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AIM: To investigate, through post hoc analysis of nine studies from the SemaglUtide Real-world Evidence (SURE) programme, the safety of once-weekly (OW) semaglutide in adults with type 2 diabetes (T2D) and in subpopulations in routine clinical practice, complementing findings from the phase 3 randomized clinical trial (RCT) SUSTAIN programme. METHODS: The SURE studies had a duration of ~30 weeks and included adults with diagnosed T2D treated with OW semaglutide. Safety information, including hypoglycaemic events, were collected and analysed for the total study population and for patient subgroups based on baseline patient characteristics, baseline co-medication and prescriber specialty. RESULTS: Of the total 3505 patients, 24.3% reported adverse events (AEs), with most patients reporting non-serious (22.3%) and mild (17.1%) AEs. AEs mainly belonged to the gastrointestinal disorders system organ class (16.3% of patients). In total, 5.1% of patients reported AEs that led to treatment discontinuation, 0.5% reported serious adverse drug reactions and 0.2% had an AE with a fatal outcome, reported as unrelated to treatment. Overall, 1.1% and 0.1% of patients reported level 2 and 3 hypoglycaemic events, respectively. A higher rate of level 2 hypoglycaemia was observed in patients with baseline microvascular complications treated with insulin versus those on insulin without these complications. CONCLUSIONS: Safety data reported in the real-world SURE studies were generally consistent with observations in phase 3 OW semaglutide RCTs. No new safety concerns were identified, highlighting that OW semaglutide is well tolerated by adults with T2D and in subpopulations in routine clinical practice.
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Large placebo-controlled trials have demonstrated kidney and cardiovascular clinical benefits of SGLT-2 inhibitors. Data from the EMPA-KIDNEY and DELIVER trials and associated meta-analyses triggered an update to the UK Kidney Association Clinical Practice Guideline on Sodium-Glucose Co-transporter-2 (SGLT-2) Inhibition in Adults with Kidney Disease. We provide a summary of the full guideline and highlight the rationale for recent updates. The use of SGLT-2 inhibitors in people with specific medical conditions, including type 1 diabetes, kidney transplants, and people admitted to hospital with heart failure is also considered, along with Recommendations for future research and Recommendations for implementation. A full "lay" summary of the guidelines is provided as an appendix to ensure that these guidelines are accessible and understandable to people who are not medical professionals.
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Diabetes Mellitus Tipo 2 , Nefropatias , Inibidores do Transportador 2 de Sódio-Glicose , Adulto , Humanos , Glicemia , Hipoglicemiantes , Rim , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Inibidores do Transportador 2 de Sódio-Glicose/farmacologia , Reino UnidoRESUMO
OBJECTIVE: To evaluate the accuracy between the intra-surgical and the peri-apical radiographic measurements of bone loss at implant with peri-implantitis. MATERIALS AND METHODS: A total of 46 Brånemark implants in 24 patients with diagnosis of peri-implantitis were included in the study. The amount of peri-implant bone loss occurred at those implants was measured during peri-implant surgery and compared to the radiographic bone loss measured by three independent examiners. RESULTS: The mean bone loss measured on radiographs underestimated the intra-surgical bone loss at the correspondent sites (0.7 mm at the mesial and 0.6 mm at the distal sites); this underestimation was found to be a consistent finding in all the three examiners. Only 21% of the radiographic measurements corresponded to the clinical bone loss assessments, while an over- and underestimation within a range of ± 1-2 mm was recorded in 57% of the cases. There was a moderate positive linear correlation between the radiographic measurements and the clinical bone loss for mesial and distal sites (r = range 0.58-0.65). The variability between the three examiners in the radiographic measurements was frequently on the range of ± 1-2 mm. CONCLUSION: The radiographic measurements of bone loss at implant affected by peri-implantitis often underestimated the clinical bone loss occurred at the implants. A difference of about ± 1-2 mm in the estimation of radiographic bone loss could be merely assigned as inter-examiner different assessments.
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Perda do Osso Alveolar/diagnóstico , Implantação Dentária Endóssea/efeitos adversos , Perda do Osso Alveolar/diagnóstico por imagem , Perda do Osso Alveolar/cirurgia , Processo Alveolar/diagnóstico por imagem , Processo Alveolar/patologia , Processo Alveolar/cirurgia , Humanos , Período Intraoperatório , Variações Dependentes do Observador , Radiografia Dentária , Estudos RetrospectivosRESUMO
BACKGROUND: Patient education is a fundamental aspect of self-management of diabetes. The aim of this study was to understand whether a social media platform is a viable method to deliver education to people with diabetes and understand if people would engage and interact with it. METHODS: Education sessions were provided via 3 platforms in a variety of formats. "Tweetorials" and quizzes were delivered on the diabetes101 Twitter account, a virtual conference via Zoom and video presentations uploaded to YouTube. Audience engagement during and after the sessions were analyzed using social media metrics including impressions and engagement rate using Twitter analytics, Tweepsmap, and YouTube Studio. RESULTS: A total of 22 "tweetorial" sessions and 5 quizzes with a total of 151 polls (both in tweetorial and quiz sessions) receiving a total of 21,269 votes took place. Overall, the 1-h tweetorial sessions gained 1,821,088 impressions with an engagement rate of 6.3%. The sessions received a total of 2,341 retweets, 2,467 replies and 10,060 likes. The quiz days included 113 polls receiving 16,069 votes. The conference covered 8 topics and was attended live by over 100 people on the day. The video presentations on YouTube have received a total of 2,916 views with a watch time of 281 h and 8,847 impressions. CONCLUSION: Despite the limitations of social media, it can be harnessed to provide relevant reliable information and education about diabetes allowing people the time and space to learn at their own pace.
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Diabetes Mellitus , Mídias Sociais , Humanos , Pandemias , Diabetes Mellitus/terapiaRESUMO
BACKGROUND: Healthcare systems worldwide have been adversely affected by the Coronavirus disease 2019 (COVID-19) pandemic. There has been a substantial decrease in admissions for acute medical conditions with longer delays between the onset of the symptoms and hospital treatment compared to the pre-pandemic period. The impact of the COVID pandemic on primary care services is uncertain. AIM: Using an online survey, we examined the impact of the COVID pandemic on primary care diabetes services in the UK. METHODS: An online survey was developed by the Primary Care Diabetes Society research group and administered to healthcare and allied health professionals delivering diabetes care in the UK from January to May 2021. Descriptive statistics and odds ratios (ORs) with 95% confidence intervals (CIs) were estimated. RESULTS: Of the 1070 professionals surveyed, 975 (91.1%) completed the questionnaire. Most respondents were nurses or nurse practitioners (59.7%) and doctors (32.9%). The mean age of respondents was 52 years and 79% were female. The majority of respondents felt overloaded with work (71.2%) or emotionally drained at the end of a working day (79.1%) compared with the pre-pandemic period. Being a doctor and worried about infecting a family member with the Coronavirus were each associated with an increased odds of being substantially overworked or emotionally drained: (OR = 2.52; 95% CI, 1.25-5.07) and (OR = 2.05; 95% CI, 1.24-3.39), respectively. The most common consultation method used to provide diabetes care during the pandemic was telephone consultation (92.0%). Overall 79.1% of respondents felt the COVID-19 pandemic had had moderate to significant impact on their practice's ability to provide routine diabetes care; 70.6% of respondents felt the COVID-19 pandemic had had moderate to significant impact on their practice's ability to provide routine health checks or screening for type 2 diabetes and approximately half of respondents (48.3%) reported encountering mental health concerns in people with diabetes. CONCLUSIONS: COVID-19 pandemic has had significant impact on the ability of healthcare professionals and their practices to deliver routine diabetes care. Failure to restore primary care provision urgently and safely to at least pre-pandemic levels in a sustainable manner may lead to emotionally drained and overworked workforce in primary care, place additional burden on the already overburdened healthcare system and worse outcomes for patients.
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COVID-19 , Diabetes Mellitus Tipo 2 , COVID-19/epidemiologia , Estudos Transversais , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/epidemiologia , Diabetes Mellitus Tipo 2/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , Atenção Primária à Saúde , Encaminhamento e Consulta , SARS-CoV-2 , Telefone , Reino Unido/epidemiologiaRESUMO
INTRODUCTION: This post hoc pooled analysis of four real-world studies (SURE Canada, Denmark/Sweden, Switzerland and UK) aimed to characterize the use of once-weekly (OW) semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), in patients with type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS: The Semaglutide Real-world Evidence (SURE) studies had a duration of ~30 weeks. Changes in glycated hemoglobin (HbA1c) and body weight (BW) were analyzed for the overall population and the following baseline subgroups: GLP-1RA-naïve/GLP-1RA switchers; body mass index <25/≥25-<30/≥30-<35/≥35 kg/m2; age <65/≥65 years; HbA1c <7%/≥7-≤8%/>8-≤9%/>9%; T2D duration <5/≥5-<10/≥10 years. Data for patients achieving treatment targets were analyzed in the overall population and the baseline HbA1c ≥7% subgroup. RESULTS: Of 1212 patients, 960 were GLP-1RA-naïve and 252 had switched to semaglutide from another GLP-1RA. In the overall population, HbA1c was reduced from baseline to end of study (EOS) by -1.1% point and BW by -4.7 kg; changes were significant for all subgroups. There were significantly larger reductions of HbA1c and BW in GLP-1RA-naïve versus GLP-1RA switchers and larger reductions in HbA1c for patients with higher versus lower baseline HbA1c. At EOS, 52.6% of patients in the overall population achieved HbA1c <7%. No new safety concerns were identified in any of the completed SURE studies. CONCLUSIONS: In this pooled analysis, patients with T2D initiating OW semaglutide showed significant improvements from baseline to EOS in HbA1c and BW across various baseline subgroups, including patients previously treated with a GLP-1RA other than semaglutide, supporting OW semaglutide use in clinical practice. TRAIL REGISTRATION NUMBERS: NCT03457012; NCT03631186; NCT03648281; NCT03876015.
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Diabetes Mellitus Tipo 2 , Idoso , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Peptídeos Semelhantes ao Glucagon/uso terapêutico , Hemoglobinas Glicadas/análise , Humanos , Hipoglicemiantes/uso terapêuticoRESUMO
The scientific landscape of treatments for type 2 diabetes (T2D) has changed rapidly in the last decade with newer treatments becoming available. However, a large proportion of people with T2D are not able to achieve glycaemic goals because of clinical inertia. The majority of T2D management is in primary care, where clinicians (medical, nursing and pharmacist staff) play an important role in addressing patient needs and achieving treatment goals. However, management of T2D is challenging because of the heterogeneity of T2D and complexity of comorbidity, time constraints, guidance overload and the evolving treatments. Additionally, the current coronavirus disease pandemic poses additional challenges to the management of chronic diseases such as T2D, including routine access to patients for monitoring and communication. Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are a class of agents that have evolved rapidly in recent years. These agents act in a glucose-dependent manner to promote insulin secretion and inhibit glucagon secretion, as well as enhancing satiety and reducing hunger. As a result, they are effective treatment options for people with T2D, achieving glycated haemoglobin reductions, weight loss and potential cardiovascular benefit, as monotherapy or as add-on to other glucose-lowering therapies. However, given the complexity of managing T2D, it is important to equip primary care clinicians with clear information regarding efficacy, safety and appropriate positioning of GLP-1 RA therapies in clinical practice. This review provides a summary of clinical and real-world evidence along with practical guidance, with the aim of aiding primary care clinicians in the initiation and monitoring of GLP-1 RAs to help ensure that desired outcomes are realised. Furthermore, a benefit/risk tool has been developed on the basis of current available evidence and guidelines to support primary care clinicians in selecting individuals who are most likely to benefit from GLP-1 RA therapies, in addition to indicating clinical situations where caution is needed.
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INTRODUCTION: Once-weekly (OW) semaglutide was associated with clinically relevant improvements in glycaemic control and body weight versus comparators in the SUSTAIN randomised controlled trials (RCTs). SURE UK, which is one of a series of individual studies that comprise the SURE programme, evaluated the use of OW semaglutide in a real-world patient population with type 2 diabetes (T2D) in the UK. METHODS: In this prospective, observational study, adults (≥ 18 years) with ≥ 1 documented glycated haemoglobin (HbA1c) value ≤ 12 weeks before semaglutide initiation were enrolled. The primary endpoint was change in HbA1c from baseline to end of study (EOS; ~ 30 weeks, although due to the COVID-19 pandemic, visits up to week 52 were permitted). Secondary endpoints included change in body weight, waist circumference and patient-reported outcomes (PROs). Physicians were to report all episodes of documented or severe hypoglycaemia, fatal events, serious adverse drug reactions, pregnancies and adverse events (AEs) in foetuses/newborn infants; other AEs during the study period could be reported on a voluntary basis. RESULT: The estimated mean change in HbA1c from baseline to EOS was - 16.3 mmol/mol [95% confidence interval (CI): - 18.22, - 14.37] (- 1.5%-points [95% CI - 1.67, - 1.31]; p < 0.0001) among the 171 enrolled patients who completed the study on treatment. Mean body weight change was - 5.8 kg (95% CI - 6.75, - 4.94; p < 0.0001). Sensitivity analyses showed similar results. Improvements were also observed in other secondary endpoints, including PROs. No new safety concerns were identified with semaglutide treatment. CONCLUSION: Patients receiving OW semaglutide experienced statistically significant and clinically relevant reductions from baseline in HbA1c and body weight. These results are in line with those of the SUSTAIN RCTs and support the use of OW semaglutide in routine clinical practice in adults with T2D in the UK. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03876015.
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More than 1.8 million cancer diagnoses will be made in 2020 driving substantial health and economic burden for patients. The financial impact of out-of-pocket payments for hospital stays, outpatient services, physician appointments, and prescription drugs is a particular challenge. At the same time, the treatment of cancer is undergoing substantial transformation with growing benefits for patients. The complex factors contributing to the economic burden must be addressed so that patients have broad access to innovative oncology medicines both today and tomorrow. There are 2 parallel actions that are needed to drive broad reductions in costs while not putting at risk the incredible potential innovation awaiting these same patients: (i) the private sector must work together across the health care sector to accelerate innovative value-based partnerships; and (2) policymakers need to drive policy reforms that help ease out-of-pocket costs and remove barriers to and enable scaling of value-based care.
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Indústria Farmacêutica/economia , Gastos em Saúde/normas , Neoplasias/tratamento farmacológico , Neoplasias/economia , HumanosRESUMO
Falls affect a growing number of the population each year. Clinical methods to assess fall risk usually evaluate the performance of specific motions such as balancing or Sit-to-Stand. Unfortunately, these techniques have been shown to have poor predictive power, and are unable to identify the portions of motion that are most unstable. To this end, it may be useful to identify the set of body configurations that can accomplish a task under a specified control strategy. The resulting strategy-specific boundary between stable and unstable motion could be used to identify individuals at risk of falling. The recently proposed Stability Basin is defined as the set of configurations through time that do not lead to failure for an individual under their chosen control strategy. This paper presents a novel method to compute the Stability Basin and the first experimental validation of the Stability Basin with a perturbative Sit-to-Stand experiment involving forwards or backwards pulls from a motor-driven cable with 11 subjects. The individually-constructed Stability Basins are used to identify when a trial fails, i.e. when an individual must switch from their chosen control strategy (indicated by a step or sit) to recover from a perturbation. The constructed Stability Basins correctly predict the outcome of trials where failure was observed with over 90 % accuracy, and correctly predict the outcome of successful trials with over 95 % accuracy. The Stability Basin was compared to three other methods and was found to estimate the stable region with over 45 % more accuracy in all cases. This study demonstrates that Stability Basins offer a novel model-based approach for quantifying stability during motion, which could be used in physical therapy for individuals at risk of falling.
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The ability to quantitatively measure stability is essential to ensuring the safety of locomoting systems. While the response to perturbation directly reflects the stability of a motion, this experimental method puts human subjects at risk. Unfortunately, existing indirect methods for estimating stability from unperturbed motion have been shown to have limited predictive power. This paper leverages recent advances in dynamical systems theory to accurately estimate the stability of human motion without requiring perturbation. This approach relies on kinematic observations of a nominal Sit-to-Stand motion to construct an individual-specific dynamic model, input bounds, and feedback control that are then used to compute the set of perturbations from which the model can recover. This set, referred to as the stability basin, was computed for 14 individuals, and was able to successfully differentiate between less and more stable Sit-to-Stand strategies for each individual with greater accuracy than existing methods.
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Acidentes por Quedas , Movimento/fisiologia , Equilíbrio Postural/fisiologia , Postura/fisiologia , Fenômenos Biomecânicos , Feminino , Humanos , Masculino , RiscoRESUMO
OBJECTIVE: To provide a road map of buccal cortical bone thickness in interradicular locations where miniscrew implants are commonly placed. MATERIALS AND METHODS: Cone-beam computed tomography images from 100 study quadrants (50 maxillary and 50 mandibular) were studied. Cortical bone thickness was measured at the most mesial point, the midpoint, and the most distal point in interradicular areas from the canine to the first molar in both arches at 4 mm and 6 mm from the alveolar ridge. Indicator variables of whether the cortical bone thickness was thinner than 1 mm and thicker than 1.5 mm were constructed and analyzed in a general linear mixed model. RESULTS: Buccal cortical bone was significantly thinner at a point bisecting two teeth than the bone adjacent to the teeth (P < .0001). The site with the greatest percentage of measurements <1 mm (20%) was at the midpoint bisecting the mandibular canine and the first premolar. The site with the highest percentage of measurements >1.5 mm (50%) was in the mandible adjacent to the first molar (distal to the midpoint of the second premolar and first molar) at 6 mm from the alveolar crest. CONCLUSION: Cortical bone thickness is significantly thinner centrally between two teeth than in the areas adjacent to the roots.
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Tomografia Computadorizada de Feixe Cônico , Osso Cortical/anatomia & histologia , Osso Cortical/diagnóstico por imagem , Mandíbula/anatomia & histologia , Mandíbula/diagnóstico por imagem , Maxila/anatomia & histologia , Maxila/diagnóstico por imagem , Adulto , Feminino , Humanos , Masculino , Estudos Retrospectivos , Adulto JovemRESUMO
OBJECTIVE: To examine the gender differences in managing practice and staff members in orthodontic practices. MATERIALS AND METHODS: All orthodontists in Virginia and Maryland (n = 427) were surveyed and demographic information was collected. For the crude analyses of the data, a Fisher's exact test or chi(2) test was performed. For the adjusted analyses, genders were compared using a logistic regression or analysis of covariance. The covariates were adjusted for age, program length, years in practice, number of years since graduation, and practice state. RESULTS: The length of the residency program attended did not differ with gender. No gender differences in practice ownership or creating the practice were observed. There was a significant gender difference in implementation of performance reviews: female orthodontists were more likely to provide performance reviews and tended to accept more poor reviews before staff termination than male orthodontists. However, when provided, no gender difference was observed in the number of performance reviews. CONCLUSION: Gender has a significant impact on the implementation of performance reviews in practices. Practice ownership status was not influenced by providers' gender.