Spelling suggestions: "subject:"glargine"" "subject:"enlargine""
1 |
Dosage des analogues de l'insuline à l'aide de deux immunodosages de l'insuline humaine évaluation analytique et application à l'étude de la biotransformation de la glargine /Agin, Arnaud Sapin, Rémy. January 2008 (has links) (PDF)
Thèse de doctorat : Biologie médicale : Strasbourg 1 : 2006. / Titre provenant de l'écran-titre. Bibliogr. p. 142-163.
|
2 |
Robust Modelling of the Glucose-Insulin System for Tight Glycaemic Control of Less Critical Care PatientsAbdul Razak, Normy Norfiza January 2012 (has links)
In the intensive care units, hyperglycaemia among the critically ill is associated with poor outcomes. Many studies have been done on managing hyperglycaemia
in the critically ill. Patients in the ICU continue to benefit from the outcome of extensive studies including several randomized clinical trials on glycaemic control
with intensive insulin therapy. Tight glycaemic control has now emerged as a major research focus in critical care due to its potential to simultaneously reduce both mortality and cost. Although the debate on tight glycaemic control is
on going, managing glycaemic level in ICUs is gaining widespread acceptance as the adverse effects are well known. However, in the less acute wards, to date there have only been a single randomized, controlled study to examine the
benefit of glycaemic control. Patients in the less acute wards do not receive the same level of care, as glycaemic control is not regarded as important and not a priority. Glycaemic goals in the less acute wards are often judged based on clinical experience rather than adhering to a standard protocol or a treatment guideline. It is important that patients in the less acute wards received the level of care as practised in the ICU. If hyperglycaemia worsens outcome in the ICU, a similar effect is seen within less acute wards. Hence, tight glycaemic control needs to be
extended in the less critical setting as well. To support the establishment of a control protocol for patients in less acute wards, a method that has been successful in the critical care and can be adapted to the less acute wards, is the model based or model-derived control protocol. Model-based protocol can deliver a safe and effective patient-specific control, which means the glycaemic control protocol
can be devised to each individual patient. Hence, a physiological model that represents the glucose-insulin regulatory system is presented in this thesis. The
developed model, Intensive Control Insulin-Nutrition-Glucose (ICING) is based on the best aspects of two previous clinically-validated glucose-insulin models.
|
3 |
Fetal Exposure to Antidiabetic Drugs: The Role of the PlacentaPollex, Erika 01 September 2010 (has links)
Gestational diabetes, a common medical complication in pregnancy, may lead to severe fetal consequences if left untreated. A major concern with the use of antidiabetic drugs in pregnancy is the potential for placental transfer and fetal toxicity. The presence of endocytic pathways and several ABC transporter proteins has been demonstrated in the human placenta and are believed to play an important role in determining fetal exposure to drugs used in pregnancy. The objective of this thesis is to investigate the safety and transfer of the oral hypoglycemic agent, glyburide, and the new long acting insulin analog, insulin glargine, across the human placenta.
The oral antidiabetic, glyburide, has been shown to be actively effluxed across the placenta in the fetal to maternal direction. The transport of glyburide in the presence of a breast cancer resistance protein (BCRP) inhibitor was investigated in the dually perfused human placenta model. The results of the perfusion studies indicate that BCRP plays a role in protecting the fetus from the accumulation of glyburide. Subsequently, cellular studies were carried out to determine the effect of the naturally occurring single nucleotide polymorphism within the coding region of BCRP (C421A/Q141K) on glyburide transport. Results suggest that glyburide transport may be reduced in the presence of the Q141K polymorphism.
While insulin remains as the gold standard, the potential for maternal hypoglycemia with insulin injection has resulted in the development of insulin analogs. Insulin glargine, a human insulin analog, has a long half life with no pronounced peak when compared to currently used NPH insulin. Human placental perfusion experiments examining the extent and rate of transfer of insulin glargine across the placenta demonstrated that, at therapeutic concentrations, insulin glargine does not cross the placenta to a measurable extent. To further determine the fetal safety of insulin glargine therapy compared with NPH insulin, a systematic review and meta-analysis were performed. No evidence was identified for increased adverse fetal outcomes with the use of insulin glargine during pregnancy. Overall, the results of this research serve to provide improved treatment options for women with diabetes in pregnancy.
|
4 |
Fetal Exposure to Antidiabetic Drugs: The Role of the PlacentaPollex, Erika 01 September 2010 (has links)
Gestational diabetes, a common medical complication in pregnancy, may lead to severe fetal consequences if left untreated. A major concern with the use of antidiabetic drugs in pregnancy is the potential for placental transfer and fetal toxicity. The presence of endocytic pathways and several ABC transporter proteins has been demonstrated in the human placenta and are believed to play an important role in determining fetal exposure to drugs used in pregnancy. The objective of this thesis is to investigate the safety and transfer of the oral hypoglycemic agent, glyburide, and the new long acting insulin analog, insulin glargine, across the human placenta.
The oral antidiabetic, glyburide, has been shown to be actively effluxed across the placenta in the fetal to maternal direction. The transport of glyburide in the presence of a breast cancer resistance protein (BCRP) inhibitor was investigated in the dually perfused human placenta model. The results of the perfusion studies indicate that BCRP plays a role in protecting the fetus from the accumulation of glyburide. Subsequently, cellular studies were carried out to determine the effect of the naturally occurring single nucleotide polymorphism within the coding region of BCRP (C421A/Q141K) on glyburide transport. Results suggest that glyburide transport may be reduced in the presence of the Q141K polymorphism.
While insulin remains as the gold standard, the potential for maternal hypoglycemia with insulin injection has resulted in the development of insulin analogs. Insulin glargine, a human insulin analog, has a long half life with no pronounced peak when compared to currently used NPH insulin. Human placental perfusion experiments examining the extent and rate of transfer of insulin glargine across the placenta demonstrated that, at therapeutic concentrations, insulin glargine does not cross the placenta to a measurable extent. To further determine the fetal safety of insulin glargine therapy compared with NPH insulin, a systematic review and meta-analysis were performed. No evidence was identified for increased adverse fetal outcomes with the use of insulin glargine during pregnancy. Overall, the results of this research serve to provide improved treatment options for women with diabetes in pregnancy.
|
5 |
A Cost-Effectiveness Analysis Comparing Glargine Versus Rosiglitazone or Pioglitazone for Patients Failing Metformin Plus a SulfonylureaSpaeth, Brianne, Fontana, Barbara January 2008 (has links)
Class of 2008 Abstract / Objectives: To determine the cost-effectiveness of adding a thiazolidinedione (TZD) versus insulin glargine (glargine) as a triple regimen for treatment of Type 2 diabetes mellitus for patients not controlled with metformin and a sulfonylurea.
Methods: A decision analytic model was developed to compare the clinical outcomes and costs of triple therapy with either a TZD or glargine. Published literature was used to determine treatment efficacy and the frequency of clinically important adverse effects. Cost data were obtained from the 2007 Physician Fee Reference and North Carolina Industrial Commission website. The decision tree was built using TreeAge software. Clinical outcome measures included HgA1c (A1C) control, hypoglycemia frequency, and the development of edema associated with the use of these medications. A Monte Carlo probabilistic sensitivity analysis was conducted to determine the mean and 95% CIs for both treatment efficacy and costs.
Results: There was no statistically significant difference in the efficacy of adding either a TZD or glargine in achieving a goal A1C ≤ 7%. However, glargine triple therapy was estimated to be significantly less costly than TZD triple therapy ($3,161/yr; 95% CI $3,116 to $3,356 versus $3,769/yr; 95% CI $3,667 to $3,902, respectively).
Conclusions: Most patients requiring triple therapy for the management of T2DM should receive glargine rather than a TZD due to the significantly lower cost producing similar clinical efficacy.
|
6 |
Insulin Glargine and Cancer Risk: An Opinion Statement of the Endocrine and Metabolism Practice and Research Network of the American College of Clinical PharmacyEdwards, Krystal L., Riche, Daniel M., Stroup, Jeffrey S., Goldman-Levine, Jennifer D., Padiyara, Rosalyn S., Cross, L. B., Kane, Michael P. 01 September 2010 (has links)
Diabetes mellitus has reached epidemic proportions worldwide, eliciting extensive research on both the disease process and its treatment. Regardless of diabetes type, the progressive nature of the disease makes insulin the long-term mainstay of diabetes management. Recently, the insulin analog glargine was reported in several epidemiologic studies to be associated with an increased risk of cancer. Inconsistent study results and media attention have caused much angst and concern to health care professionals and the general population. A clear understanding of the current evidence is needed to adequately develop a patient-oriented risk:benefit assessment. Members of the Endocrine and Metabolism Practice and Research Network of the American College of Clinical Pharmacy evaluated available evidence to provide guidance and discussion on the risk of cancer with insulin glargine use. We believe the current link between insulin glargine and cancer is tenuous but merits further evaluation. An independent analysis of all available glargine clinical trial data should be performed, and a vigorous postmarketing safety study of glargine should be conducted. Until more substantial data are available, however, neither the choice of initial insulin therapy nor insulin maintenance regimens should be influenced by the current information linking insulin glargine to cancer.
|
7 |
Évaluation d'une cohorte d'enfants diabétiques de type I traités selon un schéma basal-bolus en relais d'un schéma conventionnelPotier, Grégory. Brouard-Orzechowski, Christine. January 2006 (has links) (PDF)
Thèse d'exercice : Médecine. Médecine générale : Paris 12 : 2006. / Titre provenant de l'écran-titre. Bibliogr. f. 53-58.
|
8 |
Custo-utilidade da insulina glargina e insulina isófana (NPH) para o tratamento de pacientes com diabetes mellitus tipo 2 atendidos no Sistema Único de Saúde do Município de RecifeCARVALHO, Dayse Cabral de 31 October 2014 (has links)
Submitted by Fabio Sobreira Campos da Costa (fabio.sobreira@ufpe.br) on 2017-07-17T15:08:05Z
No. of bitstreams: 2
license_rdf: 811 bytes, checksum: e39d27027a6cc9cb039ad269a5db8e34 (MD5)
CUSTO UTILIDADE DA INSULINA GLARGINA E NPH REV 4.pdf: 871032 bytes, checksum: 61243dd09cce2d9260cb9239a873d2ca (MD5) / Made available in DSpace on 2017-07-17T15:08:06Z (GMT). No. of bitstreams: 2
license_rdf: 811 bytes, checksum: e39d27027a6cc9cb039ad269a5db8e34 (MD5)
CUSTO UTILIDADE DA INSULINA GLARGINA E NPH REV 4.pdf: 871032 bytes, checksum: 61243dd09cce2d9260cb9239a873d2ca (MD5)
Previous issue date: 2014-10-31 / INTRODUÇÃO: O Diabetes Mellitus é um transtorno metabólico, caracterizado por
hiperglicemia. É considerada condição sensível à Atenção Primária, tendo impacto
por reduzir ou retardar as complicações da doença. A reposição de insulina para o
diabete mellitus tipo 2 é indicada quando somente mudanças no estilo de vida
associados a hipoglicemiante oral forem insuficientes para obter controle glicêmico.
OBJETIVOS: Determinar o custo-utilidade da insulina glargina e insulina NPH para o
tratamento de pacientes com diabetes mellitus tipo 2 atendidos no Sistema Único de
Saúde do Município de Recife – PE. MÉTODOS: Foi realizada comparação da
categoria custos médicos diretos de duas intervenções terapêuticas indicadas para o
tratamento do diabete mellitus tipo 2. A avaliação de custo-utilidade foi realizada a
partir da perspectiva do Sistema Único de Saúde. Foi considerado um horizonte
analítico de 10 anos. Os dados coletados foram de fontes secundárias, de sistema
de informação em saúde, dados dos relatórios emitidos nos sistemas de
informatização das Farmácias do Recife e da Farmácia do Estado de Pernambuco e
fontes da literatura. Para a análise de decisão, foram consideradas as hipoglicemias
noturnas e não noturnas graves e não graves. RESULTADOS: O indivíduo médio,
representante de Pernambuco, apresenta 8,7 anos de diagnóstico do DM2, recebem
aproximadamente 14,4 frascos de insulina NPH ou Glargina ao ano, dados estes,
utilizados na probabilidade de transição. Para o cenário das complicações agudas, o
custo do usuário foi calculado para 2013: sem complicação em uso da insulina NPH
foi de R$ 1.237,95 e para insulina Glargina R$ 4.935,42. Foi considerado 12
episódios de hipoglicemia noturna grave ao ano. A redução de risco de hipoglicemia
para pacientes em uso da insulina Glargina é de 50,9% apresentando cinco
episódios ao ano. A razão de custo incremental (RCEI) do presente estudo, indica
um valor agregado adicionado de R$ 12.987,4892 por AVAQ ganho a cada ano de
tratamento com a insulina glargina em relação a NPH. CONCLUSÕES: Houve
redução de episódio de hipoglicemia noturna grave da insulina glargina comparado
com a insulina NPH. Os dados apresentados não permite afirmar qual da
intervenção é mais efetiva, apenas mostra que a insulina glargina tem um maior
custo-utilidade e um custo médico direto maior. Os custos incrementais e os
benefícios alcançados em anos de vidas ganhos produziu uma Razão de R$
12.987,4892 ao ano para a insulina glargina. Diante das incertezas acerca da
efetividade das insulinas analisadas, faz-se necessário a realização de estudos
aprofundados entre estas intervenções terapêuticas. / INTRODUCTION: Diabetes mellitus is a metabolic disorder characterized by
hyperglycemia. It is considered sensitive to Primary Health Care, considering its
impacting to reduce or delay complications of the disease. Replacement of insulin for
diabetes mellitus type 2 is indicated only when changes in lifestyle associated with
oral hypoglycemic agents are insufficient to obtain glycemic control. OBJECTIVES:
To determine the cost-utility of insulin glargine and NPH insulin for the treatment of
patients with type 2 diabetes mellitus treated at the Unified Health System of the
Municipality of Recife - Pernambuco. METHODS: We compared the direct medical
costs of category two therapeutic interventions indicated for the treatment of diabetes
mellitus type 2 was performed Assessment of cost-utility analysis was performed
from the perspective of the Health System was considered an analytic horizon of 10
years.. The data were collected from secondary sources of health information system
data reports issued in the computerization of Pharmacies and Pharmacy Recife
Pernambuco State and literature sources systems. For decision analysis, were
considered nocturnal hypoglycemia and nocturnal not serious and not serious.
RESULTS AND DISCUSSION: The average individual, representative of
Pernambuco, has 8.7 years of diagnosis of T2DM, receive approximately 14.4 vials
of NPH or glargine per year, these data are used in the transition probability. For the
setting of acute complications, the user cost was calculated for 2013: Uncomplicated
in use NPH insulin was R$ 1,237.95 and R$ 4,935.42 insulin glargine. Was
considered 12 episodes of severe nocturnal hypoglycemia per year. The reduced risk
of hypoglycemia for patients on insulin glargine is 50.9% with five episodes per year.
The ratio of incremental cost (ICER) of this study, indicates a value added of R$
12,987.4892 per QALY gained every year of treatment with insulin glargine
compared to NPH. CONCLUSION: There was a reduction of severe nocturnal
hypoglycemia episode of insulin glargine compared with NPH insulin. The data
presented allows not say which intervention is most effective, just shows that insulin
glargine has a higher utility cost and a direct medical cost higher. Incremental costs
and benefits achieved gains in years of life produced a ratio of R$ 12.987,4892 year
to insulin glargine. Given the uncertainties about the effectiveness of insulin
analyzed, it is necessary to conduct in-depth studies of these therapeutic
interventions.
|
9 |
What Is the Role of Concentrated Insulin in Diabetes Management?Mospan, Cortney M. 01 June 2016 (has links)
Two concentrated analog insulins, long-acting insulin glargine U-300 (Toujeo) and rapid-acting insulin lispro (Humalog U-200), were recently approved by the FDA. Providers must be aware of clinical differences in these new product formulations compared with their nonconcentrated formulations, so that they can select appropriate patients for these products and minimize drug errors.
|
10 |
DESENVOLVIMENTO E VALIDAÇÃO DE MÉTODOS CROMATOGRÁFICOS PARA AVALIAÇÃO DE TEOR/POTÊNCIA DE INSULINA GLARGINA / DEVELOPMENT AND VALIDATION OF CHROMATOGRAPHIC METHODS FOR THE CONTENT/POTENCY EVALUATION OF INSULIN GLARGINESchramm, Vanessa Grigoletto 30 March 2016 (has links)
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior / hans, and is secreted into the bloodstream. It plays and important role in regulating the
metabolic activities of the body, particularly the homeostasis of the blood glucose. Insulin
glargine is a recombinant human insulin analogue produced by DNA technology using a
strain of Escherichia coli and the insulin glargine differ only by three amino acids from
human insulin. Reversed-phase liquid chromatography (RP-LC) and size exclusion liquid
chromatography (SE-LC) methods were developed and validated for the assessment of insulin
glargine in biopharmaceutical formulations. A RP-LC method was carried out on a Jupiter C4 column (250 mm x 4.6 mm i.d.), maintained at 30 ºC. The mobile phase A consisted of 0.05
M sodium sulphate buffer, pH 2.5, and the mobile phase B was acetonitrile. The SE-LC
method was carried out on a BioSep-SEC-S 2000 column (300 mm x 7.8 mm i.d.),
maintained at 25 ºC. The mobile phase consisted of 0.03 M MES acid buffer, pH 2.5, run
isocratically at a flow rate of 0.6 mL/min. Chromatographic separation was obtained with
retention times of 7.5 min, and 9.9 min, and was linear over the concentration range of 0.05 -
200 μg/mL (R2 = 0.9998) and 0.02 - 180 μg/mL (R2 = 0.9999), respectively, for RP-LC and
SE-LC, with photodiode array (PDA) detection at 214 nm and 200 nm for RP-LC and SE-LC
methods, respectively. The limits of detection and quantitation were 0.018 and 0.054 μg/mL,
respectively, for the RP-LC and 0.009 and 0.027 μg/mL, for the SE-LC. Specificity was
established in degradation studies, which also showed that there was no interference of the
excipients. Equally, the accuracy was 100.13% and 99.38%, with bias lower than 0.85% and
than 0.86%. The validated methods were applied for the determination of insulin glargine and
related proteins and high molecular mass, in biotechnology-derived products, giving lower
mean differences of the estimated content/potencies of 0.21% and 0.16% for the RP-LC and
SE-LC related, compared to the in vitro cell culture assay. It is concluded that represents a
contribution to establish alternatives to monitor stability, quality control and thereby assure
therapeutic efficacy of the biotechnology-derived medicine. / A insulina humana é um hormônio secretado pelas células β, das ilhotas de
Langerhans, e regula os níveis sanguíneos de glicose. A insulina glargina é produzida pela
tecnologia do DNA recombinante, expressa em Escherichia coli, e difere da insulina humana
pela modificação da aspargina na posição 21 da cadeia A por uma glicina, além da adição de
dois resíduos de arginina C-terminais na cadeia B. No presente trabalho foram desenvolvidos
e validados métodos por cromatografia líquida em fase reversa (CL-FR) e por exclusão
molecular (CL-EM) para a avaliação de insulina glargina em formulações biofarmacêuticas.
No método por CL-FR, foi utilizada coluna Júpiter C4 (250 mm x 4,6 mm d.i.), mantida a 30
ºC. A fase móvel A foi constituída por tampão sulfato de sódio 0,05 M, pH 2,5, e a fase móvel
B por acetonitrila, eluídas com fluxo constante de 0,5 mL/min. No método por CL-EM foi
utilizada coluna BioSep-SEC-S 2000 (300 mm x 7.8 mm d.i.), mantida a 25 ºC. A fase móvel
foi constituída de tampão MES 0,03 M, pH 2,5, eluída em vazão isocrática de 0,6 mL/min.
Para ambos os métodos utilizou-se detector de arranjo de diodos (DAD) com detecções em
214 nm e 200 nm para CL-FR e CL-EM, respectivamente. A separação cromatográfica foi
obtida nos tempos de 7,5 e 9,9 min, sendo linear na faixa de concentração de 0,05 - 200
μg/mL (R2 = 0,9998) e 0,02 - 180 μg/mL (R2 = 0,9999), respectivamente, para os métodos
por CL-FR e CL-EM. Os limites de detecção e quantificação foram 0,018 e 0,054 μg/mL,
respectivamente, para o método por CL-FR e 0,009 e 0,027 μg/mL por CL-EM. A
especificidade foi avaliada em estudos de degradação, que também demonstraram que não
houve interferência dos excipientes. A exatidão foi 100,13 e 99,38%, com bias inferior a 0,85
e 0,86%, respectivamente, para os métodos por CL-FR e CL-EM. Os métodos propostos
foram aplicados para avaliação da potência de insulina glargina, de proteínas relacionadas
agregados de alta massa molecular em formulações biofarmacêuticas, e os resultados foram
comparados com o bioensaio por cultura de células in vitro, observando-se diferenças das
médias de teor/potência 0,21% e 0,16% inferiores para os métodos por CL-FR e CL-EM.
Concluí-se que representa contribuição para estabelecer procedimentos para monitorar a
estabilidade, o controle da qualidade, garantindo a segurança e eficácia terapêutica do
produto biotecnológico.
|
Page generated in 0.0241 seconds