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1.
Diabetes Care ; 2024 Jun 22.
Artigo em Inglês | MEDLINE | ID: mdl-38907683

RESUMO

OBJECTIVE: To determine whether semaglutide slows progression of glycemia in people with cardiovascular disease and overweight or obesity but without diabetes. RESEARCH DESIGN AND METHODS: In a multicenter, double-blind trial, participants aged ≥45 years, with BMI ≥27 kg/m2, and with preexisting cardiovascular disease but without diabetes (HbA1c <6.5%) were randomized to receive subcutaneous semaglutide (2.4 mg weekly) or placebo. Major glycemic outcomes were HbA1c and proportions achieving biochemical normoglycemia (HbA1c <5.7%) and progressing to biochemical diabetes (HbA1c ≥6.5%). RESULTS: Of 17,604 participants, 8,803 were assigned to semaglutide and 8,801 to placebo. Mean ± SD intervention exposure was 152 ± 56 weeks and follow-up 176 ± 40 weeks. In both treatment arms mean nadir HbA1c for participants was at 20 weeks. Thereafter, HbA1c increased similarly in both arms, with a mean difference of -0.32 percentage points (95% CI -0.33 to -0.30; -3.49 mmol/mol [-3.66 to -3.32]) and with the difference favoring semaglutide throughout the study (P < 0.0001). Body weight plateaued at 65 weeks and was 8.9% lower with semaglutide. At week 156, a greater proportion treated with semaglutide were normoglycemic (69.5% vs. 35.8%; P < 0.0001) and a smaller proportion had biochemical diabetes by week 156 (1.5% vs. 6.9%; P < 0.0001). The number needed to treat was 18.5 to prevent a case of diabetes. Both regression and progression were dependent on glycemia at baseline, with the magnitude of weight reduction important in mediating 24.5% of progression and 27.1% of regression. CONCLUSIONS: In people with preexisting cardiovascular disease and overweight or obesity but without diabetes, long-term semaglutide increases regression to biochemical normoglycemia and reduces progression to biochemical diabetes but does not slow glycemic progression over time.

2.
Nat Med ; 2024 May 13.
Artigo em Inglês | MEDLINE | ID: mdl-38740993

RESUMO

In the SELECT cardiovascular outcomes trial, semaglutide showed a 20% reduction in major adverse cardiovascular events in 17,604 adults with preexisting cardiovascular disease, overweight or obesity, without diabetes. Here in this prespecified analysis, we examined effects of semaglutide on weight and anthropometric outcomes, safety and tolerability by baseline body mass index (BMI). In patients treated with semaglutide, weight loss continued over 65 weeks and was sustained for up to 4 years. At 208 weeks, semaglutide was associated with mean reduction in weight (-10.2%), waist circumference (-7.7 cm) and waist-to-height ratio (-6.9%) versus placebo (-1.5%, -1.3 cm and -1.0%, respectively; P < 0.0001 for all comparisons versus placebo). Clinically meaningful weight loss occurred in both sexes and all races, body sizes and regions. Semaglutide was associated with fewer serious adverse events. For each BMI category (<30, 30 to <35, 35 to <40 and ≥40 kg m-2) there were lower rates (events per 100 years of observation) of serious adverse events with semaglutide (43.23, 43.54, 51.07 and 47.06 for semaglutide and 50.48, 49.66, 52.73 and 60.85 for placebo). Semaglutide was associated with increased rates of trial product discontinuation. Discontinuations increased as BMI class decreased. In SELECT, at 208 weeks, semaglutide produced clinically significant weight loss and improvements in anthropometric measurements versus placebo. Weight loss was sustained over 4 years. ClinicalTrials.gov identifier: NCT03574597 .

3.
JAMA ; 331(1): 38-48, 2024 01 02.
Artigo em Inglês | MEDLINE | ID: mdl-38078870

RESUMO

Importance: The effect of continued treatment with tirzepatide on maintaining initial weight reduction is unknown. Objective: To assess the effect of tirzepatide, with diet and physical activity, on the maintenance of weight reduction. Design, Setting, and Participants: This phase 3, randomized withdrawal clinical trial conducted at 70 sites in 4 countries with a 36-week, open-label tirzepatide lead-in period followed by a 52-week, double-blind, placebo-controlled period included adults with a body mass index greater than or equal to 30 or greater than or equal to 27 and a weight-related complication, excluding diabetes. Interventions: Participants (n = 783) enrolled in an open-label lead-in period received once-weekly subcutaneous maximum tolerated dose (10 or 15 mg) of tirzepatide for 36 weeks. At week 36, a total of 670 participants were randomized (1:1) to continue receiving tirzepatide (n = 335) or switch to placebo (n = 335) for 52 weeks. Main Outcomes and Measures: The primary end point was the mean percent change in weight from week 36 (randomization) to week 88. Key secondary end points included the proportion of participants at week 88 who maintained at least 80% of the weight loss during the lead-in period. Results: Participants (n = 670; mean age, 48 years; 473 [71%] women; mean weight, 107.3 kg) who completed the 36-week lead-in period experienced a mean weight reduction of 20.9%. The mean percent weight change from week 36 to week 88 was -5.5% with tirzepatide vs 14.0% with placebo (difference, -19.4% [95% CI, -21.2% to -17.7%]; P < .001). Overall, 300 participants (89.5%) receiving tirzepatide at 88 weeks maintained at least 80% of the weight loss during the lead-in period compared with 16.6% receiving placebo (P < .001). The overall mean weight reduction from week 0 to 88 was 25.3% for tirzepatide and 9.9% for placebo. The most common adverse events were mostly mild to moderate gastrointestinal events, which occurred more commonly with tirzepatide vs placebo. Conclusions and Relevance: In participants with obesity or overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and augmented initial weight reduction. Trial Registration: ClinicalTrials.gov Identifier: NCT04660643.


Assuntos
Fármacos Antiobesidade , Obesidade , Redução de Peso , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Método Duplo-Cego , Polipeptídeo Inibidor Gástrico/administração & dosagem , Polipeptídeo Inibidor Gástrico/efeitos adversos , Polipeptídeo Inibidor Gástrico/farmacologia , Polipeptídeo Inibidor Gástrico/uso terapêutico , Obesidade/tratamento farmacológico , Obesidade/complicações , Sobrepeso/complicações , Sobrepeso/tratamento farmacológico , Resultado do Tratamento , Redução de Peso/efeitos dos fármacos , Receptor do Peptídeo Semelhante ao Glucagon 2/administração & dosagem , Receptor do Peptídeo Semelhante ao Glucagon 2/agonistas , Receptor do Peptídeo Semelhante ao Glucagon 2/uso terapêutico , Incretinas/administração & dosagem , Incretinas/efeitos adversos , Incretinas/farmacologia , Incretinas/uso terapêutico , Fármacos Antiobesidade/administração & dosagem , Fármacos Antiobesidade/efeitos adversos , Fármacos Antiobesidade/farmacologia , Fármacos Antiobesidade/uso terapêutico , Quimioterapia de Manutenção , Injeções Subcutâneas , Suspensão de Tratamento
4.
Obes Pillars ; 6: 100062, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-37990658

RESUMO

Background: Certification of obesity medicine for physicians in the United States occurs mainly via the American Board of Obesity Medicine (ABOM). Obesity medicine is not recognized as a subspecialty by the American Board of Medical Specialties (ABMS) or the American Osteopathic Association (AOA). This review examines the value of specialization, status of current ABOM Diplomates, governing bodies involved in ABMS/AOA Board Certification, and the advantages and disadvantages of an ABMS/AOA recognized obesity medicine subspecialty. Methods: Data for this review were derived from PubMed and appliable websites. Content was driven by the expertise, insights, and perspectives of the authors. Results: The existing ABOM obesity medicine certification process has resulted in a dramatic increase in the number of Obesity Medicine Diplomates. If ABMS/AOA were to recognize obesity medicine as a subspecialty under an existing ABMS Member Board, then Obesity Medicine would achieve a status like other ABMS recognized subspecialities. However, the transition of ABOM Diplomates to ABMS recognized subspecialists may affect the kinds and the number of physicians having an acknowledged focus on obesity medicine care. Among transition issues to consider include: (1) How many ABMS Member Boards would oversee Obesity Medicine as a subspecialty and which physicians would be eligible? (2) Would current ABOM Diplomates be required to complete an Obesity Medicine Fellowship? If not, then what would be the process for a current ABOM Diplomate to transition to an ABMS-recognized Obesity Medicine subspecialist (i.e., "grandfathering criteria")? and (3) According to the ABMS, do enough Obesity Medicine Fellowship programs exist to recognize Obesity Medicine as a subspecialty? Conclusions: Decisions regarding a transition to an ABMS recognized Obesity Medicine Subspecialty versus retention of the current ABOM Diplomate Certification should consider which best facilitates medical access and care to patients with obesity, and which best helps obesity medicine clinicians be recognized for their expertise.

5.
Diabetes Obes Metab ; 25(11): 3171-3180, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37424165

RESUMO

AIMS: To determine the relationship between exposure and weight-loss trajectories for the glucagon-like peptide-1 analogue semaglutide for weight management. MATERIALS AND METHODS: Data from one 52-week, phase 2, dose-ranging trial (once-daily subcutaneous semaglutide 0.05-0.4 mg) and two 68-week phase 3 trials (once-weekly subcutaneous semaglutide 2.4 mg) for weight management in people with overweight or obesity with or without type 2 diabetes were used to develop a population pharmacokinetic (PK) model describing semaglutide exposure. An exposure-response model describing weight change was then developed using baseline demographics, glycated haemoglobin and PK data during treatment. The ability of the exposure-response model to predict 1-year weight loss based on weight data collected at baseline and after up to 28 weeks of treatment, was assessed using three independent phase 3 trials. RESULTS: Based on population PK, exposure levels over time consistently explained the weight-loss trajectories across trials and dosing regimens. The exposure-response model had high precision and limited bias for predicting body weight loss at 1 year in independent datasets, with increased precision when data from later time points were included in the prediction. CONCLUSION: An exposure-response model has been established that quantitatively describes the relationship between systemic semaglutide exposure and weight loss and predicts weight-loss trajectories for people with overweight or obesity who are receiving semaglutide doses up to 2.4 mg once weekly.


Assuntos
Diabetes Mellitus Tipo 2 , Humanos , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Sobrepeso/complicações , Sobrepeso/tratamento farmacológico , Redução de Peso , Peptídeos Semelhantes ao Glucagon/efeitos adversos , Obesidade/complicações , Obesidade/tratamento farmacológico , Peptídeo 1 Semelhante ao Glucagon/uso terapêutico
7.
JMIR Form Res ; 7: e40062, 2023 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-36602855

RESUMO

BACKGROUND: Despite the increasing prevalence of obesity, the use of pharmacotherapy treatment remains low. Telehealth platforms have the potential to facilitate access to pharmacotherapy interventions, but little is known about telehealth patients. OBJECTIVE: This study describes a large patient population taking Plenity, an oral superabsorbent hydrogel (OSH) used in the treatment of excess weight or obesity (BMI 25-40 kg/m2). The analysis compared differences in weight loss practices and in-person access to obesity care among telehealth patients with preobesity and obesity. METHODS: This was a cross-sectional assessment of a random sample of 20,000 telehealth patients who completed a structured, web-based visit and received at least one prescription of OSH. Patients were eligible to receive care via telehealth if they were adults, were not pregnant, and had a BMI ≥25 kg/m2. During the visit, patients provided baseline health information including comorbidities, diet, and exercise habits. Their zip code of residence was used to determine their proximity to an obesity medicine provider. Descriptive statistical analysis and tests of differences (chi-square and 2-tailed t tests) were used to compare patients with preobesity (BMI 25-29.9 kg/m2) and obesity (BMI 30-40 kg/m2). RESULTS: Most (15,576/20,000, 77.88%) of the cohort were female, with a mean age of 44 (SD 11) years and a mean BMI of 32.4 (SD 4.1) kg/m2. Among the cohort, 32.13% (6426/20,000) had preobesity, and 40.18% (8036/20,000) of all patients had ≥1 weight-related comorbidity. Almost all (19,732/20,000, 98.66%) patients attempted 1 weight loss method before OSH and half (10,067/20,000, 50.34%) tried ≥4 different methods. Exercise and low-calorie diets were the most attempted weight loss methods, and 28.76% (5752/20,000) of patients reported a prior prescription of weight loss medication. Patients with obesity were more likely than patients with preobesity to have previously tried commercial weight loss plans (7294/13,574, 53.74% vs 2791/6426, 43.43%; P<.001), specialized diets (8493/13,574, 62.57% vs 3799/6426, 59.12%; P<.001), over-the-counter supplements (6807/13,574, 50.15% vs 2876/6426, 44.76%; P<.001), and prescription weight loss medications (4407/13,574, 32.47% vs 1345/6426, 20.93%; P<.001). Females were more likely to seek treatment for preobesity (5332/15,576, 34.23% vs 1094/4424, 24.73% male; P<.001) and reported fewer comorbidities (5992/15,576, 38.47% vs 2044/4424, 46.2% male; P<.001), despite >90% of both sexes reporting the belief that excess weight negatively affected their health (14,247/15,576, 91.47% female participants, 4116/4424, 93.04% male participants). Moreover, 29.25% (5850/20,000) of patients lived in the same zip code and 85.15% (17,030/20,000) lived in the same county as an obesity medicine provider. CONCLUSIONS: Data from this large patient cohort supports the potential for telehealth to provide prescriptive weight management treatment to a population seeking care. Patients with preobesity are an undertreated population who actively seek new weight management options. Female participants sought weight management treatment earlier in the disease continuum than males, despite reporting fewer comorbidities.

8.
Postgrad Med ; 134(4): 359-375, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-35315311

RESUMO

Obesity is a chronic disease with increasing prevalence. It affects quality of life and renders those affected at increased risk of mortality. For people living with obesity, weight loss is one of the most important strategies to improve health outcomes and prevent or reverse obesity-related complications. In line with newly released clinical practice guidelines, weight loss targets for people living with obesity should be defined individually based on their clinical profile, and progress measured in the context of improvements in health outcomes, rather than weight loss alone. We outline current treatment options for clinically meaningful weight loss and briefly discuss pharmacological agents and devices under development. Numerous studies have shown that weight loss of ≥5% results in significant improvements in cardiometabolic risk factors associated with obesity; this degree of weight loss is also required for the approval of novel anti-obesity medications by the US Food and Drug Administration. However, some obesity-related comorbidities and complications, such as non-alcoholic steatohepatitis, obstructive sleep apnea, gastroesophageal reflux disease and remission of type 2 diabetes, require a greater magnitude of weight loss to achieve clinically meaningful improvements. In this review, we assessed the available literature describing the effect of categorical weight losses of ≥5%, ≥10%, and ≥15% on obesity-related comorbidities and complications, and challenge the concept of clinically meaningful weight loss to go beyond percentage change in total body weight. We discuss weight-loss interventions including lifestyle interventions and therapeutic options including devices, and pharmacological and surgical approaches as assessed from the available literature.


Assuntos
Fármacos Antiobesidade , Diabetes Mellitus Tipo 2 , Fármacos Antiobesidade/uso terapêutico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Humanos , Obesidade/tratamento farmacológico , Obesidade/terapia , Qualidade de Vida , Redução de Peso
9.
Postgrad Med ; 133(8): 979-987, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34538196

RESUMO

PURPOSE OF THE STUDY: Obesity is a major risk factor for development and worsening of osteoarthritis (OA). Managing obesity with effective weight loss strategies can improve patients' OA symptoms, functionality, and quality of life. However, little is known about the clinical journey of patients with both OA and obesity. This study aimed to map the medical journey of patients with OA and obesity by characterizing the roles of health care providers, influential factors, and how treatment decisions are made. STUDY DESIGN: A cross-sectional study was completed with 304 patients diagnosed with OA and a body mass index (BMI) of ≥30 kg/m2 and 101 primary care physicians (PCPs) treating patients who have OA and obesity. RESULTS: Patients with OA and obesity self-manage their OA for an average of five years before seeking care from a healthcare provider, typically a PCP. Upon diagnosis, OA treatments were discussed; many (61%) patients reported also discussing weight/weight management. Despite most (74%) patients being at least somewhat interested in anti-obesity medication, few (13%) discussed this with their PCP. Few (12%) physicians think their patients are motivated to lose weight, but almost all (90%) patients have/are currently trying to lose weight. Another barrier to effective obesity management in patients with OA is the low utilization of clinical guidelines for OA and obesity management by PCPs. CONCLUSIONS: As the care coordinator of patients with OA and obesity, PCPs have a key role in supporting their patients in the treatment journey; obesity management guidelines can be valuable resources.


PLAIN LANGUAGE SUMMARYOsteoarthritis (OA) is a disease where the soft tissue between joints wears out causing pain and swelling. Obesity, having unhealthy extra body weight, increases the chances of a person getting OA and can make their OA worse.We wanted to learn more about what patients with OA and obesity experience as they try to manage their OA, including the doctors they talked to, the treatments they used, and if their weight was discussed. To better understand this journey, 304 people with OA and obesity and 101 primary care doctors who treat people with OA and obesity took an online survey.We found that people with OA and obesity tried to manage their OA symptoms on their own for an average of five years before going to a doctor for help. Many (54%) talked with their primary care doctor first. When people with obesity were told by doctors that they had OA, most people (61%) said that they talked about weight and weight loss. Most people (72%) also talked with their doctors about OA treatments.Few doctors (12%) thought their patients were serious about losing weight but almost all patients (90%) said they had tried or were still trying to lose weight. About half of doctors followed guidelines for taking care of people with OA (51%) and obesity (61%).Primary care doctors play a key role in helping patients with OA and obesity. Doctors can follow guidelines and provide treatment options including referrals to other specialists to support weight loss efforts.


Assuntos
Obesidade/tratamento farmacológico , Osteoartrite/terapia , Relações Médico-Paciente , Médicos de Atenção Primária/psicologia , Médicos de Atenção Primária/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Atenção Primária à Saúde/normas , Idoso , Atitude do Pessoal de Saúde , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto
10.
Popul Health Manag ; 24(4): 482-491, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33180000

RESUMO

Obesity is a chronic disease that poses serious health and societal burdens. Although guidelines exist for obesity management in primary care, evaluating the success of obesity treatment programs is hampered by lack of established, robust quality measures. This study aimed to develop, and test for feasibility, measures for operational tracking, quality performance, and patient-centered care in the context of a national collaborative to develop a model for obesity management in the US primary care setting. The authors developed and evaluated 7 measures used to track the care of patients with overweight or obesity (n = 226,727 at baseline) receiving care within 10 health care organizations (HCOs). Measure categories included: (1) operational tracking (obesity/overweight prevalence and prevalence of obesity-related complications); (2) quality performance (obesity diagnosis, change in weight over time, anti-obesity medication prescriptions, and assessment of obesity-related complications); and (3) patient-centered care (patient-reported outcomes). Measures were tested for feasibility, variability across HCOs, ability to detect differences over time, and value to the HCOs. All measures were feasible to collect, provided value to the participating HCOs, and demonstrated variation and ability to detect differences over time (eg, rates of documented diagnosis of obesity classes 1, 2, and 3 increased from 29%, 46%, and 66%, respectively, at baseline to 35%, 53%, and 71% at study end). This study confirmed the feasibility and perceived value of 7 operational, performance, and patient-centered measures collected in primary care practices in 10 HCOs over an 18-month period.


Assuntos
Obesidade , Assistência Centrada no Paciente , Adulto , Instalações de Saúde , Humanos , Obesidade/epidemiologia , Obesidade/terapia , Sobrepeso , Atenção Primária à Saúde
11.
Obesity (Silver Spring) ; 28(12): 2305-2309, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33029901

RESUMO

OBJECTIVE: This study aimed to explore the relationship between an obesity diagnosis and weight loss as a percentage of total body weight loss over 9 to 15 months, using electronic health record data. METHODS: An observational study of 688,878 adult patients at 15 health systems with BMI ≥ 30 kg/m2 examined the relationship between weight loss and documentation of obesity diagnosis. Multivariable logistic regression models were created using a stepwise backwards elimination procedure to identify potential predictors of weight loss. RESULTS: Of patients with BMI ≥ 30, 44.9% had an obesity diagnosis on a claim or electronic health record problem list; 16.9% and 5.9% lost ≥ 5% and ≥ 10% of their body weight, respectively. Multivariable logistic regression models revealed a diagnosis of obesity on the same day as the initial weight (odds ratio [OR] = 1.3; CI: 1.2-1.3; P < 0.001) as a predictor of ≥ 5% total body weight loss in 9 to 15 months. Other significant predictors included an antiobesity medication prescription, female sex, diagnosis of type 2 diabetes, Medicare/Medicaid insurance, and number of ambulatory visits. CONCLUSIONS: While controlling for potentially confounding factors, documentation of an obesity diagnosis remained independently predictive of at least 5% weight loss. This suggests that documenting a diagnosis of obesity may be an important step toward engaging patients to lose weight.


Assuntos
Obesidade/diagnóstico , Redução de Peso/fisiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estados Unidos
12.
Psychiatry Res ; 292: 113282, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32711168

RESUMO

We tested the predictive validity of the Progress Assessment (PA), a brief counselor administered tool for use in measurement-based care for substance use disorders. The PA includes 5 items assessing relapse risk and 5 items assessing factors protective against relapse. Data were drawn from a completed study of continuing care for cocaine dependence (McKay et al., 2013) and includes 12 months of follow-up on158 participants (76% male) who received brief telephone or face-to-face sessions. Each session began with the administration of the PA, followed by cognitive-behavioral counseling tied to the results of the PA and anticipated risky situations. Outcome was assessed via urine toxicology every 3 months. As administered in an effectiveness trial, average PA risk and protective scales within each 3-month segment of the study predicted urine toxicology results at the end of that period, with higher risk scores and lower protective scores predicting greater rates of cocaine positive urine drug screens. PA scores did not predict dropout from continuing care participation. The 10-item PA shows promise as a pragmatic clinical tool for ongoing monitoring during continuing care for substance dependence.


Assuntos
Aconselhamento/normas , Conselheiros/normas , Entrevistas como Assunto/normas , Relatório de Pesquisa/normas , Transtornos Relacionados ao Uso de Substâncias/psicologia , Transtornos Relacionados ao Uso de Substâncias/terapia , Adulto , Aconselhamento/métodos , Feminino , Seguimentos , Humanos , Entrevistas como Assunto/métodos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Recidiva , Reprodutibilidade dos Testes , Transtornos Relacionados ao Uso de Substâncias/diagnóstico , Resultado do Tratamento
13.
Virol Sin ; 35(2): 212-226, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31833037

RESUMO

Vectored vaccines based on highly attenuated modified vaccinia Ankara (MVA) are reported to be immunogenic, tolerant to pre-existing immunity, and able to accommodate and stably maintain very large transgenes. MVA is usually produced on primary chicken embryo fibroblasts, but production processes based on continuous cell lines emerge as increasingly robust and cost-effective alternatives. An isolate of a hitherto undescribed genotype was recovered by passage of a non-plaque-purified preparation of MVA in a continuous anatine suspension cell line (CR.pIX) in chemically defined medium. The novel isolate (MVA-CR19) replicated to higher infectious titers in the extracellular volume of suspension cultures and induced fewer syncytia in adherent cultures. We now extend previous studies with the investigation of the point mutations in structural genes of MVA-CR19 and describe an additional point mutation in a regulatory gene. We furthermore map and discuss an extensive rearrangement of the left telomer of MVA-CR19 that appears to have occurred by duplication of the right telomer. This event caused deletions and duplications of genes that may modulate immunologic properties of MVA-CR19 as a vaccine vector. Our characterizations also highlight the exceptional genetic stability of plaque-purified MVA: although the phenotype of MVA-CR19 appears to be advantageous for replication, we found that all genetic markers that differentiate wildtype and MVA-CR19 are stably maintained in passages of recombinant viruses based on either wildtype or MVA-CR.


Assuntos
Vetores Genéticos , Instabilidade Genômica , Deleção de Sequência , Vaccinia virus/genética , Vaccinia virus/isolamento & purificação , Replicação Viral , Animais , Linhagem Celular , Patos , Genótipo , Mutação Puntual , Recombinação Genética , Ensaio de Placa Viral
14.
Drug Alcohol Depend ; 205: 107647, 2019 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-31675546

RESUMO

OBJECTIVE: Recent clinical practice guidelines recommend the delivery of evidence-based psychotherapies for both substance use disorder (SUD) and posttraumatic stress disorder (PTSD) within the same treatment episode for patients with SUD/PTSD comorbidity. This randomized clinical trial evaluated the comparative effectiveness of integrating versus phasing evidence-based psychotherapies for SUD and PTSD among veterans with co-occurring SUD/ PTSD. METHOD: 183 veterans with DSM-IV PTSD and SUD at two VA Medical Centers were randomized to one of two psychotherapies during which Motivational Enhancement Therapy [MET] for SUD and Prolonged Exposure [PE] for PTSD were either phased or integrated throughout treatment. Primary outcomes as evaluated by blinded assessors were percent days with drug use or heavy drinking and PTSD symptomology. We hypothesized integrated MET/PE (n = 95) would yield better SUD and PTSD-related outcomes at posttreatment than phased MET/PE (n = 88). RESULTS: In intent-to-treat analyses (n=183), both treatment groups achieved clinically (d=0.46 - 1.06) and statistically significant reductions in SUD (p < 0.01) and PTSD (p < 0.01) symptomology; the time by treatment interactions were not significant. Post-hoc analyses could not confirm statistical non-inferiority; between-group effect sizes suggest a lack of clinically-meaningful differences between the two treatment approaches (d=0.08 - 0.27). CONCLUSIONS: Our hypothesis that integrated MET/PE would result in better outcomes than phased MET/PE across a range of PTSD and SUD measures was not supported; both strategies for combining two single-disorder treatments for co-occurring SUD/PTSD yielded significant symptom reduction.


Assuntos
Psicoterapia/métodos , Transtornos de Estresse Pós-Traumáticos/epidemiologia , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Veteranos/psicologia , Adulto , Comorbidade , Feminino , Humanos , Terapia Implosiva/métodos , Masculino , Método Simples-Cego , Resultado do Tratamento
15.
Obesity (Silver Spring) ; 27(7): 1063-1067, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31231957

RESUMO

OBJECTIVE: Obesity Medicine Education Collaborative (OMEC) was formed to develop obesity-focused competencies and benchmarks that can be used by undergraduate and graduate medical education program directors. This article describes the developmental process used to create the competencies. METHODS: Fifteen professional organizations with an interest in obesity collaborated to form OMEC. Using the six Core Competencies of the Accreditation Council for Graduate Medical Education as domains and as a guiding framework, a total of 36 group members collaborated by in-person meetings, email exchange, and conference calls. An iterative process was used by each working subgroup to develop the competencies and assessment benchmarks. The initial work was subsequently externally reviewed by 19 professional organizations. RESULTS: Thirty-two competencies were developed across the six domains. Each competency contains five descriptive measurement benchmarks for evaluator rating. CONCLUSIONS: This set of OMEC obesity-focused competencies is the first evaluation tool developed to be used within undergraduate and graduate medical training programs for both formative and summative assessments. Routine and more robust assessment is expected to increase the competence of health care providers to assess, prevent, and treat obesity. In addition to dissemination, the competencies and benchmarks will need to undergo evaluation for further validity and practicality.


Assuntos
Competência Clínica/normas , Educação de Pós-Graduação em Medicina/normas , Obesidade , Humanos
17.
J Fam Pract ; 65(7 Suppl): S13-6, 2016 07.
Artigo em Inglês | MEDLINE | ID: mdl-27565105

RESUMO

Lifestyle modification is not a short-term endeavor, and maintaining a healthy weight requires sustained changes in dietary and physical activity. Intensive behavioral intervention can help modify deep-rooted behaviors and provide the support required to both initiate and maintain the behavioral changes that are needed to achieve weight loss goals.


Assuntos
Terapia Comportamental , Dieta Mediterrânea , Estilo de Vida , Obesidade/terapia , Cooperação do Paciente , Atenção Primária à Saúde , Índice de Massa Corporal , Ensaios Clínicos como Assunto , Dieta Mediterrânea/economia , Medicina Baseada em Evidências , Humanos , Medicare , Metanálise como Assunto , Obesidade/dietoterapia , Obesidade/economia , Sobrepeso/terapia , Satisfação do Paciente , Atenção Primária à Saúde/economia , Fatores de Risco , Estados Unidos
18.
J Fam Pract ; 65(7 Suppl): S23-5, 2016 07.
Artigo em Inglês | MEDLINE | ID: mdl-27565108

RESUMO

The role of bariatric surgery in the management of patients with obesity is expanding owing to the amount of data that are accumulating; these data demonstrate significant short- and long-term health benefits, including control or remission of obesity-related complications, as well as acceptable long-term safety.


Assuntos
Cirurgia Bariátrica , Obesidade/cirurgia , Seleção de Pacientes , Atenção Primária à Saúde , Redução de Peso , Cirurgia Bariátrica/métodos , Índice de Massa Corporal , Medicina Baseada em Evidências , Humanos , Satisfação do Paciente , Fatores de Risco , Resultado do Tratamento
19.
J Fam Pract ; 65(7 Suppl): S25-7, 2016 07.
Artigo em Inglês | MEDLINE | ID: mdl-27565109

RESUMO

Determining what treatment options the patient's insurance will cover and considering the patient's out-of-pocket costs are important actions to be taken while collaborating with the patient and other team members and during the development and implementation of the treatment plan. Reimbursement is available to PCPs for some obesity-related services.


Assuntos
Reembolso de Seguro de Saúde/economia , Obesidade/economia , Obesidade/terapia , Educação de Pacientes como Assunto , Atenção Primária à Saúde/economia , Índice de Massa Corporal , Humanos , Reembolso de Seguro de Saúde/normas , Comunicação Interdisciplinar , Guias de Prática Clínica como Assunto , Atenção Primária à Saúde/organização & administração , Fatores de Risco , Estados Unidos
20.
J Fam Pract ; 65(7 Suppl): S9-S13, 2016 07.
Artigo em Inglês | MEDLINE | ID: mdl-27565111

RESUMO

Although improvement of physical appearance is a primary motivating factor for patients, the fundamental purpose of weight loss is to improve health. Patients should be managed in the context of a chronic disease, taking a systematic approach to treatment. Lifestyle modification is the cornerstone of weight management.


Assuntos
Terapia Comportamental , Estilo de Vida , Obesidade/terapia , Atenção Primária à Saúde , Redução de Peso , Índice de Massa Corporal , Diabetes Mellitus Tipo 2/prevenção & controle , Humanos , Sobrepeso/terapia , Fatores de Risco
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