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1.
Indian J Ophthalmol ; 68(2): 391-395, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31957735

RESUMO

Purpose: An observational study to assess the sensitivity and specificity of the Medios smartphone-based offline deep learning artificial intelligence (AI) software to detect diabetic retinopathy (DR) compared with the image diagnosis of ophthalmologists. Methods: Patients attending the outpatient services of a tertiary center for diabetes care underwent 3-field dilated retinal imaging using the Remidio NM FOP 10. Two fellowship-trained vitreoretinal specialists separately graded anonymized images and a patient-level diagnosis was reached based on grading of the worse eye. The images were subjected to offline grading using the Medios integrated AI-based software on the same smartphone used to acquire images. The sensitivity and specificity of the AI in detecting referable DR (moderate non-proliferative DR (NPDR) or worse disease) was compared to the gold standard diagnosis of the retina specialists. Results: Results include analysis of images from 297 patients of which 176 (59.2%) had no DR, 35 (11.7%) had mild NPDR, 41 (13.8%) had moderate NPDR, and 33 (11.1%) had severe NPDR. In addition, 12 (4%) patients had PDR and 36 (20.4%) had macular edema. Sensitivity and specificity of the AI in detecting referable DR was 98.84% (95% confidence interval [CI], 97.62-100%) and 86.73% (95% CI, 82.87-90.59%), respectively. The area under the curve was 0.92. The sensitivity for vision-threatening DR (VTDR) was 100%. Conclusion: The AI-based software had high sensitivity and specificity in detecting referable DR. Integration with the smartphone-based fundus camera with offline image grading has the potential for widespread applications in resource-poor settings.

2.
J Assoc Physicians India ; 67(9): 65-68, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31561692

RESUMO

Background: Current European hypertension guidelines recommend to initiate the treatment of patients with moderate to severe hypertension with a Single Pill Combination (SPC) containing two drugs, as SPC use leads to more effective and faster blood pressure control. The guidelines also recommend tighter blood pressure control in hypertensive patients with cardiovascular risk factors such as diabetes mellitus. Objective: To evaluate efficacy on blood pressure reduction and acceptability of the single pill combination of Perindopril/Indapamide in patients with moderate to severe hypertension. Methods: In this multicentre, prospective, observational study, patients with moderate to severe hypertension were prescribed Perindopril 4mg/ Indapamide 1.25 mg for 90 days. The primary outcomes were blood pressure decrease and achievement of BP control. Patients were up-titrated to Perindopril 8 mg/Indapamide 2.5 mg SPC, if target BP control (≤140/90 mm Hg) could not be achieved by day 30. Results: In this study, 173 hypertensive patients, with a mean age of 51 years were enrolled at 3 centres from different geographic areas within India. Mean SBP/DBP decreased significantly from baseline (155.70 (±10.39) / 95.72 (±6.99) mmHg) over 90 days (30.31 (±14.15) / 17.14 (±9.33) mmHg; p < 0.0000). Few side effects were reported during the 90-day period. Conclusion: : Perindopril/Indapamide given as a SPC was found to be an effective and well-tolerated antihypertensive combination resulting in rapid blood pressure control in patients with moderate to severe hypertension.


Assuntos
Anti-Hipertensivos/uso terapêutico , Hipertensão/tratamento farmacológico , Indapamida/uso terapêutico , Perindopril/uso terapêutico , Pressão Sanguínea , Combinação de Medicamentos , Humanos , Índia , Pessoa de Meia-Idade , Estudos Prospectivos
3.
Diabetes Obes Metab ; 20(6): 1535-1541, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29436761

RESUMO

We investigated the long-term efficacy and safety of gemigliptin and the efficacy and safety of gemigliptin treatment after once-daily treatment with sitagliptin 100 mg, in patients with type 2 diabetes. This was a 28-week extension of a 24-week, randomized, double-blind, parallel study of gemigliptin or sitagliptin added to ongoing metformin therapy. After randomization to sitagliptin 100 mg qd (S), gemigliptin 25 mg bid (G1) or gemigliptin 50 mg qd (G2) and after completing 24 weeks of treatment, 118 patients switched from gemigliptin 25 mg bid to 50 mg qd (G1/G2), 111 patients continued gemigliptin 50 mg qd (G2/G2) and 106 patients switched from sitagliptin 100 mg qd to gemigliptin 50 mg qd (S/G2). All 3 treatments reduced glycated haemoglobin (HbA1c) (S/G2,-0.99% [95% CI -1.25%, -0.73%]; G1/G2, -1.11% [95% CI -1.33%, -0.89%]; G2/G2, -1.06% [95% CI -1.28%, -0.85%]). The percentage of patients achieving HbA1c < 6.5% was 27.6% in the G1/G2 group at both Week 24 and Week 52, and ranged from 27.3% to 32.7% in the G2/G2 group (difference in proportions, 5% [95% CI -6%, 17%]), while it increased from 6.8% to 27.3% from Week 24 to Week 52 in the S/G2 group (difference in proportions, 20% [95% CI 7%, 34%]). Addition of gemigliptin 50 mg qd to metformin was shown to be efficacious for 52 weeks. Switching from sitagliptin 100 mg to gemigliptin 50 mg showed consistent glyacemic control over the previous treatment.


Assuntos
Diabetes Mellitus Tipo 2/prevenção & controle , Inibidores da Dipeptidil Peptidase IV/administração & dosagem , Hipoglicemiantes/administração & dosagem , Metformina/administração & dosagem , Piperidonas/administração & dosagem , Pirimidinas/administração & dosagem , Fosfato de Sitagliptina/administração & dosagem , Idoso , Diabetes Mellitus Tipo 2/sangue , Inibidores da Dipeptidil Peptidase IV/efeitos adversos , Método Duplo-Cego , Esquema de Medicação , Substituição de Medicamentos , Feminino , Hemoglobina A Glicada/efeitos dos fármacos , Hemoglobina A Glicada/metabolismo , Humanos , Hipoglicemiantes/efeitos adversos , Masculino , Metformina/efeitos adversos , Pessoa de Meia-Idade , Piperidonas/efeitos adversos , Pirimidinas/efeitos adversos , Fosfato de Sitagliptina/efeitos adversos , Resultado do Tratamento
4.
Diabetes Ther ; 7(4): 765-776, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27761881

RESUMO

INTRODUCTION: Dapagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, is a promising drug approved for the treatment of type 2 diabetes mellitus (T2DM). However, its cost is an obstacle for use in developing countries like India. Thus, we aimed to analyse the impact on the cost of insulin therapy after adding dapagliflozin for patients using insulin in real-world clinical practice. METHODS: This retrospective chart review study included patients with uncontrolled T2DM previously on maximum doses of OADs and insulin therapy, initiated on dapagliflozin. Parameters measured were: HbA1c, changes in weight and insulin dosage, frequency and cost, at baseline and after 3 months of adding dapagliflozin 10 mg. Hospital records of patients attending the diabetes outpatient departments at the study centres were scrutinised to identify eligible patients. A treat-to-target approach was used to make changes in the insulin dosages and regimen. The cost of insulin was calculated based on the total daily dose, cost per unit based on the formulation and insulin delivery device. Statistical analysis included descriptive and inferential methods. RESULTS: Overall, 70 patients meeting the inclusion criteria were included in the study. The mean age of patients and duration of T2DM were 52.6 ± 10 and 12 ± 5 years respectively. The mean reduction in HbA1c and weight was 2.1 ± 1% (p < 0.01) and 2.4 ± 1 kg (p < 0.01) respectively. Genital mycotic infections were reported in two (2.8%) patients. The mean reduction in the total daily dose of insulin was 9.5 ± 6 units. A significant reduction in the daily insulin requirement (19.87%, p < 0.01) was observed. The cost of insulin decreased by 22.3% or 17.8 ± 15 INR per day ($0.27 ± 0.22 per day) and the frequency of insulin shots administered per day decreased significantly (p < 0.01). In 12.8% and 2.8% of patients the frequency of administration of insulin decreased by one and two injections per day respectively. CONCLUSIONS: Reduction in HbA1c and body weight along with minimal side effects was observed. Addition of dapagliflozin reduced the insulin daily dose requirement and cost of insulin therapy in these patients. FUNDING: Diacon Hospital, Bangalore, India.

5.
J Assoc Physicians India ; 64(9): 40-44, 2016 09.
Artigo em Inglês | MEDLINE | ID: mdl-27762514

RESUMO

BACKGROUND AND AIM: The number of patients with type 2 diabetes (T2DM) is increasing. Most patients with T2DM are uncontrolled and fail to achieve their target Hba1c. In recent years, newer agents such as SGLT2 inhibitors (SGLT2i) have been approved for clinical use. Though data from clinical trials and sub set analysis of Indian patients in global studies are promising, real world evidence from standard clinical practice in India is lacking. The aim of this study was to analyze the metabolic parameters in patients with T2DM on SGLT2i in real world clinical practice. MATERIAL AND METHODS: This was a prospective, longitudinal study of 100 patients with uncontrolled T2DM attending the outpatient of a specialized diabetes hospital. Their metabolic parameters were evaluated at baseline and after 3 months of follow up. They were categorized based on their baseline anti diabetic medications into four groups (25 in each).The groups were as follows: metformin plus sulfonylurea, metformin plus DPP4 inhibitor, triple drug regimen with metformin plus DPP4 inhibitor plus sulfonylurea, and patients on insulin and on triple drug therapy with metformin plus sulfonylurea plus DPP4 inhibitor. Patients in each group were initiated with an SGLT2i. Descriptive statistical analysis was carried out using Microsoft excel. T test was used to calculate the p value at 5 % level of significance. RESULTS: The mean age of the subjects in the study population was 53.20±12.1 years and the duration of diabetes was 13.1±7.26 years. The mean Hba1c reduction and weight reduction observed was 1.02±0.24% and 2.64±1.27 kg respectively. Genital pruritis was reported in 4% of the patients. There was a 16.6% reduction in the daily insulin requirement at follow up when compared to baseline. No other side effects were observed. The reductions in Hba1c and weight were statistically significant (p<0.05) across all groups. CONCLUSIONS: This study demonstrates that when SGLT2i are added at any stage of the disease spectrum with any of the preexisting therapeutic agents for patients with uncontrolled T2DM, there is an improvement in glycemic control and body weight, with minimal side effects. The real world study data on Indian patients appears to be promising.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Inibidores do Transportador 2 de Sódio-Glicose , Inibidores da Dipeptidil Peptidase IV/uso terapêutico , Quimioterapia Combinada , Feminino , Hemoglobina A Glicada/análise , Humanos , Índia , Insulina/uso terapêutico , Estudos Longitudinais , Masculino , Metformina/uso terapêutico , Pessoa de Meia-Idade , Estudos Prospectivos , Perda de Peso
6.
Indian J Endocrinol Metab ; 20(1): 114-8, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26904479

RESUMO

CONTEXT: Type 2 diabetes mellitus (T2DM) in young adults is increasing in India. Data on the prevalence of cardiovascular (CV) risk factors and complications associated with young-onset T2DM (YOD) at the time of diagnosis of diabetes are limited. This data can aid in aggressive diabetes management, CV risk reduction, and prevention of complications. AIM: To determine the prevalence of CV risk factors, micro and macrovascular complications in patients with newly diagnosed YOD. To assess the percentage of patients who require statin therapy based on current American Diabetes Association (ADA) guidelines. SETTINGS AND DESIGN: This was a retrospective cross-sectional study of 1500 patients with newly detected YOD across seven centers from 2013 to 2015. DESIGNS AND METHODS: Patients were evaluated for complications of diabetes and CV risk factors such as body mass index (BMI), hypertension, dyslipidemia, and smoking. STATISTICAL ANALYSIS: Measurements have been presented as mean ± standard deviation; results on categorical measurements have been presented in percentages. RESULTS: The mean age, glycated hemoglobin and BMI were 34.7 ± 4.2 years, 9.9 ± 2.4%, and 26.8 ± 4.7 kg/m(2). Hypertension, dyslipidemia, BMI >23 kg/m(2), and smoking were presented in 27.6%, 62.4%, 84.2%, and 24%. Diabetic retinopathy, neuropathy, and nephropathy were seen in 5.1%, 13.2%, and 0.9%. Ischemic heart disease, peripheral vascular disease, and stroke were presented in 0.7%, 2%, and 0.1%. As per current guidelines, 95.33% needed statin therapy. CONCLUSION: This study demonstrates that patients with YOD have micro and macrovascular complications at diagnosis. Nearly, every patient required a statin to reduce CV risk. This highlights the importance of screening patients with YOD for CV risk factors and complications of diabetes at the time of diagnosis.

7.
Diabetes Metab Syndr Obes ; 8: 189-96, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25926748

RESUMO

Diabetes mellitus (DM) is one of the most dreaded metabolic disorders in the world today. It is the leading cause of morbidity and mortality, and plays a cardinal role in quality of life and health economics. DM is associated with a high prevalence of microvascular and macrovascular complications. DM is a very important cardiovascular (CV) risk factor. Cardiovascular disease (CVD) has been implicated as the prime cause of mortality and morbidity in patients with DM. Hence, treatment of DM goes beyond glycemic control, and demands a multidisciplinary approach that comprehensively targets risk factors inherent in CV events. Lipid abnormalities are undoubtedly common in patients with DM, and they contribute to an increased risk of CVD. A high-risk lipid profile, termed atherogenic dyslipidemia of diabetes (ADD), is known to occur in patients with DM. The use of lipid-lowering agents, a quintessential part of the multifactorial risk factor approach, is a crucial intervention to minimize diabetes-related complications. In this article, we discuss the role of peroxisome proliferator activator receptor (PPAR) alpha/gamma (α/γ) agonist, saroglitazar, in the management of ADD. While statins are irrefutably the first line of drugs for dyslipidemia management in patients with residual CV risk while on a statin, PPAR α/γ agonists have been found to be of substantial benefit. Data from the PRESS I-VI clinical trials testify to the fact that saroglitazar and fibrates have similar efficacy in reducing triglycerides and improving high-density lipoprotein. The ancillary benefit of improved glycemic control, without the weight gain of PPAR γ agonists, is an added advantage. Reduction in ADD, improved glycemic control, efficacy at par with fibrates, and an acceptable safety profile form the grounds on which this group of PPAR α/γ agonists, with their novel mechanism, holds a promising future in the management of diabetic dyslipidemia.

8.
Indian J Endocrinol Metab ; 18(3): 355-60, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24944931

RESUMO

BACKGROUND: Prevalence of diabetes is on an increase in India, currently there is limited nation-wide data regarding the prevalence of chronic complications in diabetic patients at diagnosis. This information will help health-care professionals approach management more aggressively to prevent complications. OBJECTIVE: To determine the prevalence of chronic complications in newly-diagnosed Type 2 diabetic (T2D) patients in India. DESIGN AND METHODS: This was a cross-sectional survey of T2D patients, diagnosed within 3 months of their first visit to the centers doing the survey. Each patient was screened for diabetic complications, hypertension, dyslipidemia, and body mass index. Family history was recorded. Standard protocols were used to make the diagnosis of retinopathy, neuropathy and nephropathy. Data analysis was carried out using the standard statistical techniques. RESULTS: Of the total 4,600 (males 67%, females 33%) newly diagnosed patients with T2D, majority were from the age group 41-50 years (40%). 13.15% of newly detected India T2D had neuropathy 6.1% had retinopathy and 1.06% had nephropathy. Risk factors of macro vascular complication such as hypertension, obesity, and dyslipidemia were observed in 23.3%, 26%, and 27% of patients respectively. Ischemic heart disease was noticed in 6%. CONCLUSION: High prevalence of micro vascular complications was present at diagnosis along with association of CV cardiovascular risk factors among Indian T2D. In view of this, screening must be instituted for all diabetics for complications at the time of diagnosis itself.

9.
Arch Med Sci ; 9(5): 936-43, 2013 Oct 31.
Artigo em Inglês | MEDLINE | ID: mdl-24273582

RESUMO

Type 2 diabetes mellitus (T2DM) is one of the most common chronic diseases worldwide, presenting a great challenge to the public health systems due to high morbidity and mortality, because of frequent micro-/macro-vascular complications. Many treatment options are now available, with different efficacy as well as mechanisms of action to improve deranged glucose metabolism. We review some of the available data on derivatives of meglitinide, namely nateglinide and repaglinide. These two compounds increase insulin secretion by a mechanism similar to the one of sulfonylureas, but with a shorter half-life. Nateglinide and repaglinide, derivatives of meglitinides, have characteristic pharmacodynamic and pharmacokinetic properties that, together with their proposed mechanism of action, make them useful for type 2 diabetes mellitus, especially when used in combination therapy.

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