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1. Long and Short-term Metformin Consumption as a Potential Therapy to Prevent Complications of COVID-19

Author

Elnaz Shaseb, Saba Ghaffary, Alireza Garjani, Elnaz Zoghi, Nasrin Maleki Dizaji, Somaieh Soltani, Parvin Sarbakhsh, Mohammad Hossein Somi, Parya Valizadeh, Ali Taghizadieh, Masood Faghihdinevari, Mojtaba Varshochi, Behrooz Naghily, Zhinous Bayatmakoo, Parviz Saleh, Sepehr Taghizadeh, Mehdi Haghdoost, Hamid Owaysi, Fatemeh Ravanbakhsh Ghavghani, Mohammad Kazem Tarzamni, Rojin Moradi, Fateme Javan Ali Azar, Saeid Shabestari Khiabani, Ardavan Ghazanchaei, Sana Hamedani, and Shahabeddin Hatefi

Subjects
covid-19, diabetes mellitus, metformin, intubation, Therapeutics. Pharmacology, RM1-950
Abstract

Purpose: The aim of the study is to evaluate the effect of metformin in complication improvement of hospitalized patients with COVID-19. Methods: This was a randomized clinical trial that involved 189 patients with confirmed COVID-19 infection. Patients in the intervention group received metformin-500 mg twice daily. Patients who received metformin before admission were excluded from the control group. Patients who were discharged before taking at least 2000 mg of metformin were excluded from the study. Primary outcomes were vital signs, need for ICU admission, need for intubation, and mortality. Results: Data showed that patients with diabetes with previous metformin in their regimen had lower percentages of ICU admission and death in comparison with patients without diabetes (11.3% vs. 26.1% (P=0.014) and 4.9% vs. 23.9% (P≤0.001), respectively). Admission time characteristics were the same for both groups except for diabetes and hyperlipidemia, which were significantly different between the two groups. Observations of naproxen consumption on endpoints, duration of hospitalization, and the levels of spO2 did not show any significant differences between the intervention and the control group. The adjusted OR for intubation in the intervention group versus the control group was 0.21 [95% CI, 0.04-0.99 (P=0.047)]. Conclusion: In this trial, metformin consumption had no effect on mortality and ICU admission rates in non-diabetic patients. However, metformin improved COVID-19 complications in diabetic patients who had been receiving metformin prior to COVID-19 infection, and it significantly lowered the intubation rates.

Published
2023
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2. Utilization Evaluation of Antimicrobial Agents in Neutropenic Cancer Patients in a Teaching hospital: Urgent of Drug Utilization Evaluation Studies

Author

Hadi Hamishehkar, Elnaz Zoghi, Hadi Chavoushi, Simin Ozar-Mashayekhi, Parina Asgharian, Taher Entezari-Maleki, and Haleh Rezaee

Subjects
Drug Utilization Evaluation, Febrile neutropenia, Antibiotics, Therapeutics. Pharmacology, RM1-950, Pharmacy and materia medica, RS1-441
Abstract

Background: More than 80% of patients with hematologic malignancies will develop fever during more than one chemotherapy cycle combined with neutropenia. We aim to evaluate empiric antibiotic strategies in Febrile Neutropenic (FN) cancer patients. Methods: This is a concurrent study performed in the “Shahid Ghazi” teaching hospital, hematology-oncology center of Tabriz, Iran during the period of December 2011 to September2012. During this period, patients with FN were evaluated in view of antibiotics utilization based on Infectious Disease Society of America (IDSA) and National Comprehensive Cancer Network (NCCN) instructions. Results: Seventy patients had a total of 91 episodes of FN in the duration of this study. Among them 63 (90%) patients were the cases of acute leukemia. For 88 (96.7 %) patients, imipenem was used as the initial empirical antibiotic regimen. It was changed to piperacillin/tazobactam in 8 (8.8%) of them without indication. Cultures didn’t obtain before the initiation of empirical therapy in 19 (20.9%) episodes. Empiric vancomycin didn’t discontinue after 3 days even if it was not warranted in 23 episodes. In 16 cases vancomycin was switched to teicoplanin. The fluconazole dosages generally given to patients were all suboptimal. Adjusting the dosages of vancomycin or imipenem was not done correctly in 13 (14.29%) episodes. Conclusion: The results of this study showed that choosing antimicrobial agents and their dosing for prophylaxis and treatment of FN patients and discharge antimicrobial planning of FN patients do not follow the evaluated guidelines. Drug Usage Evaluation studies need to be done regularly in such a center.

Published
2015

3. Atorvastatin versus Placebo in ICU Patients with COVID-19: Ninety-day Results of the INSPIRATION-S Trial

Author

Azita H. Talasaz, Parham Sadeghipour, Hooman Bakhshandeh, Babak Sharif-Kashani, Farid Rashidi, Mohammad Taghi Beigmohammadi, Keivan Gohari Moghadam, Somaye Rezaian, Ali Dabbagh, Seyed Hashem Sezavar, Mohsen Farrokhpour, Atefeh Abedini, Rasoul Aliannejad, Taghi Riahi, Mahdi Yadollahzadeh, Somayeh Lookzadeh, Parisa Rezaeifar, Samira Matin, Ouria Tahamtan, Keyhan Mohammadi, Elnaz Zoghi, Hamid Rahmani, Seyed Hossein Hosseini, Seyed Masoud Mousavian, Homa Abri, Pardis Sadeghipour, Elahe Baghizadeh, Farnaz Rafiee, Sepehr Jamalkhani, Ahmad Amin, Bahram Mohebbi, Seyed Ehsan Parhizgar, Mahshid Soleimanzadeh, Maryam Aghakouchakzadeh, Vahid Eslami, Pooya Payandemehr, Hossein Khalili, Hamed Talakoob, Taranom Tojari, Shadi Shafaghi, Sanaz Tabrizi, Hessam Kakavand, Alireza Kashefizadeh, Atabak Najafi, David Jimenez, Aakriti Gupta, Mahesh V. Madhavan, Sanjum S. Sethi, Sahil A. Parikh, Manuel Monreal, Naser Hadavand, Alireza Hajighasemi, Khalil Ansarin, Majid Maleki, Saeed Sadeghian, Stefano Barco, Bob Siegerink, Erica S. Spatz, Gregory Piazza, Ajay J. Kirtane, Benjamin W. Van Tassell, Gregory Y. H. Lip, Frederikus A. Klok, Samuel Z. Goldhaber, Gregg W. Stone, Harlan M. Krumholz, and Behnood Bikdeli

Subjects
Adult, Atorvastatin/therapeutic use, Male, Intensive Care Units, Treatment Outcome, Double-Blind Method, COVID-19, Humans, Thrombosis/drug therapy, Female, Hematology, Middle Aged
Abstract

Background In the INSPIRATION-S trial, atorvastatin versus placebo was associated with a nonsignificant 16% reduction in 30-day composite of venous/arterial thrombosis or death in intensive care unit (ICU) patients with COVID-19. Thrombo-inflammatory response in coronavirus disease 2019 (COVID-19) may last beyond the first 30 days. Methods This article reports the effects of atorvastatin 20 mg daily versus placebo on 90-day clinical and functional outcomes from INSPIRATION-S, a double-blind multicenter randomized trial of adult ICU patients with COVID-19. The main outcome for this prespecified study was a composite of adjudicated venous/arterial thrombosis, treatment with extracorporeal membrane oxygenation (ECMO), or all-cause mortality. Functional status was assessed with the Post-COVID-19 Functional Scale. Results In the primary analysis, 587 patients were included (age: 57 [Q1–Q3: 45–68] years; 44% women). By 90-day follow-up, the main outcome occurred in 96 (33.1%) patients assigned to atorvastatin and 113 (38.0%) assigned to placebo (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.60–1.05, p = 0.11). Atorvastatin in patients who presented within 7 days of symptom onset was associated with reduced 90-day hazard for the main outcome (HR: 0.60, 95% CI: 0.42–0.86, p interaction = 0.02). Atorvastatin use was associated with improved 90-day functional status, although the upper bound CI crossed 1.0 (ORordinal: 0.64, 95% CI: 0.41–1.01, p = 0.05). Conclusion Atorvastatin 20 mg compared with placebo did not significantly reduce the 90-day composite of death, treatment with ECMO, or venous/arterial thrombosis. However, the point estimates do not exclude a potential clinically meaningful treatment effect, especially among patients who presented within 7 days of symptom onset. (NCT04486508).

Published
2023
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4. Intermediate-Dose versus Standard-Dose Prophylactic Anticoagulation in Patients with COVID-19 Admitted to the Intensive Care Unit:90-Day Results from the INSPIRATION Randomized Trial

Author

Samuel Z. Goldhaber, Naser Hadavand, Aakriti Gupta, Ajay J. Kirtane, Samira Matin, Seyed Ehsan Parhizgar, Gregory Piazza, Mahesh V. Madhavan, Babak Sharif-Kashani, Benjamin W. Van Tassell, Sahil A. Parikh, Parisa Rezaeifar, Vahid Eslami, Homa Abri, Sanaz Hariri Tabrizi, Mohammad Taghi Beigmohammadi, Atabak Najafi, Paul P. Dobesh, Seyed Hossein Hosseini, Farid Rashidi, Hossein Khalili, Bahram Mohebbi, Ali Dabbagh, Manuel Monreal, Behnood Bikdeli, Hooman Bakhshandeh, Elnaz Zoghi, Rasoul Aliannejad, Majid Maleki, Farnaz Rafiee, Atefeh Abedini, Gregory Y.H. Lip, Samrand Fattah Ghazi, Keivan Gohari Moghadam, Pooya Payandemehr, Shadi Shafaghi, Seyed Masoud Mousavian, Alireza Kashefizadeh, Mahdi Yadollahzadeh, Mohsen Farrokhpour, Shaghayegh Shahmirzaei, Ouria Tahamtan, Sepehr Jamalkhani, Gregg W. Stone, Parham Sadeghipour, Azita Hajhossein Talasaz, Alireza Hajighasemi, David Jiménez, Harlan M. Krumholz, Hamid Reza Rahmani, Sanjum S. Sethi, Ahmad Amin, Hessam Kakavand, Somayeh Lookzadeh, Pardis Sadeghipour, Elahe Baghizadeh, Saeed Sadeghian, Seyed Hashem Sezavar, Taghi Riahi, and Keyhan Mohammadi

Subjects
Male, Critical Care, medicine.medical_treatment, Hemorrhage, Kaplan-Meier Estimate, Iran, 030204 cardiovascular system & hematology, heparin, law.invention, Cohort Studies, 03 medical and health sciences, Extracorporeal Membrane Oxygenation, 0302 clinical medicine, Randomized controlled trial, law, Intensive care, Antithrombotic, medicine, Extracorporeal membrane oxygenation, Humans, 030212 general & internal medicine, Enoxaparin, anticoagulation, Pandemics, Stroke, Aged, Dose-Response Relationship, Drug, SARS-CoV-2, business.industry, Hazard ratio, Anticoagulants, COVID-19, Thrombosis, enoxaparin, Hematology, Middle Aged, trial, medicine.disease, Intensive care unit, COVID-19 Drug Treatment, Intensive Care Units, Anesthesia, Female, business
Abstract

Background Thrombotic complications are considered among the main extrapulmonary manifestations of coronavirus disease 2019 (COVID-19). The optimal type and duration of prophylactic antithrombotic therapy in these patients remain unknown. Methods This article reports the final (90-day) results of the Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) study. Patients with COVID-19 admitted to intensive care were randomized to intermediate-dose versus standard-dose prophylactic anticoagulation for 30 days, irrespective of hospital discharge status. The primary efficacy outcome was a composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation (ECMO), or all-cause death. The main safety outcome was major bleeding. Results Of 600 randomized patients, 562 entered the modified intention-to-treat analysis (median age [Q1, Q3]: 62 [50, 71] years; 237 [42.2%] women), of whom 336 (59.8%) survived to hospital discharge. The primary outcome occurred in 132 (47.8%) of patients assigned to intermediate dose and 130 (45.4%) patients assigned to standard-dose prophylactic anticoagulation (hazard ratio [HR]: 1.21, 95% confidence interval [CI]: 0.95–1.55, p = 0.11). Findings were similar for other efficacy outcomes, and in the landmark analysis from days 31 to 90 (HR: 1.59, 95% CI: 0.45–5.06). There were 7 (2.5%) major bleeding events in the intermediate-dose group (including 3 fatal events) and 4 (1.4%) major bleeding events in the standard-dose group (none fatal) (HR: 1.82, 95% CI: 0.53–6.24). Conclusion Intermediate-dose compared with standard-dose prophylactic anticoagulation did not reduce a composite of death, treatment with ECMO, or venous or arterial thrombosis at 90-day follow-up.

Published
2022
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5. Effect of Intermediate-Dose vs Standard-Dose Prophylactic Anticoagulation on Thrombotic Events, Extracorporeal Membrane Oxygenation Treatment, or Mortality among Patients with COVID-19 Admitted to the Intensive Care Unit:The INSPIRATION Randomized Clinical Trial

Author

Bahram Mohebbi, Rasoul Aliannejad, Farnaz Rafiee, Gregory Y.H. Lip, Alireza Kashefizadeh, Somayeh Lookzadeh, Pooya Payandemehr, Taghi Riahi, Samira Matin, Shaghayegh Shahmirzaei, Manuel Monreal, Benjamin W. Van Tassell, Inspiration Investigators, Gregg W. Stone, Aakriti Gupta, Vahid Eslami, Babak Sharif-Kashani, Seyed Hashem Sezavar, Parisa Rezaeifar, Samuel Z. Goldhaber, Hossein Khalili, Hooman Bakhshandeh, Elnaz Zoghi, Sanaz Hariri Tabrizi, Homa Abri, Paul P. Dobesh, Farid Rashidi, Keivan Gohari Moghadam, Pardis Sadeghipour, Hamid Reza Rahmani, Ajay J. Kirtane, Seyed Hossein Hosseini, Sanjum S. Sethi, Ali Dabbagh, Ahmad Amin, Hessam Kakavand, Harlan M. Krumholz, Seyed Masoud Mousavian, Saeed Sadeghian, David Jiménez, Keyhan Mohammadi, Shadi Shafaghi, Sahil A. Parikh, Gregory Piazza, Mahesh V. Madhavan, Ouria Tahamtan, Alireza Hajighasemi, Majid Maleki, Atefeh Abedini, Mohsen Farrokhpour, Atabak Najafi, Seyed Ehsan Parhizgar, Behnood Bikdeli, Mahdi Yadollahzadeh, Sepehr Jamalkhani, Parham Sadeghipour, Azita Hajhossein Talasaz, Elahe Baghizadeh, Naser Hadavand, Samrand Fattah Ghazi, and Mohammad Taghi Beigmohammadi

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, Hemorrhage, Iran, Placebo, 01 natural sciences, Drug Administration Schedule, law.invention, 03 medical and health sciences, Extracorporeal Membrane Oxygenation, 0302 clinical medicine, Randomized controlled trial, Interquartile range, law, Internal medicine, Outcome Assessment, Health Care, Odds Ratio, Extracorporeal membrane oxygenation, Humans, Medicine, 030212 general & internal medicine, Enoxaparin, 0101 mathematics, Aged, Venous Thrombosis, business.industry, 010102 general mathematics, Oxygen Inhalation Therapy, Absolute risk reduction, Anticoagulants, COVID-19, Thrombosis, General Medicine, Odds ratio, Length of Stay, Middle Aged, medicine.disease, Thrombocytopenia, Intensive care unit, Pulmonary embolism, Hospitalization, Intensive Care Units, Treatment Outcome, Female, Pulmonary Embolism, business
Abstract

Importance: Thrombotic events are commonly reported in critically ill patients with COVID-19. Limited data exist to guide the intensity of antithrombotic prophylaxis. Objective: To evaluate the effects of intermediate-dose vs standard-dose prophylactic anticoagulation among patients with COVID-19 admitted to the intensive care unit (ICU). Design, Setting, and Participants: Multicenter randomized trial with a 2 × 2 factorial design performed in 10 academic centers in Iran comparing intermediate-dose vs standard-dose prophylactic anticoagulation (first hypothesis) and statin therapy vs matching placebo (second hypothesis; not reported in this article) among adult patients admitted to the ICU with COVID-19. Patients were recruited between July 29, 2020, and November 19, 2020. The final follow-up date for the 30-day primary outcome was December 19, 2020. Interventions: Intermediate-dose (enoxaparin, 1 mg/kg daily) (n = 276) vs standard prophylactic anticoagulation (enoxaparin, 40 mg daily) (n = 286), with modification according to body weight and creatinine clearance. The assigned treatments were planned to be continued until completion of 30-day follow-up. Main Outcomes and Measures: The primary efficacy outcome was a composite of venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality within 30 days, assessed in randomized patients who met the eligibility criteria and received at least 1 dose of the assigned treatment. Prespecified safety outcomes included major bleeding according to the Bleeding Academic Research Consortium (type 3 or 5 definition), powered for noninferiority (a noninferiority margin of 1.8 based on odds ratio), and severe thrombocytopenia (platelet count 3/µL). All outcomes were blindly adjudicated. Results: Among 600 randomized patients, 562 (93.7%) were included in the primary analysis (median [interquartile range] age, 62 [50-71] years; 237 [42.2%] women). The primary efficacy outcome occurred in 126 patients (45.7%) in the intermediate-dose group and 126 patients (44.1%) in the standard-dose prophylaxis group (absolute risk difference, 1.5% [95% CI,-6.6% to 9.8%]; odds ratio, 1.06 [95% CI, 0.76-1.48]; P =.70). Major bleeding occurred in 7 patients (2.5%) in the intermediate-dose group and 4 patients (1.4%) in the standard-dose prophylaxis group (risk difference, 1.1% [1-sided 97.5% CI,-∞ to 3.4%]; odds ratio, 1.83 [1-sided 97.5% CI, 0.00-5.93]), not meeting the noninferiority criteria (P for noninferiority >.99). Severe thrombocytopenia occurred only in patients assigned to the intermediate-dose group (6 vs 0 patients; risk difference, 2.2% [95% CI, 0.4%-3.8%]; P =.01). Conclusions and Relevance: Among patients admitted to the ICU with COVID-19, intermediate-dose prophylactic anticoagulation, compared with standard-dose prophylactic anticoagulation, did not result in a significant difference in the primary outcome of a composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality within 30 days. These results do not support the routine empirical use of intermediate-dose prophylactic anticoagulation in unselected patients admitted to the ICU with COVID-19. Trial Registration: ClinicalTrials.gov Identifier: NCT04486508.

Published
2021
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6. Mathematical representation of fluorescence intensity of probes in aqueous binary solvent mixtures

Author

Masoumeh Shaghaghi, Abolghasem Jouyban, William E. Acree, Elnaz Zoghi, Noruz Karami, and Brian J. Clark

Subjects
Sociology and Political Science, Clinical Biochemistry, Analytical chemistry, Binary number, Test probe, Biochemistry, Fluorescence, chemistry.chemical_compound, Computer Simulation, Pyridoxal, Spectroscopy, Fluorescent Dyes, Aqueous solution, Mathematical model, Water, Solvent, Clinical Psychology, Fluorescence intensity, chemistry, Solubility, Alcohols, Solvents, Thermodynamics, Law, Social Sciences (miscellaneous)
Abstract

Fluorescence intensities of propranolol and atenolol in binary solvent mixtures at various temperatures are measured and mathematical models are proposed to represent the fluorescence intensity data. The results showed that the proposed models are able to correlate/predict the data with reasonable error. The fluorescence intensity of pyridoxal HCl in binary solvents at 25 °C is also determined and represented by the proposed model as an additional test probe.

Published
2011

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