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1.
Am J Pharm Educ ; : 100758, 2024 Jul 16.
Artigo em Inglês | MEDLINE | ID: mdl-39025464

RESUMO

OBJECTIVE: The objective is to describe the impact of a curricular revision process using the 8-step Kotter change model to decrease curricular overload in a PharmD program at a public, research-intensive school of pharmacy. METHODS: In alignment with the 8-step Kotter Change Model, the first step was to create urgency for change, which was supported by calls to action to address curricular overload. Next, a coalition of change leaders was formed, who developed seven curriculum renewal targets to collectively address curricular overload. This vision was communicated at faculty meetings throughout the change process, with requests for feedback. Five curricular working groups were formed to empower action based on their charges. Quick wins were created by early adopters, which built momentum and led to a more streamlined course change process. Lastly, making changes stick requires ongoing evaluation. RESULTS: In total, required didactic credits were reduced from 92.6 to 79 and didactic courses were reduced from 31 to 23, while ensuring that all required content remained. For many courses, contact hours were also reduced to align with allotted credit hours. Obstacles and challenges were encountered along the way, and a collaborative approach to finding solutions proved beneficial. CONCLUSION: Key recommendations for implementing curricular changes to address overload include having a change model in place, and identifying change leaders to support change and address faculty concerns efficiently. Effective communication through repetition of messaging is critical. Although change is complex, leaning into it with patience and perseverance can lead to success.

2.
BMJ Med ; 2(1): e000372, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37680340

RESUMO

Type 2 diabetes is a chronic and progressive cardiometabolic disorder that affects more than 10% of adults worldwide and is a major cause of morbidity, mortality, disability, and high costs. Over the past decade, the pattern of management of diabetes has shifted from a predominantly glucose centric approach, focused on lowering levels of haemoglobin A1c (HbA1c), to a directed complications centric approach, aimed at preventing short term and long term complications of diabetes, and a pathogenesis centric approach, which looks at the underlying metabolic dysfunction of excess adiposity that both causes and complicates the management of diabetes. In this review, we discuss the latest advances in patient centred care for type 2 diabetes, focusing on drug and non-drug approaches to reducing the risks of complications of diabetes in adults. We also discuss the effects of social determinants of health on the management of diabetes, particularly as they affect the treatment of hyperglycaemia in type 2 diabetes.

3.
Diabetes Ther ; 14(12): 1979-1996, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37751142

RESUMO

INTRODUCTION: Diabetes is associated with significant economic burden. Moreover, cardiovascular disease (CVD), including heart failure, and chronic kidney disease (CKD) are common comorbidities, leading to premature mortality. We conducted a systematic review to assess the humanistic and economic burden of cardio-renal-metabolic (CRM) conditions in individuals ≥ 18 years with CVD, CKD, and type 2 diabetes mellitus. METHODS: We searched Embase® and Medline® databases from 2011 to January 10, 2022 for English publications reporting humanistic and economic burden outcomes from observational studies, real-world evidence, and economic model studies. Intervention and validation studies were excluded. Study quality was assessed using the Newcastle-Ottawa Scale. Abstracts/posters were identified from four conferences (2020-2022). RESULTS: Of 1804 studies identified, 22 (including four conference publications) were selected involving 351,296,930 participants (one modeled the US population); eight reported healthcare resource utilization (HCRU), seven only cost data, six HCRU and cost data, one reported quality-of-life data (11/18 and 7/18 had estimated low and medium risk of bias, respectively). Participants were predominantly ≥ 65 years and identified as having White ethnicity. Higher costs and HCRU were observed in patients with all three conditions compared to those with two or none. Urban/metropolitan and insured patients had higher healthcare expenditure and service utilization compared to uninsured and racial/ethnic minority populations. Comorbidities were associated with increased hospitalizations, higher costs, and more emergency department visits. In general, patients identified as having Black ethnicity had low odds of using healthcare services, possibly due to disparities in healthcare access and distrust in the system. Limitations included no adjustment for inflation and a predominance of retrospective studies. CONCLUSIONS: This review showed a greater economic burden for patients with CRM conditions, with a clear trend between increasing numbers of comorbidities and increasing healthcare costs/resource use. Comparisons between countries are complicated and the scarcity of evidence from minority racial and ethnic groups and lack of data from non-US geographies warrant further investigation.

5.
Am J Pharm Educ ; 87(7): 100029, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-37380263
6.
Diabetes Spectr ; 36(1): 5-13, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36818408

RESUMO

Aim: This study's aim was to compare the time and accuracy of use and participants' satisfaction and preferences with pen devices for the once-weekly glucagon-like peptide 1 (GLP-1) receptor agonists dulaglutide, exenatide XR BCise, and semaglutide. Materials and methods: In this triple crossover, open-label, simulated injection study, GLP-1 receptor agonist pen devices were compared, with time and accuracy of use and participants' satisfaction and preferences as primary outcomes. Participants had type 2 diabetes and were naive to GLP-1 receptor agonist therapy. Participants watched instructional videos for each device, demonstrated administration, and then provided feedback after each demonstration. Investigators tracked errors and omissions of demonstration steps for accuracy and time. Differences across devices were compared using univariate mixed models, adjusting for multiple comparisons. Results: Of the 60 participants, 50% were male, a majority (65%) were Caucasian, and most (65%) had adequate health literacy. Participants rated the dulaglutide device easier to use than those of exenatide XR BCise or semaglutide (P <0.001 for each). Participants expressed greater satisfaction with the dulaglutide device compared with those of exenatide XR BCise or semaglutide (P <0.01 for each). Most participants (75%) preferred the dulaglutide device overall; however, many participants (61%) preferred the size and portability of the semaglutide device. The dulaglutide device took less time to use than the exenatide XR BCise or semaglutide devices (69 vs. 126 and 146 seconds, respectively; P <0.001 for each). Participants were less accurate when using the dulaglutide device. Conclusion: Most participants preferred the dulaglutide device. The dulaglutide device took the least amount of time to demonstrate; however, demonstration accuracy was lower.

7.
J Diabetes Complications ; 36(12): 108332, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36375235

RESUMO

The objective of this article is to review the efficacy and safety of tirzepatide and discuss its potential role in the treatment of type 2 diabetes. Tirzepatide is a novel once-weekly dual GIP and GLP-1 receptor agonist which has been studied in the SURPASS clinical trials in doses of 5 mg, 10 mg, and 15 mg. Tirzepatide phase III clinical trials, SURPASS-1 through SURPASS-5, demonstrate that this medication is safe and effective in treating type 2 diabetes both with and without a variety of background medications versus placebo, semaglutide, insulin degludec, and insulin glargine in different patient populations. Most adverse events were gastrointestinal in nature, with a relatively low withdrawal rate in the active treatment arms. It seems likely that tirzepatide will be recommended as a preferred option in the American Diabetes Association treatment algorithm for high glucose lowering effects in patients with a compelling need for low hypoglycemia risk and weight loss. However, the positioning of tirzepatide in the treatment algorithm will ultimately be dependent on the results of the cardiovascular outcomes trial (CVOT) or other outcome-based trials. Tirzepatide is effective for treating type 2 diabetes by lowering glycated hemoglobin and contributing to significant weight loss.


Assuntos
Diabetes Mellitus Tipo 2 , Receptor do Peptídeo Semelhante ao Glucagon 1 , Humanos , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/induzido quimicamente , Polipeptídeo Inibidor Gástrico/efeitos adversos , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Hemoglobinas Glicadas , Hipoglicemiantes/efeitos adversos , Redução de Peso , Ensaios Clínicos Fase III como Assunto
8.
J Manag Care Spec Pharm ; 28(6): 592-603, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35352995

RESUMO

BACKGROUND: People with type 2 diabetes (T2D) who change their basal insulin (BI) may have variable persistence with therapy. Compared with first-generation (long-acting) BI analogs (insulin glargine 100U/mL [Gla-100]; insulin detemir [IDet]), second-generation (longer-acting) BI analogs (insulin glargine 300U/mL [Gla-300]; insulin degludec) have similar glycated hemoglobin (HbA1c) attainment and lowered hypoglycemia risk, which could impact treatment persistence. OBJECTIVE: To compare persistence, adherence, health care resource utilization (HRU), and costs for individuals switching from neutral protamine Hagedorn insulin or a first-generation BI analog with either the second-generation BI, Gla-300, or an alternative first-generation BI analog (Gla-100 or IDet). METHODS: We used Optum Clinformatics claims data from adults (aged ≥ 18 years) with T2D who had received BI (neutral protamine Hagedorn, Gla-100, IDet) in the 6-month baseline period, and switched to either Gla-300 or an alternative first-generation BI (Gla-100 or IDet; treatment switch = index date) between April 1, 2015, and August 31, 2019. Participants were followed for 12 months, until plan disenrollment, or until death, whichever occurred first. Cohorts were propensity score matched (PSM) on baseline characteristics. The primary outcome was the proportion who were persistent with therapy at 12 months. Secondary outcomes were adherence (proportion of days covered); change in HbA1c; and all-cause, diabetes-related, and hypoglycemia-related HRU and costs. RESULTS: PSM generated 3,077 participants/group (mean age: 68 years, 52% female). Cohorts were well balanced except for hospitalization, which was adjusted in models as a covariate. During the 12-month follow-up period, participants who received Gla-300 vs first-generation BI had greater persistence with (45.5% vs 42.1%; adjusted P = 0.0001), and adherence to (42.8% vs 38.2%; adjusted P = 0.0006), BI therapy and a statistically larger reduction in HbA1c at 12 months (-0.65% vs -0.45%; adjusted P = 0.0040). The proportion of participants achieving HbA1c less than 8% (47.2% vs 40.9%; P < 0.0001), but not less than 7% (21.2% vs 20.8%), was significantly higher for Gla-300 vs first-generation BI. All-cause (45.3 vs 65.9 per 100 patient-years [P100PY]) and diabetes-related (21.5 vs 29.1 P100PY), but not hypoglycemia-related, hospitalizations (1.0 vs 1.5 P100PY) were significantly (P < 0.0001) lower for Gla-300 vs first-generation BI. Similarly, all-cause (111.9 vs 148.8 P100PY), diabetes-related (54.8 vs 74.2 P100PY), and hypoglycemia-related (2.9 vs 5.7 P100PY) emergency department (ED) visits were significantly lower for Gla-300 (all P < 0.0001). Costs for all-cause hospitalizations and hypoglycemia-related ED visits were significantly lower for Gla-300 vs first-generation BI. Although pharmacy costs were significantly higher for Gla-300 vs first-generation BI, all-cause total health care costs were not significantly different: $41,255 vs $45,316 per person per year, respectively. CONCLUSIONS: In this claims-based analysis of people with T2D receiving BI, switching to Gla-300 was associated with significantly better persistence, adherence, and HbA1c reduction compared with switching to an alternative first-generation BI analog. All-cause HRU was significantly lower; despite significantly higher pharmacy costs, total health care costs were similar. DISCLOSURES: This study was funded by Sanofi US. Medical writing support was provided by Helen Jones, PhD, CMPP, of Evidence Scientific Solutions and funded by Sanofi US. Dr Wright is on the speakers' bureau and sits on the advisory boards for Abbot Diabetes, Bayer, Boehringer Ingelheim, Eli Lilly, and Sanofi; sits on the advisory board for Medtronic; and is a consultant for Abbot Diabetes, Bayer, Boehringer Ingelheim, and Eli Lilly. Dr Malone is on advisory boards for Novartis and Avalere and consults for Pear Therapeutics, Sarepta, and Strategic Therapeutics. Dr Trujillo sits on advisory boards for Novo Nordisk and Sanofi. Drs Gill, Zhou, and Preblick and Mr Li are employees and stockholders of Sanofi. Mr Huse is an employee of Evidera and a contractor for Sanofi. Dr Reid is a speaker and consultant for Novo Nordisk and Sanofi-Aventis and is a consultant for AstraZeneca and Intarcia.


Assuntos
Diabetes Mellitus Tipo 2 , Hipoglicemia , Adulto , Idoso , Diabetes Mellitus Tipo 2/tratamento farmacológico , Feminino , Hemoglobinas Glicadas/análise , Custos de Cuidados de Saúde , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemia/epidemiologia , Hipoglicemiantes , Insulina/uso terapêutico , Insulina Glargina , Masculino , Estudos Retrospectivos
9.
Ther Adv Endocrinol Metab ; 12: 2042018821997320, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33767808

RESUMO

Glucagon-like peptide-1 receptor agonists (GLP-1 RA) are attractive options for the treatment of type 2 diabetes (T2D) because they effectively lower A1C and weight while having a low risk of hypoglycemia. Some also have documented cardiovascular benefit. The GLP-1 RA class has grown in the last decade, with several agents available for use in the United States and Europe. Since the efficacy and tolerability, dosing frequency, administration requirements, and cost may vary between agents within the class, each agent may offer unique advantages and disadvantages. Through a review of phase III clinical trials studying dulaglutide, exenatide twice daily, exenatide once weekly, liraglutide, lixisenatide, semaglutide, and oral semaglutide, 14 head-to-head trials were identified that evaluated the safety and efficacy of GLP-1 RA active comparators. The purpose of this review is to provide an analysis of these trials. The GLP-1 RA head-to-head clinical studies have demonstrated that all GLP-1 RA agents are effective therapeutic options at reducing A1C. However, differences exist in terms of magnitude of effect on A1C and weight as well as frequency of adverse effects.

10.
Ann Pharmacother ; 54(8): 780-787, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32052651

RESUMO

Objective: To review the safety, efficacy, and administration of intranasal (IN) glucagon for the management of hypoglycemia. Data Source: A literature search of PubMed/MEDLINE (1995 to November 2019) using the terms intranasal glucagon, nasal glucagon, glucagon, hypoglycemia treatment, and hypoglycemia management was completed. Study Selection and Data Extraction: English-language studies evaluating IN glucagon were evaluated. Data Synthesis: IN glucagon is a newly approved product for the treatment of hypoglycemia in patients with diabetes, 4 years and older. Administered as a 3-mg dose, it was shown to be noninferior to intramuscular (IM) glucagon. In comparison trials, more than 98% of hypoglycemic events were treated successfully with IN glucagon in both pediatric and adult patients. In simulated and real-world studies, IN glucagon was administered in less than a minute for the majority of scenarios. IM glucagon took longer to administer, ranging from 1 to 4 minutes, and often, patients did not receive the intended full dose. Nausea and vomiting, known adverse events for glucagon, as well as local adverse events were most commonly reported with IN glucagon. Relevance to Patient Care and Clinical Practice: IN glucagon is safe, effective, easy to use, and does not require reconstitution prior to use, which can lead to faster delivery in a severe hypoglycemic event. It does not require age- or weight-based dosing. This delivery method offers an option for someone who fears needles or is uncomfortable with injections. Conclusion: IN glucagon is a safe, effective, easy to use, needle-free treatment option for severe hypoglycemia.


Assuntos
Tratamento de Emergência/métodos , Glucagon/administração & dosagem , Glucagon/uso terapêutico , Hipoglicemia/tratamento farmacológico , Administração Intranasal , Adulto , Glicemia/análise , Ensaios Clínicos como Assunto , Diabetes Mellitus/tratamento farmacológico , Feminino , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/efeitos adversos , Hipoglicemiantes/uso terapêutico , Masculino , Náusea/induzido quimicamente
11.
J Diabetes Complications ; 34(4): 107520, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31952996

RESUMO

BACKGROUND: Previously, the only available glucagon-like peptide-1 receptor agonists (GLP-1 RA) were injectable. Approval of oral semaglutide (Rybelsus®) represents the first orally available GLP-1 RA. OBJECTIVE: To review the literature and describe pharmacologic, pharmacokinetic, and pharmacodynamics properties; clinical safety; and efficacy of oral semaglutide, a newly approved oral GLP-1 RA. METHODS: A MEDLINE (1995-October 2019) and ClinicalTrials.gov search was conducted using the terms oral semaglutide, semaglutide, PIONEER, and a combination of those terms. Reference citations from publications identified were also reviewed. All English-language studies, including abstracts, evaluating oral semaglutide use in humans were included in this review. CONCLUSIONS: The approval of oral semaglutide (Rybelsus®) represents a paradigm shift in the management of T2D as this is the first FDA-approved oral GLP-1 RA. Oral semaglutide may be an attractive option for patients with T2D who require improved glycemic control, would like to lose weight, and who are not interested in injectable therapy. However, the lack of positive cardiovascular (CV) and renal data are significant limitations to its use.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Peptídeos Semelhantes ao Glucagon/administração & dosagem , Administração Oral , Peso Corporal/efeitos dos fármacos , Sistema Cardiovascular/efeitos dos fármacos , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/epidemiologia , Peptídeos Semelhantes ao Glucagon/efeitos adversos , Peptídeos Semelhantes ao Glucagon/farmacocinética , Controle Glicêmico/métodos , Controle Glicêmico/estatística & dados numéricos , Humanos , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/efeitos adversos , Resultado do Tratamento
12.
Ther Adv Endocrinol Metab ; 10: 2042018819890527, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31807264

RESUMO

Type 1 diabetes is a challenging disease that is largely managed with the use of insulin. The risk of hypoglycemia, side effects of weight gain, and high glucose variability associated with insulin use have prompted researchers to explore additional therapies to treat this condition. Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a class of medications that lower glucose in type 2 diabetes patients independent of insulin action, and have been studied for use in the type 1 diabetes population. Sotagliflozin is an SGLT2 inhibitor that demonstrates a unique binding affinity for the SGLT1 receptor. A total of three phase III clinical trials (inTandem1, inTandem2, and inTandem3) were conducted to evaluate the safety and efficacy of sotagliflozin in type 1 diabetes. A modest hemoglobin A1C reduction of 0.3-0.4% was observed, with secondary benefits of reduced glucose variability, reduced insulin dosage, and positive weight loss effects. Overall there was a reduction in the risk of severe hypoglycemia with sotagliflozin, but a higher rate of ketone formation and risk of diabetic ketoacidosis was observed, along with increased mycotic infections and volume depletion effects.

13.
Diabetes Ther ; 10(4): 1337-1346, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31148053

RESUMO

INTRODUCTION: Diabetes numeracy (DN) skills are crucial in patients on insulin pump therapy. Little evidence exists regarding DN in this patient population. METHODS: This exploratory, observational, cross-sectional study assessed the DN levels of patients on insulin pump therapy and potential relationships with glycemic control and self-management behaviors. Seventy-two patients on insulin pump therapy were recruited from one specialty endocrinology clinic. Subjects completed validated tools to measure DN [Diabetes Numeracy Test (DNT-15)] and self-management behaviors [Diabetes Self-Management Questionnaire (DSMQ)]. A general diabetes questionnaire assessed socioeconomic information and self-efficacy. Additional self-management behaviors and glycemic control data were collected from patients' medical records. Patients were categorized into two groups based on DNT-15 scores to explore potential relationships between DN scores and patient characteristics, glycemic control, and self-management behaviors. RESULTS: Average age was 52 ± 15 years, glycosylated hemoglobin (A1C) was 7.7% ± 1.2% (61 mmol/mol), duration of diabetes was 28 ± 15 years, and duration of pump use was 3.4 ± 1.3 years. The average DNT-15 score was 87.5% ± 18%. Forty-three participants (60%) scored ≥ 90% and 29 participants (40%) scored < 90%. Eighteen percent were unable to calculate the carbohydrate content from a nutrition label. Participants with lower DNT-15 scores had higher A1C levels (8.0% vs. 7.5%, p = 0.04), were older (58.3 vs. 47.7, p = 0.003), were more likely to describe their diabetes self-care as poor (p = 0.04), and were less confident in using their pump features (p = 0.02) than those with higher DNT-15 scores. CONCLUSION: Many patients on insulin pump therapy have deficiencies with DN which may be associated with older age and higher A1C levels.

15.
Ther Adv Endocrinol Metab ; 9(8): 255-258, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30181851

RESUMO

BACKGROUND: A case of 5-alpha-dihydrotestosterone (DHT) elevation associated with phentermine initiation is reported, and possible mechanisms are discussed. There are no published reports of this association in the literature. METHODS: Clinical and laboratory information is described. RESULTS: A 72-year-old male with metastatic prostate cancer taking dutasteride to lower his DHT levels initiated phentermine 15 mg daily for weight loss. His DHT level drawn within 1 week prior to starting phentermine was 9.9 pg/ml. When reporting for follow up 2 weeks later, his DHT level had increased to 114 pg/ml. The DHT level was checked again 2 weeks after that visit, and had increased to 174 pg/ml. At that time, phentermine was discontinued, and 1 week later, the DHT level had decreased to 20.1 pg/ml. Over the next 4 months, the patient's DHT levels were maintained at less than 20 pg/ml. Phentermine 15 mg daily was then reinitiated while his DHT level was 7.5 pg/ml. Two weeks after resuming phentermine, his DHT level had again increased to 196 pg/ml. The patient's phentermine was then discontinued, and around 1 week later, his DHT level had fallen to 5.1 pg/ml. CONCLUSION: A 72-year-old male with metastatic prostate cancer experienced profound increases in DHT upon initiation of phentermine despite continuation of his baseline dutasteride therapy. The etiology of these increases is still unclear.

16.
Ann Pharmacother ; 52(12): 1224-1232, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-29932006

RESUMO

OBJECTIVE: To review efficacy and safety of the glucagon-like peptide-1 receptor agonist (GLP-1 RA) semaglutide for type 2 diabetes (T2D). DATA SOURCES: A literature search of PubMed/MEDLINE and EMBASE using the term semaglutide was completed through April 2018. A search of clinicaltrials.gov was also conducted. STUDY SELECTION AND DATA EXTRACTION: English-language studies assessing the efficacy and/or safety of semaglutide were evaluated. DATA SYNTHESIS: Semaglutide is a newly approved GLP-1 RA for the treatment of T2D. Administered once weekly at a dose of 0.5 or 1 mg, it has been compared with placebo, sitagliptin, insulin glargine, a combination of oral antidiabetic therapies, and 2 GLP-1 RAs, exenatide ER and dulaglutide, and demonstrated greater efficacy compared with these therapies. Published data from studies ranging from 30 to 104 weeks duration demonstrate efficacy with decreases in hemoglobin A1C (A1C) ranging from 1.1% to 2.2%. Studies show reductions in weight from 1.4 to 6.5 kg. Semaglutide demonstrated a reduction in the composite outcome of cardiovascular (CV) death, nonfatal myocardial infarction, or nonfatal stroke compared with placebo in patients at high risk of CV events (hazard ratio = 0.74; P = 0.02). Common adverse effects include nausea, vomiting, and diarrhea as seen with other GLP-1 RAs. Relevance to Patient Care and Clinical Practice: Semaglutide represents an attractive GLP-1 RA considering its A1C and weight reduction. It provides patient convenience and high patient satisfaction. CONCLUSIONS: Semaglutide is an appealing option for the treatment of T2D as a once-weekly GLP-1 RA with established glycemic, CV, and weight benefits.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Peptídeo 1 Semelhante ao Glucagon/agonistas , Peptídeos Semelhantes ao Glucagon/administração & dosagem , Hipoglicemiantes/administração & dosagem , Glicemia/efeitos dos fármacos , Glicemia/metabolismo , Peso Corporal/efeitos dos fármacos , Peso Corporal/fisiologia , Ensaios Clínicos Fase III como Assunto/métodos , Diabetes Mellitus Tipo 2/sangue , Esquema de Medicação , Hemoglobinas Glicadas/metabolismo , Humanos , Redução de Peso/efeitos dos fármacos , Redução de Peso/fisiologia
17.
Diabetes Obes Metab ; 20(11): 2690-2694, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-29923298

RESUMO

This post hoc analysis of gastrointestinal (GI) adverse events (AEs) from the phase 3 LixiLan-L (NCT02058160) and LixiLan-O (NCT02058147) trials aimed to determine the frequency and timing of nausea, vomiting, and diarrhoea for iGlarLixi, a titratable, fixed-ratio combination of insulin glargine 100 units/mL (iGlar) and lixisenatide, versus iGlar alone or iGlar and lixisenatide alone, in patients with type 2 diabetes uncontrolled with oral antidiabetes drugs (OADs) or basal insulin ± OADs. In iGlarLixi-treated patients, the rate of GI AEs during the initial weeks of treatment was lower versus patients treated with lixisenatide alone (9.6% and 11.7% of iGlarLixi-treated patients in LixiLan-L and LixiLan-O, respectively, vs. 27.5% of lixisenatide-treated patients in LixiLan-O). Beyond day 60, these rates were generally low and similar to those of lixisenatide. These lower rates are likely due to the gradual titration of lixisenatide in iGlarLixi. Median durations of intermittent GI AEs in the iGlarLixi arms were 6.0, 2.0 and 2.5 days (LixiLan-L), and 5.0, 1.0 and 3.5 days (LixiLan-O), respectively. iGlarLixi-associated GI AEs were transient, mostly mild or moderate in severity, and occurred mainly during initial titration.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Gastroenteropatias/epidemiologia , Insulina Glargina/administração & dosagem , Insulina Glargina/efeitos adversos , Peptídeos/administração & dosagem , Peptídeos/efeitos adversos , Adulto , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/metabolismo , Combinação de Medicamentos , Feminino , Gastroenteropatias/induzido quimicamente , Humanos , Incidência , Masculino , Período Pós-Prandial , Estudos Retrospectivos
18.
Ther Adv Endocrinol Metab ; 9(4): 113-121, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29619208

RESUMO

BACKGROUND: We wanted to determine whether basal insulin requirements change when patients transition from insulin glargine U-100 (Gla-100) to insulin glargine U-300 (Gla-300) or insulin degludec. METHODS: This study involved subjects seen in the University of Colorado Health Endocrine Clinic who were transitioned from Gla-100 to either Gla-300 (n = 95) or insulin degludec (n = 39). The primary outcome was the difference between baseline Gla-100 dose and dose of Gla-300 or insulin degludec prescribed after first follow-up visit within 1-12 months. Secondary outcomes included changes in glycemic control and empiric dose conversion from Gla-100 to Gla-300 or insulin degludec on the day of transition. Wilcoxon rank sum tests evaluated changes in insulin doses, and paired t tests assessed changes in glycemic control using GraphPad statistical software. RESULTS: Median daily basal insulin dose increased for individuals transitioned from Gla-100 to Gla-300 from 30 [19-60 interquartile range (IQR)] units at baseline to 34.5 (19-70 IQR) units after follow up (p = 0.01). For patients transitioned to insulin degludec, dose changes from baseline to follow up were not significantly different (p = 0.56). At the time of transition, the prescribed dose of Gla-300 or insulin degludec did not significantly differ from the previous dose of Gla-100 (p = 0.73 and 0.28, respectively), indicating that empiric dose adjustments were not routinely prescribed. CONCLUSIONS: Patients who transitioned from Gla-100 to Gla-300 had increased basal insulin requirements between visits, while basal insulin requirements for those transitioned from Gla-100 to insulin degludec were not significantly different.

19.
Ther Adv Endocrinol Metab ; 9(3): 69-79, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-29492243

RESUMO

There have been several new treatment approaches established for the management of hyperglycemia in type 2 diabetes (T2D), with treatment guidelines listing both glucagon-like peptide 1 receptor agonists (GLP-1 RAs) and basal insulin therapies as considerations for patients who have failed to control their blood glucose with oral antidiabetic agents. New studies have highlighted the importance of initiating combination therapy earlier in the T2D disease process to avoid clinical inertia and prevent the long-term complications arising from uncontrolled diabetes. Until recently, both GLP-1 RAs and basal insulin therapies were only available as single agents, but there are now two combination pen devices that deliver both a GLP-1 RA and basal insulin simultaneously. This article reviews the current clinical evidence evaluating the use of these combination GLP-1 RA/basal insulin preparations to treat T2D, presents both potential benefits as well as possible downsides with the use of these agents, and discusses the current place in therapy these products represent in the management of T2D.

20.
Postgrad Med ; 130(4): 365-374, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29569978

RESUMO

The alarming rise in the number of people living with type 2 diabetes (T2D) presents primary care physicians with increasing challenges associated with long-term chronic disease care. Studies have shown that the majority of patients are not achieving or maintaining glycemic goals, putting them at risk of a wide range of diabetes-related complications. Disease- and self-management programs have been shown to help patients improve their glycemic control, and are likely to be of particular benefit for patients with diabetes dealing with these issues. Anticipatory guidance is an individualized, proactive approach to patient education and counseling by a health-care professional to support patients in better coping with problems before they arise. It has been shown to improve disease outcomes in a variety of chronic conditions, including diabetes. While important at all stages, anticipatory guidance may be of particular importance during changes in treatment regimens, and especially during transition to, and escalation of, insulin-based regimens. The aim of this article is to provide advice to physicians on anticipatory guidance for basal-insulin dosing, focusing on appropriate basal-insulin-dose increase and prevention of potentially deleterious basal-insulin doses, so called overbasalization. It also provides an overview of new treatment options for patients with T2D who are not well controlled on basal-insulin therapy, fixed-ratio combinations of basal insulin and glucagon-like peptide-1 receptor agonists, and advice on the type of anticipatory guidance needed to ensure safe and appropriate switching to these therapies.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Educação de Pacientes como Assunto/métodos , Aconselhamento , Gerenciamento Clínico , Combinação de Medicamentos , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Humanos , Hipoglicemia/induzido quimicamente , Insulina Glargina/uso terapêutico , Peptídeos/uso terapêutico , Autocuidado , Autogestão
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