scholarly journals A multicenter randomized placebo controlled trial of rifampin to reduce pedal amputations for osteomyelitis in veterans with diabetes (VA INTREPID)

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Mary T. Bessesen ◽  
Gheorghe Doros ◽  
Adam M. Henrie ◽  
Kelly M. Harrington ◽  
John A. Hermos ◽  
...  

Abstract Background The prevalence of diabetes mellitus continues to inexorably rise in the United States and throughout the world. Lower limb amputations are a devastating comorbid complication of diabetes mellitus. Osteomyelitis increases the risk of amputation fourfold and commonly presages death. Antimicrobial therapy for diabetic foot osteomyelitis (DFO) varies greatly, indicating that high quality data are needed to inform clinical decision making. Several small trials have indicated that the addition of rifampin to backbone antimicrobial regimens for osteomyelitis outside the setting of the diabetic foot results in 28 to 42% higher cure rates. Methods/design This is a prospective, randomized, double-blind investigation of the addition of 6 weeks of rifampin, 600 mg daily, vs. matched placebo (riboflavin) to standard-of-care, backbone antimicrobial therapy for DFO. The study population are patients enrolled in Veteran Health Administration (VHA), ages ≥18 and ≤ 89 years with diabetes mellitus and definite or probable osteomyelitis of the foot for whom an extended course of oral or intravenous antibiotics is planned. The primary endpoint is amputation-free survival. The primary hypothesis is that using rifampin as adjunctive therapy will lower the hazard rate compared with the group that does not use rifampin as adjunctive therapy. The primary hypothesis will be tested by means of a two-sided log-rank test with a 5% significance level. The test has 90% power to detect a hazard ratio of 0.67 or lower with a total of 880 study participants followed on average for 1.8 years. Discussion VA INTREPID will test if a rifampin-adjunctive antibiotic regimen increases amputation-free survival in patients seeking care in the VHA with DFO. A positive finding and its adoption by clinicians would reduce lower extremity amputations and their associated physical and emotional impact and reduce mortality for Veterans and for the general population with diabetic foot osteomyelitis. Given that rifampin-adjunctive regimens are currently employed for therapy for the majority of DFO cases in Europe, and only in a small minority of cases in the United States, the trial results will impact therapeutic decisions, even if the null hypothesis is not rejected. Trial registration Registered January 6, 2017 at ClinicalTrials.gov, NCT03012529.

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 121-OR ◽  
Author(s):  
TAO ZHOU ◽  
DIANJIANYI SUN ◽  
XIANG LI ◽  
YORIKO HEIANZA ◽  
HOIRUN NISA ◽  
...  

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Lauren Parlett ◽  
Qinli Ma ◽  
Qian Shi ◽  
Geoffrey Crawford ◽  
Laura Herrera Scott ◽  
...  

AbstractThis claims-based retrospective cohort study examined the prevalence and incremental impact of non-alcoholic steatohepatitis among children with type 2 diabetes mellitus in the United States. Although diagnoses of non-alcoholic steatohepatitis were not common among diabetic children, it was associated with significantly higher incremental healthcare cost and risk of hospitalization.


2021 ◽  
pp. 154041532110370
Author(s):  
Alyssia M. Miller De Rutté ◽  
Amanda Barrie

Background: Acculturation to the United States has been previously studied in Spanish-speaking populations, but little is known about the potential relationship between acculturation and type 2 diabetes mellitus (T2DM). Objective: The purpose of this systematic review was to explore the relationship between acculturation and T2DM in Spanish-speaking populations in the United States. Methods: Selected studies collected from a review of literature were analyzed by population, ethnicity, acculturation scale, and significance. Results: Thirty-two eligible articles showed conflicting data between the effects of acculturation on T2DM. Conclusion: Overall, studies yielded inconclusive results on the significance of the relationship between acculturation and diabetes in Spanish-speaking populations, which merit further investigation.


2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Aditi Malhotra ◽  
Hal A Skopicki ◽  
Smadar Kort ◽  
Noelle Mann ◽  
Puja Parikh

Background: There is a paucity of data regarding prevalence of cardiovascular disease (CVD) and corresponding cardiovascular (CV) risk factors in transgender individuals. We sought to assess the prevalence of CV risk factors and CVD in transgender persons in the United States. Methods: The 2018 Centers for Disease Control’s Behavioral Risk Factor Surveillance Survey was utilized to identify a cohort of 1,038 transgender individuals in the United States. Presence of CVD was noted with a single affirmative response to the following questions: “Has a health care professional ever told you that you had any of the following:” (1) a heart attack or myocardial infarction, (2) angina or coronary heart disease, (3) a stroke? Results: Among the 1,038 transgender individuals studied, a total of 145 (14.0%) had CVD while 893 (86.0%) did not. No differences in prevalence of CVD was noted in transgender individuals who transitioned from male-to-female (n=387), female-to-male (n=400), and gender nonconforming status (n=251) (15.0% vs 13.8% vs 12.7%, p=0.72). Transgender individuals with CVD were older, had lower annual income, higher rates of smoking (28.4% vs 18.1%, p=0.004), and higher rates of multiple co-morbidities including asthma (26.6% vs 17.4%, p = 0.009), skin cancer (21.8% vs 5.0%, p <0.001), non-skin cancers (16.8% vs 6.8%, p <0.001), chronic obstructive pulmonary disease (27.5% vs 7.0%, p <0.001), arthritis (65.3% vs 28.7%, p<0.001), depressive disorder (42.7% vs 31.0%, p= 0.006), chronic kidney disease (16.2% vs 3.3%, p< 0.001), and diabetes mellitus (42.0% vs 12.7%, p <0.001). No significant differences in race, health insurance status, or body mass index was noted between transgender individuals with CVD versus those without. In multivariable analysis, independent predictors of CVD in transgender individuals included older age, diabetes mellitus [odds ratio (OR) 2.82, 95% confidence interval (CI) 1.73 - 4.58], chronic kidney disease (OR 3.69, 95% CI 1.80 - 7.57), chronic obstructive pulmonary disease (OR 2.18, 95% CI 1.19 - 3.99), and depressive disorder (OR 1.82, 95% CI 1.09 - 3.03). Conclusions: In this observational contemporary study, CVD was prevalent in 14% of transgender individuals in the United States. Predictors of CVD in the transgender population exist and transgender persons should be appropriately screened for CV risk factors so as to minimize their risk of CVD.


Author(s):  
Ting Bao ◽  
Luke J. Peppone ◽  
Patricia Robinson

There are 15.5 million cancer survivors in the United States because of, in part, improvements in therapy. As a result, there will be an increased burden of long- and late-term complications of cancer care, such as metabolic alterations. These metabolic changes will include alterations in bone resorption, obesity, hypercholesterolemia, and diabetes mellitus. The majority of cancer treatment–related toxicities have focused on endocrine therapy; however, chemotherapy and supportive medications, such as steroids, contribute to the development of these disorders. Because of the chronicity of these metabolic changes and their impact on morbidity, cancer risk, and outcomes as well other negative effects, including musculoskeletal pain and vasomotor symptoms, alternative strategies must be developed. These strategies should include nonpharmacologic approaches. Here, we summarize metabolic changes secondary to cancer care and integrative approaches to help alleviate therapy-associated toxicities.


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S340-S341
Author(s):  
Rheanne K Maravelas ◽  
Thomas Melgar ◽  
Sapna Sadarangani ◽  
Neiberg Lima ◽  
Zachary Rich ◽  
...  

Abstract Background Pyomyositis is a spontaneous infection of skeletal muscle that can lead to abscess formation and sepsis. The purpose of our study was to better describe the characteristics, risk factors, and trends of primary pyomyositis in the United States. Methods This study is a retrospective review of data from the Healthcare Utilization Project Nationwide Inpatient Sample Database from 2002 to 2014. We systematically searched ICD-9 codes and included diagnoses of infective myositis and/or tropical pyomyositis and excluded progressive myositis ossificans and/or traumatic myositis ossificans. We compiled lists of codes for co-occurring infections, candidate risk factors, and microbiological data. Each group of related ICD-9 codes was combined into a single composite indicator. SAS studio was utilized for analysis. Results The database included a total of 100,790,900 discharges accounting for 482,872,274 weighted discharges with 13,011 pyomyositis cases accounting for 62,657 weighted cases. The patients with pyomyositis were significantly more likely to be younger, male, and have a longer duration of hospitalization. The proportion of discharges with pyomyositis has steadily risen more than 3-fold from 0.0054% to 0.0209%. Of the cases of pyomyositis, a minority had co-occurring deep tissue infections: 16.9% had osteomyelitis and 8.8% had septic arthritis. We found significantly higher rates of co-occurrence with HIV, diabetes mellitus, organ transplant, alcohol abuse, and chronic kidney disease compared with the general hospitalized population, suggesting these as relevant risk factors. When microorganisms were diagnosed, Staphylococus aureus was most common, followed by Streptococcus spp. Conclusion Our study identified a rapid increase in pyomyositis cases in the United States over our 12-year study period. Our results substantiate risk factors for pyomyositis related to immunosuppression and suggest that diabetes mellitus may be an important risk factor in the United States. Identifying causative organisms is helpful for empiric treatment. It is important that clinicians be aware of this emerging diagnosis relevant in both temperate and tropical areas of the globe. Disclosures All authors: No reported disclosures.


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