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Introducción: La diabetes mellitus tipo 2 es un problema de salud pública mundial y es una de las principales causas de mortalidad en Ecuador. La Sitagliptina fue el primer fármaco potenciador del sistema de las incretinas comercializado localmente. Los países no tienen recursos ilimitados para atender las necesidades de salud de su población, por lo que deben adoptar las intervenciones sanitarias más adecuadas, considerando los costos que un país pueda asumir y sostener. Objetivo: Sintetizar los resultados de estudios de costo-efectividad de la sitagliptina para el tratamiento oral combinado de pacientes adultos con diabetes tipo 2 en comparación con sulfonilureas. Metodología: Se realizó una revisión sistemática sin metaanálisis basado en las recomendaciones PRISMA. Los términos de búsqueda se estructuraron en base a la estrategia PICO y la pesquisa se realizó en las bases de datos: Pubmed, Tripdatabase y Pubmed Central para artículos de evaluaciones de tecnologías sanitarias, evaluaciones económicas y guías de práctica clínica, y para las políticas de cobertura se utilizó HTAiVortal y Google avanzado. Resultados: Se seleccionaron 3 ensayos clínicos y 8 revisiones sistemáticas-metaanálisis, 2 estudios de cohorte, 3 políticas de cobertura y 1 estudio de costo-efectividad. Tres revisiones sistemáticas establecieron pocos efectos modestos en cuanto a los efectos hipoglicemiantes de sitagliptina en adultos y adultos mayores; con un bajo riesgo de hipoglicemia. Un metaanálisis de 25 ensayos clínicos reportó mayor riesgo cardiovascular en los pacientes tratados con sitagliptina. Una revisión sistemática con evaluación económica mostró que la sitagliptina con metformina fue una alternativa costo-efectiva versus añadir una sulfonilurea o roziglitazona. Conclusiones: Por el perfil de costo-efectividad podría considerarse a la sitagliptina como segundo fármaco para pacientes que no consiguen control glicémico con dosis máximas de metformina, o en donde su asociación a una sulfonilurea no sea factible (por riesgos de hipoglicemia o adultos mayores).
Introduction: Type 2 diabetes mellitus is a global public health problem, being one of the main causes of mortality in Ecuador. Sitagliptin was the first locally marketed incretin-enhancing drug. Countries do not have unlimited resources to meet the health needs of their population, so they must adopt the most appropriate health interventions, considering the costs that a country can assume and sustain. Objective: To synthesize the results of cost-effectiveness studies of sitagliptin for combined oral treatment of adult patients with type 2 diabetes, compared with sulfonylureas.Methodology: This is a systematic review study without meta-analysis, conducted on PRISMA recommendations. The in-formation search was structured under the PICO strategy and the searches were conducted in Pubmed, Tripdatabase and Pubmed Central for articles on health technology evaluations, economic evaluations and clinical practice guides and for coverage policies HTAiVortal and advanced Google were used.Results: 3 clinical trials and 8 systematic reviews-meta-analysis, 2 cohort studies, 3 coverage policies and 1 cost-effectiveness study were selected. Three systematic reviews establish few effects regarding the hypoglycemic effects of sitagliptin in adults and elderly, with a low risk of hypoglycemia. A meta-analysis of 25 clinical trials reported an increased cardiovascular risk in patients treated with sitagliptin. A systematic review with economic evaluation showed that sitagliptin with metformin was a cost-effective alternative, versus adding a sulfonylurea or roziglitazone.Conclusions: Due to its cost-effectiveness profile, sitagliptin could be considered as a second drug for patients who do not achieve glycemic control with maximum doses of metformin, or where its association with a sulfonylurea is not feasible (due to risks of hypoglycemia or elderly).
Subject(s)
Humans , Middle Aged , Aged , Diabetes Mellitus/drug therapy , Sitagliptin Phosphate/therapeutic use , Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination , Cost-Effectiveness Analysis , Hypoglycemic AgentsABSTRACT
Objective: Sitagliptin phosphate and metformin hydrochloride tablet is an FDA approved combination product for the treatment of diabetes mellitus type 2. There are no reported evidence for estimation of undesired (S)-sitagliptin in a combination product. The objective of this study was to develop a high sensitive liquid chromatography method for the determination of (S)-enantiomer of sitagliptin phosphate in a fixed dose combination formula of metformin and sitagliptin. Methods: The proposed novel high-performance liquid chromatography (HPLC) method uses programmed gradient elution of a mixture of ethanol-diethylamine(DEA) 100:0.1 (v/v) as mobile phase-A and a mixture of methanol-water 60:40 (v/v) as mobile phase-B. The chromatographic conditions were designed to nullify the metformin interference and in which sitagliptin enantiomers elute first and followed by metformin. A satisfactory resolution (≥2.5) between (S)-sitagliptin and active form (R)-sitagliptin was achieved with gradient elution on Chiralpak IA column (5μm, 4 × 250 mm) at a flow rate of 0.5 ml/min and the detector wavelength set at 265 nm. The injection volume set as 10 µl. The developed method has been validated as per the International Conference on Harmonisation (ICH) guidelines. Results: The proposed HPLC method for determination of (S)-sitagliptin, showed good linearity in the concentration range of 0.5 µg/ml to 13.6 µg/ml and capable to quantify accurately up to the lowest level (LOQ) of 0.017%. The validated method was successfully applied to quantify the (S)-sitagliptin for different marketed formulations of sitagliptin with metformin and sitagliptin alone, and the corresponding recovery values were found to be in the range of 95.1% to 98.4%. Conclusion: The proposed validated HPLC method was found to be suitable for the quantitative determination of (S)-sitagliptin in the formulations of sitagliptin with metformin and sitagliptin alone.
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OBJECTIVE: To assess the efficacy and safety of sitagliptin compared with voglibose added to combined metformin and insulin in patients with newly diagnosed type 2 diabetes (T2DM). METHODS: In this 12-week prospective, randomized, parallel trial, 70 newly diagnosed T2DM patients with glycosylated hemoglobin (HbA1c) ≥9% and/or fasting plasma glucose (FPG) ≥11.1 mmol/L were randomized (1:1) to receive sitagliptin 100 mg per day + metformin + insulin glargine or voglibose 0.2 mg three times daily + metformin + insulin glargine. Change in HbA1c at week 12 was the primary endpoint. RESULTS: The mean baseline HbA1c was 11.0% in the patients. The changes in HbA1c from baseline were -6.00% in the sitagliptin group and -3.58% in the voglibose group, and the between-group difference was -2.42% (95% CI -1.91 to -2.93, p=0.02). The differences in FPG and homeostatic model assessment of β-cell function (HOMA-β) and the change in body weight between groups from baseline were -2.95 mmol/L (p=0.04), 43.91 (p=0.01) and -2.23 kg (p=0.01), respectively. One patient (2.9%) in the sitagliptin group and three patients (8.6%) in the voglibose group exhibited hypoglycemia. CONCLUSIONS: Sitagliptin added to combined metformin and insulin therapy showed greater efficacy and good safety regarding hypoglycemia in patients with newly diagnosed T2DM compared with voglibose.
Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Diabetes Mellitus, Type 2/drug therapy , Sitagliptin Phosphate/therapeutic use , Hypoglycemic Agents/therapeutic use , Inositol/analogs & derivatives , Metformin/therapeutic use , Prospective Studies , Treatment Outcome , Inositol/therapeutic useABSTRACT
BACKGROUND: We evaluated the efficacy and safety of acarbose add-on therapy in Korean patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with metformin and sitagliptin. METHODS: A total of 165 subjects were randomized to metformin and sitagliptin (Met+Sita, n=65), metformin, sitagliptin, and acarbose (Met+Sita+Acarb, n=66) and sitagliptin and acarbose (Sita+Acarb, exploratory assessment, n=34) therapy in five institutions in Korea. After 16 weeks of acarbose add-on or metformin-switch therapy, a triple combination therapy was maintained from week 16 to 24. RESULTS: The add-on of acarbose (Met+Sita+Acarb group) demonstrated a 0.44%±0.08% (P<0.001 vs. baseline) decrease in glycosylated hemoglobin (HbA1c) at week 16, while changes in HbA1c were insignificant in the Met+Sita group (−0.09%±0.10%, P=0.113). After 8 weeks of triple combination therapy, HbA1c levels were comparable between Met+Sita and Met+Sita+Acarb group (7.66%±0.13% vs. 7.47%±0.12%, P=0.321). Acarbose add-on therapy demonstrated suppressed glucagon secretion (area under the curve of glucagon, 4,726.17±415.80 ng·min/L vs. 3,314.38±191.63 ng·min/L, P=0.004) in the absence of excess insulin secretion during the meal tolerance tests at week 16 versus baseline. The incidence of adverse or serious adverse events was similar between two groups. CONCLUSION: In conclusion, a 16-week acarbose add-on therapy to metformin and sitagliptin, effectively lowered HbA1c without significant adverse events. Acarbose might be a good choice as a third-line therapy in addition to metformin and sitagliptin in Korean subjects with T2DM who have predominant postprandial hyperglycemia and a high carbohydrate intake.
Subject(s)
Humans , Acarbose , Diabetes Mellitus, Type 2 , Drug Therapy, Combination , Glucagon , Glycated Hemoglobin , Hyperglycemia , Incidence , Insulin , Korea , Meals , Metformin , Sitagliptin PhosphateABSTRACT
Resumen La diabetes es una enfermedad con importante prevalencia en todo el mundo. Se calcula que cerca de 415 millones de personas la padecen en la actualidad y que para el año 2040 esta cifra aumentará poco más del 50%. Debido a esto, se estima que gran parte de los ingresos por urgencias serán de pacientes diabéticos o sujetos a los cuales esta patología se les diagnosticará en dicha hospitalización; esta situación hace necesario conocer los lineamientos y las recomendaciones de las guías para el manejo intrahospitalario de los pacientes con hiperglucemia. El pilar fundamental del manejo hospitalario de diabetes es la monitorización intensiva, junto con la educación al paciente y la administración de insulina. El control glicémico es clave debido a que disminuye complicaciones intrahospitalarias. Cabe resaltar que el control estricto puede llevar a hipoglucemias, por lo que los episodios deben ser debidamente documentados y su causa corregida de inmediato.
Abstract Diabetes is a disease with significant prevalence worldwide. According to the latest estimates, about 415 million people suffer from this condition and this figure will almost double by 2040. For this reason, a large part of emergency admissions will be related to diabetic patients or subjects who will be diagnosed with this pathology while hospitalized. Hospital-related hyperglycemia due to stress, medications and parenteral nutrition are also a common finding. In consequence, it is imperative for health care providers to become familiar with inpatient hyperglycemia management. Intensive glucose monitoring, patient education and insulin administration are essential for treating this condition. Glycemic control is fundamental as it decreases nosocomial complications. It should be noted that strict control may lead to hypoglycemia, so episodes should be properly documented and their cause corrected immediately.
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OBJECTIVE:To observe the effects of sitagliptin phosphate combine with acarbose on blood glucose,blood lipid and the serum glucose transporter 4(GLUT4)in elderly patients with type 2 diabetes. METHODS:86 elderly patients with type 2 diabetes were randomly divided into control group and observation group,43 cases in each group. All patients received guidance about diet,exercise and living habits,etc.,as well as the care about psychology and medication. Based on it,control group was given Acarbose tablet 50 mg/times,tid,chewing when a meal;observation group was given Acarbose tablet(the same dosage and usage)+ Sitagliptin phosphate tablet 100 mg/times,qd,orally. They were treated for 3 months. Fasting blood glucose(FBG),2 h postprandial blood glucose(2 hPG),glycosylated hemoglobin(HbAlc),body mass index(BMI),fasting insulin(FINs),insulin resistance index(HOMA-IR),islet B-cell function index(HOMA-B),total cholesterol(TC),triglyceride(TG),low-density lipo-protein cholesterol(LDL-C),high-density lipoprotein cholesterol(HDL-C)before and after treatment in 2 groups were compared, the incidence of adverse reactions was recorded. Other 43 healthy people were selected as healthy control group,the differences of serum GLUT4 levels before and after treatment between the 2 groups and healthy control group were respectively compared. RE-SULTS:After treatment,the BMI,FBG,2 hPG,HbAlc,HOMA-IR,FINs,TC,TG and LDL-C level were significantly lower than before,observation group was lower than control group;HOMA-B and HDL-C level were significantly higher than before,ob-servation group was higher than control group,with statistical significance(P0.05),while the serum GLUT4 level in observation group was significant higher than before and control group;and the serum GLUT4 level in 2 groups were still significant lower than healthy control group(P0.05). CON-CLUSIONS:Sitagliptin phosphate combine with acarbose can effectively control patients'blood glucose and lipid levels in the treatment of elderly patients with type 2 diabetes,improve HOMA-B and serum GLUT4 level,and does not increase the incidence of adverse reactions,with good safety.
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Objective To investigate the effect of atorvastatin calcium combined with sitagliptin phosphate on β2-microglobulin (β2-MG ) in peripheral blood and serum uric acid ( UA) levels in patients with type 2 diabetes.Methods A total of 78 patients with type 2 diabetes in endocrinology department from Hangzhou Xiasha Hospital were collected and randomly divided into the control group and the experimental group, with 39 cases in each group.The two groups of patients were treated by conventional treatment, life intervention, the control group were treated by metformin hydrochloride sustained-release tablet and sitagliptin phosphate, the experimental group were treated on the basis of control group with atorvastatin calcium.Both groups were treated for 3 cycles, one cycle for 7 days.The clinical curative effect,β2-MG in peripheral blood and urine, serum UA levels and adverse reactions were compared between two groups after treatment.Results After treatment, compared with control group, the clinical total effective rate in experimental group was higher (P<0.05).The serum IgG,β2-MG, urineβ2-MG and UAlb, serum UA levels were lower in two groups post-treatment compared with pre-treatment(P<0.05).Compared with control group, serum IgG, β2-MG, urine β2-MG and UAlb, serum UA levels were lower (P<0.05).There was no significant difference between two groups.Conclusion The atorvastatin calcium combined with sitagliptin phosphate has a significant efficacy in the treatment of patients with type 2 diabetes, it could down-regulate β2-MG in peripheral blood and urine and serum UA levels, improve immunity and prevent patients from cardiovascular complications.
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BACKGROUND: The use of dipeptidyl peptidase-4 (DPP-4) inhibitors is increasing among renal transplant patients with diabetes. However, the glucose-lowering efficacies of various DPP-4 inhibitors and their effects on blood cyclosporine levels have not been fully investigated. We compared the glucose-lowering efficacies of DPP 4 inhibitors and evaluate their effects on the blood levels of cyclosporine in renal transplant recipients with diabetes. METHODS: Sixty-five renal allograft recipients who received treatment with DPP-4 inhibitors (vildagliptin, sitagliptin, or linagliptin) following kidney transplant were enrolled. The glucose-lowering efficacies of the DPP-4 inhibitors were compared according to the changes in the hemoglobin A1c (HbA1c) levels after 3 months of treatment. Changes in the trough levels of the cyclosporine were also assessed 2 months after treatment with each DPP-4 inhibitor. RESULTS: HbA1c significantly decreased in the linagliptin group in comparison with other DPP-4 inhibitors (vildagliptin –0.38%±1.03%, sitagliptin –0.53%±0.95%, and linagliptin –1.40±1.34; P=0.016). Cyclosporine trough levels were significantly increased in the sitagliptin group compared with vildagliptin group (30.62±81.70 ng/mL vs. –24.22±53.54 ng/mL, P=0.036). Cyclosporine trough levels were minimally changed in patients with linagliptin. CONCLUSION: Linagliptin demonstrates superior glucose-lowering efficacy and minimal effect on cyclosporine trough levels in comparison with other DPP-4 inhibitors in kidney transplant patients with diabetes.
Subject(s)
Humans , Allografts , Cyclosporine , Diabetes Mellitus , Dipeptidyl-Peptidase IV Inhibitors , Hyperglycemia , Kidney , Kidney Transplantation , Pilot Projects , TransplantationABSTRACT
Objective To observe the effect of Sitagliptin Phosphate Tablets combined with shenmai on type 2 diabetes.Methods Sixty diabetes patients were divided into two groups randomly:treatment group were received Sitagliptin Phosphate Tablets and shenmai;the control group were given acarbose.14 weeks later,the indications FBG,2HBG,HbA1 C,TC,TG,LDL-C,HDL-C,hypoglycemia happen rate,BMI,blood rheology,transcranial Doppler ultrasound(TCD)were tested to see if there is any change.Results After treatment,two groups of FBG,2hBG,HbA1 C,TC,TG,LDL-C,HDL-C levels compared with those before treatment were statistically significant(P＜0.05 or P＜0.01),but the treatment group on lipid control more than those in the control group;treatment group therapy in reducing the risk of hypoglycaemia and weight gain than the control group(P＜0.05);the whole blood viscosity,plasma viscosity,low viscosity and hematocrit of treatment group were significantly lower(P＜0.05),while the control group showed no significant change;the abnormal rate of treatment group was 52.6％,significantly better than the control group 86.5％(P＜0.05).Conclusion The effect of Sitagliptin Phosphate Tablets combined with shenmai on type 2 diabetes was significant,compared with the traditional antidiabetic drugs,the combination is effective hypoglycemic control fat and less adverse reactions.