5 results on '"Fady T. Botros"'
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2. Follow‐up of SARS‐CoV‐2 positive subgroup from the Asymptomatic novel CORonavirus iNFection study
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Charles Williams, Meghan E. Jones, Jennifer L. Miller, Fady T. Botros, Iris Goetz, Kristin J. Meyers, Nancy Clifford, David H. Manner, Jianfei Jiang, Jack Knorr, Brad Woodward, and Brian Dillman
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Male ,Longitudinal study ,asymptomatic infections ,medicine.disease_cause ,SARS‐CoV‐2 ,0302 clinical medicine ,COVID-19 Testing ,Nasopharynx ,Prevalence ,Medicine ,030212 general & internal medicine ,Longitudinal Studies ,Fatigue ,Research Articles ,Coronavirus ,Aged, 80 and over ,Transmission (medicine) ,Headache ,Middle Aged ,Viral Load ,Hospitalization ,Infectious Diseases ,COVID-19 Nucleic Acid Testing ,Positive test result ,030211 gastroenterology & hepatology ,Female ,medicine.symptom ,Viral load ,Research Article ,Adult ,medicine.medical_specialty ,Adolescent ,Fever ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Asymptomatic ,Specimen Handling ,03 medical and health sciences ,Young Adult ,Internal medicine ,Virology ,Humans ,Aged ,business.industry ,SARS-CoV-2 ,Symptom development ,COVID-19 ,Cross-Sectional Studies ,Dyspnea ,business ,Follow-Up Studies - Abstract
A nested longitudinal study within theAsymptomatic novel CORonavirus iNFfection study followed participants with positive nasopharyngeal swab to query for development of symptoms and assess duration of positive reverse transcription‐polymerase chain reaction (RT‐PCR) test results. Of the 91 participants initially testing positive, 86 participated in follow‐up approximately 14 days after study enrollment; of those 86 participants, 19 (22.1%) developed at least one symptom at any time after the initial positive severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) test result. The median number of days to symptom development after their initial positive test result was 6 (range 1–29 days). No participants reported a SARS‐CoV‐2‐related hospitalization. The most frequently reported symptoms were fatigue or muscle aches (10.5%), headache (9.3%), fever (5.8%), and shortness of breath (5.8%). Of the 78 participants who submitted a nasopharyngeal swab for repeat RT‐PCR testing, 17 (21.8%) remained positive at Day 14, 4 of which continued to test positive at Day 28. These findings reinforce the probable role of silent SARS‐CoV‐2 infections in community transmission, and that reliance on symptom development will miss a large proportion of infections. Broad testing programs not limited to individuals presenting with symptoms are critical for identifying persons with SARS‐CoV‐2 infection and ultimately slowing transmission.
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- 2021
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3. A cross‐sectional community‐based observational study of asymptomatic SARS‐CoV‐2 prevalence in the greater Indianapolis area
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Iris Goetz, Fady T. Botros, Kristin J. Meyers, Jack Knorr, David H. Manner, Meghan E. Jones, and Brad Woodward
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Adult ,Male ,medicine.medical_specialty ,Indiana ,Adolescent ,Fever ,Epidemiology ,Short Communication ,Population ,Short Communications ,medicine.disease_cause ,Asymptomatic ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Internal medicine ,Nasopharynx ,Virology ,Pandemic ,medicine ,Prevalence ,Humans ,Medical history ,030212 general & internal medicine ,Cities ,education ,Asymptomatic Infections ,Coronavirus ,Aged ,education.field_of_study ,business.industry ,COVID-19 ,Middle Aged ,Confidence interval ,Cross-Sectional Studies ,Infectious Diseases ,Cough ,COVID-19 Nucleic Acid Testing ,030211 gastroenterology & hepatology ,Observational study ,Female ,Public Health ,medicine.symptom ,business - Abstract
The Asymptomatic novel CORonavirus iNfection (ACORN) study was designed to investigate the prevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the asymptomatic adult population of the Indianapolis metropolitan area, to follow individuals testing positive for the development of symptoms, and to understand duration of positive test results. ACORN is a cross-sectional community-based observational study of adult residents presenting asymptomatic for COVID-like illness, defined as the self-reported absence of the following three symptoms in the last 7 days: fever (≥100°F), new-onset or worsening cough, and new-onset or worsening shortness of breath. SARS-CoV-2 infection was determined by real-time reverse transcription-polymerase chain reaction in nasopharyngeal swab samples. SARS-CoV-2 infection prevalence was expressed as a point estimate with 95% confidence interval (CI). Test results are reported for 2953 participants who enrolled and underwent nasopharyngeal swab testing between 7 April 2020 and 16 May 2020. Among tested participants, 91 (3.1%; 95% CI: 2.5%-3.7%) were positive for SARS-CoV-2. Overall, baseline characteristics, medical history, and infection risk factors were comparable between SARS-CoV-2 positive and negative participants. Within the ongoing 14-day follow-up period for positive participants, 58 (71.6%) of 81 assessed participants remained asymptomatic while others (n = 23, 28.4%) reported one or more symptoms. Indiana had "Stay-at-Home" orders in place during nearly the entire test period reported here, yet 3.1% of asymptomatic participants tested positive for SARS-CoV-2. These results indicate screening questions had limited predictive utility for testing in an asymptomatic population and suggest broader testing strategies are needed. Importantly, these findings underscore that more research is needed to understand the viral transmission and the role asymptomatic and presymptomatic individuals play in this global pandemic.
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- 2020
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4. Effects of once‐weekly dulaglutide on kidney function in patients with type 2 diabetes in phase II and III clinical trials
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Greg Anglin, T. Dwight McKinney, Katherine R. Tuttle, Kristine D. Harper, Jaime A. Davidson, and Fady T. Botros
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Male ,Endocrinology, Diabetes and Metabolism ,Glucagon-Like Peptides ,Insulin Glargine ,Type 2 diabetes ,030204 cardiovascular system & hematology ,Kidney Function Tests ,Diabetic nephropathy ,0302 clinical medicine ,Endocrinology ,Brief Report ,clinical trial ,Acute Kidney Injury ,Middle Aged ,Treatment Outcome ,Creatinine ,Female ,type 2 diabetes ,medicine.symptom ,medicine.drug ,Glomerular Filtration Rate ,medicine.medical_specialty ,Recombinant Fusion Proteins ,Urology ,Renal function ,030209 endocrinology & metabolism ,Placebo ,Glucagon-Like Peptide-1 Receptor ,03 medical and health sciences ,Clinical Trials, Phase II as Topic ,Internal medicine ,dulaglutide ,Internal Medicine ,medicine ,Albuminuria ,Humans ,Hypoglycemic Agents ,Aged ,business.industry ,Insulin glargine ,diabetic nephropathy ,diabetes complications ,medicine.disease ,Immunoglobulin Fc Fragments ,Clinical Trials, Phase III as Topic ,Diabetes Mellitus, Type 2 ,Dulaglutide ,Brief Reports ,business ,GLP‐1 ,Kidney disease - Abstract
Dulaglutide is a once-weekly glucagon-like peptide-1 receptor agonist approved for the treatment of type 2 diabetes (T2D). Integrated data from 9 phase II and III trials in people with T2D (N = 6005) were used to evaluate the effects of dulaglutide on estimated glomerular filtration rate (eGFR [Chronic Kidney Disease Epidemiology Collaboration]), urine albumin-to-creatinine ratio (UACR) and kidney adverse events (AEs). No significant differences in eGFR were observed during treatment for dulaglutide vs placebo, active comparators or insulin glargine (mean ± standard deviation values: dulaglutide vs placebo: 87.8 ± 17.7 vs 88.2 ± 17.9 mL/min/1.73 m2 , P = .075; dulaglutide vs active comparators: 89.9 ± 16.7 vs 88.8 ± 16.3 mL/min/1.73 m2 , P = .223; and dulaglutide vs insulin glargine: 85.9 ± 18.2 vs 83.9 ± 18.6 mL/min/1.73 m2 , P = .423). Lower UACR values were observed for dulaglutide vs placebo, active comparators and insulin glargine (at 26 weeks, median [Q1-Q3] values were: dulaglutide vs placebo: 8.0 [4.4-20.4] vs 8.0 [4.4-23.9] mg/g, P = .023; dulaglutide vs active comparators: 8.0 [4.4-21.2] vs 8.9 [4.4-27.4] mg/g, P = .013; and dulaglutide vs insulin glargine: 8.9 [4.4-29.2] vs 12.4 [5.3-50.5] mg/g, P = .029). AEs reflecting potential acute renal failure were 3.4, 1.7 and 7.0 events/1000 patient-years for dulaglutide, active comparators and placebo, respectively. In conclusion, dulaglutide treatment of clinical trial participants with T2D did not affect eGFR and slightly decreased albuminuria.
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- 2016
5. Cardiovascular safety for once-weekly dulaglutide in type 2 diabetes: a pre-specified meta-analysis of prospectively adjudicated cardiovascular events
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Keith C. Ferdinand, Charles Atisso, Fady T. Botros, and Philip T. Sager
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Blood Glucose ,Male ,Endocrinology, Diabetes and Metabolism ,Glucagon-Like Peptides ,Kaplan-Meier Estimate ,030204 cardiovascular system & hematology ,0302 clinical medicine ,Risk Factors ,Clinical endpoint ,Medicine ,Myocardial infarction ,Prospective Studies ,Stroke ,Original Investigation ,Randomized Controlled Trials as Topic ,Hazard ratio ,Type 2 diabetes ,Incretin ,Middle Aged ,Treatment Outcome ,Cardiovascular Diseases ,Female ,Cardiology and Cardiovascular Medicine ,medicine.drug ,medicine.medical_specialty ,Recombinant Fusion Proteins ,030209 endocrinology & metabolism ,MACE ,Risk Assessment ,Drug Administration Schedule ,Glucagon-Like Peptide-1 Receptor ,Cardiovascular events ,03 medical and health sciences ,Internal medicine ,Humans ,Hypoglycemic Agents ,Aged ,Proportional Hazards Models ,business.industry ,Proportional hazards model ,Unstable angina ,Protective Factors ,medicine.disease ,Immunoglobulin Fc Fragments ,Meta-analysis ,Clinical Trials, Phase III as Topic ,Diabetes Mellitus, Type 2 ,Dulaglutide ,business ,Mace ,Biomarkers ,Glucagon-like peptide-1 (GLP-1) - Abstract
Background Patients with type 2 diabetes (T2D) have a substantial increased risk for cardiovascular (CV) disease and associated mortality than those without diabetes. Dulaglutide is a once-weekly glucagon-like peptide-1 receptor agonist that is approved for treatment of T2D. Methods This meta-analysis evaluates the CV risk in patients with T2D treated with dulaglutide in 9 randomized safety and efficacy trials. Mean (median) treatment duration was 333 (358) days. Reported CV events were independently adjudicated by a treatment-blinded clinical endpoint committee. The primary measure was a 4-component major adverse CV event (4-component MACE) composite endpoint of death due to CV causes, nonfatal myocardial infarction (MI), nonfatal stroke, or hospitalization for unstable angina. Additional pre-specified endpoints included adjudicated coronary revascularizations, hospitalization for heart failure, and all-cause mortality. A Cox proportional hazards regression model (stratified by study) was used to estimate the hazard ratio (HR) and confidence interval (CI). Tests of treatment effects for the primary endpoint were conducted at a 2-sided alpha level of 0.0198 and a corresponding 98.02 % CI was calculated. Statistical heterogeneity between the strata (studies) was tested by including in the Cox model an interaction term between treatment and strata. Results The analysis included 6010 randomized patients [dulaglutide: 3885; comparator therapy (active or placebo): 2125]; cumulative exposure to dulaglutide or comparator therapy was 3941 and 2223 patient-years, respectively. The demographic and baseline CV disease characteristics were similar across groups. Twenty-six (0.67 %) patients in the dulaglutide group versus 25 (1.18 %) in the comparator group experienced a primary 4-component MACE (HR 0.57; adjusted 98.02 % CI 0.30, 1.10). Results for the 3-component MACE (composite endpoint of death due to CV causes, nonfatal MI or stroke), 6-component MACE (composite endpoint of death due to CV causes, nonfatal MI or stroke, hospitalization for unstable angina or heart failure, or coronary revascularizations) and all-cause mortality were consistent with the primary analysis (HR
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