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1.
Menopause ; 31(4): 342-354, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38471077

RESUMO

IMPORTANCE: Vasomotor symptoms (VMS) affect many postmenopausal persons and impact sleep and quality of life. OBJECTIVE: This systematic review examines the literature describing the safety and efficacy of neurokinin-3 receptor antagonists approved and in development for postmenopausal persons with VMS. EVIDENCE REVIEW: A search of MEDLINE, EMBASE, and International Pharmaceutical Abstracts was conducted using the search terms and permutations of neurokinin-3 receptor antagonist, elinzanetant, fezolinetant, and osanetant. Inclusion criteria of reporting on efficacy or safety of fezolinetant, elinzanetant, or osanetant; studies in participants identifying as female; full record in English; and primary literature were applied. Abstract-only records were excluded. Extracted data were synthesized to allow comparison of reported study characteristics, efficacy outcomes, and safety events. Eligible records were evaluated for risk of bias via the Cochrane Risk of Bias 2 tool for randomized studies and the Grading of Recommendations Assessment, Development and Evaluation system was used. This study was neither funded nor registered. FINDINGS: The search returned 191 records; 186 were screened after deduplication. Inclusion criteria were met by six randomized controlled trials (RCT), four reported on fezolinetant, and two reported on elinzanetant. One record was a post hoc analysis of a fezolinetant RCT. An additional study was identified outside the database search. Three fezolinetant RCT demonstrated a reduction in VMS frequency/severity, improvement in Menopause-Specific Quality of Life scores, and improvement in sleep quality at weeks 4 and 12 compared with placebo without serious adverse events. The two RCT on elinzanetant also showed improvements in VMS frequency and severity. All eight records evaluated safety through treatment-emergent adverse events; the most common adverse events were COVID-19, headache, somnolence, and gastrointestinal. Each record evaluated had a low risk of bias. There is a strong certainty of evidence as per the Grading of Recommendations Assessment, Development and Evaluation system. CONCLUSIONS AND RELEVANCE: Because of the high-quality evidence supporting the efficacy of fezolinetant and elinzanetant, these agents may be an effective option with mild adverse events for women seeking nonhormone treatment of VMS.


Assuntos
Compostos Heterocíclicos com 2 Anéis , Fogachos , Menopausa , Piperidinas , Receptores da Neurocinina-3 , Sudorese , Tiadiazóis , Sistema Vasomotor , Feminino , Humanos , Compostos Heterocíclicos com 2 Anéis/farmacologia , Compostos Heterocíclicos com 2 Anéis/uso terapêutico , Menopausa/efeitos dos fármacos , Menopausa/fisiologia , Receptores da Neurocinina-3/antagonistas & inibidores , Tiadiazóis/química , Tiadiazóis/uso terapêutico , Piperidinas/farmacologia , Piperidinas/uso terapêutico , Fogachos/tratamento farmacológico , Sudorese/efeitos dos fármacos , Sistema Vasomotor/efeitos dos fármacos , Sistema Vasomotor/fisiopatologia
2.
Curr Pharm Teach Learn ; 15(8): 715-721, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37487786

RESUMO

INTRODUCTION: Pharmacists must be knowledgeable to care for all patients, including transgender and gender diverse individuals. Some institutions may have gaps in their pharmacy school curriculum specific to transgender contraceptive care. The current study evaluated and offered recommendations regarding the current state of transgender contraceptive care education within pharmacy curricula. METHODS: An 18-question anonymous survey was developed and sent to members of the American Association of Colleges of Pharmacy - Pharmacy Practice section contact list. The survey collected baseline demographic characteristics and curricular information, including whether contraception for transgender individuals was taught and the modalities utilized. The institutional review board at Butler University reviewed and approved this survey project. RESULTS: A response rate of 68% was obtained (99 of 144 institutions). Of those institutions responding, 39% reported that contraception for transgender individuals is taught as part of the curriculum at their respective institutions. In addition, a diverse set of teaching modalities were reported, such as didactic and team-based learning. Only six (4.3%) of the 138 individual faculty respondents indicated they obtained training focused on transgender care. CONCLUSIONS: Approximately 40% of the responding institutions reported teaching about contraception care for transgender individuals. Based on this survey, the authors encourage institutions to assess their current curriculum and incorporate this topic accordingly. In addition, the authors recommend offering development opportunities for faculty and student pharmacists so that current and future health care professionals are best equipped to provide care for all patients in any practice.


Assuntos
Educação em Farmácia , Pessoas Transgênero , Humanos , Estados Unidos , Pessoas Transgênero/educação , Estudos Transversais , Anticoncepção , Anticoncepcionais
3.
Curr Pharm Teach Learn ; 15(6): 551-558, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-37355387

RESUMO

INTRODUCTION: The pharmacist's role in reproductive health is evolving. Since 46 states allow providers to refuse to provide reproductive health services, it is important to consider whether learning is impacted by institution restrictions on contraception teaching, advocacy, and research. METHODS: An electronic survey was emailed to deans of all pharmacy schools on the American Association of Colleges of Pharmacy Institutional Membership list with a request to share with faculty teaching women's health content within their curriculum. The survey collected information about contraception teaching, research, and advocacy. RESULTS: Of 145 schools contacted, 39 (27%) provided complete responses. Of these, 22 (56%) were public, not religiously-affiliated, seven (18%) were private, not religiously-affiliated, six (15%) were private, currently religiously-affiliated, and four were (10%) private, historically religiously-affiliated. All respondents taught hormonal contraception in the required curriculum and 15 (39%) taught miscarriage management/abortifacients. None reported restrictions on contraception teaching or research. One respondent cited an advocacy restriction for contraception methods due to violation of the school's beliefs, and another cited an advocacy restriction for miscarriage management/abortifacients. Respondents noted students expressed ethical questions/concerns about refusing to dispense contraception (59%), dispensing certain contraceptives (54%), dispensing to minors (46%), and dispensing all contraceptives (21%). Additionally, respondents reported pharmacists/faculty expressed ethical questions/concerns about refusing to dispense contraception (31%), dispensing to minors (21%), dispensing certain contraceptives (15%), and all contraceptives (13%). CONCLUSIONS: Overall, respondents reported no restrictions in contraception teaching and scholarship and minimal advocacy restrictions. Faculty should consider ethical questions/concerns from students, faculty, and pharmacists when teaching this material.


Assuntos
Abortivos , Aborto Espontâneo , Farmácia , Gravidez , Humanos , Feminino , Estados Unidos , Instituições Acadêmicas , Anticoncepção , Inquéritos e Questionários , Anticoncepcionais/uso terapêutico
4.
J Am Pharm Assoc (2003) ; 63(4): 1168-1174, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37084809

RESUMO

BACKGROUND: Raspberry leaf products are recommended by health care providers to induce labor despite insufficient efficacy and safety data. Less is known about community pharmacists' knowledge and recommendations regarding raspberry leaf products. OBJECTIVE: The primary end point was to describe New York State community pharmacist recommendations regarding raspberry leaf for labor induction. Secondary end points evaluated pharmacists' assessment of the patient for additional information, citation of a supporting reference, provision of safety and efficacy information, recommendation of a patient-appropriate reference, and change in recommendation after learning about the obstetrician-gynecologist's recommendation. DESIGN: Using a list of registered New York State pharmacies via a Freedom of Information Law request, a randomized representative sample of included pharmacy types (grocery store, drugstore chain, independent, and mass merchandising) was called using a mystery caller approach. Calls were conducted by one investigator throughout July 2022. Data collection included items specific to the primary and secondary outcomes. This study was approved by the associated institutional review board. SETTING AND PARTICIPANTS: New York State community pharmacists from grocery store, drugstore chain, independent, and mass merchandising pharmacies were called using the mystery caller approach. OUTCOME MEASURES: The primary endpoint was measured by the number of evidence-based recommendations made by pharmacists. RESULTS: The study included 366 pharmacies. Despite insufficient efficacy and safety data, there were 308 recommendations to use raspberry leaf products (n = 308 of 366, 84.1%). Most pharmacists attempted to collect additional patient information (n = 278 of 366, 76.0%). Many pharmacists did not clearly convey safety (n = 168 of 366, 45.9%) or efficacy (n = 197 of 366, 53.8%) information. Of those who discussed safety or efficacy, many said raspberry leaf products were safe and effective (n = 125 of 198, 63.1%; n = 82 of 169, 48.5%). Pharmacists often referred or deferred the patient to another medical professional for more information (n = 92 of 282, 32.6%). CONCLUSION: There is an opportunity to improve pharmacists' knowledge on the use of raspberry leaf products for the induction of labor and in making evidence-based recommendations when limited or conflicting efficacy and safety data exist.


Assuntos
Serviços Comunitários de Farmácia , Farmácias , Rubus , Humanos , Farmacêuticos , New York
5.
J Am Pharm Assoc (2003) ; 63(3): 720-724, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36775738

RESUMO

The coronavirus disease 2019 (COVID-19) pandemic has elicited many health concerns, including the impact of the infection and vaccine on reproductive health. Although robust evidence demonstrates the safety of all available COVID-19 vaccines, misinformation and disinformation related to the vaccine continue to circulate. As accessible and essential health care workers, it is crucial that pharmacists are informed of the evidence related to effects of the COVID-19 infection and vaccinations on reproductive health care. Menstrual cycle changes have been noted owing to COVID-19 infection, pandemic stress, and COVID-19 vaccination. COVID-19 infection and vaccination have not been shown to influence female fertility, pregnancy rates, and lactation. The use of exogenous estrogen may further contribute to an increased risk of thromboembolism with COVID-19 infection, and differences in the risk of cerebral venous sinus thrombosis appear to exist between the types of vaccines. The benefits of COVID-19 vaccination outweigh any risks. Shared decision-making is necessary when discussing vaccination with patients. Pharmacists play a vital role in dispelling misinformation and disinformation related to the impact of COVID-19 illness and vaccination on reproductive health care.


Assuntos
COVID-19 , Farmacêuticos , Gravidez , Humanos , Feminino , Vacinas contra COVID-19/efeitos adversos , Pessoal de Saúde , Lactação , Vacinação
6.
Pharmacy (Basel) ; 10(6)2022 Dec 10.
Artigo em Inglês | MEDLINE | ID: mdl-36548328

RESUMO

BACKGROUND: The objective of this systematic review was to characterize the efficacy and safety of evening primrose (EP) for facilitation of parturition in peripartum persons. METHODS: This search sought records related to the efficacy and safety of EP preparations to facilitate parturition. Eligibility criteria were primary literature with efficacy or safety outcomes reported; studied in peripartum persons; and available in English. Records were excluded if they were available as abstracts only. Data was synthesized by study characteristics, patient demographics, and outcomes. The RoB2 and ROBINS-I were used to assess risk of bias. RESULTS: A total of 11 studies met inclusion criteria: seven randomized placebo-controlled trials, one randomized non placebo-controlled trial, one case study, one observational retrospective study, and one quasi-experimental cross-sectional study. Efficacy outcomes included Bishop scores and duration of labor during the different phases. Reported adverse events were generally mild and included increased blood pressure, decreased heart rate, pain, bleeding, nausea, and vomiting. Important risks of bias exist across the literature reviewed. CONCLUSIONS: The use of EP for parturition in peripartum individuals is not recommended. Further research is warranted before use during parturition or the peripartum period. Other: The authors deny conflicts of interest. The study was neither registered nor funded.

7.
J Pharm Pract ; : 8971900221142681, 2022 Nov 25.
Artigo em Inglês | MEDLINE | ID: mdl-36427222

RESUMO

Complications throughout the peripartum period may be caused by preexisting conditions or pregnancy-induced conditions and may alter pharmacotherapy management. Pharmacotherapy management during late pregnancy and delivery requires careful consideration due to changing hormones, hemodynamic status, and pharmacokinetics, and concerns for potential maternal and/or fetal morbidity. Increased maternal and fetal monitoring are often required and may lead to therapy changes. Pharmacists, as key members of the interprofessional team, can contribute essential perspective to the management of postpartum pharmacotherapy through assessment and recommendation of appropriate and judicious use of medications.

8.
Pharmacy (Basel) ; 10(5)2022 Aug 26.
Artigo em Inglês | MEDLINE | ID: mdl-36136838

RESUMO

BACKGROUND: Postmenopausal women may be at an increased risk for cardiovascular events. The postmenopausal transition represents a key time for implementation of preventative strategies to reduce the risk of cardiovascular disease. The objective of this study was to evaluate the appropriate use of primary prophylaxis of cardiovascular disease in this population and to determine if an opportunity exists for improvement in primary prevention prescribing. METHODS: A single-center, retrospective study was conducted of postmenopausal women aged 45-60 years between 1 October 2019 and 30 April 2021 with a diagnosis of a new major adverse cardiovascular event (MACE). This study was approved by the University at Buffalo Institutional Review Board. RESULTS: After application of inclusion and exclusion criteria, 231 patients were included and analyzed. Median age was 55 years; 66.6% white; median body mass index was 30.11 kg/m2; 30.3% history of diabetes; 51.1% current smokers; 82.3% with a primary care provider (PCP); 97.6% insured. Patients with diabetes, current smokers, and those without a PCP were more likely to have inappropriate primary prevention use than patients without diabetes, non-smokers, and with a PCP, respectively (78.7% vs. 51.3%, p = 0.0002; 57.6% vs. 42.4%, p = 0.0177; 73.7% vs. 56.0%, p = 0.0474). Specifically, current smokers, and those with diabetes had significantly more inappropriate use of aspirin and statins for primary prevention than non-smokers and patients without diabetes. CONCLUSIONS: This study observed the use of appropriate primary prevention therapies in postmenopausal women and found that an opportunity may exist to improve prescribing appropriate primary prevention therapies for certain groups, most notably in postmenopausal women with diabetes, smokers, uninsured, and those without a PCP.

9.
J Am Pharm Assoc (2003) ; 62(3): 674-682.e5, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35277362

RESUMO

BACKGROUND: Uterine fibroids constitute a significant health problem in the United States, affecting upward of 11 million people. OBJECTIVE: Characterize the literature regarding the incidence of amenorrhea and reductions in abnormal uterine bleeding and fibroid size and to report on clinically relevant safety outcomes of oral medications that may be used to manage symptomatic uterine fibroids to assist in choice of therapeutic options. METHODS: A literature search was conducted through December 31, 2021, using Embase, MEDLINE, and International Pharmaceutical Abstracts databases. Primary literature reporting on safety or efficacy data of any oral medication for the treatment of symptomatic uterine fibroids was included. Relevant study characteristics, outcomes, and safety data were extracted. Data extraction was performed in duplicate with any discordant data reconciled by the entire investigative team. RESULTS: A total of 41 studies met inclusion criteria-28 randomized control trials (RCTs), 11 prospective observational studies, 1 phase-1 pharmacokinetic study, and 1 pooled study. The majority of literature involved the study of mifepristone (n = 26, [63.4%]), followed by vilaprisan (n = 5, [12.2%]), elagolix (n = 5, [12.2%]), relugolix (n = 4, [9.8%]), and linzagolix (n = 1 [2.4%]). A total of 33 articles (80.5%) reported results pertaining to the efficacy objectives of this review with all medications statistically significantly improving at least one of these domains. Hot flashes, liver function test abnormalities, and endometrial hyperplasia were the most often reported adverse events. Of the RCTs, 7 of 28 (25%) had a moderate-high risk of bias (RoB), whereas 10 of 11 (90.9%) observational studies had a moderate-high RoB. The majority of moderate-high RoB studies involved the study of mifepristone (15 of 18, 83.3%). CONCLUSIONS: Given higher quality of evidence, confirmed therapeutic efficacy, and a milder adverse effect profile, the contemporary gonadotropin releasing hormone antagonists (elagolix, relugolix, linzagolix) and vilaprisan represent preferred oral treatment options for the management of uterine fibroids.


Assuntos
Leiomioma , Neoplasias Uterinas , Ácidos Carboxílicos/uso terapêutico , Ensaios Clínicos Fase I como Assunto , Feminino , Humanos , Leiomioma/tratamento farmacológico , Mifepristona , Estudos Observacionais como Assunto , Pirimidinas , Ensaios Clínicos Controlados Aleatórios como Assunto , Neoplasias Uterinas/tratamento farmacológico
10.
J Pharm Pract ; 35(6): 991-999, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33926292

RESUMO

Polycystic ovary syndrome (PCOS) is a common cause of female infertility. To conduct a systematic review assessing the efficacy and safety of black cohosh for ovulation-induction through hormone regulation and increased endometrial thickness to improve pregnancy rates in women with PCOS-related infertility. Preferred Reporting Items for Systematic Reviews and Meta-Analyses was used. A search of Medline, Embase, International Pharmaceutical Abstracts, Science Direct, and Cumulative Index of Nursing and Allied Health Literature spanning origin to December 19, 2020 was conducted using keywords and permutations of "black cohosh" and "PCOS." A search for "PCOS" in the National Clinical Trials database and International Clinical Trials Registry Platform was conducted in December 2020 to identify additional records. Eligibility criteria included reported efficacy or safety outcomes; studies in women with PCOS; English language; and primary literature. Eligible records were evaluated using applicable risk-of-bias tools. A total of 181 records were screened after deduplication from 207 results. Two randomized controlled trials (RCT) met inclusion criteria. Review of 1386 records from clinical trial registries and subsequent scoping searches resulted in identification of 4 additional records (3 published). Improvement in hormone regulation and endometrial thickness were found for black cohosh groups compared to clomiphene citrate (CC). Three RCTs reported improved pregnancy rates using black cohosh plus CC. There were no differences in adverse events. Studies demonstrated several risk-of-bias concerns. There is a lack of high-quality evidence supporting the effectiveness of black cohosh for improving pregnancy rates in PCOS-related infertility. Short-term use of black cohosh appears to be safe.


Assuntos
Cimicifuga , Infertilidade Feminina , Síndrome do Ovário Policístico , Gravidez , Feminino , Humanos , Síndrome do Ovário Policístico/complicações , Síndrome do Ovário Policístico/tratamento farmacológico , Fármacos para a Fertilidade Feminina/uso terapêutico , Clomifeno/uso terapêutico , Infertilidade Feminina/tratamento farmacológico , Infertilidade Feminina/etiologia , Preparações Farmacêuticas , Hormônios/uso terapêutico
11.
Am J Pharm Educ ; 86(4): 8667, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-34385172

RESUMO

In 2014, the pharmacist's role in the United States expanded to include prescribing hormonal contraception, and this practice is currently addressed by policy in 14 states and the District of Columbia. Training and education requirements for this expanded scope of practice vary between states and are changing rapidly. The objective of this review is to examine how student pharmacists are taught to provide contraceptive care, specifically for prescribing ongoing hormonal contraception and emergency contraception, and to identify potential gaps in the United States pharmacy curricula related to contraception. Despite steady adoption into community pharmacy practice, there is sparse literature assessing educational methods used to teach contraceptive care. This review offers recommendations to promote consistent and comprehensive student pharmacist education in providing contraceptive care across institutions, regardless of state policy status.


Assuntos
Educação em Farmácia , Farmacêuticos , Anticoncepcionais , Acesso aos Serviços de Saúde , Contracepção Hormonal , Humanos , Estudantes , Estados Unidos
12.
Pharmacy (Basel) ; 9(4)2021 Dec 16.
Artigo em Inglês | MEDLINE | ID: mdl-34941634

RESUMO

Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity, mortality, and reduced quality of life for patients. Proper use of inhaler devices is critical for effective drug delivery and prevention of COPD progression. The primary endpoint of this study was a mean percent increase in correct steps associated with inhaler technique after pharmacist education. The co-primary endpoint was a 25% increase in the proportion of patients correctly identifying the appropriate use of short-acting versus long-acting inhaler types. This was an interventional quasi-experimental study of patients hospitalized at a 491-bed tertiary academic medical center with a COPD exacerbation to assess a pharmacist-led COPD care plan. Eligible patients included general floor, adult patients admitted with a primary diagnosis of COPD exacerbation. The primary investigator recorded initial inhaler technique scores through a paper checklist, and provided education about device types and usage. Patients were reassessed within 48 h to determine if pharmacist education improved inhaler knowledge. A total of 67 patients received the COPD care plan before hospital discharge. At baseline, patients scored a median of 81.8% (67.5-97.0) of steps correct across all inhaler device types. After pharmacist education, patient scores increased to a median of 100% (90.9-100.0) (p < 0.0001). The proportion of patients correctly identifying when to use short-acting versus long-acting inhalers increased from 73.1% to 98.5% (p < 0.0001). Implementation of a pharmacist-led care plan for patients admitted for COPD exacerbation was associated with an increase in correct steps for appropriate inhaler technique and understanding of inhaler device types after pharmacist education.

13.
Pharmacy (Basel) ; 9(2)2021 Mar 27.
Artigo em Inglês | MEDLINE | ID: mdl-33801678

RESUMO

This systematic review evaluates the efficacy and safety of l-arginine alone or in combination for the treatment of women with hypoactive sexual desire disorder (HSDD) or related conditions, such as female sexual interest/arousal disorder and female sexual arousal disorder. Medline, Embase, International Pharmaceutical Abstracts, Science Direct, and the Cumulative Index to Nursing and Allied Health Literature were searched using keywords "arginine", "Lady Prelox", "ArginMax", "Stronvivo", "Ristela", "hypoactive sexual desire disorder", "female sexual interest arousal disorder", "female sexual arousal disorder", "sexual dysfunction", "sexual behavior", "dyspareunia", "libido", and permutations thereof. Relevant records were retained if they were primary literature, conducted in women with HSDD or related conditions, and published as full text in English. Five randomized controlled trials and two nonrandomized studies met eligibility criteria. Six of the seven studies reported either an increase in the total mean Female Sexual Function Index score or significant increases in multiple domains therein. One study assessed vaginal pulse amplitude and found a statistically significant increase in a combination treatment group compared to placebo. No significant side effects were reported. Four of seven studies had potential risk-of-bias concerns per Cochrane assessments. This systematic review found that combination products containing l-arginine in the form of ArginMax or Lady Prelox may be considered for the treatment of HSDD and related conditions in women regardless of age.

14.
J Pharm Pract ; 34(2): 230-238, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31390938

RESUMO

INTRODUCTION: Pharmacist prescribing of contraception is becoming increasingly available in selected states. The objective of this study was to assess US community pharmacists' perspectives on expanding access, barriers, and facilitators since states have begun pharmacist scope of practice expansions for prescribing contraception. METHODS: A survey study of US community pharmacists' support for expanded access models, pharmacist prescribing practices and interest, and importance of safety, cost, and professional practice issues for prescribing was conducted. RESULTS: Pharmacists are generally supportive of pharmacist prescribing and behind-the-counter models for hormonal contraception and generally opposed to over-the-counter access. A majority (65%) are interested in prescribing hormonal contraception. The top motivation for prescribing contraception is enjoying individual patient contact (94%). Safety concerns (eg, patients not obtaining health screenings) remained most important for pharmacist implementation, followed by cost (eg, lack of payment or reimbursement for pharmacists' services), and professional practice (eg, pharmacist time constraints and liability) issues. CONCLUSION: This study provides an updated understanding of attitudes toward models of expanded access to hormonal contraception, interest in prescribing, and barriers and facilitators to this service among community pharmacists. Many barriers such as time and reimbursement remain unchanged. This information can inform policy and implementation efforts.


Assuntos
Farmácias , Farmacêuticos , Atitude do Pessoal de Saúde , Acesso aos Serviços de Saúde , Contracepção Hormonal , Humanos , Papel Profissional , Estados Unidos
15.
Am J Health Syst Pharm ; 77(5): 336-345, 2020 Feb 19.
Artigo em Inglês | MEDLINE | ID: mdl-32073124

RESUMO

PURPOSE: Postpartum depression (PPD) is defined as a major depressive episode occurring during pregnancy or within 4 weeks of delivery that may have significant consequences for mother and infant. Antidepressants are used to treat PPD, but their effectiveness may be limited by a slow time to peak effect. Brexanolone is Food and Drug Administration-approved for the management of PPD; its use requires patient participation in a risk evaluation and mitigation strategies (REMS) program. This review evaluates the efficacy and safety of brexanolone in PPD. SUMMARY: Four completed studies, 1 quasi-experimental study and 3 randomized controlled trials (RCTs), were reviewed. Females who had moderate or severe PPD during the third trimester or within 4 weeks of delivery and were less than 6 months postpartum at initiation of therapy were included. Improvement in Hamilton Rating Scale for Depression (HAM-D) scores was assessed in addition to safety outcomes and scores on other depression rating scales. All studies demonstrated statistical improvement in HAM-D scores from baseline with brexanolone vs placebo use at the end of infusions (ie, hour 60). Results with regard to sustained HAM-D score improvements were mixed in the RCTs at 30-day follow-up. The most frequent adverse events in brexanolone-treated patients were sedation, dizziness, somnolence, and headache. The severe or serious adverse effect of presyncope, syncope, or loss of consciousness was reported by 4% of participants. CONCLUSION: With a rapid onset of action, brexanolone could be considered advantageous over traditional therapies for PPD in patients for whom a rapid response is required due to severity of disease. Significant concerns remain regarding sustained effect and use in patients outside of the clinical trial setting.


Assuntos
Antidepressivos/uso terapêutico , Depressão Pós-Parto/tratamento farmacológico , Pregnanolona/uso terapêutico , beta-Ciclodextrinas/uso terapêutico , Antidepressivos/efeitos adversos , Depressão Pós-Parto/fisiopatologia , Combinação de Medicamentos , Feminino , Humanos , Gravidez , Pregnanolona/efeitos adversos , Escalas de Graduação Psiquiátrica , Ensaios Clínicos Controlados Aleatórios como Assunto , Avaliação de Risco e Mitigação , Índice de Gravidade de Doença , beta-Ciclodextrinas/efeitos adversos
16.
Ann Pharmacother ; 54(2): 178-186, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31510755

RESUMO

Objective: This review identified and evaluated apps intended to aid women in conception that were available across major mobile platforms; secondary objectives were to highlight additional criteria and considerations when evaluating conception-related apps. Data Sources: Apple iTunes and Google Play stores were searched using the keywords conception, fertility, and pregnant. Data Selection: Included apps were as follows: contained in the first 50 search results; presented in English; intended for layperson use; updated July 1, 2018, or after; marketed as a conception aid; and used a defined fertility tracking method. Excluded apps were intended for men only, marketed for contraception only, promoted a single fertility service or branded product, or not found in both app stores. Data Extraction: Apps were evaluated using the adapted APPLICATIONS Scoring System. Two additional criteria were assessed: inclusion of a privacy policy and inclusion of a search function, medical terminology glossary, or Frequently Asked Questions section. Data Synthesis: A total of 300 apps were screened; 7 app pairs were analyzed. Scores ranged from 9 to 13 of a possible 15 points (mean = 11; median = 11). No app reported advisement from a health professional during development. Relevance to Patient Care in Clinical Practice: Widely available apps that score highly per the adapted APPLICATIONS Scoring System may be considered for use by and recommended to women seeking apps useful for conception. Conclusion: Evaluation tools should evolve as app features change. Criteria related to privacy and search functions that promote health literacy should be considered for future app evaluation tools.


Assuntos
Fertilização/fisiologia , Aplicativos Móveis , Métodos Naturais de Planejamento Familiar/métodos , Educação de Pacientes como Assunto/métodos , Smartphone , Feminino , Humanos , Aplicativos Móveis/normas , Gravidez
17.
Pharmacotherapy ; 39(11): 1095-1104, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31505045

RESUMO

l-glutamine was approved by the U.S. Food and Drug Administration (FDA) for sickle cell disease (SCD) in 2017. A vaso-occlusive crisis (VOC) occurs in persons with SCD and is associated with acute pain episodes. This systematic review summarizes the evidence for l-glutamine in the prevention of VOC and associated pain in patients with SCD. Medline, Embase, and International Pharmaceutical Abstracts were searched for records reporting on l-glutamine use in persons with SCD. Eligibility criteria identified primary reports of investigations conducted in humans who were administered l-glutamine, reported on outcomes related to VOC or associated pain, published in English, and were available as full text. All relevant efficacy, safety, participant demographic data, and study method characteristics were extracted and documented. Risk-of-bias assessments were conducted using the Risk of Bias in Non-Randomized Studies-of Interventions (ROBINS-I) tool and the revised Cochrane risk-of-bias tool for randomized studies. Three studies assessing the effect of exogenous l-glutamine administration in patients with SCD met eligibility criteria: one prospective nonrandomized controlled study and two prospective randomized controlled trials. Rate of VOC and related hospitalizations were reduced in patients receiving l-glutamine, although some conflicting results were noted between studies. l-glutamine was generally well tolerated. Limitations of one or more of the eligible studies included small sample size, nonblinding, and study groups that differed at baseline. l-glutamine has limited high-quality evidence supporting its use. Although l-glutamine is FDA approved for the prevention of frequent episodes of VOC pain, only one randomized controlled trial has strong evidence to support this indication. Based on the results of a systematic review, l-glutamine may be considered for patients unable to receive hydroxyurea or in addition to hydroxyurea for reduction in VOC and associated pain.


Assuntos
Anemia Falciforme/tratamento farmacológico , Glutamina/uso terapêutico , Dor/prevenção & controle , Anemia Falciforme/complicações , Glutamina/efeitos adversos , Hospitalização/estatística & dados numéricos , Humanos , Dor/etiologia , Ensaios Clínicos Controlados Aleatórios como Assunto
18.
P T ; 42(11): 692-698, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-29089725

RESUMO

Idarucizumab is the first reversal agent approved for the direct thrombin inhibitor dabigatran. The authors summarize the findings from the clinical trial series and describe case reports, post-marketing data, and ongoing studies.

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