica Continuada , Ginecologia , Obstetrícia , Médicos , Padrões de Prática Médica , Fatores Etários , Anticoncepcionais Femininos/administração & dosagem , Anticoncepcionais Femininos/efeitos adversos , Anticoncepcionais Orais/administração & dosagem , Anticoncepcionais Orais/efeitos adversos , Implantes de Medicamento/administração & dosagem , Implantes de Medicamento/efeitos adversos , Feminino , Ginecologia/educação , Pesquisas sobre Atenção à Saúde , Acessibilidade aos Serviços de Saúde , Humanos , Internato e Residência , Dispositivos Intrauterinos de Cobre/efeitos adversos , Dispositivos Intrauterinos Medicados/efeitos adversos , Levanogestrel/administração & dosagem , Levanogestrel/efeitos adversos , Obstetrícia/educação , Guias de Prática Clínica como Assunto , Sociedades Médicas , Estados Unidos , Recursos Humanos
7.
Obstet Gynecol ; 121(5): 951-958, 2013 May.
Artigo em Inglês | MEDLINE | ID: mdl-23635730

RESUMO

OBJECTIVE: Many U.S. health care providers remain reluctant to prescribe intrauterine devices (IUDs) to teenagers as a result of concerns about serious complications. This study examined whether 15-19-year-old IUD users were more likely to experience complications, failure, or early discontinuation than adult users aged 20-24 years and 25-44 years and whether there were differences in these outcomes between users of levonorgestrel-releasing intrauterine systems and copper IUDs. METHODS: A retrospective cohort study was conducted using health insurance claims obtained from a private insurance company of 90,489 women who had an IUD inserted between 2002 and 2009. Logistic regression models were used to estimate the odds of experiencing complications, method failure, or early discontinuation within 12 months of insertion by age group and type of IUD inserted. RESULTS: Serious complications, including ectopic pregnancy and pelvic inflammatory disease, occurred in less than 1% of patients regardless of age or IUD type. Women aged 15-19 years were more likely than those aged 25-44 years to have a claim for dysmenorrhea (odds ratio [OR] 1.4, confidence interval [CI] 1.1-1.6), amenorrhea (OR 1.3, CI 1.1-1.5), or normal pregnancy (OR 1.4, CI 1.1-1.8). Overall, early discontinuation did not differ between teenagers and women aged 25-44 years (13% compared with 11%, P>.05). However, use of the levonorgestrel-releasing intrauterine system was associated with fewer complications and less early discontinuation than the copper IUD in all age groups. CONCLUSIONS: The IUD is as appropriate for teenagers to use as it is for older women, with serious complications occurring infrequently in all groups. The levonorgestrel-releasing intrauterine system may be a better choice than the copper IUD as a result of lower odds of complications, discontinuation, and failure. LEVEL OF EVIDENCE: II.


Assuntos
Anticoncepcionais Femininos/efeitos adversos , Dispositivos Intrauterinos Medicados/efeitos adversos , Dispositivos Intrauterinos Medicados/estatística & dados numéricos , Dispositivos Intrauterinos/efeitos adversos , Dispositivos Intrauterinos/estatística & dados numéricos , Levanogestrel/efeitos adversos , Adolescente , Adulto , Fatores Etários , Estudos de Coortes , Anticoncepcionais Femininos/administração & dosagem , Feminino , Humanos , Seguro Saúde , Dispositivos Intrauterinos de Cobre/efeitos adversos , Dispositivos Intrauterinos de Cobre/estatística & dados numéricos , Levanogestrel/administração & dosagem , Estudos Retrospectivos , Adulto Jovem
8.
Pharmacotherapy ; 33(5): 549-57, 2013 May.
Artigo em Inglês | MEDLINE | ID: mdl-23450827

RESUMO

Family planning remains a high priority area for the United States, with goals to increase the proportion of pregnancies that are intended, reduce pregnancy rates among adolescents, and increase contraceptive use prioritized in the Healthy People 2020 objectives. Contraception intended for use after unprotected intercourse, known as emergency contraception, remains underutilized. Levonorgestrel is one method of oral emergency contraception, which prevents fertilization and does not disrupt an already established pregnancy; thus, timing of administration is critical. Despite data demonstrating safety and efficacy, evidence-based decision making has been overshadowed by politically charged actions involving levonorgestrel emergency contraception for over a decade. The Women's Health Practice and Research Network of the American College of Clinical Pharmacy supports expanded access to levonorgestrel emergency contraception and removal of barriers such as age restrictions on the nonprescription drug product. Pharmacists remain a key provider of emergency contraceptive services and can help ensure timely access. In states where direct pharmacy access to emergency contraception is available, pharmacists are encouraged to participate. Education, research, and advocacy are other important responsibilities for pharmacists in this arena.


Assuntos
Anticoncepção Pós-Coito/estatística & dados numéricos , Anticoncepcionais Pós-Coito , Acessibilidade aos Serviços de Saúde , Levanogestrel , Medicamentos sem Prescrição , Adolescente , Fatores Etários , Anticoncepcionais Pós-Coito/administração & dosagem , Anticoncepcionais Pós-Coito/efeitos adversos , Esquema de Medicação , Feminino , Regulamentação Governamental , Acessibilidade aos Serviços de Saúde/legislação & jurisprudência , Humanos , Levanogestrel/administração & dosagem , Levanogestrel/efeitos adversos , Medicamentos sem Prescrição/administração & dosagem , Educação de Pacientes como Assunto , Assistência Farmacêutica , Gravidez , Gravidez na Adolescência/prevenção & controle , Gravidez na Adolescência/estatística & dados numéricos , Sociedades Farmacêuticas , Estados Unidos , Serviços de Saúde da Mulher
10.
N Engl J Med ; 368(2): 128-37, 2013 Jan 10.
Artigo em Inglês | MEDLINE | ID: mdl-23301731

RESUMO

BACKGROUND: Menorrhagia is a common problem, yet evidence to inform decisions about therapy is limited. In a pragmatic, multicenter, randomized trial, we compared the levonorgestrel-releasing intrauterine system (levonorgestrel-IUS) with usual medical treatment in women with menorrhagia who presented to their primary care providers. METHODS: We randomly assigned 571 women with menorrhagia to treatment with levonorgestrel-IUS or usual medical treatment (tranexamic acid, mefenamic acid, combined estrogen-progestogen, or progesterone alone). The primary outcome was the patient-reported score on the Menorrhagia Multi-Attribute Scale (MMAS) (ranging from 0 to 100, with lower scores indicating greater severity), assessed over a 2-year period. Secondary outcomes included general quality-of-life and sexual-activity scores and surgical intervention. RESULTS: MMAS scores improved from baseline to 6 months in both the levonorgestrel-IUS group and the usual-treatment group (mean increase, 32.7 and 21.4 points, respectively; P<0.001 for both comparisons). The improvements were maintained over a 2-year period but were significantly greater in the levonorgestrel-IUS group than in the usual-treatment group (mean between-group difference, 13.4 points; 95% confidence interval, 9.9 to 16.9; P<0.001). Improvements in all MMAS domains (practical difficulties, social life, family life, work and daily routine, psychological well-being, and physical health) were significantly greater in the levonorgestrel-IUS group than in the usual-treatment group, and this was also true for seven of the eight quality-of-life domains. At 2 years, more of the women were still using the levonorgestrel-IUS than were undergoing the usual medical treatment (64% vs. 38%, P<0.001). There were no significant between-group differences in the rates of surgical intervention or sexual-activity scores. There were no significant differences in serious adverse events between groups. CONCLUSIONS: In women with menorrhagia who presented to primary care providers, the levonorgestrel-IUS was more effective than usual medical treatment in reducing the effect of heavy menstrual bleeding on quality of life. (Funded by the National Institute of Health Research Health Technology Assessment Programme; ECLIPSE Controlled-Trials.com number, ISRCTN86566246.).


Assuntos
Anticoncepcionais Femininos/uso terapêutico , Dispositivos Intrauterinos Medicados , Levanogestrel/uso terapêutico , Menorragia/tratamento farmacológico , Qualidade de Vida , Adulto , Antifibrinolíticos/efeitos adversos , Antifibrinolíticos/uso terapêutico , Anticoncepcionais Femininos/administração & dosagem , Anticoncepcionais Femininos/efeitos adversos , Estrogênios/efeitos adversos , Estrogênios/uso terapêutico , Feminino , Seguimentos , Humanos , Levanogestrel/administração & dosagem , Levanogestrel/efeitos adversos , Ácido Mefenâmico/efeitos adversos , Ácido Mefenâmico/uso terapêutico , Menorragia/cirurgia , Pessoa de Meia-Idade , Progestinas/efeitos adversos , Progestinas/uso terapêutico , Índice de Gravidade de Doença , Comportamento Sexual , Ácido Tranexâmico/efeitos adversos , Ácido Tranexâmico/uso terapêutico
11.
Contraception ; 88(3): 337-40, 2013 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-23261234

RESUMO

In developing countries, antenatal care is used by more women than any other reproductive health services available and many women who receive antenatal care will not receive intrapartum care by a trained provider and even fewer will receive postnatal care. At present, antenatal care provides contraceptive counselling but not contraceptive provision. An important reason for this is the perceived absence of a suitable method that could be distributed or started during antenatal care. In this article, we discuss the available options. We conclude that antenatal insertion of subdermal contraceptive implants is very likely to be safe and ethically defensible where access to contraceptive services is poor.


Assuntos
Anticoncepcionais Femininos/administração & dosagem , Países em Desenvolvimento , Cuidado Pré-Natal , Administração Cutânea , Adolescente , Adulto , Anticoncepção/ética , Anticoncepção/métodos , Comportamento Contraceptivo , Anticoncepcionais Femininos/efeitos adversos , Feminino , Acessibilidade aos Serviços de Saúde , Humanos , Levanogestrel/administração & dosagem , Levanogestrel/efeitos adversos , Levanogestrel/sangue , Pessoa de Meia-Idade , Gravidez , Adulto Jovem
12.
Contraception ; 85(3): 224-34, 2012 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-22067761

RESUMO

The contraceptive profile of the levonorgestrel-releasing intrauterine system (LNG-IUS; Mirena®) is well established, with efficacy similar to that achieved with sterilization and rapid return to fertility after discontinuation of use. The LNG-IUS is typically associated with transient menstrual disturbance during the first few months of use, but this usually settles with continued use, with a concomitant decrease in menstrual blood loss. Overall, the safety profile of the LNG-IUS has been well established across a wide population of women, and the available data do not suggest that the LNG-IUS adversely affects bone health or increase the risk of adverse cardiovascular events or breast and uterine cancers. This article reviews the literature to provide updated information on the risks and benefits associated with the LNG-IUS, particularly focusing on its use in contraception.


Assuntos
Anticoncepcionais Femininos/administração & dosagem , Dispositivos Intrauterinos Medicados/efeitos adversos , Levanogestrel/administração & dosagem , Anticoncepcionais Femininos/efeitos adversos , Análise Custo-Benefício , Feminino , Humanos , Dispositivos Intrauterinos Medicados/economia , Levanogestrel/efeitos adversos , Medição de Risco
13.
Health Technol Assess ; 15(19): iii-xvi, 1-252, 2011 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-21535970

RESUMO

OBJECTIVE: The aim of this project was to determine the clinical effectiveness and cost-effectiveness of hysterectomy, first- and second-generation endometrial ablation (EA), and Mirena® (Bayer Healthcare Pharmaceuticals, Pittsburgh, PA, USA) for the treatment of heavy menstrual bleeding. DESIGN: Individual patient data (IPD) meta-analysis of existing randomised controlled trials to determine the short- to medium-term effects of hysterectomy, EA and Mirena. A population-based retrospective cohort study based on record linkage to investigate the long-term effects of ablative techniques and hysterectomy in terms of failure rates and complications. Cost-effectiveness analysis of hysterectomy versus first- and second-generation ablative techniques and Mirena. SETTING: Data from women treated for heavy menstrual bleeding were obtained from national and international trials. Scottish national data were obtained from the Scottish Information Services Division. PARTICIPANTS: Women who were undergoing treatment for heavy menstrual bleeding were included. INTERVENTIONS: Hysterectomy, first- and second-generation EA, and Mirena. MAIN OUTCOME MEASURES: Satisfaction, recurrence of symptoms, further surgery and costs. RESULTS: Data from randomised trials indicated that at 12 months more women were dissatisfied with first-generation EA than hysterectomy [odds ratio (OR): 2.46, 95% confidence interval (CI) 1.54 to 3.93; p = 0.0002), but hospital stay [WMD (weighted mean difference) 3.0 days, 95% CI 2.9 to 3.1 days; p < 0.00001] and time to resumption of normal activities (WMD 5.2 days, 95% CI 4.7 to 5.7 days; p < 0.00001) were longer for hysterectomy. Unsatisfactory outcomes associated with first- and second-generation techniques were comparable [12.2% (123/1006) vs 10.6% (110/1034); OR 1.20, 95% CI 0.88 to 1.62; p = 0.2). Rates of dissatisfaction with Mirena and second-generation EA were similar [18.1% (17/94) vs 22.5% (23/102); OR 0.76, 95% CI 0.38 to 1.53; p = 0.4]. Indirect estimates suggested that hysterectomy was also preferable to second-generation EA (OR 2.32, 95% CI 1.27 to 4.24; p = 0.006) in terms of patient dissatisfaction. The evidence to suggest that hysterectomy is preferable to Mirena was weaker (OR 2.22, 95% CI 0.94 to 5.29; p = 0.07). In women treated by EA or hysterectomy and followed up for a median [interquartile range (IQR)] duration of 6.2 (2.7-10.8) and 11.6 (7.9-14.8) years, respectively, 962/11,299 (8.5%) women originally treated by EA underwent further gynaecological surgery. While the risk of adnexal surgery was similar in both groups [adjusted hazards ratio 0.80 (95% CI 0.56 to 1.15)], women who had undergone ablation were less likely to need pelvic floor repair [adjusted hazards ratio 0.62 (95% CI 0.50 to 0.77)] and tension-free vaginal tape surgery for stress urinary incontinence [adjusted hazards ratio 0.55 (95% CI 0.41 to 0.74)]. Abdominal hysterectomy led to a lower chance of pelvic floor repair surgery [hazards ratio 0.54 (95% CI 0.45 to 0.64)] than vaginal hysterectomy. The incidence of endometrial cancer following EA was 0.02%. Hysterectomy was the most cost-effective treatment. It dominated first-generation EA and, although more expensive, produced more quality-adjusted life-years (QALYs) than second-generation EA and Mirena. The incremental cost-effectiveness ratios for hysterectomy compared with Mirena and hysterectomy compared with second-generation ablation were £1440 per additional QALY and £970 per additional QALY, respectively. CONCLUSIONS: Despite longer hospital stay and time to resumption of normal activities, more women were satisfied after hysterectomy than after EA. The few data available suggest that Mirena is potentially cheaper and more effective than first-generation ablation techniques, with rates of satisfaction that are similar to second-generation techniques. Owing to a paucity of trials, there is limited evidence to suggest that hysterectomy is preferable to Mirena. The risk of pelvic floor surgery is higher in women treated by hysterectomy than by ablation. Although the most cost-effective strategy, hysterectomy may not be considered an initial option owing to its invasive nature and higher risk of complications. Future research should focus on evaluation of the clinical effectivesness and cost-effectiveness of the best second-generation EA technique under local anaesthetic versus Mirena and types of hysterectomy such as laparoscopic supracervical hysterectomy versus conventional hysterectomy and second-generation EA. FUNDING: The National Institute for Health Research Health Technology Assessment programme.


Assuntos
Técnicas de Ablação Endometrial/métodos , Histerectomia/métodos , Levanogestrel/uso terapêutico , Menorragia/tratamento farmacológico , Menorragia/cirurgia , Anticoncepcionais Femininos/efeitos adversos , Anticoncepcionais Femininos/economia , Anticoncepcionais Femininos/uso terapêutico , Análise Custo-Benefício , Técnicas de Ablação Endometrial/efeitos adversos , Técnicas de Ablação Endometrial/economia , Feminino , Humanos , Histerectomia/efeitos adversos , Histerectomia/economia , Levanogestrel/efeitos adversos , Levanogestrel/economia , Menorragia/economia , Satisfação do Paciente , Complicações Pós-Operatórias/epidemiologia , Anos de Vida Ajustados por Qualidade de Vida , Tempo , Resultado do Tratamento
15.
Int J Gynaecol Obstet ; 112(3): 171-8, 2011 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-21269626

RESUMO

OBJECTIVE: To review the literature for economic and health-related quality of life outcomes data associated with the use of the levonorgestrel-releasing intrauterine system (LNG-IUS) in the management of heavy menstrual bleeding. METHODS: We searched the MEDLINE and EMBASE databases simultaneously using the Ovid interface to review the literature in a systematic manner for economic and health-related quality of life outcomes data associated with the use of the LNG-IUS in women with heavy menstrual bleeding. Articles were then selected for further review based on the relevance of their titles and/or abstracts. We identified 17 articles for inclusion in this review. RESULTS: Treating heavy menstrual bleeding with the LNG-IUS was found to be cost-effective in various countries and settings. Moreover, irrespective of the measuring instrument used, health-related quality-of-life outcomes were found to be improved to a degree similar to that achieved with endometrial ablation or hysterectomy. In some cases, the LNG-IUS appeared to be more effective and less costly than the surgical options. CONCLUSION: The LNG-IUS is a cost-effective treatment option for heavy menstrual bleeding when pharmacologic treatment is indicated.


Assuntos
Anticoncepcionais Femininos/uso terapêutico , Dispositivos Intrauterinos Medicados/efeitos adversos , Levanogestrel/efeitos adversos , Levanogestrel/uso terapêutico , Metrorragia/tratamento farmacológico , Qualidade de Vida , Análise Custo-Benefício , Feminino , Humanos , Histerectomia/economia , Dispositivos Intrauterinos Medicados/economia , Levanogestrel/economia , Metrorragia/economia , Metrorragia/cirurgia , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
16.
Expert Rev Cardiovasc Ther ; 8(2): 211-5, 2010 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-20136607

RESUMO

Hormonal contraceptives are a popular method of contraception, but their use has been associated with an increased risk for venous thromboembolism. In order to reduce such risk, these compounds have been changed in their dosage, chemical composition and route of administration. The absolute risk of death from pulmonary embolism in contraceptive users has been estimated to be 10.5 (95% CI: 6.2-16.6) per million woman-years. The safest option is an oral contraceptive containing levonorgestrel combined with a low dose of estrogen. Identifying women at increased risk for venous thromboembolism is difficult, and greater use of thromboprophylaxis during immobility or minor surgery should be warranted. Several authors have called for all women to be screened for thrombophilia before prescription of hormonal contraceptives, but its cost-effectiveness remains uncertain.


Assuntos
Anticoncepcionais Orais Hormonais/efeitos adversos , Tromboembolia Venosa/epidemiologia , Anticoncepcionais Orais Combinados/efeitos adversos , Anticoncepcionais Orais Hormonais/uso terapêutico , Estrogênios/administração & dosagem , Estrogênios/efeitos adversos , Feminino , Humanos , Imobilização/efeitos adversos , Incidência , Levanogestrel/efeitos adversos , Programas de Rastreamento/economia , Embolia Pulmonar/induzido quimicamente , Embolia Pulmonar/epidemiologia , Embolia Pulmonar/mortalidade , Medição de Risco , Trombofilia/diagnóstico , Tromboembolia Venosa/induzido quimicamente
18.
Eur J Contracept Reprod Health Care ; 13(3): 231-7, 2008 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-18609346

RESUMO

OBJECTIVES: To evaluate patient satisfaction and improvement in quality of life (QoL) among women with idiopathic menorrhagia treated with the levonorgestrel intrauterine system (LNG-IUS). STUDY DESIGN: Prospective-observational study with one-year follow-up in which 225 women were enrolled who had a LNG-IUS inserted for control of idiopathic menorrhagia. Bleeding, tolerability, user satisfaction, and health-related QoL (by means of the SF-36 QoL questionnaire) were assessed. RESULTS: There was a statistically significant reduction in the amount of bleeding, an increase of haemoglobin and ferritin levels, and an improved QoL score. A high degree of satisfaction was reported by over 98% of patients. CONCLUSIONS: The LNG-IUS is an effective and well-tolerated treatment modality in idiopathic menorrhagia. The QoL of women treated with the LNG-IUS is markedly improved, causing high levels of patient satisfaction. This IUS can be regarded as a first-choice therapy in idiopathic menorrhagia.


Assuntos
Anticoncepcionais Femininos/uso terapêutico , Levanogestrel/uso terapêutico , Menorragia/tratamento farmacológico , Satisfação do Paciente , Qualidade de Vida , Adulto , Anticoncepcionais Femininos/efeitos adversos , Feminino , Ferritinas/sangue , Seguimentos , Hemoglobinas/análise , Humanos , Dispositivos Intrauterinos Medicados , Levanogestrel/efeitos adversos , Menorragia/sangue , Pessoa de Meia-Idade , Estudos Prospectivos , Perfil de Impacto da Doença , Espanha
19.
Afr J Reprod Health ; 11(1): 90-7, 2007 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-17982951

RESUMO

The case notes of 377 clients who accepted Norplant out of 11961 acceptors of family planning methods in the Department of Obstetrics and Gynaecology University of Benin Teaching Hospital, between January 1985 and December 1996 were retrieved and analysed at the end of 2004, for socio-demographic characteristics of the clients, side effects and complications reported and reasons for discontinuation in relation to duration of use. The daily register of the acceptors were analysed for new acceptors of other methods during the same period and confirmed with their case notes. The acceptance incidence of Norplant was 3.2%. The mean age and parity of the acceptors were 32.2 +/- 4.5 years and 3.9 +/- 1.8 respectively. The duration of use ranged between 6 months and 13 years. 65% of the acceptors reported menstrual abnormalities. 48% of them reported reduced bleeding pattern, while 7.5% (25) discontinued method under 4 years of use because of increased bleeding episodes. Other side effects reported were headache 6%, weight gain 3%, mastalgia 1.8%, decreased libido 1.8%, abdominal pain 1.5% and hypertension 1.2%. 20.4% (68) discontinued the use under 4 years because of desire to have another baby. 38.6% (129) had implants removed at 5 years, while 20.1% (67) continued the use for 6-13 years before removal and replacement with another set. Husband's request for removal constituted 7.2% (24). The effectiveness was 100% as no pregnancy was reported during the study period. The continuation rate at 5 years was 58.7%. 43 clients were however lost to follow up. Norplant was found to be an effective and acceptable method of long-term reversible contraception with minimal side effects. The low incidence was attributed to the fact that the implants were donor driven and not included in the country contraceptive logistic system. Norplant acceptors who continued the use after 5 years did so, because they enjoyed it and did not want to part with them without replacement of new sets.


Assuntos
Anticoncepcionais Femininos/uso terapêutico , Levanogestrel/uso terapêutico , Adolescente , Adulto , Anticoncepcionais Femininos/administração & dosagem , Anticoncepcionais Femininos/efeitos adversos , Uso de Medicamentos , Feminino , Humanos , Bombas de Infusão Implantáveis , Levanogestrel/administração & dosagem , Levanogestrel/efeitos adversos , Pessoa de Meia-Idade , Nigéria , Fatores Socioeconômicos
20.
S D Med ; 60(3): 99-101, 103-5, 2007 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-17455578

RESUMO

Unintended and teenage pregnancies are major public health concerns in the United States. Emergency contraception is used to prevent pregnancy after failure of a contraceptive method or after unprotected intercourse. Expanded use of emergency contraception has the potential to reduce unintended pregnancy and induced abortions, while reducing state and federal healthcare expenditures. The recent approval of Plan B as an over-the-counter medication for individuals over 18 years of age should improve access to this medication. However, there are still widespread misconceptions about the mechanisms and implications of emergency contraception. Expanded access to emergency contraception is associated with increased use, but not associated with decreased efficacy, increased sexual risk-taking behavior, or less consistent use of traditional birth control methods. This review is designed to provide clinicians with information regarding the use of emergency contraception for reproductive age patients. It includes a brief description of methods of use, mechanisms of action, and side effect profiles of the most commonly used methods of emergency contraception, levonorgestrel and the Yuzpe method.


Assuntos
Anticoncepção Pós-Coito , Anticoncepcionais Femininos/administração & dosagem , Anticoncepcionais Orais Sintéticos/administração & dosagem , Anticoncepcionais Hormonais Pós-Coito , Levanogestrel/administração & dosagem , Gravidez na Adolescência , Gravidez não Desejada , Aborto Induzido , Adolescente , Adulto , Ensaios Clínicos como Assunto , Comportamento Contraceptivo , Anticoncepção Pós-Coito/economia , Anticoncepção Pós-Coito/métodos , Anticoncepcionais Femininos/efeitos adversos , Anticoncepcionais Orais Sintéticos/efeitos adversos , Anticoncepcionais Hormonais Pós-Coito/administração & dosagem , Anticoncepcionais Hormonais Pós-Coito/efeitos adversos , Anticoncepcionais Hormonais Pós-Coito/economia , Anticoncepcionais Hormonais Pós-Coito/farmacologia , Feminino , Custos de Cuidados de Saúde , Humanos , Levanogestrel/efeitos adversos , Medicamentos sem Prescrição , Gravidez , Assunção de Riscos , Comportamento Sexual , Fatores de Tempo , Estados Unidos , United States Food and Drug Administration , Organização Mundial da Saúde
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