Assessing Medicare Part D Claim Completeness Using Medication Self-Reports: The Role of Veteran Status and Generic Drug Discount Programs

Medicare Part D claims are commonly used for research, but missing claims could compromise their validity. This study assessed two possible causes of missing claims: veteran status and Generic Drug Discount Programs (GDDP)

The utilization of nonprescription medications in Saudi patients with cardiovascular diseases

Background: Cardiovascular diseases (CVDs) are the most common cause of disease-related death in Saudi Arabia. The incidence of CVDs continues to increase, presenting a major health care problem. Nonprescription medications are widely used by patients with CVD and may cause adverse drug events, either by worsening the disease or by harmfully interacting with prescribed medications. We investigated the patterns of nonprescription medication utilization and the factors associated with their use in patients with CVD. Methods: This was a cross-sectional study conducted at the Cardiology Clinics of an academic tertiary health care center. Participants were asked about their sociodemographic characteristics, medical history and frequency of using nonprescription medications including over-the-counter (OTC) products, dietary supplements, and herbal products. Moreover, we investigated the participants’ sources of information about nonprescription medications. Multivariate logistic regression analysis was conducted to examine the predictors of nonprescription medication use. Results: A total of 209 participants were interviewed. The mean age of the participants was 56 ± 15 years, and 110 (52.6%) were female. Of the 209 participants, 116 (55%) reported routine use of nonprescription medications. Black seeds and garlic were the most frequently used herbal products. Acetaminophen, cold/cough remedies, and ibuprofen were the most commonly reported OTC drugs. Of the surveyed patients, 54 (46.5%) used nonprescription medications to manage cardiovascular conditions specifically. Compared with other comorbidities, diabetes mellitus was associated with a higher use of nonprescription medications. Conclusion: In patients with CVD, the routine use of nonprescription medications was common for a number of reasons. Health care providers should proactively discuss nonprescription use with their CVD patients to avoid potential harmful outcomes. Keywords: Nonprescription medications, Nonconventional medicine, Complementary and alternative medicine, Over-the-counter medicine, Cardiovascular disease, Cardiac patients, Herbal medicine, Traditional medicine

Metformin is not associated with lactic acidosis in patients with diabetes undergoing coronary artery bypass graft surgery: a case control study

Abstract Background Metformin associated lactic acidosis (MALA) is a rare but lethal complication. There is no consensus regarding when to stop and resume metformin in patients who undergo coronary artery bypass grafting (CABG). This study aimed to determine if uninterrupted metformin administration in patients with diabetes undergoing CABG increases the risk of lactic acidosis. Methods Over a span of 12 months (2015–2016), 127 patients with type 2 diabetes underwent isolated CABG. Of those, 41 patients (32%) continued taking metformin and 86 patients (68%) took other antidiabetic agents. Patients taking metformin took the drug until the day of surgery and resumed taking it 3 h after extubation. Results There were no differences in clinical outcomes or complications between groups. Serial measurement of cardiac, liver, and kidney biomarkers were similar between groups. The mean peak lactic acid level was significantly higher in the non-metformin users (5.4 ± 2.6 vs. 7.4 ± 4.1 mmol/l; P = 0.001). Multivariable logistic regression analysis identified the need for vasopressor administration as an independent predictor of lactic acidosis (odds ratio: 7.3, 95% confidence interval: 2.5–20.6; P < 0.001). Conclusion In the absence of risk factors associated with persistent lactic acidosis, such as shock or acute kidney or liver injury, continued peri-operative metformin administration was not associated with the occurrence of lactic acidosis in patients undergoing CABG. Elevated lactic acid levels seem to be directly related to tissue anoxia caused by escalating vasopressor support after surgery

Plasma Trimethylamine N-Oxide Levels Are Associated with Poor Kidney Function in People with Type 2 Diabetes

Previous studies have linked elevated plasma trimethylamine N-oxide (TMAO) levels to poor renal function. The relationship between TMAO and chronic kidney disease (CKD) in type 2 diabetes (T2D) is still unclear. We investigated the association between plasma TMAO levels and CKD in patients with T2D. A cross-sectional study of 133 patients with T2D with or without CKD has been conducted. Blood biomarkers of kidney function, diabetes, and inflammation were assessed in the study participants. Plasma TMAO levels were quantified using UPLC-MS/MS. People with T2D and CKD exhibited significantly higher plasma TMAO levels [10.16 (5.86&ndash;17.45) &micro;mol/L] than those without CKD [4.69 (2.62&ndash;7.76) &micro;mol/L] (p = 0.002). Participants in the highest quartile of TMAO levels (&gt;8.38 &micro;mol/L) presented relatively elevated serum creatinine levels and a higher number of people with CKD than those in the lower quartiles. TMAO levels were significantly correlated with kidney function biomarkers, including estimated glomerular filtration rate and urinary albumin to creatinine ratio. The association between TMAO and CKD was evident (p &lt; 0.0001) and remained significant after adjusting for risk factors of kidney disease, including age, gender, body mass index, duration of diabetes, and smoking. These findings suggest the association between plasma TMAO and CKD in patients with T2D

Association between Plasma Trimethylamine N-Oxide Levels and Type 2 Diabetes: A Case Control Study

Animal and human studies have reported conflicting results on the relationship between circulating trimethylamine N-oxide (TMAO) levels and risk of Type 2 diabetes (T2D). This study aimed to compare plasma TMAO levels in people with or without T2D and explore the association of TMAO and T2D. A prospective case-control study of 297 participants, 164 healthy controls and 133 patients with T2D, was conducted. TMAO levels were quantified by UPLC-MS/MS. Comorbidities, dietary patterns, physical activity, and blood biomarkers were assessed. Median (IQR) plasma TMAO levels were significantly higher in diabetes cases (4.95 (2.84&ndash;8.35) &micro;mol/L) compared to healthy controls (3.07 (2.05&ndash;4.82) &micro;mol/L) (p &lt; 0.001). The association between TMAO and T2D was significant in the non-adjusted Model 1 (p &lt; 0.001) and after adjusting for confounders of diabetes including age, BMI, and level of education in Model 2 (p = 0.04). When the association was further adjusted for physical activity and diet in Model 3, plasma TMAO levels at only the highest quartile (&gt;6.40 &micro;mol/L) were associated with the risk of diabetes (OR = 3.36, 95% CI [1.26, 9.04], p = 0.02). The results presented suggest an association between plasma TMAO levels and T2D. A significant correlation was found between red meat consumption and increased levels of TMAO in T2D patients. A longitudinal study is warranted to further evaluate the correlation between TMAO and T2D

The association of vitamin D deficiency and glucose control among diabetic patients

Objective: To evaluate the association between the level of vitamin D and glycemic control among patients with diabetes. Research design and method: We analyzed data collected from NHANES 2003–2006. We included only non-pregnant adult diabetic persons 18 years or older. Participants who had vitamin D level less than 20 ng/ml were considered as having vitamin D deficiency. Participants were considered to have a glucose control if the HbA1c level was less than 7% [53 mmol/L]. We used student’s t test to compare the difference in HbA1c means between people with Diabetes with and without a vitamin D deficiency. We used a multivariate logistic regression model to predict the relationship between glucose control and vitamin D deficiency. We used race/ethnicity, BMI, age, gender, type of diabetic medication used, having health insurance or not, and comorbid conditions (hypertension, anemia, cholesterol, liver disease, and kidney disease) as control variables. Results: The study population included a total of 929 non-institutionalized, non-pregnant, diabetic adult persons. About 57% of patients with diabetes had a vitamin D deficiency. Blacks (non-Hispanic patients) with diabetes had the highest rate of vitamin D deficiency (79%). The unadjusted means of HbA1c were significantly different between diabetic patients with no vitamin D deficiency and those with a vitamin D deficiency (7.06% [54 mmol/L], 7.56 % [59 mmol/L], respectively, P < 0.0001). Multivariate adjustment showed a small but not significant, increase in odds (11%) of having uncontrolled diabetes in patients with a vitamin D deficiency after adjustment for other factors. Conclusion: Vitamin D deficiency is very common in patients with diabetes. We found no significant association between vitamin D level and glycemic control in patients with diabetes after adjustment for control variables. Keywords: Vitamin D deficiency, Diabetes, Glucose control, HbA1

Radioiodination and biodistribution of newly synthesized 3-benzyl-2-([3-methoxybenzyl]thio)benzo[g]quinazolin-4-(3H)-one in tumor bearing mice

3-Benzyl-2-((3-methoxybenzyl)thio)benzo[g]quinazolin-4(3H)-one was previously synthesized and proved by physicochemical analyses (HRMS, 1H and 13C NMR). The target compound was examined for its radioactivity and the results showed that benzo[g]quinazoline was successfully labeled with radioactive iodine using NBS via an electrophilic substitution reaction. The reaction parameters that affected the labeling yield such as concentration, pH and time were studied to optimize the labeling conditions. The radiochemical yield was 91.2 ± 1.22% and the in vitro studies showed that the target compound was stable for up to 24 h. The thyroid was among the other organs in which the uptake of 125I-benzoquinazoline has increased significantly over the time up to 4.1%. The tumor uptake was 6.95%. Radiochemical and metabolic stability of the benzoquinazoline in vivo/in vitro and biodistribution studies provide some insights about the requirements for developing more potent radiopharmaceutical for targeting the tumor cells. Keywords: Benzo[g]quinazoline, Radioiodination, Biodistribution, Tumor cell, NB

Advancing pharmaceuticals and patient safety in Saudi Arabia: A 2030 vision initiative

Low-quality medicines deliver sub-optimal clinical outcomes and waste precious health resources. It is important to ensure that public funds are spent on healthcare technologies that meet national regulatory bodies such as the Saudi Food and Drug Authority (SFDA), quality standards for safety, efficacy, and quality. Medicines quality is a complicated combination of pre-market regulatory specifications, appropriate sourcing of ingredients (active pharmaceutical ingredient (API), excipients, etc.), manufacturing processes, healthcare ecosystem communications, and regular and robust pharmacovigilance practices. A recent conference in Riyadh, sponsored by King Saud University, sought to discuss these issues and develop specific policy recommendations for the Saudi 2030 Vision plan. This and other efforts will require more and more creative educational programs for physicians, pharmacists, hospitals, and patients, and, most importantly evolving regulations on quality standards and oversight by Saudi health authorities