scholarly journals Methylprednisolone, venous thromboembolism, and association with heparin to 30 days in hospital survival in severe Covid-19 pneumonia

2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Ronaldo C. Go ◽  
Themba Nyirenda ◽  
Maryam Bojarian ◽  
Davood K. Hosseini ◽  
Mehek Rahim ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Low Dose ◽  
Cox Regression ◽  
Propensity Score Analysis ◽  
Youden Index ◽  
High Dose ◽  
Index Method ◽  
Hospital Survival ◽  
High Dose Methylprednisolone ◽  
D Dimer

Abstract Background Mortality in severe COVID-19 pneumonia is associated with thrombo-inflammation. Corticosteroids are given to attenuate the inflammation, but they are associated with thrombosis. The aims of this study were to determine the risk of venous thromboembolism between no methylprednisolone and methylprednisolone (dose versus duration) and to evaluate any synergistic dose-dependent association of heparin and methylprednisolone to 30 days in hospital survival. Methods This was a secondary analysis of a retrospective cohort. Patients included in this study were ≥ 18 years of age and admitted for severe COVID-19 pneumonia between March and June 2020 in 13 hospitals in New Jersey, United States. A propensity score analysis between administration of methylprednisolone and no methylprednisolone was fitted for 11 variables and Youden Index Method was used to determine cut-off between low dose and high dose methylprednisolone. Multivariate cox regression was to assess risk. Results In 759 patients, the incidence of venous thromboembolism was 9% of patients who received methylprednisolone and 3% of patients who did not receive methylprednisolone with a [RR 2.92 (95% CI 1.54, 5.55 P < 0.0001)]. There was a higher incidence of mechanical ventilation in the methylprednisolone group. The median d-dimer between patients with venous thromboembolism was higher compared to those without (P < 0.0003). However, the d-dimer was not statistically significant between those who had venous thromboembolism between methylprednisolone and no methylprednisolone groups (P = 0.40). There was no higher risk in high dose versus low dose [RR = 0.524 (95% CI 0.26, 1.06 P 0.4)]; however, the risk for venous thromboembolism between methylprednisolone for > 7 days and ≤ 7 days was statistically significant (RR 5.46 95% CI 2.87, 10.34 P < 0.0001). Patients who received low dose methylprednisolone and therapeutic heparin had a trend towards higher risk of mortality compared to prophylactic heparin (HR 1.81 95% CI 0.994 to 3.294) (P = 0.0522). There was no difference in 30 days in hospital survival between high dose methylprednisolone with prophylactic or therapeutic heparin (HR 0.827 95% CI 0.514 to 1.33) (P = 0.4335). Conclusion Methylprednisolone for > 7 days had a higher association of venous thromboembolism. There was no added benefit of therapeutic heparin to methylprednisolone on mechanically ventilated patients.

scholarly journals Methylprednisolone, Venous Thromboembolism, and Association with Heparin to 30 Days Hospital Survival in Severe COVID-19 Pneumonia

2021 ◽  
Author(s):  
Ronaldo C. Go ◽  
Themba Nyirenda ◽  
Maryam Bojarian ◽  
Davood Hosseini ◽  
Mehek Rahim ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Low Dose ◽  
Cox Regression ◽  
Propensity Score Analysis ◽  
Secondary Analysis ◽  
Youden Index ◽  
High Dose ◽  
Index Method ◽  
Hospital Survival ◽  
D Dimer

Abstract BACKGROUNDMortality in severe COVID-19 pneumonia is associated with thrombo-inflammation. Corticosteroids are given to attenuate the inflammation, but they are associated with thrombosis. The aims of this study were to determine the incidence of venous thromboembolism between no methylprednisolone and methylprednisolone (dose versus duration) and to evaluate the synergistic dose-dependent association of heparin and methylprednisolone to 30 days in hospital survival. METHODSThis was a secondary analysis of a retrospective cohort. Patients included in this study were older than 18 years of age and admitted for severe COVID-19 pneumonia between March to June 2020 in 13 hospitals in New Jersey, United States. A propensity score analysis between administration of methylprednisolone and no methylprednisolone was fitted for 11 variables and Youden Index Method was used to determine cut-off between low dose and high dose methylprednisolone. Multivariate cox regression was performed to assess hazard ratio.RESULTSIn 759 patients, the incidence of venous thromboembolism was 9% of patients who received methylprednisolone and 3% of patients who did not receive methylprednisolone with a [HR =2.92 (95% CI 1.54, 5.55 P< 0.0001)]. The was a higher incidence of mechanical ventilation in the methylprednisolone group. The median d-dimer between patients with venous thromboembolism was higher compared to those without (P<0.0003). However, the d-dimer was not statistically significant between those who had venous thromboembolism between methylprednisolone and no methylprednisolone groups. (P 0.40). There was no higher risk in high dose versus low dose[RR=0.524 (95% CI 0.26, 1.06 P 0.4)]; however, the risk for DVT/PE between methylprednisolone for > 7 days and < 7 days was statistically significant. (RR=5.46 95% CI 2.87, 10.34 P < 0.0001). Patients who received low dose and therapeutic heparin had a trend towards higher risk of mortality compared to prophylactic heparin (HR=1.81 95% CI 0.994 to 3.294) (P=0.0522). There was no difference in 30 days in hospital survival between high dose with prophylactic or therapeutic heparin (HR=0.827 95% CI 0.514 to 1.33) (P=0.4335). CONCLUSIONSMethylprednisolone for > 7 days had a higher association of venous thromboembolism. There was no added benefit of therapeutic heparin to methylprednisolone on mechanically ventilated patients.

scholarly journals Methylprednisolone, Venous Thromboembolism, and Association with Heparin to 30 Days in Hospital Survival in Severe COVID-19 Pneumonia

2021 ◽  
Author(s):  
Ronaldo C. Go ◽  
Themba Nyirenda ◽  
Maryam Bojarian ◽  
Davood Hosseini ◽  
Mehek Rahim ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Low Dose ◽  
Cox Regression ◽  
Propensity Score Analysis ◽  
Secondary Analysis ◽  
Youden Index ◽  
High Dose ◽  
Index Method ◽  
Hospital Survival ◽  
D Dimer

Abstract BACKGROUNDMortality in severe COVID-19 pneumonia is associated with thrombo-inflammation. Corticosteroids are given to attenuate the inflammation, but they are associated with thrombosis. The aims of this study were to determine the risk of venous thromboembolism between no methylprednisolone and methylprednisolone (dose versus duration) and to evaluate the synergistic dose-dependent association of heparin and methylprednisolone to 30 days in hospital survival. METHODSThis was a secondary analysis of a retrospective cohort. Patients included in this study were older than 18 years of age and admitted for severe COVID-19 pneumonia between March to June 2020 in 13 hospitals in New Jersey, United States. A propensity score analysis between administration of methylprednisolone and no methylprednisolone was fitted for 11 variables and Youden Index Method was used to determine cut-off between low dose and high dose methylprednisolone. Multivariate cox regression was performed to assess risk.RESULTSIn 759 patients, the incidence of venous thromboembolism was 9% of patients who received methylprednisolone and 3% of patients who did not receive methylprednisolone with a [RR =2.92 (95% CI 1.54, 5.55 P< 0.0001)]. The was a higher incidence of mechanical ventilation in the methylprednisolone group. The median d-dimer between patients with venous thromboembolism was higher compared to those without (P<0.0003). However, the d-dimer was not statistically significant between those who had venous thromboembolism between methylprednisolone and no methylprednisolone groups. (P 0.40). There was no higher risk in high dose versus low dose[RR=0.524 (95% CI 0.26, 1.06 P 0.4)]; however, the risk for DVT/PE between methylprednisolone for > 7 days and < 7 days was statistically significant. (RR=5.46 95% CI 2.87, 10.34 P < 0.0001). Patients who received low dose and therapeutic heparin had a trend towards higher risk of mortality compared to prophylactic heparin (HR=1.81 95% CI 0.994 to 3.294) (P=0.0522). There was no difference in 30 days in hospital survival between high dose with prophylactic or therapeutic heparin (HR=0.827 95% CI 0.514 to 1.33) (P=0.4335). CONCLUSIONSMethylprednisolone for > 7 days had a higher association of venous thromboembolism. There was no added benefit of therapeutic heparin to methylprednisolone on mechanically ventilated patients.

scholarly journals Racial/ethnic Disparities on Inflammation and Response to Methylprednisolone in Severe Covid-19 Pneumonia

2021 ◽  
Author(s):  
Ronaldo C. Go ◽  
Themba Nyirenda ◽  
Maryam Bojarian ◽  
Davood Karimi Hosseini ◽  
Kevin Kim ◽  
...  
Keyword(s):  
Inflammatory Markers ◽  
Asian Indians ◽  
Low Dose ◽  
Ethnic Disparities ◽  
Prolonged Survival ◽  
High Dose ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
High Dose Methylprednisolone ◽  
Racial Ethnic

Abstract BACKGROUNDRacial/Ethnic minorities are at higher risk for Severe COVID-19. This may be related to social determinants that lead to chronic inflammatory states. The aims of the study were to determine if there are racial/ethnic differences between the inflammatory markers of survivors and non-survivors and if there was a dose dependent association of methylprednisolone to in hospital survival. METHODSThis was a secondary analysis of a retrospective cohort. Patients were older than 18 years of age and admitted for severe COVID-19 Pneumonia Between March to June 2020 in 13 Hospitals in New Jersey, United States. Comparison of inflammatory markers used Kruskal-Wallis followed by pairwise comparison using two-sided Wilcoxon rank sum test. A Youden Index Method was used to determine the cut-off between low dose and high dose methylprednisolone. For each racial/ethnic group, cox regression was used to determine the association to survival between no methylprednisolone and methylprednisolone (high dose versus low dose). RESULTSPropensity matched sample (n=759) between no methylprednisolone (n=380) and methylprednisolone (n=379) had 338 Whites, 102 Blacks, 61 Asian/Indians, and 251 Non-Black Non-White Hispanics. Interleukin-6, C-reactive protein, ferritin, and d-dimer values were higher in non-survivors compared to survivors except in Asian/Indian survivors who had higher ferritin values compared to non-survivors (median: 1,265 vs 418 ug/L, P=0.0211). Black and Hispanic survivors had persistently elevated C-reactive protein, (10.2 mg/mL) and (13.70 mg/mL) respectively. Low dose methylprednisolone was associated with prolonged 60 days in hospital survival over no methylprednisolone in Whites (P<0.0001), Asian/Indians (P=0.0180), and Hispanics (P=0.0004). Regardless of dose, methylprednisolone was not associated with prolonged survival in Blacks. High dose methylprednisolone was associated with worse survival in Hispanics. (P=0.0181). CONCLUSIONRacial/Ethnic disparities with inflammatory markers in survivors and non-survivors preclude the use of one marker as predictor of survival. Low dose methylprednisolone is associated with prolonged survival in Asian/Indians, Hispanics, and Whites. Methylprednisolone, regardless of dose, was not associated with prolonged survival in Blacks.

scholarly journals High-dose corticosteroids improve the prognosis of Bell's palsy compared with low-dose corticosteroids: A propensity score analysis

2019 ◽  
Vol 122 (3) ◽  
pp. 258-259
Author(s):  
Takashi Fujiwara ◽  
Yasuharu Haku ◽  
Takuya Miyazaki ◽  
Atsuhiro Yoshida ◽  
Shin-ich Sato ◽  
...  
Keyword(s):  
Propensity Score ◽  
Low Dose ◽  
Propensity Score Analysis ◽  
Bell’S Palsy ◽  
High Dose ◽  
Bell's Palsy ◽  
Score Analysis

Baseline Thrombophilic Alterations and Risk of Venous Thromboembolism in 266 Multiple Myeloma Patients Primarily Treated with Thalidomide and High-Dose Dexamethasone.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3997-3997
Author(s):  
Elena Zamagni ◽  
Lelia Valdre ◽  
Michela Cini ◽  
Cristina Legnani ◽  
Patrizia Tosi ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Venous Thromboembolism ◽  
Protein C ◽  
Low Dose ◽  
Autologous Transplantation ◽  
Phase Iii ◽  
High Dose ◽  
Induction Phase ◽  
Newly Diagnosed ◽  
Dose Warfarin

Abstract Venous thromboembolism (VTE) has emerged as a major adverse event of primary induction therapy with thalidomide (thal) and dexamethasone (dex) for newly diagnosed multiple myeloma (MM). Aim of the present study was to investigate the relationship between thrombophilic alterations and the risk of VTE in 266 patients who received four months of therapy with thal (200 mg/d) and pulsed high-dose dex in preparation for double autologous transplantation. The rate of VTE in the whole group of patients was 11.6%. The risk of VTE was 26.3% (86.2% patient-years) among the first 19 patients who entered the study and did not received any prophylaxis against thrombosis. The corresponding value among the remaining 247 patients who received thromboprophylaxis with fixed low-dose (1.25 mg/d) warfarin during the four months of thal-dex therapy was 10.6% (35.5% patient-years) (P=0.04). Episodes of VTE occurred at a median of 53 days from the start of thal therapy and, with the exception of 3 patients, were observed after at least a partial response to thal-dex was documented. No VTE events were recorded during the first two months after the end of the induction phase. After VTE occurrence, the majority of patients went on with thal treatment plus full anticoagulation, without evidence of progression of thrombosis. One hundred and ninety patients were evaluated for the presence of thrombophilic alterations at baseline and at the end of thal-dex therapy. The prevalence of factor V Leiden (3.2%) or g20210A prothrombin (2.1%) polymorphism in patients with MM was similar to that observed in 183 healthy controls (3.3%, P= 0.81; 3.8%, P= 0.50, respectively). The relative risk of VTE for patients carrying one of these thrombophilic alterations was 20% compared with 9.4% for patients who lacked both of them (P= 0.58). Reduced protein C and S activities or acquired activated protein C resistance (aAPCR) were recorded at baseline in 11% and 7.4% of MM patients, respectively. Abnormal values at baseline normalized almost completely at the end of treatment. Carriers of aAPCR and/or of reduced levels of natural anticoagulants at baseline did not have a significantly higher risk of VTE compared with normal patients (15.2% vs 9.3%; P=0.49). In conclusion, no significant relationship was found between baseline thrombophilic alterations, including aAPCR, and the risk of thal-related VTE. Prophylaxis with fixed low-dose warfarin was associated with an apparent decrease in the rate of VTE in comparison with a subgroup of patients who did not receive any thromboprophylaxis. A prospective phase III study comparing low molecular weight heparin with fixed low-dose warfarin with aspirin is currently ongoing in Italy to evaluate the best prophylaxis against the risk of thal-related VTE for patients with newly diagnosed MM.

scholarly journals Safety of benzodiazepines and opioids in interstitial lung disease: a national prospective study

2018 ◽  
Vol 52 (6) ◽  
pp. 1801278 ◽  
Author(s):  
Sabrina Bajwah ◽  
Joanna M. Davies ◽  
Hanan Tanash ◽  
David C. Currow ◽  
Adejoke O. Oluyase ◽  
...  
Keyword(s):  
Interstitial Lung Disease ◽  
Lung Disease ◽  
Low Dose ◽  
Cox Regression ◽  
Oral Morphine ◽  
High Dose ◽  
Opioid Use ◽  
Respiratory Compromise ◽  
Oral Morphine Equivalent ◽  
Morphine Equivalent

Safety concerns are a barrier to prescribing benzodiazepines (BDZs) and opioids in interstitial lung disease (ILD). We therefore examined the association of BDZs and opioids on risk of admission to hospital and death.We conducted a population-based longitudinal cohort study of fibrotic ILD patients starting long-term oxygen therapy in Sweden between October 2005 and December 2014. Effects of BDZs and opioids on rates of admission to hospital and mortality were analysed using Fine–Gray and Cox regression while adjusting for potential confounders.We included 1603 patients (61% females). BDZs were used by 196 (12%) patients and opioids were used by 254 (15%) patients. There was no association between BDZs and increased admission. Treatment with high- versus low-dose BDZs was associated with increased mortality (subdistribution hazard ratio (SHR) 1.46, 95% CI 1.08–1.98 versus 1.13, 95% CI 0.92–1.38). Opioids showed no association with increased admission. Neither low-dose opioids (≤30 mg·day−1 oral morphine equivalent) (SHR 1.18, 95% CI 0.96–1.45) nor high-dose opioids (>30 mg·day−1 oral morphine equivalent) (SHR 1.11, 95% CI 0.89–1.39) showed association with increased mortality.This first ever study to examine associations between BDZ and opioid use and harm in ILD supports the use of opioids and low-dose BDZs in severely ill patients with respiratory compromise.

Experimental osteonecrosis induced by a combination of low-dose lipopolysaccharide and high-dose methylprednisolone in rabbits

2008 ◽  
Vol 75 (5) ◽  
pp. 573-578 ◽  
Author(s):  
Xinghuo Wu ◽  
Shuhua Yang ◽  
Deyu Duan ◽  
Yukun Zhang ◽  
Jing Wang
Keyword(s):  
Low Dose ◽  
High Dose ◽  
High Dose Methylprednisolone

scholarly journals Dexamethasone vs methylprednisolone high dose for Covid-19 pneumonia

PLoS ONE ◽  
2021 ◽  
Vol 16 (5) ◽  
pp. e0252057
Author(s):  
Miguel Alejandro Pinzón ◽  
Santiago Ortiz ◽  
Héctor Holguín ◽  
Juan Felipe Betancur ◽  
Doris Cardona Arango ◽  
...  
Keyword(s):  
Intensive Care ◽  
Clinical Outcome ◽  
Recovery Time ◽  
Oral Prednisone ◽  
P Value ◽  
High Dose ◽  
High Dose Methylprednisolone ◽  
Laboratory Results ◽  
D Dimer

Background There is no effective therapy for the severe acute respiratory syndrome by coronavirus 2 (SARS-CoV2) responsible for the Coronavirus disease 2019 (Covid-19). To date, dexamethasone has shown a decrease in mortality in patients who require oxygen, especially those with invasive mechanical ventilation. However, it is unknown if another corticosteroid can be used, the optimal dose and its duration, to achieve a better clinical outcome. The objective of the study was to compare the differences in clinical outcome and laboratory results in hospitalized patients with severe SARS-CoV2 Pneumonia treated with dexamethasone at 6 mg doses versus patients treated with high-dose methylprednisolone. Materials and methods Ambispective cohort study with survival analysis of 216 patients diagnosed with severe Covid-19 pneumonia confirmed by polymerase chain reaction for SARS-CoV2 by Berlin protocol, who were hospitalized in a high-complexity clinic in Medellín, Colombia. The patients should also have supplementary oxygen and radiological confirmation of Pneumonia by chest tomography. Sample size was not calculated since the total population that met the inclusion criteria was evaluated. 111 patients were treated with the institutional protocol with intravenous dexamethasone 6 mg QD for seven to 10 days if they required oxygen. Since September 15, 2020, the hospitalization protocol of the clinic was modified by the Infectious Diseases and Pulmonology service, recommending a high dose of methylprednisolone of 250 to 500 mg every day for three days with a subsequent change to oral prednisone 50 mg every day for 14 days. The protocol was not applied in the intensive care unit, where dexamethasone continued to be administered. The clinical outcome and differences in laboratory results of the patients who received dexamethasone vs. the prospective cohort that received methylprednisolone from September 15 to October 31, 2020, were evaluated. Follow-up was carried out by outpatient consultation one month after discharge or by telephone, inquiring about readmission or living-dead status. Results 216 patients had Covid-19 pneumonia documented by ground-glass imaging and alveolar pressure / inspired oxygen fraction (PaFi) less than 300. 111 patients received dexamethasone (DXM) and 105 received methylprednisolone (MTP). Patients in the DXM group evolved to severe ARDS in a higher proportion (26.1% vs 17.1% than the MTP group). Upon completion 4 days of treatment with parenteral corticosteroid, laboratory markers of severity decreased significantly in the group that received MTP, CRP 2.85 (2.3–3.8) vs 7.2 (5.4–9.8), (p-value < 0.0001), D-dimer 691 (612–847) vs 1083 (740–1565) (p-value = 0.04) and DHL 273 (244–289) vs 355 (270.6–422) (p-value = 0.01). After starting the corticosteroid, transfer to the intensive care unit (4.8% vs. 14.4%) and mortality (9,5% vs. 17.1%) was lower in the group that received MTP. Recovery time was shorter in patients treated with MTP, three days (3–4) vs. DXM 6 days (5–8) (p-value < 0.0001). At 30-day follow-up, 88 (92.6%) were alive in MTP vs 58 (63.1%) of those who received dexamethasone. Conclusions In this study, the treatment of severe Covid-19 Pneumonia with high-dose methylprednisolone for three days followed by oral prednisone for 14 days, compared with 6 mg dexamethasone for 7 to 10 days, statistically significantly decreased the recovery time, the need for transfer to intensive care and the severity markers C-reactive protein (CRP), D-dimer and LDH. Randomized controlled studies with methylprednisolone are required to corroborate its effect, and studies in a population hospitalized in intensive care wards.

scholarly journals An Investigation Into the Beneficial Effects of High-Dose Interferon beta 1-a, Compared to Low-Dose Interferon Beta 1-a (the base therapeutic regimen) in moderate to severe COVID-19

2021 ◽  
Author(s):  
Ilad Alavi Darazam ◽  
Firouze Hatami ◽  
Mohammad Mahdi Rabiei ◽  
Mohamad Amin Pourhoseingholi ◽  
Minoosh Shabani ◽  
...  
Keyword(s):  
Regression Model ◽  
Low Dose ◽  
Interferon Beta ◽  
Cox Regression ◽  
Intervention Group ◽  
Control Group ◽  
P Value ◽  
High Dose ◽  
Cox Regression Model ◽  
Subcutaneous Injections

Abstract Introduction: Coronavirus disease 2019 (COVID-19) has been a serious obstacle in front of public health. Interferon-beta 1a (IFN-β 1a) has been used to treat patients with COVID-19. We aimed to compare the effectiveness of high dose IFN-β 1a compared to low dose IFN-β 1a (the base therapeutic regimen) in moderate to severe COVID-19 cases.Methods: In this randomized, controlled, and clinical trial, eligible patients with confirmed SARS-CoV-2 infections were randomly assigned to receive one of the two following therapeutic regimens: The intervention group was treated with high dose IFN-β 1a (Recigen) (Subcutaneous injections of 88μg (24,000 IU) on days 1, 3, 6) + lopinavir /ritonavir (Kaletra) and the control group was treated with low dose IFN-β 1a (Recigen) (Subcutaneous injections of 44μg (12,000 IU) on days 1, 3, 6) + lopinavir /ritonavir (Kaletra) (400mg/100 mg twice a day for 10 days, orally, in all two groups). Result:A total of 168 COVID- 19 confirmed patients underwent randomization; 83 were assigned to the intervention group and 85 were assigned to the control group. Median Time To Clinical Improvement (TTIC) for cases treated with low dose of IFN-β1a was shorter than that for cases treated with high dose of IFN-β1a (6 vs10 days; P=0.018). Hazard Ratio for TTCI in the Cox regression model was 1.56 (95% CI: 1.05-2.30, P-value=0.026). Due to differences between some baseline clinical factors between intervention and control group, we; therefore, performed an adjusted analysis by including spo2, D-dimer and CRP in Cox regression model. The model failed to reach a significant difference between two groups. The adjusted HR was 1.37 (95% CI: 0.88-2.12, P-value=0.16). No difference was observed in terms of mortality between two groups. ConclusionThe use of high-dose IFN-β 1a did not improve TTCI in hospitalized patients with moderate to severe COVID-19. Also, it has not any significant effect in mortality reduction compared with treating with low-dose IFN-β 1a.Trial registration: The trial was confirmed by the Ethics in Medical Research Committee of the Shahid Beheshti University of Medical Sciences. signed informed consents were obtained from all the participants or their legally authorized representatives. This trial has been registered as ClinicalTrials.gov, NCT04521400.

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