• Caring for communities: A 4-year pharmacy partnership focused on diabetes and cardiovascular health.
    3 months ago
    Current community pharmacy practice faces several substantial pressures affecting the business model. Transitioning to a more patient-centered focus and providing additional direct patient care services that will eventually be billed for and reimbursed by third-party payers is a strategy for evolving this practice. This manuscript describes the impact of a 4-year funded project involving a network of independent pharmacies partnering with an academic pharmacy school to implement direct patient care services in diabetes and cardiovascular disease. Eleven independent pharmacies participated in the practice transformation project, receiving direct support from pharmacy faculty to build an infrastructure and begin offering formalized programs for diabetes and cardiovascular disease management. Each pharmacy selected which services they would implement and build across the 4 years. An emphasis was placed on establishing bi-directional communication with medical provider offices and identifying high-risk patients with these disease states to set up monthly meetings to optimize their health. All pharmacies successfully established 1 or more services in the areas of diabetes and/or cardiovascular disease and reported regular communication with local providers to summarize services and discuss specific patient concerns. All pharmacies implemented a blood pressure monitoring service at their location and 9 (82%) successfully provided a self-monitoring blood pressure program. Five pharmacies received accreditation to offer diabetes self-management education services, and 2 pharmacies received recognition to provide the National Diabetes Prevention Program. Seven pharmacies established appointment-based monthly counseling with high-risk patients. Implementation of these services is an important initial step in prioritizing direct patient care in the community pharmacy setting.
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  • Real-time continuous glucose monitoring vs self-monitoring of blood glucose in distinct multi-ethnic cohorts of patients living with insulin-treated type 2 diabetes in the United States: A cost-utility analysis from a Medicare perspective.
    3 months ago
    For individuals living with type 2 diabetes (T2D) requiring insulin therapy, the use of real-time continuous glucose monitoring (rt-CGM) yields significant clinical benefits relative to self-monitoring of blood glucose (SMBG).

    To determine the cost-utility of rt-CGM vs SMBG in a US setting, for a simulated cohort of individuals with T2D receiving insulin therapy.

    The IQVIA CORE Diabetes Model version 10 was employed for this analysis, which was conducted over a remaining lifetime horizon. Clinical effectiveness data were sourced from a large-scale, retrospective cohort study set in the United States. Direct medical costs were obtained from a range of published studies for the Medicare setting and by using relevant Healthcare Common Procedure Coding System codes for Medicare. A willingness- to-pay (WTP) threshold of $50,000 per quality-adjusted life-year (QALY) was used, with future effects and costs discounted at 3% per annum. The base case was conducted from a Medicare perspective. One-way and probabilistic sensitivity analyses were performed.

    From a Medicare perspective, the use of rt-CGM yielded mean total direct medical costs of $107,215, alongside 7.584 QALYs over a time horizon of 50 years. Comparatively, SMBG was associated with lower mean total direct medical costs of $100,116 while yielding only 6.818 QALYs. The final incremental cost-utility ratio was $9,265 per QALY gained, showing that at a WTP threshold of $50,000 per QALY gained, rt-CGM was cost-effective relative to SMBG. Results from the 1-way sensitivity analysis showed rt-CGM to be dominant when a commercial plan perspective was adopted and more cost-effective for 100% Black, Native American, and Hispanic cohorts when compared with a 100% White cohort.

    In a simulated cohort representative of individuals living with T2D and receiving insulin therapy, rt-CGM may be cost-effective compared with SMBG from a Medicare perspective. Therefore, rt-CGM plausibly possesses the potential to address existing racial and ethnic disparities in diabetes-related outcomes for patients within the United States.
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  • Effect of SGLT2 inhibitors on thiazolidinedione-induced changes in the volume status of patients with type 2 diabetes mellitus: a 6-month follow-up prospective study.
    3 months ago
    To ascertain the impact of combining sodium-glucose cotransporter 2 inhibitors (SGLT2is) with thiazolidinediones on fluid balance in patients with type 2 diabetes mellitus.

    This prospective study followed patients over a 6-month period, with data collected at three time points. The study commenced with the administration of pioglitazone on the same day. At the 3-month mark of the study, SGLT2is (dapagliflozin or empagliflozin) were subsequently integrated into the patients' treatment regimens. At each time point, bioimpedance spectroscopy was employed to the volume status of the patients, and an assessment of their glycemic, renal, and lipid parameters was conducted. Their fluid status was evaluated on the basis of the overhydration value and the relative hydration index.

    The study sample consisted of 60 type 2 diabetes mellitus patients with a mean age of 52.5 years. While notable increases in the mean overhydration value and relative hydration index were observed during the initial 3-month period (p < 0.001), a significant decline was evident in the second 3-month period (p < 0.001). However, no significant change in the adipose tissue index, fat mass, or body cell mass was found at the 6-month follow-up. Significant improvements were achieved in liver function test results, glycemic parameters, and the lipid profile. Renal parameters did not change significantly during the 6-months of follow-up.

    SGLT2is have been shown to be effective in improving fluid retention associated with thiazolidinediones and in maintaining euvolemic fluid status.
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  • Incidence and Predictors of Surgical Site Infections Following Open Elective and Emergency Surgery: A Prospective Observational Study.
    3 months ago
    Surgical site infections (SSIs) are a major contributor to postoperative morbidity, particularly in low- and middle-income countries, where infection control practices may be less stringent. This study evaluated the incidence and predictors of SSIs in patients undergoing open surgeries at a tertiary hospital in Chennai, India.

    A prospective cohort study was conducted over a two-year period, including 250 patients who underwent open surgeries. Patients were monitored for SSIs from surgery until discharge. Data on patient demographics, comorbidities, lifestyle factors, and surgical variables were collected. Statistical analysis included chi-square tests and multivariate logistic regression to identify independent predictors of SSIs.

    The overall incidence of SSIs was 22 (8.8%). Risk factors significantly associated with SSIs were diabetes mellitus 12/73 (16.4%), smoking 5/23 (21.7%), alcohol consumption 6/24 (25.0%), emergency surgery 10/53 (18.9%), and contaminated wounds 9/20 (45.0%). Multivariate logistic regression analysis identified several independent predictors of SSIs. Diabetes mellitus was significantly associated with a higher risk of SSIs (odds ratio, OR: 3.21, 95% CI: 1.41-7.30, p = 0.005), as was undergoing emergency surgery (OR: 2.93, 95% CI: 1.19-7.23, p = 0.020). The presence of contaminated wounds was found to be the strongest predictor, with an OR of 5.82 (95% CI: 2.01-16.87, p = 0.001). Smoking also showed a significant association with increased SSI risk (OR: 2.52, 95% CI: 1.01-6.29, p = 0.048). Additionally, a longer duration of surgery was independently associated with SSIs (OR: 1.86, 95% CI: 1.07-3.21, p = 0.027).

    SSIs were associated with diabetes, emergency surgeries, contaminated wounds, smoking, and prolonged surgical duration. These findings may help guide targeted preventive strategies.
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  • Women from rural Guatemala who speak Mayan languages have reduced odds of diabetes, hypertension and obesity.
    3 months ago
    Indigenous languages are integral to the individual and collective identity of humankind. Health benefits of speaking Indigenous languages have been demonstrated but may also be masked by various forms of linguistic and ethnic discrimination. Guatemala has experienced a significant degree of Mayan language loss and endangerment in recent decades. Recognition of the positive associations between Mayan languages and health may positively influence their trajectory.

    We undertook a cross-sectional analysis of a pre-existing dataset from a clinical population of women from Central and Western Guatemala. We compared prevalence of diabetes, hypertension, obesity and underweight among Mayan- and Spanish-speaking Indigenous women, and among non-Indigenous women. We used multiple logistic regression to estimate adjusted odds ratios for each condition by language preference, controlling for confounding factors.

    A total of 10,876 women were included in the analysis. Indigenous speakers of Mayan languages had the lowest prevalence of diabetes, hypertension and obesity, and non-Indigenous women had the highest prevalence of underweight. After controlling for sociodemographic factors, Mayan language preference was associated with decreased odds of diabetes [aOR 0.80, 95%CI (0.67, 0.94)], hypertension [aOR 0.80, 95%CI (0.71, 0.91)] and obesity [aOR 0.82, 95%CI (0.74, 0.90)].

    The reduced odds of diabetes, hypertension and obesity among women who prefer to speak Mayan languages might be explained by cultural and lifestyle factors that are inextricably tied to Mayan language use. These findings are consistent with several previous studies, although associations between Indigenous languages and obesity have been varied. Our findings strengthen the impetus to maintain the vitality of Mayan languages in Guatemala.
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  • NITROSAMINES IN METFORMIN AND HYDROCHLOROTHIAZIDE: "HUMAN SAFE PHOTOCARCINOGENS" WITHIN THE POLYPHARMACY AS GENERATOR FOR PHOTOTOXICITY/ PHOTOCARCINOGENICITY AND THE SUBSEQUENT DEVELOPMENT OF MULTIPLE KERATINOCYTE CARCINOMAS. DOUBLE HATCHET FLAP AS OPTIMAL AND NECESSARY DERMATOSURGICAL DECISION IN TWO NEW PATIENTS.
    3 months ago
    The issues that have been identified to date as potentially pivotal in relation to skin cancer in general, but also keratinocytic cancer in particular, mainly concern the permanent potentiation of concepts such as phototoxicity and hence its subsequent photocarcinogenicity over time. Studies by scientific teams dating back more than 50 years have defined the phototoxicity of nitrosamines as a rather non-specific property, regardless of whether the last mentioned have a carcinogenic effect or not. Recently or in 11/ 2024, hydrochlorothiazide was officially declared by the IARC/ International agency on cancer research as carcinogenic to humans due to its phototoxicity. Similar to sartans, metformin, beta blockers and calcium antagonists, hydrochlorothiazide are also associated with contamination from nitrosamines and all of them are scientifically and pathogenetically linked to phototoxicity and carcinogenicity in humans. The photocarcinogenic risk of those drugs in humans based on availability of nitrosamines in drugs seems to remain in all likelihood uncalculated by the regulators' tests, which are tailored to assess the purely carcinogenic risk, which in practice is also inaccurately calculated for a number of points. The cumulative phototoxicity and subsequent photocarcinogenicity in humans differ from pure carcinogenicity in bacteria and rodents. According to a number of international clinical observational studies, concomitant use of more than 1 antihypertensive drug is also associated with a significantly higher risk of developing skin cancer, and in patients with diabetes mellitus this risk is further increased. Polymedication of potentially contaminated drug production is logically associated pathogenetically with the intake of a larger amount of photocarcinogens and/or mutagens in parallel. The present article highlights and is indicative of the following facts: nitroso (photo)carcinogenesis is an undeniable fact that is integral to photocarcinogenesis and skin cancer pathogenesis. Nitrosogenesis of skin cancer is mediated and regulated most likely by the nitrosamine content of drugs. Drug-mediated Photo nitroso genesis/ Carcinogenesis of skin cancer accounts for the occurrence and progression of a significantly greater number of tumors compared to pure Photocarcinogenesis. Permanent intake of potentially contaminated polymedication leads to clinical manifestation of multiple skin tumors. We present two cases of patients who developed scalp tumors treated successfully with double hatchet flap. One of them developed a scalp tumor but also an additional auricular tumor in the context of a potential nitrosamine-contaminated polydrug regimen including 1) metformin, 2) bisoprolol, 3) amlodipine/valsartan/hydrochlorothiazide. The double hatchet flap technique and the role of drug-induced Nitroso Carcinogenesis/Photo Nitroso Carcinogenesis/Oncopharmacogenesis due to the permanent intake of phototoxic, genotoxic substances (within drugs), also known as nitrosamines, is commented. Complete elimination regimens of nitrosamines in drugs appear to be the safest solution to this global problem concerning skin cancer and cancer in general worldwide.
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  • Knowledge and Practices of the Jeddah Population Towards Tinea Pedis: A Cross-Sectional Study.
    3 months ago
    Tinea pedis is a widespread fungal infection that primarily affects the feet, with risk factors including excessive sweating and tight-fitting footwear. Preventive measures, such as maintaining clean and dry feet and wearing sandals in moist environments, are key in preventing its occurrence. Despite its prevalence and preventability, there is limited research on the knowledge and practices related to tinea pedis in Jeddah, Saudi Arabia.

    A cross-sectional study was conducted through a validated questionnaire among 696 Jeddah residents utilizing Google Forms that were distributed online via social media. Participants were recruited using convenience sampling. Collected data was analyzed using Statistical Software for Social Science (SPSS) version 27.

     The results revealed that most participants were unaware of tinea pedis (70.3%) and its risk factors (75.7%) and symptoms (74.6%). Diabetes mellitus was the most frequently selected risk factor, identified by 81.8% of participants from the list provided in the questionnaire. Only 33.3% examined their feet regularly, while 79.5% used nail scissors and 54.7% wore socks regularly. A significant proportion (82.2%) washed their feet three or more times daily. Regular foot examination (odds ratio (OR) = 1.901, p = 0.001) and wearing socks regularly (OR = 1.598, p = 0.027) were significant predictors of awareness, while occupation (unemployed) was also associated with higher odds of awareness (OR = 4.445, p = 0.005). Other factors like age, gender, and education showed no significant association.

    Most participants demonstrated significantly poor knowledge of tinea pedis and its risk factors despite its preventable nature. Practices like the regular foot examination and wearing socks were significant predictors of awareness, while lifestyle factors like prolonged sports shoe use and sporadic workouts increased vulnerability. Public health efforts should focus on improving awareness and preventive practices, particularly among high-risk groups such as individuals with diabetes.
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  • Correlation Between Blood Glucose Variability Indices Using Continuous Glucose Monitoring in Gestational Diabetes Patients and Abnormal Glucose Levels 42 Days Postpartum.
    3 months ago
    Objective: This study was aimed at analyzing the impact of blood glucose variability (GV) in gestational diabetes mellitus (GDM) patients on glucose outcomes 42 days postpartum and pregnancy outcomes. Additionally, it explored differences between various GV indices and evaluated their predictive values. Methods: This retrospective study included 75 pregnant women diagnosed with GDM. Continuous glucose monitoring (CGM) was initiated postdiagnosis, and outcomes were followed up. Oral glucose tolerance tests (OGTTs) were conducted 42 days postpartum to assess glucose response. Results: A total of 75 patients were included, among whom 8 (10.67%) exhibited impaired fasting glucose (IFG) and 7 (9.33%) impaired glucose tolerance (IGT) in the 42-day postpartum OGTT. No cases of diabetes were diagnosed. The results of the postpartum OGTT were significantly correlated with various GV indexes. In multivariate analysis, LBGI (OR: 1.437; 95% CI: 1.015-2.035; p = 0.041), M value (OR: 1.215; 95% CI: 1.030-1.434; p = 0.021), and TBR% (OR: 1.138; 95% CI: 1.020-1.271; p = 0.021) independently influenced IFG. Receiver operating characteristic (ROC) analysis indicated areas under the curve (AUCs) of 0.877 (95% CI: 0.760~0.994), 0.853 (95% CI: 0.730~0.975), 0.869 (95% CI: 0.748~0.991), and 0.793 (95% CI: 0.622~0.963) of IFG prediction model performance of TBR%, LBGI, M value, and HbA1c% combined with age, BMI, and family history of diabetes, respectively. Conclusion: Blood GV is an independent factor influencing IFG 42 days postpartum in GDM women, especially with hypoglycemia. It can increase the predictive efficiency of the postpartum abnormal blood glucose prediction model. Trial Registration: Chinese Clinical Trial Registry number: ChiCTR2100054833.
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  • Cost-utility analysis of empagliflozin compared with dapagliflozin in patients with type 2 diabetes in China.
    3 months ago
    Empagliflozin, a sodium-glucose cotransporter 2 inhibitor, performs a reduction in the all-cause mortality and cardiovascular mortality in type 2 diabetes mellitus (T2DM) patients compared to dapagliflozin, which has been included in the national volume-based procurement in China. The objective of this study is to evaluate the long-term cost-utility of the addition of empagliflozin (10 mg or 25 mg) versus dapagliflozin (10 mg) in T2DM patients with insufficient control by metformin monotherapy from the perspective of Chinese health care payers.

    The IQVIA CORE diabetes model was used for cost-utility analysis to compare the long-term economics of empagliflozin (10 or 25 mg) versus dapagliflozin (10 mg) respectively. In the two independent analyses, the discount rate was 5% per year, and the utility value was derived from the published literatures. The baseline demographic and biochemical data, as well as treatment efficacy data were obtained from the EMPA-REG MET clinical trial and network meta-analysis, respectively.

    Compared with dapagliflozin 10 mg, empagliflozin 10 mg and empagliflozin 25 mg improved the life expectancy by 0.011 and 0.02 years, and improved the quality adjusted life years (QALYs) by 0.011 and 0.02 years, respectively. The total cost of empagliflozin group (10 mg) was 279 Chinese Yuan lower than that of the dapagliflozin group (10 mg), making it an absolutely economical choice. The total cost of empagliflozin (25 mg) was expected to be 1,601 Chinese Yuan higher than dapagliflozin, with an incremental cost-utility ratio (ICUR) of 80,052 Chinese Yuan per QALY, below the set ‌willingness to pay (WTP) threshold of 85,698 Chinese Yuan per QALY.

    For T2DM patients with insufficient control by metformin monotherapy, the addition of empagliflozin 10 mg showed better efficacy and lower cost compared to dapagliflozin 10 mg, making it an absolutely economical choice. Based on the set WTP threshold, empagliflozin 25 mg was also a more cost-effective treatment option than dapagliflozin from the perspective of Chinese healthcare payers.
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  • Genetic variability in sodium-glucose cotransporter 2 and glucagon-like peptide 1 receptor effect on glycemic and pressure control in type 2 diabetes patients treated with SGLT2 inhibitors and GLP-1RA in the everyday clinical practice.
    3 months ago
    We investigated the impact of genetic polymorphisms in the GLP1R and SLC5A2 genes on the response to treatment with glucagon-like peptide-1 receptor (GLP-1R) agonists and sodium-glucose co-transporter-2 (SLGT2) inhibitors in patients with type 2 diabetes mellitus (T2DM) in everyday clinical practice.

    In our prospective interventional cohort open-label real-world genetic association study (DRKS-ID: DRKS00034478, https://drks.de/search/en/trial/DRKS00034478), we enrolled 161 clinically well-defined T2DM patients who received SGLT2 inhibitors and/or GLP-1R agonists alongside other medications for 3-6 months. The study's primary outcomes (HbA1c, body mass, and blood pressure) were measured before the treatment and at the follow-up at 3-6 months. GLP1R rs6923761, rs10305420, and SLC5A2 rs9934336 genotypes were determined by competitive allele-specific polymerase chain reaction. In patients receiving GLP-1R agonists, we analyzed the effect of GLP1R polymorphisms on the patients' response to treatment, while in patients receiving SGLT2 inhibitors, we analyzed the impact of the SLC5A2 polymorphism on the treatment effect.

    Treatment with prescribed antihyperglycemic drugs improved all primary outcomes (p < 0.050). The normal GLP1R rs6923761 G allele was associated with a greater reduction in HbA1c with GLP-1R agonists treatment than the polymorphic A allele in the dominant model (p = 0.029).

    The prevalent polymorphic A allele of GLP1R rs6923761 polymorphism was associated with the clinically relevant lower glycemic response to GLP-1R agonists. The described impact extends to everyday clinical practice, indicating that knowledge of these genetic polymorphisms could facilitate the development of targeted and personalized therapy in managing T2DM.
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