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2.
AAPS PharmSciTech ; 20(5): 189, 2019 May 20.
Artigo em Inglês | MEDLINE | ID: mdl-31111256

RESUMO

Batch-level inference-based quality control is the standard practice for drug products. However, rare drug product defects may be missed by batch-level statistical sampling, where a subset of vials in a batch is tested quantitatively but destructively. In 2013, a suspension insulin product, NovoLog® Mix 70/30 was recalled due to a manufacturing error, which resulted in insulin strength deviations up to 50% from the labeled value. This study analyzed currently marketed FlexPen® devices by the water proton transverse relaxation rate using a benchtop nuclear magnetic resonance relaxometer. The water proton transverse relaxation rate was found to be sensitive to detecting concentration changes of the FlexPen® product. These findings support the development of vial-level verification-based quality control for drug products where every vial in a batch is inspected quantitatively but nondestructively.


Assuntos
Insulinas Bifásicas/análise , Insulina Aspart/análise , Insulina Isófana/análise , Espectroscopia de Ressonância Magnética/métodos , Insulinas Bifásicas/química , Insulinas Bifásicas/normas , Insulina Aspart/química , Insulina Aspart/normas , Insulina Isófana/química , Insulina Isófana/normas , Prótons , Controle de Qualidade , Água/química
3.
Diabetes Res Clin Pract ; 150: 158-166, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30872064

RESUMO

AIMS: To compare the efficacy and safety of biphasic insulin aspart 30 (BIAsp 30) administered three times daily (TID) vs. twice daily (BID), plus metformin, in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on basal insulin ± 1 oral antidiabetic drug (OAD). METHODS: Randomised, multinational, open-label, treat-to-target trial. Subjects inadequately controlled (HbA1c 7.5-10.0%) on basal insulin and metformin ±â€¯1 OAD were randomised to BIAsp30 TID (n = 220) or BIAsp30 BID (n = 217). Primary endpoint was change from baseline in HbA1c after 24 weeks of treatment. RESULTS: Most (400/437, 91.5%) subjects completed the trial. The majority (276/400 [69.0%]) were from the China region. After 24 weeks, HbA1c decreased comparably in both BIAsp 30 groups (-1.7% vs. -1.6% [-19 vs. -18 mmol/mol], for TID and BID dosing, respectively; estimated treatment difference: -0.09% [-0.23; 0.06]95% CI, -1 mmol/mol [-3; 1], p = 0.26). Safety profiles, including number of subjects experiencing hypoglycaemia, were similar. CONCLUSIONS: BIAsp 30 administered either TID or BID with metformin was a safe and effective option when intensifying treatment after failure of basal insulin and OADs in patients with T2DM. Adding a third injection at lunchtime may be preferable if HbA1c remains above target, if the lunchtime meal is the largest meal of the day, or if persistent postprandial hyperglycaemia after lunch is observed. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT02582242.


Assuntos
Insulinas Bifásicas/uso terapêutico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemia/prevenção & controle , Hipoglicemiantes/uso terapêutico , Insulina Aspart/uso terapêutico , Insulina Isófana/uso terapêutico , Insulina/administração & dosagem , Administração Oral , Adolescente , Adulto , Glicemia/análise , Esquema de Medicação , Feminino , Hemoglobina A Glicada/análise , Humanos , Agências Internacionais , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Adulto Jovem
4.
Int J Clin Pract ; 73(6): e13348, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30912213

RESUMO

AIM OF THE STUDY: To test if changing the Iftar insulin to a 50:50 mixed analog insulin from a 30:70 human insulin at the same total dose leads to improvement in the postprandial blood glucose (taken as after the main meal). Since the intermediate acting insulin dose is effectively lowered, the pre-Suhur blood glucose is also tested to see if this rises. METHODS: The Iftar human 30:70 mixed insulin is substituted for a 50:50 one using insulin lispro protamine suspension and 50% insulin lispro (Humalog® Mix50/50™), whilst maintaining the same total dose. The participants were also changed to 75% insulin lispro protamine suspension and 25% insulin lispro (Humalog® Mix75/25™) at the same pre-Ramadan dose for their Suhur injection (Experimental group). A similar number of controls continued their 30:70 mixed human insulin at the same dose during Ramadan (Control group). Pre-Ramadan and during Ramadan fasting and postprandial (3 hours) and pre-Suhur blood glucose (BG) are tested in 20 subjects and 20 controls by the patients using home glucose meters. Hypoglycaemia, defined as a BG of ≤ 70 mg%, was tested for by the patients and noted if they experience symptoms of it. Severe hypoglycaemia occurred if the patient needed assistance for recovery. No insulin dose adjustments are made in either group and any other anti-diabetic treatment was continued. Pre- and post-Ramadan HbA1 c and body weight are measured. The number of days fasted and baseline characteristics are age, gender, and duration of diabetes are also noted. Differences between groups in parameters were assessed using ANCOVA to adjust for pre-Ramadan values of age, gender, and duration of diabetes. RESULTS: All the participants fasted for at least 29 days. The 2 groups were not significantly different at baseline. During Ramadan, mean postprandial BG in the Experimental group was lower by 21.1 mg% (1.2 mmol/l) (95% CI 12.6, 29.7; P < 0.001). Similarly, after Ramadan mean HbA1 c in the Experimental group was lower by 0.4% (95% CI 0.1%, 0.8%; P = 0.01). No significant differences between the groups were detected in mean bodyweight after Ramadan (P = 0.86) or mean fasting BG during Ramadan (P = 0.07). There was no difference in incidence of hypoglycaemia. CONCLUSIONS: Switching from human insulin mix 30:70 to analog insulin mix 50:50 results in better post main meal control in Ramadan, without affecting HbA1c, or increasing the incidence of hypoglycaemia.


Assuntos
Insulinas Bifásicas/uso terapêutico , Glicemia/efeitos dos fármacos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Jejum/sangue , Hipoglicemiantes/uso terapêutico , Insulina Lispro/uso terapêutico , Insulina Isófana/uso terapêutico , Islamismo , Adulto , Idoso , Biomarcadores/sangue , Insulinas Bifásicas/farmacologia , Diabetes Mellitus Tipo 2/sangue , Esquema de Medicação , Feminino , Hemoglobina A Glicada/metabolismo , Férias e Feriados , Humanos , Hipoglicemiantes/farmacologia , Insulina Lispro/farmacologia , Insulina Isófana/farmacologia , Masculino , Pessoa de Meia-Idade , Período Pós-Prandial , Resultado do Tratamento
5.
J Formos Med Assoc ; 118(4): 843-848, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30704815

RESUMO

Although hypersensitivity reaction to insulin was supposed to be less-frequent with current insulin analogue, case reports with different types of allergic reactions to insulin analogue were still reported. The most common form is type I hypersensitivity reaction with IgE-mediated. Besides, type III (IgG and IgM-mediated) and type IV (T-cell mediated delayed reaction) hypersensitivity reactions were also reported. Here we presented a long-standing type 2 diabetes with insulin requirements with hypersensitivity reactions to insulin actrapid, insulin aspart, insulin glargine, insulin detemir, and biphasic insulin aspart 30. Insulin desensitization was performed as initial management but failed as skin biopsy with immunohistochemical staining proved type IV hypersensitivity reaction. We continued with the next treatment approach using subcutaneous injection with the mixture of biphasic insulin aspart 30 and dexamethasone to alleviate allergy, and the result was successful with steroid-free biphasic insulin aspart 30 injection eight months later. Besides, the treatment effect had lasted after ten years even with switched type of insulin analogue from biphasic insulin aspart 30 to insulin glargine and insulin aspart. The case report demonstrated a good example of how clinicians deal with the rare but important questions of hypersensitivity reactions to insulin analogue.


Assuntos
Dexametasona/uso terapêutico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipersensibilidade Tardia/induzido quimicamente , Hipoglicemiantes/efeitos adversos , Insulina Aspart/uso terapêutico , Insulina/efeitos adversos , Insulinas Bifásicas , Combinação de Medicamentos , Feminino , Humanos , Hipoglicemiantes/administração & dosagem , Insulina/análogos & derivados , Insulina Detemir , Insulina Glargina , Insulina Isófana , Insulina de Ação Prolongada , Pessoa de Meia-Idade
6.
Brasília; CONITEC; fev. 2019. ilus, tab.
Não convencional em Português | BRISA/RedTESA | ID: biblio-1024490

RESUMO

INTRODUÇÃO: O diabetes mellitus tipo 2 (DM2) ocorre como consequência da perda progressiva da produção de insulina pelo pâncreas ou ainda pela resistência à insulina e deficiência na ação desse hormônio. Esta doença, que corresponde a cerca de 90% dos casos de todos os tipos de diabestes, representa um problema relevante de saúde pública, devido a sua natureza crônica, a gravidade das complicações e a meios necessários para controlá-las tornando-se muito onerosa tanto para os pacientes e suas famílias como para os sistemas de saúde. Para o tratamento do DM2 é recomendado um plano terapêutico que vise ao controle glicêmico e a prevenção de complicações crônicas decorrentes da doença, primeiramente por meio de condutas não medicamentosas, como educação em saúde, alimentação saudável, prática de atividade física e cessação do tabagismo, em seguida se inicia a terapia medicamentosa com antidiabético oral. Atualmente estão disponíveis no SUS as insulinas de ação intermediária (insulina NPH) e de ação rápida (insulina regu


Assuntos
Humanos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Insulina Detemir/uso terapêutico , Insulina Glargina/uso terapêutico , Insulina Isófana/uso terapêutico , Avaliação da Tecnologia Biomédica , Sistema Único de Saúde , Brasil , Análise Custo-Benefício/economia
7.
Eur J Endocrinol ; 179(4): R207-R218, 2018 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-30299889

RESUMO

Glucocorticoids are frequently prescribed to patients with a wide range of inflammatory and autoimmune diseases. The semi-synthetic glucocorticoid prednisolone is most commonly prescribed and in two main patterns. Prednisolone is prescribed short term at medium-high doses to treat an acute inflammatory illness or long term at lower doses to attenuate chronic inflammatory disease progression. In hospitalized patients with acute prednisolone-induced hyperglycaemia, there is a distinct circadian pattern of glucose elevation, which occurs predominantly in the afternoon and evening. As a morning dose of isophane insulin has a pharmacokinetic pattern that matches this pattern of glucose elevation, treatment comprising a basal dose of morning isophane insulin in combination with short-acting insulin boluses is generally recommended. However, evidence is lacking that isophane-based basal bolus insulin is more efficacious than other insulin regimens. In outpatients, low-dose prednisolone causes a small increase in post glucose-load glucose concentration but no change in overall glycaemic control as measured by glycosylated haemoglobin. If treatment is indicated, metformin has been shown to be effective and may attenuate other adverse effects of long-term prednisolone therapy. Further studies are necessary in order to identify factors underlying the variability in response to insulin therapy and clinical benefits of treatment in hospitalized patients with prednisolone-induced hyperglycaemia. In outpatients prescribed low-dose prednisolone, the cardiovascular risk associated with postprandial hyperglycaemia and efficacy of hypoglycaemic therapies should be evaluated in future randomized clinical trials.


Assuntos
Glucocorticoides/efeitos adversos , Hiperglicemia/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Insulina Isófana/uso terapêutico , Metformina/uso terapêutico , Prednisolona/efeitos adversos , Glicemia/metabolismo , Medicina Baseada em Evidências , Glucocorticoides/administração & dosagem , Hemoglobina A Glicada/metabolismo , Humanos , Hiperglicemia/induzido quimicamente , Hiperglicemia/metabolismo , Prednisolona/administração & dosagem
8.
J Vet Med Sci ; 80(11): 1720-1723, 2018 Nov 23.
Artigo em Inglês | MEDLINE | ID: mdl-30305465

RESUMO

Insulin degludec (IDeg) is a new insulin formulation that facilitates long-term control of glucose level in humans. In this study, we investigated the effects of IDeg on glycemic control in dogs. Its time-action profiles were monitored in healthy dogs using an artificial pancreas apparatus under euglycemic conditions. At 9.0-13.5 hr post-IDeg injection, an indistinct peak of glucose level was detected. Moreover, the action of IDeg was persistent for >20 hr. Both IDeg and neutral protamine Hagedorn insulin (NPH) lowered blood glucose concentrations in diabetic dogs, but IDeg caused postprandial hyperglycemia and a somewhat lower preprandial glucose level than that caused by NPH. IDeg might be ineffective in concurrently preventing postprandial hyperglycemia and preprandial hypoglycemia in a single-agent administration.


Assuntos
Diabetes Mellitus/tratamento farmacológico , Diabetes Mellitus/veterinária , Doenças do Cão/tratamento farmacológico , Insulina de Ação Prolongada/uso terapêutico , Animais , Glicemia , Cães , Relação Dose-Resposta a Droga , Insulina Isófana/administração & dosagem , Insulina Isófana/uso terapêutico , Insulina de Ação Prolongada/administração & dosagem
11.
Eur J Pediatr ; 177(10): 1497-1503, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30014302

RESUMO

There are limited studies evaluating the safety and efficacy of treatments in young people with type 2 diabetes (T2D). This study compared the efficacy and safety of insulin detemir versus neutral protamine Hagedorn (NPH) insulin, both in combination with metformin and lifestyle intervention, in children and adolescents with T2D. This randomized, open-label, phase 3 trial recruited patients (n = 42) aged 10-17 years diagnosed with T2D already receiving metformin ± other oral antidiabetic drugs ± basal insulin. Patients were randomized (1:1) to receive either insulin detemir or NPH insulin, both with the maximum tolerated dose of metformin, and lifestyle intervention, over 26 weeks. Enrollment terminated prematurely after 17 months due to a very slow recruitment rate (12% of the target met). After 26 weeks, the observed mean HbA1c value had decreased by 0.61% points in the insulin detemir group vs. 0.84% points in the NPH insulin group. The rate of symptomatic blood glucose-confirmed hypoglycemic episodes was 0.4 episodes/patient-year of exposure (PYE) for insulin detemir vs. 1.1 episodes/PYE for NPH insulin. CONCLUSION: No safety issues were revealed with either basal insulin. Due to the low number of patients recruited, no efficacy conclusions could be drawn. ClinicalTrials.gov identifier: NCT02131272. What is known: • There is a growing worldwide epidemic of type 2 diabetes in children and adolescents. • There is a lack of research and limited treatment options currently available in this population. What is new: • No safety issues with insulin detemir or neutral protamine Hagedorn insulin in children and adolescents with type 2 diabetes were observed. • Improving clinical trial recruitment, along with providing early, efficacious, and safe treatment options, in this population is critical.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Insulina Detemir/uso terapêutico , Insulina Isófana/uso terapêutico , Adolescente , Glicemia/efeitos dos fármacos , Criança , Feminino , Hemoglobina A Glicada/efeitos dos fármacos , Humanos , Hipoglicemiantes/efeitos adversos , Insulina Detemir/efeitos adversos , Insulina Isófana/efeitos adversos , Estilo de Vida , Masculino , Metformina/uso terapêutico
12.
Vet Rec ; 183(8): 262, 2018 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-30030413

RESUMO

Clinical studies that compare lente insulin and neutral protamine Hagedorn (NPH) insulin in diabetic dogs are lacking. This is a prospective, randomised, controlled clinical study aimed to compare the efficacy and safety of lente insulin and NPH insulin in diabetic dogs. Thirty client-owned, newly diagnosed diabetic dogs were included. Animals were randomised into two groups and received lente insulin or NPH insulin administered every 12 hours. Follow-up re-evaluations were done at 1, 2, 4, 6, 8 and 12 weeks. At each re-evaluation, a physical exam, blood glucose curve, and serum fructosamine concentrations were performed. At the end of the study, the median insulin dose per injection was 0.61 U/kg (range, 0.34-0.92 U/kg) and 0.49 U/kg (range, 0.23-0.68 U/kg) in the lente and NPH groups, respectively. There was a significant improvement of polyuria and polydipsia and glucose concentrations in both groups. At the end of the study, the glycaemic control was considered good in 9/15 (60 per cent) and 11/15 (73 per cent) in the lente and NPH groups, respectively. These differences were not significant. Lente insulin and NPH insulin were similarly effective in the treatment of dogs with diabetes mellitus.


Assuntos
Diabetes Mellitus/veterinária , Doenças do Cão/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Insulina Isófana/uso terapêutico , Insulina Lenta/uso terapêutico , Animais , Diabetes Mellitus/tratamento farmacológico , Cães , Feminino , Masculino , Estudos Prospectivos , Resultado do Tratamento
13.
Diabetes Obes Metab ; 20(12): 2740-2747, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-29961975

RESUMO

AIM: To confirm non-inferiority of biphasic insulin aspart 30 (BIAsp 30) plus metformin to BIAsp 30 in lowering glycated haemoglobin (HbA1c) in Chinese patients with inadequately controlled type 2 diabetes using oral antidiabetic drugs. MATERIALS AND METHODS: In this 16-week, prospective, randomized, open-label, multicentre, parallel-controlled study, patients aged 18-79 years with HbA1c ≥7% were randomized to BIAsp 30 plus metformin (n = 130) or BIAsp 30 (n = 127). Initially, 500 mg metformin was administered twice daily and BIAsp 30 was administered at 0.2-0.3 U/kg/d. Changes in HbA1c % from baseline to week 16 as well as secondary and safety endpoints were assessed. RESULTS: In total, 83.66% of patients in the BIAsp 30 plus metformin (n = 110) and the BIAsp 30 (n = 105) groups completed the study. Mean (±standard deviation) change in HbA1c from baseline to endpoint was -1.74 ± 1.64% and -1.32 ± 2.05% with BIAsp 30 plus metformin and BIAsp 30, respectively. Least squares mean treatment difference was -0.67% (95% CI, -1.06; -0.28). The upper limit of the 95% CI was <0.4 (non-inferiority margin). A significantly higher proportion of individuals reached HbA1c <7% with BIAsp 30 plus metformin than with BIAsp 30 (53.15% vs 35.19%; P = 0.0074). At endpoint, daily BIAsp 30 dose (P < 0.001) and weight gain were significantly lower (P < 0.05) in the BIAsp 30 plus metformin group compared with the BIAsp 30 group. No between-group differences in number of hypoglycaemic events were observed. CONCLUSION: BIAsp 30 plus metformin was non-inferior to BIAsp 30 in safely reducing HbA1c in this study.


Assuntos
Insulinas Bifásicas/administração & dosagem , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Insulina Aspart/administração & dosagem , Insulina Isófana/administração & dosagem , Metformina/administração & dosagem , Idoso , Diabetes Mellitus Tipo 2/sangue , Quimioterapia Combinada , Feminino , Hemoglobina A Glicada/efeitos dos fármacos , Humanos , Hipoglicemia/induzido quimicamente , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento , Ganho de Peso/efeitos dos fármacos
15.
JAMA ; 320(1): 53-62, 2018 07 03.
Artigo em Inglês | MEDLINE | ID: mdl-29936529

RESUMO

Importance: In clinical trials of patients with type 2 diabetes, long-acting insulin analogs modestly reduced the risk of nocturnal hypoglycemia compared with human neutral protamine Hagedorn (NPH) insulin, but cost 2 to 10 times more. Outcomes in clinical practice may differ from trial results. Objective: To compare the rates of hypoglycemia-related emergency department (ED) visits or hospital admissions associated with initiation of long-acting insulin analogs vs human NPH insulin in patients with type 2 diabetes. Design, Setting, and Participants: A retrospective observational study using data from Kaiser Permanente of Northern California from January 1, 2006, through September 30, 2015. Patients with type 2 diabetes who initiated a long-acting insulin analog or NPH insulin were included and censored at death, loss of health plan coverage, change in insulin treatment, or study end on September 30, 2015. Exposure: Initiation of basal insulin analogs (glargine or detemir) vs NPH insulin. Main Outcomes and Measures: The primary outcome was the time to a hypoglycemia-related ED visit or hospital admission and the secondary outcome was the change in hemoglobin A1c level within 1 year of insulin initiation. Results: There were 25 489 patients with type 2 diabetes who initiated basal insulin therapy (mean age, 60.2 [SD, 11.8] years; 51.9% white; 46.8% female). During a mean follow-up of 1.7 years, there were 39 hypoglycemia-related ED visits or hospital admissions among 1928 patients who initiated insulin analogs (11.9 events [95% CI, 8.1 to 15.6] per 1000 person-years) compared with 354 hypoglycemia-related ED visits or hospital admissions among 23 561 patients who initiated NPH insulin (8.8 events [95% CI, 7.9 to 9.8] per 1000 person-years) (between-group difference, 3.1 events [95% CI, -1.5 to 7.7] per 1000 person-years; P = .07). Among 4428 patients matched by propensity score, the adjusted hazard ratio was 1.16 (95% CI, 0.71 to 1.78) for hypoglycemia-related ED visits or hospital admissions associated with insulin analog use. Within 1 year of insulin initiation, hemoglobin A1c level decreased from 9.4% (95% CI, 9.3% to 9.5%) to 8.2% (95% CI, 8.1% to 8.2%) after initiation of insulin analogs and from 9.4% (95% CI, 9.3% to 9.5%) to 7.9% (95% CI, 7.9% to 8.0%) after initiation of NPH insulin (adjusted difference-in-differences for glycemic control, -0.22% [95% CI, -0.09% to -0.37%]). Conclusions and Relevance: Among patients with type 2 diabetes, initiation of a basal insulin analog compared with NPH insulin was not associated with a reduced risk of hypoglycemia-related ED visits or hospital admissions or with improved glycemic control. These findings suggest that the use of basal insulin analogs in usual practice settings may not be associated with clinical advantages for these outcomes.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Hospitalização/estatística & dados numéricos , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/efeitos adversos , Insulina Detemir/efeitos adversos , Insulina Glargina/efeitos adversos , Insulina Isófana/efeitos adversos , Adulto , Idoso , Glicemia/efeitos dos fármacos , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/complicações , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Humanos , Hipoglicemia/prevenção & controle , Hipoglicemiantes/uso terapêutico , Insulina Detemir/uso terapêutico , Insulina Glargina/uso terapêutico , Insulina Isófana/uso terapêutico , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
16.
J Diabetes Res ; 2018: 4817178, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29713649

RESUMO

Objective: To compare dipeptidyl peptidase-4 (DPP-4) inhibitors with neutral protamine Hagedorn (NPH) insulin, in terms of effectiveness and safety for the management of patients with type 2 diabetes mellitus (DM2) not controlled on metformin and sulfonylureas. Methods: A retrospective cohort study of individuals with DM2 newly dispensed with either DPP-4 inhibitors or NPH as third-line therapy, after metformin and sulfonylurea. Treatment discontinuation, macrovascular outcomes, and hypoglycemia were compared using multivariable Cox regression models, adjusted for sex, age, year of cohort entry, place of residence, hypertension, past history of hypoglycemia, diabetic ketoacidosis, comorbidities, and number of visits to emergency departments, outpatient physician, and hospitalizations. Results: Treatment discontinuation and hypoglycemia occurred more frequently with NPH than with DPP-4 inhibitor users. In the adjusted Cox model, the use of NPH compared to that of DPP-4 inhibitors was associated with a higher risk of discontinuation (HR: 1.33; 95% CI 1.27-1.40) and hypoglycemia (HR: 2.98; 95% CI 2.72-3.28). Risk of cardiovascular events was similar across groups. Conclusions: This real-world analysis suggests that DM2 patients initiating third-line therapy with NPH have poorer control of diabetes when compared to DPP-4 inhibitor initiators.


Assuntos
Glicemia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Inibidores da Dipeptidil Peptidase IV/uso terapêutico , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/uso terapêutico , Insulina Isófana/uso terapêutico , Idoso , Diabetes Mellitus Tipo 2/sangue , Inibidores da Dipeptidil Peptidase IV/efeitos adversos , Feminino , Humanos , Hipoglicemia/sangue , Hipoglicemiantes/efeitos adversos , Insulina Isófana/efeitos adversos , Masculino , Metformina/uso terapêutico , Pessoa de Meia-Idade , Estudos Retrospectivos , Compostos de Sulfonilureia/uso terapêutico , Suspensão de Tratamento
17.
Drugs R D ; 18(1): 27-39, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-29468559

RESUMO

Since clinical experience with biphasic insulin aspart 30 (BIAsp 30) in type 2 diabetes mellitus (T2DM) was reviewed in 2012 after 10 years of use worldwide, additional studies have been published that highlight new aspects, including use in real-world populations. Evidence from 35 new studies confirms and builds upon previous work indicating that BIAsp 30 continues to have pharmacodynamic and clinical advantages over biphasic human insulin (BHI 30), including in real-world practice with unselected populations of patients. BIAsp 30 has also been shown to be safe and efficacious as an add-on to dipeptidyl peptidase-4 (DPP-4) inhibitors. Intensification with BIAsp 30 is a safe and effective way to improve glycemic control, and titration performed by patients can achieve results that are at least comparable to those when being guided by healthcare providers. Stepwise intensification using BIAsp 30 is comparable to intensification using a basal-bolus regimen, and twice-daily BIAsp 30 provides similar glycemic control to a basal-plus regimen. Data from large observational studies, in particular, have identified patient-related characteristics that are associated with improved clinical responses, suggesting that earlier initiation and intensification of therapy is warranted. Finally, new health-economic analyses continue to confirm that BIAsp 30 is cost effective versus other therapies such as BHI 30, neutral protamine Hagedorn (NPH), or insulin glargine in both insulin-naïve and insulin-experienced patients. After 15 years of clinical use worldwide, analysis of more recent 5-year data indicates that BIAsp 30 remains a safe, effective, and simple-to-use insulin for initiation and intensification by diabetes specialists and primary care physicians in a variety of patients with T2DM.


Assuntos
Insulinas Bifásicas/uso terapêutico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Insulina Aspart/uso terapêutico , Insulina Isófana/uso terapêutico , Insulinas Bifásicas/efeitos adversos , Insulinas Bifásicas/farmacocinética , Análise Custo-Benefício , Diabetes Mellitus Tipo 2/economia , Inibidores da Dipeptidil Peptidase IV/uso terapêutico , Quimioterapia Combinada , Humanos , Hipoglicemiantes/efeitos adversos , Hipoglicemiantes/economia , Hipoglicemiantes/uso terapêutico , Insulina Aspart/efeitos adversos , Insulina Aspart/farmacocinética , Insulina Isófana/efeitos adversos , Insulina Isófana/farmacocinética
18.
Res Vet Sci ; 118: 79-85, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29421488

RESUMO

With the aim to improve current therapeutic and monitoring options for diabetic cats, the present study compared pharmacodynamic parameters of protamine zinc insulin (PZI) and insulin degludec and validated the continuous glucose monitoring system (CGMS) iPro2 with Sof-sensor and Enlite-sensor focusing on the low glycemic range. Three doses (0.1, 0.2 and 0.3IU/kg) of the two insulin preparations and the CGMS iPro2 with two different sensors were tested in six healthy cats. After each insulin administration, onset of action, time to glucose nadir and duration of action were calculated by measuring glucose concentrations with a portable blood glucose meter (PBGM). After sensor placement, paired PBGM and sensor glucose measurements were done and analytical and clinical accuracy were calculated according to the ISO 15197:2013 criteria. Onset of action, time to glucose nadir and glucose nadir were similar for both insulin formulations. Duration of action of insulin degludec was significantly longer than those of PZI at 0.1IU/kg (P=0.043) and 0.2IU/kg (P=0.043). Overall, 166/191 (87%) Sof-sensor measurements and 106/121 (88%) Enlite-sensor measurements met ISO criteria for analytical accuracy, and all sensor measurements fulfilled ISO criteria for clinical accuracy. Insulin degludec was well tolerated in healthy cats and showed longer duration of action than PZI. Further studies on the use of insulin degludec in diabetic cats might be recommended. Both sensors had good clinical accuracy, when used with the CGMS iPro2, but the analytical accuracy was below the minimum set by ISO 15197:2013.


Assuntos
Glicemia/análise , Gatos , Insulina Isófana/farmacocinética , Insulina de Ação Prolongada/farmacocinética , Monitorização Ambulatorial/veterinária , Animais , Glicemia/metabolismo , Monitorização Ambulatorial/instrumentação
19.
Patient ; 11(4): 377-389, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29322308

RESUMO

INTRODUCTION: Insulin analog glargine (GLA) has been available as one of the therapeutic options for patients with type 1 diabetes mellitus to enhance glycemic control. Studies have shown that a decrease in the frequency of hypoglycemic episodes improves the quality of life (QoL) of diabetic patients. However, there are appreciable acquisition cost differences between different insulins. Consequently, there is a need to assess their impact on QoL to provide future guidance to health authorities. METHOD: A systematic review of multiple databases including Medline, LILACS, Cochrane, and EMBASE databases with several combinations of agreed terms involving randomized controlled trials and cohorts, as well as manual searches and gray literature, was undertaken. The primary outcome measure was a change in QoL. The quality of the studies and the risk of bias was also assessed. RESULTS: Eight studies were eventually included in the systematic review out of 634 publications. Eight different QoL instruments were used (two generic, two mixed, and four specific), in which the Diabetes Treatment Satisfaction Questionnaire (DTSQ) was the most used. The systematic review did not consistently show any significant difference overall in QoL scores, whether as part of subsets or combined into a single score, with the use of GLA versus neutral protamine Hagedorn (NPH) insulin. Only in patient satisfaction measured by DTSQ was a better result consistently seen with GLA versus NPH insulin, but not using the Well-being Inquiry for Diabetics (WED) scale. However, none of the cohort studies scored a maximum on the Newcastle-Ottawa scale for quality, and they generally were of moderate quality with bias in the studies. CONCLUSION: There was no consistent difference in QoL or patient-reported outcomes when the findings from the eight studies were collated. In view of this, we believe the current price differential between GLA and NPH insulin in Brazil cannot be justified by these findings.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Insulina Glargina/uso terapêutico , Insulina Isófana/uso terapêutico , Qualidade de Vida , Glicemia , Brasil , Análise Custo-Benefício , Hemoglobina A Glicada , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/efeitos adversos , Hipoglicemiantes/economia , Insulina Glargina/efeitos adversos , Insulina Glargina/economia , Insulina Isófana/efeitos adversos , Insulina Isófana/economia , Satisfação do Paciente
20.
Diabet Med ; 35(5): 663-666, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29381818

RESUMO

BACKGROUND: Insulin allergy is a rare yet severe side effect of exogenous insulin use. Management typically involves use of alternative antihyperglycaemic agents, symptom control with antihistamines, use of different insulin formulations, and induction of tolerance with incremental doses of insulin. This treatment regimen is not always successful, and the use of omalizumab, an anti-IgE monoclonal antibody, has been used to induce tolerance to insulin. CASE REPORT: G.M. is a 62-year-old man with Type 2 diabetes mellitus. His condition was not optimized on oral agents, and insulin therapy was required. G.M. had anaphylaxis to insulin NPH, and subsequent skin-prick testing was positive to insulin aspart, insulin NPH, insulin glulisine, insulin detemir, regular insulin, insulin glargine 100 units/ml and insulin glargine 300 units/ml. He received incremental doses of several insulin formulations; however, he experienced diffuse urticaria preventing optimal glycaemic control. Three successful cases have been described in the literature of omalizumab inducing tolerance to exogenous insulin; therefore, G.M. was started on omalizumab. He subsequently tolerated treatment doses of insulin glulisine and insulin detemir with no allergic reactions and with improvement in glycaemic control. CONCLUSION: To our knowledge, this is the first described case of allergy to insulin glargine 300 units/ml and reiterates the potential use of omalizumab in insulin allergy. Further research is warranted to determine if omalizumab should be considered standard of care in difficult-to-treat insulin hypersensitivity.


Assuntos
Anafilaxia/prevenção & controle , Antialérgicos/uso terapêutico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipersensibilidade a Drogas/tratamento farmacológico , Insulina/efeitos adversos , Omalizumab/uso terapêutico , Anafilaxia/etiologia , Hipersensibilidade a Drogas/etiologia , Humanos , Insulina/análogos & derivados , Insulina/uso terapêutico , Insulina Aspart/efeitos adversos , Insulina Detemir/efeitos adversos , Insulina Detemir/uso terapêutico , Insulina Glargina/efeitos adversos , Insulina Isófana/efeitos adversos , Masculino , Pessoa de Meia-Idade
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