Tag: statistics

Endocrinol Diabetes Metab. 2021 May 15;4(3):e00259. doi: 10.1002/edm2.259. eCollection 2021 Jul.

ABSTRACT

INTRODUCTION: Cardiovascular (CV) effects of once-weekly subcutaneous (s.c.) semaglutide 0.5 and 1 mg and dulaglutide 1.5 mg are reported in their respective placebo-controlled cardiovascular outcome trials (CVOTs), SUSTAIN 6 and REWIND. There is no head-to-head CVOT comparing these treatments and heterogeneity between their CVOTs renders conventional indirect comparison inappropriate. Therefore, a matching-adjusted indirect comparison (MAIC) was performed to compare the effects of s.c. semaglutide and dulaglutide on major adverse cardiovascular events (MACE) in patients with and without established cardiovascular disease (CVD).

METHODS: Individual patient data from SUSTAIN 6 were matched with aggregate data from REWIND, using a propensity score method to balance baseline effect-modifying patient characteristics. Hazard ratios (HRs) for three-point (3P) MACE (CV death, non-fatal myocardial infarction, non-fatal stroke), anchored via placebo, were then indirectly compared between balanced populations. Sensitivity analyses were performed to test the robustness of the main analysis.

RESULTS: After matching, included effect modifiers were balanced. In the main analysis, s.c. semaglutide was associated with a statistically significant 35% reduction in 3P MACE versus placebo (HR, 0.65 [95% confidence interval [CI]; 0.48, 0.87]) and nonsignificantly greater reduction (26%) versus dulaglutide (HR, 0.74 [95% CI; 0.54, 1.01]). Results were supported by all sensitivity analyses.

CONCLUSIONS: This study demonstrated a statistically significant lower risk of 3P MACE for s.c. semaglutide versus placebo, in a population with lower prevalence of pre-existing CVD than that in the pre-specified primary analysis in SUSTAIN 6. Reduction in 3P MACE with s.c. semaglutide was greater than with dulaglutide, although not statistically significant.

PMID:34277983 | PMC:PMC8279621 | DOI:10.1002/edm2.259

Endocrinol Diabetes Metab. 2021 May 14;4(3):e00260. doi: 10.1002/edm2.260. eCollection 2021 Jul.

ABSTRACT

INTRODUCTION: Anaemia is common but often overlooked in diabetes mellitus (DM) patients. There is also no official nationwide survey registry that estimated the prevalence of anaemia in DM patients in Ethiopia. Therefore, the main aim of this study is to determine the countrywide pooled prevalence and associated factors of anaemia in DM patients.

METHODS: This systematic review and meta-analysis were conducted as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. STATA 11 software was used for all statistical analysis. Random effects model was used to estimate the pooled prevalence of anaemia and associated factors at a 95% confidence interval (CI) with its respective odds ratio (OR). Subgroup analysis and egger test were used to determine heterogeneity and publication bias, respectively.

RESULTS: Nine articles were included in this systematic review and meta-analysis with a total of 2889 DM patients. The pooled prevalence of anaemia among DM patients in Ethiopia was 22.11% (95% CI: 15.83-28.39) I ² = 94.8%. The prevalence of anaemia in type I and type II DM patients was (16.78% [95% CI: 11.53-22.04]) and (31.12% [95% CI; 9.66-52.58]), respectively. The prevalence of anaemia was higher among male (36.72% [95% CI: 22.58-50.87] I ² = 97.6%) than female (27.51% [95% CI: 16.12-38.90] I ² = 96.3%). Moreover, the odds of anaemia were higher among patients with age ˃ 60 (OR = 2.98; 95% CI: 1.83, 4.87), low estimated glomerular filtration rate (eGFR) (OR = 8.59; 95% CI: 4.76, 15.57), and duration of illness ≥5 years (OR = 2.66; 95%: 1.38, 5.13).

CONCLUSIONS: The result of this review implies that anaemia is a moderate public health problem among DM patients in Ethiopia. Older age, poor glycemic control, low eGFR and longer duration of illness were found to be the contributing factors for the development of anaemia in DM patients. Therefore, by considering the negative impact of anaemia, it is important to include anaemia screening into routine assessment of DM-related complications targeting patients with older age, poor glycemic control, low eGFR, and longer duration of illness to reduce the magnitude of the problem.

PMID:34277984 | PMC:PMC8279623 | DOI:10.1002/edm2.260

Endocrinol Diabetes Metab. 2021 May 26;4(3):e00255. doi: 10.1002/edm2.255. eCollection 2021 Jul.

ABSTRACT

INTRODUCTION: Late-night salivary cortisol (LSaC) and 24-h urinary free cortisol measurement, and overnight 1-mg dexamethasone suppression test (1 mg-DST) are the first-line screening tests recommended for Cushing’s syndrome. Through elevations in the level of cortisol-binding globulin, oral contraceptive agents lead to increases in the total plasma cortisol concentration, yielding false-positive 1 mg-DST results.

OBJECTIVE: To compare the accuracy of the overnight 1-mg DST and two-day low-dose DST (2d-DST) in female volunteers taking combined oestrogen-progestin oral contraceptives (COCs).

METHODS: This prospective study enrolled 30 healthy participants. Their plasma cortisol response levels were compared after the 1-mg DST and 2d-DST and classified into three categories: normal (≤50 nmol/L), doubtful (51-138 nmol/L) and abnormal (>138 nmol/L). Salivary cortisol was also measured at late night and after the DSTs.

RESULTS: Following the 1-mg DST and 2d-DST, the plasma cortisol concentrations decreased to a median of 69 nmol/L and 37 nmol/L, respectively (p < 0.001). A statistically significant higher proportion of unclear or abnormal results were observed after the 1-mg DST (63%) than after the 2d-DST (27%) (p = 0.004). None of the values were >138 nmol/L after the 2d-DST, while 11% of them were abnormal after the 1-mg DST (p = 0.25). No LSaC value was abnormal.

CONCLUSION: Our results suggest that, when late-night salivary cortisol is not available, the 2d-DST could be a better screening option than the 1-mg DST for women taking oral contraceptive agents who are reluctant to stop them. This finding requires confirmation in those with a suspicion of hypercortisolism.

PMID:34277979 | PMC:PMC8279609 | DOI:10.1002/edm2.255

Endocrinol Diabetes Metab. 2021 May 6;4(3):e00257. doi: 10.1002/edm2.257. eCollection 2021 Jul.

ABSTRACT

INTRODUCTION: To assess the effects of alcohol and illicit drug use in young adults (age 18-35) with type 1 diabetes (T1D) on flash glucose monitor sensor glucose (SG) readings.

METHODS: Twenty young adults with T1D were enrolled from a tertiary referral hospital outpatient department in Melbourne, Australia for a 6-week prospective observational study using flash glucose monitoring (FGM). Glucometrics comparing substance using days (SUEDs) to those without substance use (non-SUEDS) were analysed. The primary outcomes were the difference in mean SG values, its standard deviation and minutes/24-h period out of range (SG <3.9 mmol/L or >10.0 mmol/L) between matched SUEDs vs non-SUEDs. An interaction model with the primary effect of HbA1c on SG values was also performed.

RESULTS: There were no differences in the primary outcome measures between SUEDS and non-SUEDs. However, there were differences in the regression coefficients for HbA1c and glucometrics between non-SUEDs and SUEDs for mean SG, time out of range and time with SG > 10 mmol/L. This difference was also identified between non-SUEDS and days of ≥40 g alcohol for mean SG.

CONCLUSIONS: While there was no difference between glucometrics for SUEDs and non-SUEDs on primary outcomes, HbA1C was found to be a less reliable predictor of glucose patterns in the 24-h period following substance use than control days. Young adults with T1D need to monitor and respond to their glucose levels following substance use and engage in harm minimisation practices irrespective of baseline glucose control.

PMID:34277981 | PMC:PMC8279614 | DOI:10.1002/edm2.257

Endocrinol Diabetes Metab. 2021 May 3;4(3):e00251. doi: 10.1002/edm2.251. eCollection 2021 Jul.

ABSTRACT

OBJECTIVES: To investigate whether changes in complete blood count (CBC) in islet autoantibody positive children with increased genetic risk for type 1 diabetes are associated with oral glucose tolerance tests (OGTT) and HbA1c over time.

METHODS: The Environmental Determinants of Diabetes in the Young (TEDDY) study follows children with increased risk for type 1 diabetes in the United States, Germany, Sweden and Finland. In the current study, 89 Swedish TEDDY children (median age 8.8 years) positive for one or multiple islet autoantibodies were followed up to 5 (median 2.3) years for CBC, OGTT and HbA1c. A statistical mixed effect model was used to investigate the association between CBC and OGTT or HbA1c.

RESULTS: HbA1c over time increased by the number of autoantibodies (p < .001). Reduction in mean corpuscular haemoglobin (MCH) and mean cell volume (MCV) was both associated with an increase in HbA1c (p < .001). A reduction in red blood cell (RBC) counts (p = .003), haemoglobin (p = .002) and haematocrit (p = .006) levels was associated with increased fasting glucose. Increased red blood cells, haemoglobin, haematocrit and MCH but decreased levels of red blood cell distribution widths (RDW) were all associated with increased fasting insulin.

CONCLUSIONS: The decrease in RBC indices with increasing HbA1c and the decrease in RBC and its parameters with increasing fasting glucose in seroconverted children may reflect an insidious deterioration in glucose metabolism associated with islet beta-cell autoimmunity.

PMID:34277975 | PMC:PMC8279594 | DOI:10.1002/edm2.251

Endocrinol Diabetes Metab. 2021 May 14;4(3):e00252. doi: 10.1002/edm2.252. eCollection 2021 Jul.

ABSTRACT

OBJECTIVE: Diabetes technology is available and its efficacy and safety have been demonstrated; however, there is little evidence as to how this technology is being utilized and its effectiveness in vulnerable populations. This study evaluated differences in outcomes for young adults in the United States (U.S.) from lower socioeconomic (SES) backgrounds with type 1 diabetes (T1D) managed on continuous subcutaneous insulin infusion (CSII) versus multiple daily injections (MDI) or fixed-dose insulin (FDI).

RESEARCH DESIGN METHODS AND PARTICIPANTS: Utilizing the Optum® de-identified Electronic Health Record data set between 2008 and 2018 to perform a retrospective, cohort study, we identified 805 subjects with T1D aged 18-30 years with Medicaid. We evaluated median difference in HbA1c between CSII and MDI/FDI users for 24 months. Predictors of diabetic ketoacidosis (DKA)-associated hospitalizations by CSII use were evaluated using logistic regression.

RESULTS: CSII users showed statistically significant lower median HbA1c values at 24 months of follow-up compared to individuals on MDI/FDI. Non-white individuals were at lower odds of receiving treatment with CSII. Subjects on CSII were not more likely to be hospitalized for DKA compared to subjects treated with MDI/FDI. Older subjects were at lower odds of being hospitalized for DKA. Males and subjects followed by Endocrinologists were at higher odds of being hospitalized for DKA.

CONCLUSIONS: Young adults with T1D from lower SES backgrounds show improved glycaemic control when in CSII compared to MDI/FDI without increases in hospitalizations for DKA.

PMID:34277976 | PMC:PMC8279595 | DOI:10.1002/edm2.252

Endocrinol Diabetes Metab. 2021 Feb 8;4(3):e00231. doi: 10.1002/edm2.231. eCollection 2021 Jul.

ABSTRACT

INTRODUCTION: Longitudinal data on progression, complications, and management of type 2 diabetes mellitus (T2DM) across India are scarce. LANDMARC (CTRI/2017/05/008452), the first pan-India, longitudinal, prospective, observational study, aims to understand the management and real-world outcomes of T2DM over 3 years.

METHODS: Adults (≥25 to ≤60 years old at T2DM diagnosis; diabetes duration ≥2 years at enrollment; controlled/uncontrolled on ≥2 anti-diabetic agents) were enrolled. Baseline characteristics were analyzed using descriptive statistics.

RESULTS: Of the 6279 recruited participants, 6236 were eligible for baseline assessment (56.6% [n/N = 3528/6236] men; mean ± SD age: 52.1 ± 9.2 years, diabetes duration: 8.6 ± 5.6 years). mean ± SD HbA1c, fasting plasma glucose, and postprandial glucose values were 64 ± 17 mmol/mol (8.1 ± 1.6%), 142.8 ± 50.4 mg/dl, and 205.7 ± 72.3 mg/dl, respectively. Only 25.1% (n/N = 1122/6236) participants had controlled glycemia (HbA1c < 53 mmol/mol, <7%). Macrovascular and microvascular complications were prevalent in 2.3% (n/N = 145/6236) and 14.5% (n/N = 902/6236) participants, respectively. Among those with complications, non-fatal myocardial infarction (n/N = 74/145, 51.0%) and neuropathy (n/N = 737/902, 81.7%) were the most reported macrovascular and microvascular complication, respectively. Hypertension (n/N = 2566/3281, 78.2%) and dyslipidemia (n/N = 1635/3281, 49.8%) were the most reported cardiovascular risks. Majority (74.5%; n/N = 4643/6236) were taking oral anti-diabetic drugs (OADs) only, while 24.4% (n/N = 1522/6236) participants were taking OADs+insulin. Biguanides (n/N = 5796/6236, 92.9%) and sulfonylureas (n/N = 4757/6236, 76.3%) were the most reported OADs. Basal (n/N = 837/6236, 13.4%) and premix (n/N = 684/6236, 11.0%) insulins were the most reported insulins.

CONCLUSIONS: Baseline data from LANDMARC help understand the clinical/medical profile of study participants and underscore the extent of suboptimal glycemic control and prevalence of associated complications in a vast majority of Indians with T2DM.

PMID:34277959 | PMC:PMC8279635 | DOI:10.1002/edm2.231

Endocrinol Diabetes Metab. 2021 Apr 6;4(3):e00237. doi: 10.1002/edm2.237. eCollection 2021 Jul.

ABSTRACT

BACKGROUND: Clinical trials are often underpowered to detect serious but rare adverse events of a new medication. We applied a novel data mining tool to detect potential adverse events of canagliflozin, the first sodium glucose co-transporter 2 (SGLT2 inhibitor) in the United States, using real-world data from shortly after its market entry and before public awareness of its potential safety concerns.

METHODS: In a U. S. commercial claims dataset (29 March 2013-30 Sept 2015), two pairwise cohorts of patients over 18 years of age with type 2 diabetes (T2D) who were newly dispensed canagliflozin or an active comparator, that is a dipeptidyl peptidase 4 inhibitor (DPP4) or a glucagon-like peptide 1 receptor agonist (GLP1), were identified and propensity score-matched. We used variable ratio matching with up to four people receiving a DPP4 or GLP1 for each person receiving canagliflozin. We identified potential safety signals using a hierarchical tree-based scan statistic data mining method with the hierarchical outcome tree constructed based on international classification of disease coding. We screened for incident adverse events where there were more outcomes observed among canagliflozin vs. comparator initiators than expected by chance, after adjusting for multiple testing.

RESULTS: We identified two pairwise propensity score variable ratio matched cohorts of 44,733 canagliflozin vs. 99,458 DPP4 initiators, and 55,974 canagliflozin vs. 74,727 GLP1 initiators. When we screened inpatient and emergency room diagnoses, diabetic ketoacidosis was the only severe adverse event associated with canagliflozin initiation with p < .05 in both cohorts. When outpatient diagnoses were also considered, signals for female and male genital infections emerged in both cohorts (p < .05).

CONCLUSIONS AND RELEVANCE: In a large population-based study, we identified known but no other adverse events associated with canagliflozin, providing reassurance on its safety among adult patients with T2D and suggesting the tree-based scan statistic method is a useful post-marketing safety monitoring tool for newly approved medications.

PMID:34277962 | PMC:PMC8279599 | DOI:10.1002/edm2.237

Endocrinol Diabetes Metab. 2021 Mar 18;4(3):e00242. doi: 10.1002/edm2.242. eCollection 2021 Jul.

ABSTRACT

INTRODUCTION: South Asians with diabetes have more severe diabetic retinopathy (DR) and cardiovascular complications than white Caucasians. However, how big this gap is and the relation with the severity of DR has not been studied. Here, we quantify the difference in time from diabetes diagnosis until a first non-fatal Major Adverse Cardiovascular Event (TUF MACE) in different DR groups in South Asians and Europeans.

METHODS: 3831 adults with type 2 diabetes, 1358 South Asians and 2473 Europeans, treated in our diabetes clinic between 2006 and 2017 were included. Data on risk factors, diabetes duration, age of diagnosis and diabetes complications were collected from the diabetes-specific database and analysed using descriptive statistics and Cox regression. DR was graded in 3 categories, and non-fatal MACE was pre-specified.

RESULTS: Prevalence of non-fatal MACE was the same when DR was absent, increased with increasing severity of DR in both ethnic groups, but was more frequent in South Asians with DR (mild: 50 vs. 42% and severe 62 vs. 46%. Classic risk factors only differed in relation to smoking habits, which were significantly lower in South Asians.After correction for classic risk factors and age at diabetes diagnosis TUF MACE was significantly shorter in South Asians, an effect also seen in the no-DR group (4.1 yrs. HR 1.5, 95% CI 1.3-1.8 and 7.4 yrs. earlier, HR 2.0, 95% CI 1.6-2.6 for no-DR and severe DR, respectively).

CONCLUSIONS: When adjusted for age at diabetes diagnosis, we show that time until first non-fatal MACE in South Asians is significantly shorter compared to Europeans and increases from no- to severe DR.

PMID:34277967 | PMC:PMC8279625 | DOI:10.1002/edm2.242

Health Sci Rep. 2021 Jul 14;4(3):e326. doi: 10.1002/hsr2.326. eCollection 2021 Sep.

ABSTRACT

BACKGROUND AND AIMS: Acute appendicitis is one of the common causes of abdominal surgeries, however, the rate of negative appendectomy is as high as 20% as the diagnosis of appendicitis is challenging. The study aimed to evaluate complete blood count (CBC)-associated parameters among positive and negative appendectomy patients and determine their diagnostic importance.

METHODS: In this cross-sectional study, patients who suspected of acute appendicitis were included. Preoperative blood samples taken from these patients for a complete blood count. Following parameters evaluated from their CBC: white blood cell (WBC), platelet (PLT), mean platelet volume (MPV), neutrophils-to-lymphocytes ratio, platelets-to-lymphocytes ratio, red cell distribution width (RDW), and platelet distribution width (PDW). These parameters analyzed for the positive and negative appendectomy patients using statistical analysis.

RESULTS: Of 200 patients included in the study, 30 patients (15%) underwent negative appendectomy. The mean neutrophils, WBC, red blood cells, neutrophils-to-lymphocytes, and platelets-to-lymphocytes ratio was significantly high among positive appendectomy patients, (P < .05), whereas MPV to platelet ratio was significantly less in this group. The highest diagnostic power for the diagnosis of appendicitis was of neutrophils-to-lymphocytes ratio with the sensitivity of 83.5% and the specificity of 90%.

CONCLUSION: The findings of our study indicate that neutrophils-to-lymphocytes ratio alone is not sufficient for preoperative diagnosis of acute appendicitis and other CBC-related parameters did not have good sensitivity and specificity. Further studies are therefore required in this area.

PMID:34277956 | PMC:PMC8279215 | DOI:10.1002/hsr2.326