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1.
Cureus ; 16(6): e61634, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38966470

RESUMO

OBJECTIVE: Cardiac autonomic neuropathy (CAN) is one of the most serious complications of diabetes. This study aimed to analyze the correlation between neutrophil-to-lymphocyte ratio (NLR) and CAN in patients with type 2 diabetes (T2D) using 24-hour Holter ECG and to assess the relationship between NLR and severity of diabetic peripheral neuropathy (DPN). SUBJECTS & METHODS:  This cross-sectional study included 90 T2D patients with DPN confirmed by nerve conduction study (NCS). A 24-hour Holter ECG was done to detect the decrease in heart rate variability (HRV). Laboratory parameters, including fasting blood glucose, creatinine, cholesterol, triglyceride, and glycosylated hemoglobin (HbA1c) levels, as well as CBC, neutrophils, lymphocytes, NLR, and platelet-to-lymphocyte ratio (PLR), were calculated accordingly. An albumin-to-creatinine ratio (ACR) test was done and the estimated glomerular filtration rate (eGFR) was calculated. Chronic kidney disease was diagnosed by the presence of albuminuria (≥30 mg/g creatinine) and/or eGFR less than 60. RESULTS: Based on the 24-hour Holter ECG, 25 patients out of 90 (27.7%) had CAN. On comparing both the CAN and non-CAN groups, the CAN group had higher HbA1C (p = 0.005), higher NLR (p = 0.014), and higher neutrophils (p = 0.10). Also, PLR was higher in the CAN group than in the non-CAN group, but this was not statistically significant (p = 0.180). Receiver operator characteristic curve analysis revealed that NLR with a cutoff of 1.7 succeeded in detecting patients with CAN. CONCLUSION: NLR can be used as an inexpensive and accessible marker to detect patients with diabetes at risk for developing CAN.

2.
BMJ Open ; 14(3): e080891, 2024 Mar 07.
Artigo em Inglês | MEDLINE | ID: mdl-38453198

RESUMO

BACKGROUND: Chronic kidney disease (CKD) affects around 10% of the global population and has been estimated to affect around 50% of individuals with type 2 diabetes and 50% of those with heart failure. The guideline-recommended approach is to manage with disease-modifying therapies, but real-world data suggest that prescribing rates do not reflect this in practice. OBJECTIVE: To develop a cross-specialty consensus on optimal management of the patient with CKD using a modified Delphi method. DESIGN: An international steering group of experts specialising in internal medicine, endocrinology/diabetology, nephrology and primary care medicine developed 42 statements on aspects of CKD management including identification and screening, risk factors, holistic management, guidelines, cross-specialty alignment and education. Consensus was determined by agreement using an online survey. PARTICIPANTS: The survey was distributed to cardiologists, nephrologists, endocrinologists and primary care physicians across 11 countries. MAIN OUTCOMES AND MEASURES: The threshold for consensus agreement was established a priori by the steering group at 75%. Stopping criteria were defined as a target of 25 responses from each country (N=275), and a 4-week survey period. RESULTS: 274 responses were received in December 2022, 25 responses from Argentina, Australia, Brazil, Guatemala, Mexico, Singapore, South Korea, Taiwan, Thailand, Turkey and 24 responses from Egypt. 53 responses were received from cardiologists, 52 from nephrologists, 55 from endocrinologists and 114 from primary care physicians. 37 statements attained very high agreement (≥90%) and 5 attained high agreement (≥75% and <90%). Strong alignment between roles was seen across the statements, and different levels of experience (2-5 years or 5+ years), some variation was observed between countries. CONCLUSIONS: There is a high degree of consensus regarding aspects of CKD management among healthcare professionals from 11 countries. Based on these strong levels of agreement, the steering group derived 12 key recommendations focused on diagnosis and management of CKD.


Assuntos
Diabetes Mellitus Tipo 2 , Nefrologia , Insuficiência Renal Crônica , Humanos , Consenso , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/terapia , Nefrologistas , Nefrologia/métodos
3.
Curr Diabetes Rev ; 2023 Aug 11.
Artigo em Inglês | MEDLINE | ID: mdl-37581325

RESUMO

AIM: This non-interventional observational study aimed to describe the clinical outcomes of patients with T2DM treated with Gla-300 during the period of Ramadan. BACKGROUND: Type 2 diabetes mellitus (T2DM) patients who decide to fast during the holy month of Ramadan face several challenges in achieving glycemic control without increasing the risk of hypoglycemia. Insulin glargine-300 (Gla-300) has well-established safety and efficacy in improving glycemic control in multiple randomized clinical trials (RCTs). However, limited evidence is available regarding its safety and effectiveness during fasting. OBJECTIVE: The objective of this study was to assess the safety and clinical outcomes of insulin glargine-300 (Gla-300) in T2DM patients before, during, and after Ramadan. METHODS: We conducted a prospective, observational, non-comparative, multicenter study on patients with T2DM currently treated with Gla-300 who planned to fast and continue on Gla-300 during Ramadan in four countries (Egypt, Jordan, Lebanon, and Turkey). The study outcomes included the change in glycemic parameters and incidence of hypoglycemia before, during, and after Ramadan. RESULTS: One hundred and forty T2DM patients were included. Nearly 61% of the included patients had a duration of diabetes of <10 years. The mean Gla-300 daily doses during the pre-Ramadan, Ramadan, and post-Ramadan periods were 22.2 ±7.4, 20.4 ±7.5, and 22.5 ±4.7 IU, respectively. The mean change values from pre-Ramadan to Ramadan and post-Ramadan were -1.7 ±6.9 IU and 0.5 ±4.7 IU, respectively, among the included patients. The mean HbA1c decreased during the study period initiating from 7.9 ±1.4% pre-Ramadan to 6.9 ±0.4% post-Ramadan. The overall HBA1c target value was 6.9 ±0.4%, while the HbA1c target was achieved by 29 patients (21.9%). The mean fasting blood glucose (FPG) showed a reduction from baseline value in the post-Ramadan period by -0.9 ±2.3mmol/L. Five patients (3.57%) had symptomatic documented hypoglycemia during Ramadan, and none was considered to have severe hypoglycemia. CONCLUSION: Our study showed that insulin Gla-300 maintained the glycemic control of T2DM patients who decided to fast during the holy month of Ramadan without increasing the risk of hypoglycemia. Regular self-monitoring of blood glucose levels during Ramadan is highly recommended to avoid possible complications.

5.
Diabetes Obes Metab ; 25(6): 1444-1452, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-36775980

RESUMO

AIM: To investigate the epidemiology and clinical management of patients with type 2 diabetes (T2D) and established atherosclerotic cardiovascular disease (eASCVD) or high/very high ASCVD risk, defined by the 2021 European Society of Cardiology Guidelines, in seven countries in the Middle East and Africa (PACT-MEA; NCT05317845), and to assess physicians' attitudes and the basis for their decision-making in the management of these patients. MATERIALS AND METHODS: PACT-MEA is a cross-sectional, observational study undertaken in Bahrain, Egypt, Jordan, Kuwait, Qatar, South Africa and the United Arab Emirates based on a medical chart review of approximately 3700 patients with T2D in primary and secondary care settings, and a survey of approximately 400 physicians treating patients with T2D. RESULTS: The primary and secondary objectives are to determine the prevalence of eASCVD and high/very high ASCVD risk in patients with T2D. Current treatment with cardioprotective antidiabetic medication, the proportion of patients meeting the treatment criteria for reimbursement in the study countries where there is an applicable reimbursement guideline, and physician-reported factors in clinical decision-making in T2D management, will also be assessed. CONCLUSIONS: This large cross-sectional study will establish the estimated prevalence and management of eASCVD and high/very high ASCVD risk in patients with type 2 diabetes across the Middle East and Africa.


Assuntos
Aterosclerose , Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Humanos , Estudos Transversais , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Prevalência , Oriente Médio/epidemiologia , África , Aterosclerose/epidemiologia , Aterosclerose/terapia , Fatores de Risco
6.
Artigo em Inglês | MEDLINE | ID: mdl-36204125

RESUMO

Background: Medicinal plants have long been used for the treatment of type 2 diabetes mellitus (T2DM). This study aimed to investigate the hypoglycemic efficacy and safety of NW Low-Glu® (contents of one capsule are 300 mg Mas Cotek + 100 mg Cinnamomum cassia L. + 250 mg Nigella sativa L. powdered extracts) in treatment-naïve, newly diagnosed T2DM patients. Methods: This was a 12-week, double-blind, double-dummy, randomized, phase 2 clinical trial. A total of 232 male and female patients aged ≥18 and ≤65 years who were newly diagnosed with T2DM and have not received any antidiabetic drugs before and were equally randomized to receive metformin (2000 mg per day), low-dose NW Low-Glu® (content of four capsules per day), or high-dose NW Low-Glu® (content of five capsules per day). Our primary objective was to measure the mean change in HbA1c between each of the experimental arms and the metformin arm. Results: There was a significant reduction in mean HbA1c at 12 weeks compared to baseline in the low-dose (0.6 (1.4)%; p=0.002) and high-dose arms (0.8 (1.7)%; p=0.004). There was also a significant reduction in 2 hr PPG at 12 weeks in the low-dose (35.4 (74.9) mg/dL, p=0.001) and high-dose arms (24.7 (100.8) mg/dL, p=0.04). Weight reduction was significantly higher with both high-dose (1.1 (-1.7) Kg; p=0.005) and low-dose arms (0.9 (-1.5) Kg; p=0.023) compared to metformin (0.8 (-1.8) Kg). No serious AEs or deaths were reported. Conclusions: After 3 months of treatment, NW Low-Glu® was noninferior to metformin in reducing HbA1c and 2 hr PPG, while leading to significantly higher weight reduction in newly diagnosed T2DM patients. It was also safe and well tolerated.

7.
Diabetes Res Clin Pract ; 185: 109185, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-35016991

RESUMO

Fasting during Ramadan is one of the five pillars of Islam and is obligatory for all healthy Muslims from the age of puberty. Though individuals with some illness and serious medical conditions, including some people with diabetes, can be exempted from fasting, many will fast anyway. It is of paramount importance that people with diabetes that fast are given the appropriate guidance and receive proper care. The International Diabetes Federation (IDF) and Diabetes and Ramadan (DaR) International Alliance have come together to provide a substantial update to the previous guidelines. This update includes key information on fasting during Ramadan with type 1 diabetes, the management of diabetes in people of elderly ages and pregnant women, the effects of Ramadan on one's mental wellbeing, changes to the risk of macrovascular and microvascular complications, and areas of future research. The IDF-DAR Diabetes and Ramadan Practical Guidelines 2021 seek to improve upon the awareness, knowledge and management of diabetes during Ramadan, and to provide real-world recommendations to health professionals and the people with diabetes who choose to fast.


Assuntos
Diabetes Mellitus Tipo 1 , Jejum , Idoso , Diabetes Mellitus Tipo 1/terapia , Feminino , Pessoal de Saúde , Humanos , Hipoglicemiantes , Islamismo , Gravidez
9.
Diabetes Ther ; 12(2): 465-485, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33367983

RESUMO

Diabetes mellitus is a global health concern associated with significant morbidity and mortality. Inadequate control of diabetes leads to chronic complications and higher mortality rates, which emphasizes the importance of achieving glycemic targets. Although glycated hemoglobin (HbA1c) is the gold standard for measuring glycemic control, it has several limitations. Therefore, in recent years, along with the emergence of continuous glucose monitoring (CGM) technology, glycemic control modalities have moved beyond HbA1c. They encompass modern glucometrics, such as glycemic variability (GV) and time-in-range (TIR). The key advantage of these newer metrics over HbA1c is that they allow personalized diabetes management with person-centric glycemic control. Basal insulin analogues, especially second-generation basal insulins with properties such as longer duration of action and low risk of hypoglycemia, have demonstrated clinical benefits by reducing GV and improving TIR. Therefore, for more effective and accurate diabetes management, the development of an integrated approach with second-generation basal insulin and glucometrics involving GV and TIR is the need of the hour. With this objective, a multinational group of endocrinologists and diabetologists reviewed the existing recommendations on TIR, provided their clinical insights into the individualization of TIR targets, and elucidated on the role of the second-generation basal insulin analogues in addressing TIR.

10.
Diabetes Res Clin Pract ; 172: 108563, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33271230

RESUMO

AIM: The high consumption of dates during Ramadan raises the question about its glycemic index (GI) and its effect on the glycemic control in patients with type 2 diabetes (T2DM). We aimed to determine the GI of varieties of meals containing dates in healthy subjects compared to patients with T2DM and the effect of dates on the postprandial glucose excursions using continuous glucose monitoring system (CGMS). METHOD AND RESULTS: Twenty patients with T2DM and twenty healthy subjects matched for age, sex and body weight participated. Testing was applied on separate days (on 3 occasions) with 50 g of glucose and 50 g equivalent of available carbohydrates from 9 date meals. The GI was calculated as ratios of the incremental areas under the response curves for dates in comparison to glucose. Minimed-530 g-diabetes-system-with-enlite was used for continuous glucose monitoring. There was no significant difference between the mean GI of dates between both study groups. However, there was a significant difference according to the time of peak blood glucose among varieties of meals containing dates in T2DM. CONCLUSION: Studied varieties of dates have low GI. CGMS valued beyond GI calculation to study the postprandial glucose excursions among patients with T2DM.


Assuntos
Automonitorização da Glicemia/métodos , Glicemia/análise , Diabetes Mellitus Tipo 2/sangue , Carboidratos da Dieta/administração & dosagem , Índice Glicêmico , Islamismo , Adulto , Estudos de Casos e Controles , Diabetes Mellitus Tipo 2/dietoterapia , Diabetes Mellitus Tipo 2/fisiopatologia , Feminino , Voluntários Saudáveis , Humanos , Masculino , Refeições
11.
Diabetes Res Clin Pract ; 169: 108465, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32971151

RESUMO

Fasting from dawn to sunset, during the holy month of Ramadan, constitutes one of the five main pillars in Islam and is observed by the majority of Muslims. Owing to important physiological changes, Ramadan fasting holds a crucial place in the context of diabetes management. Approximately one-fifth of the world's Muslim population resides in the Middle East and Africa (MEA) region. To discuss the challenges and management of diabetes during Ramadan fasting in the MEA region, a panel of 12 experts in the field of diabetes from across the MEA region attended two expert committee meetings held in Dubai. The key point of discussion was the safety and efficacy of the use of sodium-glucose co-transporter 2 inhibitors (SGLT2i) during Ramadan, based on outcomes of the recent clinical trials with SGLT2i. This is the first consensus recommendation on the management of diabetes with SGLT2i across the MEA region during Ramadan. The document summarizes expert views and opinions on the current management of diabetes with SGLT2i during Ramadan and aims to enhance the current knowledge and understanding on the issue of diabetes management during Ramadan. This will aid the physicians of the MEA region with appropriate decision-making for their patients during Ramadan.


Assuntos
Diabetes Mellitus/tratamento farmacológico , Jejum , Islamismo , Guias de Prática Clínica como Assunto , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , África , Consenso , Desidratação/epidemiologia , Cetoacidose Diabética/epidemiologia , Feminino , Humanos , Hiperglicemia/epidemiologia , Hipoglicemia/epidemiologia , Masculino , Oriente Médio , Fatores de Risco , Inibidores do Transportador 2 de Sódio-Glicose/efeitos adversos , Infecções Urinárias/epidemiologia
12.
Diabetes Metab Res Rev ; 35(7): e3173, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31021474

RESUMO

Management guidelines continue to identify metformin as initial pharmacologic antidiabetic therapy of choice for people with type 2 diabetes without contraindications, despite recent randomized trials that have demonstrated significant improvements in cardiovascular outcomes with newer classes of antidiabetic therapies. The purpose of this review is to summarize the current state of knowledge of metformin's therapeutic actions on blood glucose and cardiovascular clinical evidence and to consider the mechanisms that underlie them. The effects of metformin on glycaemia occur mainly in the liver, but metformin-stimulated glucose disposal by the gut has emerged as an increasingly import site of action of metformin. Additionally, metformin induces increased secretion of GLP-1 from intestinal L-cells. Clinical cardiovascular protection with metformin is supported by three randomized outcomes trials (in newly diagnosed and late stage insulin-treated type 2 diabetes patients) and a wealth of observational data. Initial evidence suggests that cotreatment with metformin may enhance the impact of newer incretin-based therapies on cardiovascular outcomes, an important observation as metformin can be combined with any other antidiabetic agent. Multiple potential mechanisms support the concept of cardiovascular protection with metformin beyond those provided by reduced blood glucose, including weight loss, improvements in haemostatic function, reduced inflammation, and oxidative stress, and inhibition of key steps in the process of atherosclerosis. Accordingly, metformin remains well placed to support improvements in cardiovascular outcomes, from diagnosis and throughout the course of type 2 diabetes, even in this new age of improved outcomes in type 2 diabetes.


Assuntos
Doenças Cardiovasculares/prevenção & controle , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Metformina/uso terapêutico , Humanos , Prognóstico
13.
Diabetes Res Clin Pract ; 151: 285-289, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30822495

RESUMO

AIMS: To describe the characteristics and fasting experience of a subgroup of patients in the VISION study who initiated insulin therapy and chose to fast during Ramadan, and to discuss the VISION Ramadan substudy data in the context of previous Ramadan studies. METHODS: The VISION study was a prospective, non-interventional, observational study of adult patients with Type 2 diabetes mellitus in 6 countries in the Western Pacific, Middle East and North Africa, receiving insulin injection therapy for the first time. In this VISION Ramadan substudy, fasting data was collected during Ramadan 2014 and 2015. RESULTS: Of 1617 patients in the VISION study, data was collected for 357 patients who chose to fast during Ramadan. At baseline, mean HbA1c was 10.1%, duration of diabetes was 8.8 years, and mean BMI was 30 kg/m2. All patients with non-missing data (n = 169) received advice on fasting during Ramadan. The majority of patients fasted for the full month of Ramadan, and around one-third of patients fasted outside Ramadan. CONCLUSIONS: Here we provide an update on the characteristics and Ramadan experience of patients with Type 2 diabetes mellitus who initiated insulin therapy and chose to fast during Ramadan. There is still a need to explore patient's experience during fasting, and identify and address methods to better help manage those patients.


Assuntos
Diabetes Mellitus Tipo 2/terapia , Jejum/efeitos adversos , Diabetes Mellitus Tipo 2/patologia , Feminino , Humanos , Insulina , Islamismo , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
14.
Diab Vasc Dis Res ; 16(3): 213-226, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30606039

RESUMO

Most data on the burden of diabetes and prediabetes are from countries where local infrastructure can support reliable estimates of the burden of non-communicable diseases. Countries in the Middle East and Africa, together with Russia, have a total population of almost 2 billion, but have been relatively overlooked by authors in this field. We reviewed the prevalence and drivers of prediabetes and diabetes across this large region. A large, and variable, burden of dysglycaemia exists, especially in Middle Eastern and North African countries, associated with high levels of obesity and sedentariness, with a generally lower prevalence in most other parts of Africa. The design and size of studies are highly variable, and more research to quantify the scale of the problem is needed. Local barriers to care relating to issues concerned with gender, consanguinity, lack of understanding of diabetes, lack of understanding of obesity as a health issue, and limited resource at a national level for tracking and intervention for diabetes and other non-communicable diseases. Lifestyle interventions with proven local cost-effectiveness, enhanced access to pharmacologic intervention, and societal interventions to promote better diet and more activity will be an important element in strategies to combat these adverse trends.


Assuntos
Diabetes Mellitus Tipo 2/terapia , Saúde Global , Promoção da Saúde/organização & administração , Estilo de Vida Saudável , Hipoglicemiantes/uso terapêutico , Estado Pré-Diabético/terapia , Comportamento de Redução do Risco , Adulto , África/epidemiologia , Comorbidade , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/epidemiologia , Feminino , Humanos , Estilo de Vida , Masculino , Pessoa de Meia-Idade , Oriente Médio/epidemiologia , Estado Pré-Diabético/diagnóstico , Estado Pré-Diabético/epidemiologia , Prevalência , Prognóstico , Fatores de Proteção , Medição de Risco , Fatores de Risco , Federação Russa/epidemiologia
15.
Diabetes Res Clin Pract ; 144: 63-73, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30056190

RESUMO

AIMS: To determine the prevalence of type 2 diabetes mellitus in a sample of the adult population of Alexandria, Egypt, and to delineate the epidemiologic profile of the disease in this community. METHODS: This cross-sectional study was conducted on a representative sample of the population. Participants provided demographic data, their medical history, and blood samples for measurement of plasma glucose (fasting and after oral glucose load) and underwent a detailed physical examination. RESULTS: Of 10,640 eligible subjects, 9657 (90.8%) aged 18-90 years agreed to participate (3795 men, 5862 women). We found an age-adjusted prevalence of diabetes of 16.8% (men, 12.7%; women 19.1%); of prediabetes, 14.6% (men, 13.5%; women, 15.2%), and of newly diagnosed diabetes, 5.5% (men, 3.3%; women, 6.6%). Diabetes was most common in people older than 50 years; prediabetes was most common in 30-39-year-old men and in women younger than 20. In logistic regression analysis, factors independently associated with prediabetes were a history of dyslipidaemia, urban residence, and widowhood. Independent associated factors for diabetes were a high waist-to-hip ratio, family history of diabetes, being divorced, history of dyslipidaemia, peripheral arterial disease or hypertension, low education level, and being not working. CONCLUSIONS: We found a high prevalence of diabetes and prediabetes in Alexandria, particularly in the middle-aged population. Given globally increasing life expectancies, the number of individuals with diabetes could become particularly challenging to the Egyptian healthcare system. Comprehensive national preventive measures are urgently needed.


Assuntos
Diabetes Mellitus Tipo 2/epidemiologia , Estado Pré-Diabético/epidemiologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Egito/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Relação Cintura-Quadril , Adulto Jovem
17.
Diabetes Ther ; 8(4): 767-780, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28523482

RESUMO

INTRODUCTION: The aim of this study was to confirm the efficacy of patient-driven titration of BIAsp 30 in terms of glycemic control, by comparing it to physician-driven titration of BIAsp 30, in patients with type 2 diabetes in North Africa, the Middle East, and Asia. METHODS: A 20-week, open-label, randomized, two-armed, parallel-group, multicenter study in Egypt, Indonesia, Morocco, Saudi Arabia, and Vietnam. Patients (n = 155) with type 2 diabetes inadequately controlled using neutral protamine Hagedorn (NPH) insulin were randomized to either patient-driven or physician-driven BIAsp 30 titration. RESULTS: The noninferiority of patient-driven compared to physician-driven titration with respect to the reduction in HbA1c was confirmed. The estimated mean change in HbA1c from baseline to week 20 was -1.27% in the patient-driven arm and -1.04% in the physician-driven arm, with an estimated treatment difference of -0.23% (95% confidence interval: -0.54; 0.08). After 20 weeks of treatment, the proportions of patients achieving the target of HbA1c <7.5% were similar between titration arms; the proportions of patients achieving the target of ≤6.5% were also similar. Both titration algorithms were well tolerated, and hypoglycemic episode rates were similar in both arms. CONCLUSION: Patient-driven titration of BIAsp 30 can be as effective and safe as physician-driven titration in non-Western populations. Overall, the switch from NPH insulin to BIAsp 30 was well tolerated in both titration arms and led to improved glycemic control. A limitation of the study was the relatively small number of patients recruited in each country. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT01589653. FUNDING: Novo Nordisk A/S, Denmark.

18.
Drugs Real World Outcomes ; 3(3): 307-315, 2016 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-27747834

RESUMO

BACKGROUND: EXCITE (clinical experience of amlodipine and valsartan in hypertension) evaluated the real-world effectiveness and safety of single-pill combinations (SPCs) of amlodipine/valsartan (Aml/Val) and amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCTZ) in patients with hypertension from the Middle East and Asia. OBJECTIVE: The objective of this study was to report the results of EXCITE study from Egypt, where all patients were prescribed Aml/Val. METHODS: This was a 26-week, observational, multicenter, prospective, non-interventional, open-label study. Effectiveness was assessed as change in the mean sitting systolic/diastolic blood pressure (msSBP/msDBP) from baseline and the proportion of patients achieving the therapeutic blood pressure (BP) goal (<140/90; <130/80 mmHg in patients with diabetes mellitus) and BP response (SBP <140 mmHg or reduction of ≥20 mmHg; DBP <90 mmHg or reduction of ≥10 mmHg). Safety was monitored by recording the incidence of adverse events (AEs) and serious AEs (SAEs). RESULTS: A total of 2566 patients (mean age, 52.6 years; mean duration of hypertension, 7.9 years) were prescribed Aml/Val, of whom 2439 (95.1 %) completed the study. At week 26, Aml/Val SPC significantly (p < 0.0001) reduced msSBP/msDBP by -34.5/-19.4 mmHg from baseline (BP: 164.3/100.5 mmHg). Therapeutic goal, SBP response, and DBP response was achieved by 49.3, 91.1, and 91.4 % of patients, respectively. AEs were reported in 12.5 % of patients, with the most common including peripheral edema (1.8 %), bronchitis (1.1 %), and gastritis (0.8 %), and SAEs in 0.5 % of patients. Two deaths were reported during the study, none of which were considered to be study drug related by the investigators. CONCLUSION: Aml/Val SPC provided clinically significant BP reductions and was generally well tolerated in patients with hypertension from Egypt.

19.
Indian J Endocrinol Metab ; 19(6): 804-10, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26693432

RESUMO

OBJECTIVE: To determine the best anthropometric measurement of obesity, and its optimal cutoff, that best predicts the presence of cardiovascular risk factors among adult Egyptian population. METHODS: This is a cross-sectional study including a representative randomly chosen sample of the adult Egyptian population from all Alexandria Districts (the second largest governorate in Egypt) based on the multistage random technique. It included 3209 subjects (1567 men, 1642 women) aged 18-80 years from urban and rural areas. The response rate was 80.2%. History, blood pressure, and anthropometric measurements were taken. Laboratory investigations included fasting lipid profile, fasting plasma glucose, and serum uric acid. Different criteria of metabolic syndrome were used and compared. Receiver operator characteristic curve and Youden index were used to determine predictability and cutoffs. RESULTS: Waist circumference (WC) is the best to predict at least two other components of the metabolic syndrome as defined by the International Diabetes Federation (IDF). The optimal WC cutoffs were 100.5 and 96.25 cm for Egyptian men and women, respectively. The Joint Interim Statement definition (JIS) of metabolic syndrome was the best to predict cardiovascular disease in both genders and diabetes mellitus in women. The prevalence of metabolic syndrome and abdominal obesity was 42.5%, 61%, respectively (ATPIII definition); 43.8%, 61% (American Heart Association definition); 44.3%, 76.4% (IDF definition); 33.8%, 51.7% (IDF definition with Egyptian cutoffs); and 41.5%, 51.7% (JIS with Egyptian cutoffs). CONCLUSION: WC cutoffs in Egyptians differ from those currently recommended. Prevalence of metabolic syndrome and abdominal obesity is high in Egypt, despite being lower on using the Egyptian cutoffs.

20.
BMJ Open Diabetes Res Care ; 3(1): e000108, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26113983

RESUMO

Since the first ADA working group report on the recommendations for management of diabetes during Ramadan in 2005 and our update in 2010, we received many inquiries asking for regular updates on information regarding education, nutritional habits and new oral and injectable agents that may be useful for the management of patients with diabetes during Ramadan. Patients can be stratified into their risk of hypoglycemia and/or complications prior to the start of the fasting period of Ramadan. Those at high risk of hypoglycemia and with multiple diabetic complications should be advised against prolonged fasting. Even in the lower hypoglycemia risk group, adverse effects may still occur. In order to minimize adverse side effects during fasting in patients with diabetes and improve or maintain glucose control, education and discussion of glucose monitoring and treatment regimens should occur several weeks prior to Ramadan. Agents such as metformin, thiazolidinediones and dipeptidyl peptidase-4 inhibitors appear to be safe and do not need dose adjustment. Most sulfonylureas may not be used safely during Ramadan except with extreme caution; besides, older agents, such as chlorpropamide or glyburide, should not be used. Reduction of the dosage of sulfonylurea is needed depending on the degree of control prior to fasting. Misconceptions and local habits should be addressed and dealt with in any educational intervention and therapeutic planning with patients with diabetes. In this regard, efforts are still needed for controlled prospective studies in the field of efficacy and safety of the different interventions during the Ramadan Fast.

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