Individual Case Safety Reports Analysis for Patients with Diabetes Mellitus on Insulin in Africa and the Middle East

2021 ◽  
Vol 16 ◽  
Author(s):  
Charity R.N. Mlotshwa ◽  
Johanita R. Burger ◽  
Martine Vorster ◽  
Dorcas M. Rakumakoe ◽  
Marike Cockeran
Keyword(s):  
Diabetes Mellitus ◽  
Middle East ◽  
Microvascular Complications ◽  
Individual Case ◽  
Cross Sectional Study ◽  
Patient Age ◽  
Cross Sectional ◽  
Patient Âgé ◽  
Patients With Diabetes ◽  
Insulin Use

Background: The growing numbers of patients with diabetes mellitus in Africa and the Middle East on antidiabetic therapies necessitate an understanding of adverse event (AE) reporting in these regions. Objective: To provide an AE reporting overview in patients using insulins in Africa and the Middle East by characterizing and comparing individual case safety reports (ICSRs) features. Method: The cross-sectional study analyzed ICSR data from a global pharmaceutical company’s pharmacovigilance database for January to December 2018 to describe and compare patient demographics, report sources, reporter types, ICSR seriousness, suspect products, indication for insulin use and AE preferred terms, by country. Results: Overall 7076 ICSRs were analyzed, 63.6% from the Middle East. Most ICSRs were non-serious (91.5%), from solicited sources (83.5%), and reported by consumers (70.7%). Patients from the Middle East were, on average, 34.2 years of age, had gestational diabetes mellitus as indication (64.3%), insulin detemir as suspect product (76.5%), and exposure during pregnancy as AE preferred term (89.1%). Patients from Africa were 48.1 years old on average, a higher proportion of type 2 diabetes mellitus was observed (52.2%), human insulins the suspect product (51.6%), and blood glucose increased the AE preferred term (23.1%). Few macrovascular and microvascular complications were reported (<1% in both regions). Associations between the region and patient age, gender, report sources, reporter types, indications for insulin use, suspect products, and AE preferred term were significant (p <0.001). Conclusion: ICSRs features were region-specific and dependent on patient age, gender, report sources, reporter types, suspect products, and AE preferred terms.

scholarly journals Association between obesity and depression in patients with diabetes mellitus type 2; a study protocol

F1000Research ◽  
2015 ◽  
Vol 4 ◽  
pp. 7 ◽  
Author(s):  
Eduardo De la Cruz-Cano ◽  
Carlos Alfonso Tovilla-Zarate ◽  
Emilio Reyes-Ramos ◽  
Thelma Beatriz Gonzalez-Castro ◽  
Isela Juarez-Castro ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Diabetes Mellitus Type 2 ◽  
Cross Sectional Study ◽  
Diabetes Mellitus Type ◽  
Sectional Study ◽  
Cross Sectional ◽  
The World ◽  
Patients With Diabetes

Background: Diabetes mellitus and depression are highly prevalent conditions throughout the world and have significant impact on health outcomes. It has been estimated that diabetes mellitus type 2 affects about 246 million people in the world; nevertheless, incidence varies among countries. There is evidence that depression is associated with a poor metabolic control in patients with type 2 diabetes mellitus that present other health problems (such as hypertension and obesity). The aim of this study protocol is to determine if obesity increases the risk for depression in patient with diabetes type 2.Methods: The analysis will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).The studies suitable for inclusion will be assessed by the Newcastle-Ottawa Scale (NOS) to determine their methodological quality. To identify the studies of interest, we will search on PubMed and EBSCO databases. We will use the following keyword combinations: "Diabetes Mellitus type 2 AND obesity AND depression", "depression AND Diabetes Mellitus type 2", "Diabetes Mellitus type 2 AND body mass index cross sectional study", "depression AND obesity cross-sectional study". Causes for exclusion will be publications that studied patients diagnosed with diabetes mellitus type 1; articles that focused on the treatment and complications of diabetes mellitus type 2; publications that have studied other clinical or psychiatric conditions (for instance, seizure disorder or history of schizophrenia, bipolar disorder, psychotic symptoms or dementia).Conclusion: The results of this study will form the basis for a better understanding of the association between obesity and depression in patients with diabetes mellitus type 2, and will allow development of prediction tools and better interventions. It is evident that several modifiable and non-modifiable risk factors play an important role in the pathogenesis of diabetes among population. Currently, evidence for the deleterious effects of diabetes mellitus type 2 are based on cross-sectional or other observational designs. Therefore, this study will have important implications for future research and public health guidance.

scholarly journals Prevalence of serological markers for hepatitis and potential associated factors in patients with diabetes mellitus

2018 ◽  
Vol 26 (0) ◽  
Author(s):  
Clarissa Cordeiro Alves Arrelias ◽  
Fernando Belissimo Rodrigues ◽  
Maria Teresa da Costa Gonçalves Torquato ◽  
Carla Regina de Souza Teixeira ◽  
Flávia Fernanda Luchetti Rodrigues ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Virus Infection ◽  
Hepatitis B ◽  
Associated Factors ◽  
Venous Blood ◽  
Cross Sectional Study ◽  
Blood Collection ◽  
Serological Markers ◽  
Cross Sectional ◽  
Patients With Diabetes

ABSTRACT Objective: to estimate the prevalence of serological markers for hepatitis B and C in patients with diabetes mellitus and analyze potential associated factors. Method: a cross-sectional study with 255 patients with diabetes mellitus. Demographic, clinical, and risk behavior factors for hepatitis B and C were selected. The markers HBsAg, Anti-HBc IgG, Anti-HBc IgM, Anti-HBs, and Anti-HCV were investigated. A questionnaire and venous blood collection and inferential statistical analysis were used. Results: 16.8% of the patients had a total reactive Anti-HBc marker, 8.2% an isolated Anti-HBs, and 75% were non-reactive for all hepatitis B markers. No case of reactive HBsAg was found and 3.3% of the patients had a reactive anti-HCV marker. The prevalence of prior hepatitis B virus infection was directly associated with the time of diabetes mellitus and the prevalence of hepatitis C virus infection was not associated with the investigated variables. The prevalence of hepatitis B and C infection in patients with diabetes mellitus was higher when compared to the national, with values of 16.8% and 3.3%, respectively. Conclusion: the results suggest that patients with diabetes are a population of higher vulnerability to hepatitis B and C, leading to the adoption of preventive measures of their occurrence.

scholarly journals Thyroid hormones profile of patients with type 2 diabetes mellitus in Kano, Nigeria

2020 ◽  
Vol 3 (1) ◽  
Author(s):  
Mustapha Zainab Abubakar ◽  
Kabiru Abdulsalam ◽  
Isah A. Yahaya
Keyword(s):  
Diabetes Mellitus ◽  
Thyroid Dysfunction ◽  
Cross Sectional Study ◽  
Endocrine Disorders ◽  
Cross Sectional ◽  
Type 2 Dm ◽  
Type 2 Diabetics ◽  
Patients With Diabetes ◽  
Considerable Impact

Diabetes mellitus (DM) and thyroid disease are the two most common endocrine disorders in the general population. Several Studies have shown that thyroid dysfunction is common in patients with DM, and thyroid dysfunction have been found to have a considerable impact on the glycaemic control and often increases the risk of development of long-term complications in patients with diabetes mellitus. This study determined the prevalence of thyroid dysfunction in patients with type 2 DM in Kano, North-Western Nigeria. The study was a descriptive cross-sectional study conducted on 250 participants made up of 130 patients with type 2 DM and 120 apparently healthy non-diabetic controls. Questionnaires were used to collect information on bio data, medical history, duration of diagnosis of diabetes and type of treatment. Also, blood samples of the participants were collected and analyzed for fasting plasma glucose, fT3, fT4, and TSH. The results were interpreted using American Thyroid Associations’ criteria and the data was analyzed using the statistical software package, STATA version 20. Two hundred and thirty-four (93.6%) of the participants were euthyroid while sixteen (6.4%) were found to have various forms of thyroid dysfunction. The prevalence of thyroid dysfunction was 10% and 2.5% among type 2 diabetics and controls respectively. Among the type 2 DM patients with thyroid dysfunction, 38.5% had hypothyroidism. Thyroid dysfunction was found to be commoner among type 2 DM patients than non-diabetic individuals with hypothyroidism being the commonest disorder.

scholarly journals MDCT evaluation of coronary artery calcification in Nepalese population undergoing CT thorax examination for non-cardiac pathology

2014 ◽  
Vol 6 (4) ◽  
pp. 40-44
Author(s):  
Mukesh Kumar Gupta ◽  
Raj Kumar Rauniyar ◽  
Naveen Kumar Pandey ◽  
Deepak Kumar Yadav
Keyword(s):  
Diabetes Mellitus ◽  
Risk Factors ◽  
Cross Sectional Study ◽  
Age Group ◽  
Medical Sciences ◽  
Cross Sectional ◽  
Cardiac Pathology ◽  
Patients With Diabetes ◽  
Ct Evaluation ◽  
Atherosclerotic Risk Factors

Background:Coronary artery calcification (CAC) is frequently encountered as incidental findings during CT evaluation of thorax; however, little is known about its magnitude and association with atherosclerotic risk factors in Nepalese population. The purpose of this study was to evaluate the frequency of incidental CAC in patients undergoing standard thoracic CT examination for non-cardiac pathology and to correlate it with risk factors for coronary atherosclerosis.Methods: A hospital based prospective cross-sectional study was conducted on 216 patients over 8 month duration. The coronary arteries were evaluated for calcification on 16-slice MDCT and the frequency of CAC was correlated with atherosclerotic risk factors viz. age, sex, diabetes mellitus, hypertension, smoking and obesity.Results: Incidental CAC was seen in 72(33.3%) of total 216 patients. The rates of CAC below 40, 40-60 and above 60 years age group were 0%, 31.6% and 43.9% respectively. The frequency of CAC in male and female were 35% and 31.2% for all ages, 43.6% and 20% for 40-60 years group, and 35.2% and 61.1% for above 60 years age group respectively. The frequency of CAC was higher in patients with diabetes mellitus (47.5%), hypertension (42.3%), smoking (43%) and obesity (38.9%).Conclusion: Incidental CAC was seen in 33.3% of the patients and it had significant association with advancing age, diabetes mellitus, hypertension and smoking. Rate of CAC was significantly higher in male for 40-60 years group but the frequency drastically increased in female for above 60 years group. DOI: http://dx.doi.org/10.3126/ajms.v6i4.11205 Asian Journal of Medical Sciences Vol.6(4) 2015 40-44

scholarly journals RELUCTANCE OF PATIENTS WITH DIABETES MELLITUS TO INSULIN THERAPY; PSYCHOLOGICAL INSULIN RESISTANCE

2021 ◽  
Vol 71 (2) ◽  
pp. 602-05
Author(s):  
Umair Ali ◽  
Muhammad Wajid Munir ◽  
Jahanzeb Maqsood ◽  
Mahwash Jamil ◽  
Syed Saif Ur Rehman ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Insulin Resistance ◽  
Insulin Therapy ◽  
Demographic Data ◽  
Tertiary Care ◽  
Negative Attitude ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Validated Questionnaire ◽  
Patients With Diabetes

Objective: To evaluate factors resulting in reluctance of initiation of insulin therapy in patients with type 2 diabetes mellitus. Study Design: Cross sectional study. Place and Duration of Study: Medical OPD of a private tertiary care multi-specialty hospital in Islamabad, from Apr to Jul 2019. Methodology: Patients with diabetes mellitus between age of 30-70 years, who had poor glycaemic control on two oral antidiabetic drugs having HbA1c>9% and were insulin naïve, were included in this study. A validated questionnaire was developed which had two sections; first including the demographic data of the study populations and second having closedended dichotomous questions which were asked from patients by the treating physicians Results: A total of 180 patients with diabetes mellitus eligible for insulin therapy were included in the study, among them 52 (28.9%) were agreed to initiate the insulin. Negative attitude and beliefs include painful way of administration 85 (66.4%), difficult insulin storage 98 (76.6%), risk of hypoglycemia 82 (64.1%).The mean negative perception Score was 7.35 (SD 0.98). Conclusion: Psychological insulin resistance is present in significant diabetic population, and it is a big obstacle in insulin therapy initiation and compliance.

scholarly journals Attitudes and perceptions towards hypoglycaemia in patients with diabetes mellitus: A multinational cross-sectional study

PLoS ONE ◽  
2019 ◽  
Vol 14 (10) ◽  
pp. e0222275 ◽  
Author(s):  
Abdallah Y. Naser ◽  
Ian C. K. Wong ◽  
Cate Whittlesea ◽  
Hassan Alwafi ◽  
Amjad Abuirmeileh ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional ◽  
Attitudes And Perceptions ◽  
Patients With Diabetes

scholarly journals Anxiety among patients with diabetes mellitus evaluated using generalized anxiety disorder 7-item scale

2016 ◽  
Vol 04 (02) ◽  
pp. 133-136 ◽  
Author(s):  
Amit Thour ◽  
Ramninder Nagra ◽  
Arunjeet Gosal ◽  
Tejasav Sehrawat ◽  
Subhash Das ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Tertiary Care Hospital ◽  
Microvascular Complications ◽  
Tertiary Care ◽  
Generalized Anxiety ◽  
Care Hospital ◽  
Cross Sectional ◽  
Patients With Diabetes

Abstract Background: Anxiety has been shown to be associated with poor outcomes in people with diabetes. However, there has been limited data, especially from India, which has specifically examined whether diabetes mellitus is associated with an increased likelihood of comorbid anxiety. Aim: The aim was to estimate the prevalence of anxiety in patients with diabetes and to determine the association of anxiety with age, sex, and other related parameters. Setting: Endocrine clinic, tertiary care hospital. Design: Cross-sectional. Materials and Methods: The study was cross-sectional carried out in endocrinology clinic of tertiary care hospital in North India. Cases were patients with type 2 diabetes mellitus above 30 years of age. Anxiety was assessed using the generalized anxiety disorders 7-item (GADs-7) scale. The relationship with a sociodemographic profile, duration of diabetes, hypertension, and microvascular complications was also analyzed. Results: Seventy-three subjects (42.5% females) with mean age 50.8 ± 9.2 years were evaluated. The prevalence of anxiety was 34%. Severe anxiety (GAD-7 score ≥15) was present in three (4%) subjects, moderate anxiety (GAD-7 score ≥10) was present in six (8%) subjects, and mild anxiety was present in 16 (22%) of subjects. Anxiety increased with fasting plasma glucose, hypertension, was more in women, but the differences were not statistically significant. Conclusions: Our study demonstrates a higher prevalence of anxiety in patients with type 2 diabetes. No factor was significantly associated with anxiety. Therefore, anxiety should be assessed in each and every patient, irrespective of other factors.

scholarly journals Hepatitis B vaccination coverage in patients with diabetes mellitus

2016 ◽  
Vol 50 (2) ◽  
pp. 255-262 ◽  
Author(s):  
Clarissa Cordeiro Alves Arrelias ◽  
Fernando Bellissimo-Rodrigues ◽  
Letícia Cristina Lourenço de Lima ◽  
Anderson Soares da Silva ◽  
Nereida Kilza da Costa Lima ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Hepatitis B ◽  
Vaccination Coverage ◽  
Educational Level ◽  
Health Department ◽  
Cross Sectional Study ◽  
Hepatitis B Vaccination ◽  
Cross Sectional ◽  
Patients With Diabetes

Abstract OBJECTIVE Analyze the factors associated with full hepatitis B vaccination (three doses) in patients with diabetes mellitus. METHOD Cross-sectional study, conducted in a health unit in a city in the state of São Paulo, with 255 patients on outpatient follow-up, in 2014. Data were obtained from the computerized system of the Municipal Health Department and via a structured questionnaire. A logistic regression model was used for analysis. RESULTS Full hepatitis B vaccination was noted in 13.7% of the patients and shown to be directly associated with their educational level (OR=1.30; CI: 1.07-1.57) and current or previous work as a health professional (OR=3.21; CI: 1.16-8.89). CONCLUSION Hepatitis B vaccination coverage was found to be low in patients with diabetes mellitus, indicating their vulnerability to this serious and potentially fatal disease. Higher educational level and working in the field of health were associated with better vaccination coverage.

scholarly journals Dietary Attitude of Adults with Type 2 Diabetes Mellitus in the Kingdom of Saudi Arabia: A Cross-Sectional Study

Medicina ◽  
2020 ◽  
Vol 56 (2) ◽  
pp. 91 ◽  
Author(s):  
Waqas Sami ◽  
Khalid M Alabdulwahhab ◽  
Mohd Rashid Ab Hamid ◽  
Tariq A. Alasbali ◽  
Fahd Al Alwadani ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Saudi Arabia ◽  
Dietary Behavior ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Kingdom Of Saudi Arabia ◽  
Cross Sectional ◽  
Patients With Diabetes

Background and Objectives: There is a paucity of literature on the dietary attitude (DA) of patients with type 2 diabetes in the Kingdom of Saudi Arabia (KSA). Although the prevalence of diabetes mellitus (DM) is high in Gulf countries, there remains a lack of understanding of the importance of dietary behavior in diabetes management among patients. Understanding the behavior of patients with diabetes towards the disease requires knowledge of their DA. Therefore, this study aimed to assess and evaluate the DA of type 2 diabetes patients, and it is the first of its kind in the KSA. Material and Methods: An analytical cross-sectional study was conducted among 350 patients with type 2 diabetes. A self-administered DA questionnaire was used to collect the data. Psychometric properties of the questionnaire were assessed by face validity, content validity, exploratory factor analysis, and internal consistency reliability. The data were collected using a systematic random sampling technique. Results: The overall DA of the patients was inappropriate (p = 0.014). Patients had an inappropriate DA towards food selection (p = 0.003), healthy choices (p = 0.005), food restraint (p < 0.001), health impact (p < 0.001), and food categorization (p = 0.033). A poor DA was also observed in relation to the consumption of red meat (p <0.001), rice (p < 0.001), soup and sauces (p = 0.040), dairy products (p = 0.015), and junk food (p < 0.001). Conclusions: It is highly recommended that patients with diabetes receive counseling with an empowerment approach, as this can bring about changes in their dietary behavior, which is deeply rooted in their daily routine. Healthcare providers should also be well-informed about patients’ attitudes and beliefs towards diabetes to design tailored educational and salutary programs for this specific community. Diabetes self-management educational programs should also be provided on a regular basis with a special emphasis on diet and its related components.

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