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1.
N Engl J Med ; 385(6): 503-515, 2021 08 05.
Article in English | MEDLINE | ID: covidwho-2160403

ABSTRACT

BACKGROUND: Tirzepatide is a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 (GLP-1) receptor agonist that is under development for the treatment of type 2 diabetes. The efficacy and safety of once-weekly tirzepatide as compared with semaglutide, a selective GLP-1 receptor agonist, are unknown. METHODS: In an open-label, 40-week, phase 3 trial, we randomly assigned 1879 patients, in a 1:1:1:1 ratio, to receive tirzepatide at a dose of 5 mg, 10 mg, or 15 mg or semaglutide at a dose of 1 mg. At baseline, the mean glycated hemoglobin level was 8.28%, the mean age 56.6 years, and the mean weight 93.7 kg. The primary end point was the change in the glycated hemoglobin level from baseline to 40 weeks. RESULTS: The estimated mean change from baseline in the glycated hemoglobin level was -2.01 percentage points, -2.24 percentage points, and -2.30 percentage points with 5 mg, 10 mg, and 15 mg of tirzepatide, respectively, and -1.86 percentage points with semaglutide; the estimated differences between the 5-mg, 10-mg, and 15-mg tirzepatide groups and the semaglutide group were -0.15 percentage points (95% confidence interval [CI], -0.28 to -0.03; P = 0.02), -0.39 percentage points (95% CI, -0.51 to -0.26; P<0.001), and -0.45 percentage points (95% CI, -0.57 to -0.32; P<0.001), respectively. Tirzepatide at all doses was noninferior and superior to semaglutide. Reductions in body weight were greater with tirzepatide than with semaglutide (least-squares mean estimated treatment difference, -1.9 kg, -3.6 kg, and -5.5 kg, respectively; P<0.001 for all comparisons). The most common adverse events were gastrointestinal and were primarily mild to moderate in severity in the tirzepatide and semaglutide groups (nausea, 17 to 22% and 18%; diarrhea, 13 to 16% and 12%; and vomiting, 6 to 10% and 8%, respectively). Of the patients who received tirzepatide, hypoglycemia (blood glucose level, <54 mg per deciliter) was reported in 0.6% (5-mg group), 0.2% (10-mg group), and 1.7% (15-mg group); hypoglycemia was reported in 0.4% of those who received semaglutide. Serious adverse events were reported in 5 to 7% of the patients who received tirzepatide and in 3% of those who received semaglutide. CONCLUSIONS: In patients with type 2 diabetes, tirzepatide was noninferior and superior to semaglutide with respect to the mean change in the glycated hemoglobin level from baseline to 40 weeks. (Funded by Eli Lilly; SURPASS-2 ClinicalTrials.gov number, NCT03987919.).


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Gastric Inhibitory Polypeptide/administration & dosage , Glucagon-Like Peptides/administration & dosage , Hypoglycemic Agents/administration & dosage , Blood Glucose/analysis , Diabetes Mellitus, Type 2/blood , Dose-Response Relationship, Drug , Drug Administration Schedule , Drug Therapy, Combination , Female , Gastric Inhibitory Polypeptide/adverse effects , Glucagon-Like Peptide-1 Receptor/agonists , Glucagon-Like Peptides/adverse effects , Glycated Hemoglobin A/analysis , Humans , Hypoglycemic Agents/adverse effects , Hypoglycemic Agents/therapeutic use , Incretins/therapeutic use , Injections, Subcutaneous , Male , Metformin/therapeutic use , Middle Aged , Nausea/chemically induced , Weight Loss/drug effects
2.
Rev Assoc Med Bras (1992) ; 68(9): 1216-1220, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-2039502

ABSTRACT

INTRODUCTION: Patients with chronic diseases, such as diabetes and cardiovascular diseases, and old age, which are associated with a high risk of malnutrition and worse outcomes, are at a higher risk for developing the severe presentation of COVID-19. METHODS: This is an observational and cross-sectional study with a sample defined by convenience. Data were collected in adult inpatient units through information obtained via telephone contact with the patient/companion, records collected by the nursing staff, and medical records, tabulating demographics, body composition, previous illnesses, nutritional diagnoses, diet acceptance, and hospitalization outcomes. The following symptoms were observed: inappetence, smell, dysgeusia, odynophagia, nausea, vomiting, and diarrhea. RESULTS: Most deaths occurred after transfer to the intensive care unit (79.6%). Patients with the worst outcome had lower food intake with a cutoff point of 60% for diet acceptance, which seems to be an adequate discriminator between those who survived and those who did not. Gastrointestinal symptoms were significantly associated with food consumption below 60% of the planned goal. The symptoms most associated with lower energy intake were inappetence, dysgeusia, and nausea/vomiting. CONCLUSIONS: Reduced caloric intake and the presence of nutritional risk or its appearance during hospitalization seemed to be associated with mortality in patients with COVID-19 admitted outside the intensive care unit.


Subject(s)
COVID-19 , Adult , Brazil/epidemiology , Cross-Sectional Studies , Dysgeusia , Hospitalization , Humans , Nausea , Tertiary Care Centers , Vomiting
3.
Obstet Gynecol ; 140(4): 696-699, 2022 Oct 01.
Article in English | MEDLINE | ID: covidwho-2018211

ABSTRACT

BACKGROUND: Nausea and vomiting in pregnancy often require pharmacotherapy for symptom management. Serotonin syndrome is a rare clinical entity that can be precipitated by the medications used to treat nausea and vomiting in pregnancy. CASE: A 35-year-old pregnant individual with a history of hyperemesis gravidarum in an earlier pregnancy requiring prolonged hospitalization presented with nausea and vomiting at 7 weeks of gestation. She was incidentally found to have severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection when she was universally screened at the time of admission. She required pharmacotherapy, including prochlorperazine and ondansetron for treatment of nausea as well as sumatriptan for migraine. She developed acute spasticity, autonomic dysfunction, and temperature rise, precipitated by antiemetic therapy, consistent with serotonin syndrome. The syndrome resolved with supportive care and benzodiazepines. CONCLUSION: Serotonin syndrome is a serious clinical entity that can be provoked by the pharmacotherapy given to treat nausea and vomiting in pregnancy. This medical emergency requires early recognition and prompt management.


Subject(s)
Antiemetics , COVID-19 , Hyperemesis Gravidarum , Serotonin Syndrome , Pregnancy , Female , Humans , Adult , Serotonin Syndrome/therapy , Serotonin Syndrome/drug therapy , SARS-CoV-2 , COVID-19/drug therapy , Nausea/drug therapy , Nausea/etiology , Vomiting/drug therapy , Vomiting/etiology , Antiemetics/therapeutic use , Hyperemesis Gravidarum/drug therapy , Hyperemesis Gravidarum/diagnosis
4.
Turk J Gastroenterol ; 33(11): 955-963, 2022 Nov.
Article in English | MEDLINE | ID: covidwho-1988284

ABSTRACT

BACKGROUND: In patients with coronavirus disease 2019, the gastrointestinal symptoms have been reported increasingly in addition to the respiratory system symptoms. The studies show that the prevalence of gastrointestinal system symptoms and how the gastrointestinal system contributes to the severity and prognosis of the disease is still not clear. This study aims to find the prevalence of gastrointestinal symptoms and the correlation between the gastrointestinal symptoms and the clinical results in hospitalized patients diagnosed with coronavirus disease 2019. METHODS: This study retrospectively analyzes patients diagnosed with coronavirus disease 2019 and hospitalized in the pandemic unit between March 2020 and August 2020 and compares their demographic and clinical characteristics, laboratory and radiologic findings, coronavirus disease 2019 treatments received, the clinical course of the disease, and the gastrointestinal symptoms. RESULTS: In our study, we included 322 patients diagnosed with coronavirus disease 2019 and hospitalized; 39 patients (12.1%) were admitted to the hospital with at least one gastrointestinal symptom (nausea and vomiting, diarrhea, abdominal pain, and the loss of taste). Nausea and vomiting are the most common gastrointestinal symptoms with a prevalence of 7.1%, followed by diarrhea with 2.8%, the loss of taste with 2.2%, and abdominal pain with 1.5%. The mean age and D-dimer levels of the patients showing gastrointestinal symptoms were lower than those who did not have any gastrointestinal symptoms. We did not find a significant correlation between the presence of the gastrointestinal symptoms and the severity of the disease, treatment received, risk of acute respiratory distress syndrome and septic shock, admission to the intensive care unit, the need for mechanical ventilation, the mortality rate or the length of hospitalization in the medical floor or the intensive care unit. CONCLUSION: In this study, we observed that 12.1% of coronavirus disease 2019 patients apply to the hospital due to gastrointestinal symptoms. Furthermore, the gastrointestinal symptoms do not seem to affect the severity and the course of the disease, it is important to identify coronavirus disease 2019 patients showing unusual symptoms such as the gastrointestinal symptoms at an early stage to protect healthcare professionals from infection risk.


Subject(s)
Ageusia , COVID-19 , Gastrointestinal Diseases , Humans , COVID-19/epidemiology , SARS-CoV-2 , Prevalence , Retrospective Studies , Turkey/epidemiology , Gastrointestinal Diseases/epidemiology , Gastrointestinal Diseases/diagnosis , Diarrhea/epidemiology , Diarrhea/etiology , Abdominal Pain/epidemiology , Abdominal Pain/etiology , Vomiting , Nausea
5.
J Endourol ; 36(7): 934-940, 2022 07.
Article in English | MEDLINE | ID: covidwho-1931771

ABSTRACT

Objective: As the coronavirus disease 2019 (COVID-19) global pandemic continues, there is increased value in performing same-day discharge (SDD) protocols to minimize viral exposure and maintain the appropriate surgical treatment for oncologic patients. In this scenario, we performed a prospective analysis of outcomes of our patients undergoing SDD protocol after robot-assisted radical prostatectomy (RARP). Materials and Methods: The SDD criteria included patients with no intraoperative complications, stable postoperative hemoglobin levels (compared with preoperative values), stable vital signs, normal urine output, ambulation with assistance and independently without dizziness, tolerance of clear liquids without nausea or vomiting, pain control with oral medication, and patient/family confidence with SDD. Patients older than 70 years, concomitant general surgery operations, multiple comorbidities, and complex procedures such as salvage surgery were excluded from our protocol. Results: Of the 101 patients who met the criteria for SDD, 73 (72%) had an effective SDD. All SDF (same day discharge failure) patients were discharged one day after surgery. Intraoperative characteristics were not statistically different with a median operative time of 92 (81-107) vs 103 (91-111) minutes for SDD and SDF, respectively. Of the 28 SDF patients, the most common reasons for staying were anesthesia-related factors of nausea (35%), drowsiness (7%), patient/caregiver preference (25%), pain (14%), labile blood pressure (7%), arrhythmia (7%), and dizziness (7%). There was no significant difference in readmission rates, complication rates, or postoperative pain scores between SDD and SDF patients. Conclusions: In our experience, SDD for patients undergoing RARP can be safely and feasibly incorporated into a clinical care pathway without increasing readmission rates. We were effective in 72% of cases because of coordinated care between anesthetics, nursing staff, and appropriate patient selection. We also believe that incorporating pre- and postoperative patient education and assurance is crucial to minimize their exposure to COVID-19 during the surgical treatment for prostate cancer.


Subject(s)
COVID-19 , Robotic Surgical Procedures , Robotics , Dizziness/complications , Humans , Male , Nausea/complications , Pain/etiology , Patient Discharge , Postoperative Complications/etiology , Prostatectomy/methods , Referral and Consultation , Robotic Surgical Procedures/methods
6.
J Neurol ; 269(11): 5702-5709, 2022 Nov.
Article in English | MEDLINE | ID: covidwho-1930408

ABSTRACT

BACKGROUND: Headache is one of the most frequently reported symptoms in post-COVID patients. The clinical phenotype of COVID-19 headache combines phenotypic features of both tension-type headache (TTH) and migraine. We aimed to assess the effectiveness, side effects and predictors of amitriptyline (AMT) response in a real-world study setting. METHODS: We performed an observational multicentric study with a retrospective cohort. All consecutive patients with confirmed COVID-19 infection who received AMT for post-COVID headache from March 2020 to May 2021 were included. Response was evaluated by the reduction in the number of headache days per month (HDM) between weeks 8 and 12, compared with the baseline. We explored which variables were associated with a higher probability of response to AMT. RESULTS: Forty-eight patients were eligible for the study, 40/48 (83.3%) females, aged 46.85 (SD: 13.59) years. Patients had history of migraine 15/48 (31.3%) or TTH 5/48 (10.4%). The mean reduction of HDM was 9.6 (SD: 10.9; 95% CI 6.5, 12.7) days. Only 2/48 (5%) of patients discontinued AMT due to poor tolerability. History of TTH (10.9, 95% CI 1.3, 20.6) and nausea (- 8.5, 95% CI - 14.6, - 2.5) were associated with AMT response. CONCLUSIONS: This study provides real-world evidence of the potential benefit of AMT in patients with post-COVID-19 headache, especially in patients with history of TTH and without concomitant nausea.


Subject(s)
COVID-19 , Migraine Disorders , Tension-Type Headache , Amitriptyline/adverse effects , COVID-19/complications , Female , Headache/drug therapy , Humans , Male , Migraine Disorders/diagnosis , Migraine Disorders/drug therapy , Migraine Disorders/epidemiology , Nausea , Retrospective Studies , Tension-Type Headache/diagnosis , Tension-Type Headache/drug therapy , Tension-Type Headache/epidemiology
7.
Ir Med J ; 115(5): 599, 2022 05 25.
Article in English | MEDLINE | ID: covidwho-1888056

ABSTRACT

Aims To describe readmissions of hospitalised patients with COVID-19, define predictors of readmission and explore the long term outcomes using the SF-12 score compared to patients who were not readmitted and those not hospitalised. Methods A single centre retrospective in North Inner-City Dublin. Recruitment was done through a COVID follow up clinic. Predictors of readmission and SF-12 scores at two timepoints post follow up at median 3 months and 12 months. Results Seventy (45%) participants were admitted, with a median age of 49.5 years (IQR 41.3-56.9), 36(51%) of whom were female. Unscheduled readmissions at ≤30 days in COVID-19 patients were 9(12.9%) and length of stay was four days (IQR 2-5). Readmissions were due to ongoing symptoms(n=9(64.3%)) or new complications(n=5(35.7%)). Mechanical ventilation and having symptoms of nausea and vomiting on index admission were predictive of readmission. (p=0.002). SF-12 scores at one year of readmitted patients were not different to patients who were never admitted at median one year follow up, p=.089. Conclusions Most readmissions were of short duration. Early follow up of patients post MV or who had nausea and vomiting on index admission should be prioritised. Wellbeing of readmitted patients was not different to those never hospitalised, at one year.


Subject(s)
COVID-19 , Adult , Female , Humans , Male , Middle Aged , Nausea , Patient Readmission , Retrospective Studies , Risk Factors , Vomiting
8.
Stroke Vasc Neurol ; 7(2): 172-175, 2022 04.
Article in English | MEDLINE | ID: covidwho-1832555

ABSTRACT

BACKGROUND: Acute vestibular syndrome (AVS) features continuous dizziness and may result from a benign inner ear disorder or stroke. The head impulse-nystagmus-test of skew (HINTS) bedside assessment is more sensitive than brain MRI in identifying stroke as the cause of AVS within the first 24 hours. Clinicians' perspectives of the test in UK secondary care remains unknown. Here, we explore front-line clinicians' perspectives of use of the HINTS for the diagnosis of AVS. METHODS: Clinicians from two large UK hospitals who assess AVS patients completed a short online survey, newly designed with closed and open questions. RESULTS: Almost half of 73 total responders reported limited (n=33), or no experience (n=19), reflected in low rates of use of HINTS (n=31). While recognising the potential utility of HINTS, many reported concerns about subjectivity, need for specialist skills and poor patient compliance. No clinicians reported high levels of confidence in performing HINTS, with 98% identifying training needs. A lack of formalised training was associated with onward specialist referrals and neuroimaging (p=0.044). CONCLUSIONS: Although the low sample size in this study limits the generalisability of findings to wider sites, our preliminary data identified barriers to the application of the HINTS in AVS patients and training needs to improve rapid, cost-effective and accurate clinical diagnosis of stroke presenting with vertigo.


Subject(s)
Nystagmus, Pathologic , Stroke , Acute Disease , Head Impulse Test , Humans , Nausea , Nystagmus, Pathologic/complications , Nystagmus, Pathologic/diagnosis , Stroke/diagnosis , United Kingdom , Vertigo/diagnosis , Vertigo/etiology , Vomiting
9.
Sao Paulo Med J ; 140(3): 372-377, 2022.
Article in English | MEDLINE | ID: covidwho-1833818

ABSTRACT

BACKGROUND: Favipiravir is generally used in treating coronavirus disease 2019 (COVID-19) pneumonia in Turkey. OBJECTIVE: To determine the side effects of favipiravir and whether it is a good treatment option. DESIGN AND SETTING: Retrospective study conducted in Atatürk Chest Diseases and Chest Surgery Training and Research Hospital, Ankara, Turkey. METHODS: 357 patients who completed favipiravir treatment at the recommended dose were included. 37 patients with drug side effects and 320 patients without drug side effects were examined in two groups. RESULTS: Side effects were observed in 37 (10.36%) out of 357 patients using favipiravir. The most common side effect was liver dysfunction, in 26 (7.28%) of the patients. The following other side effects were also observed: diarrhea (1.4%), nausea (0.84%), abdominal pain (0.28%) and thrombocytopenia (0.28%). One patient (0.28%) presented both increased transaminases and nausea. CONCLUSION: In this study, it was determined that favipiravir may constitute an alternative for treating COVID-19 pneumonia given that its side effects are generally well tolerated and not serious.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Amides , Antiviral Agents/adverse effects , COVID-19/drug therapy , Drug-Related Side Effects and Adverse Reactions/drug therapy , Humans , Nausea/chemically induced , Nausea/drug therapy , Pyrazines , Retrospective Studies , SARS-CoV-2 , Treatment Outcome
10.
G Ital Nefrol ; 39(2)2022 Apr 21.
Article in English | MEDLINE | ID: covidwho-1801193

ABSTRACT

Introduction: Some hemodialysis patients are reluctant to undergo COVID-19 vaccination for the fear of developing adverse events (AEs). The aim of this study was to verify the safety of the mRNA-1273 vaccine in hemodialysis patients. Methods: We conducted a retrospective analysis of in-center hemodialysis patients who underwent mRNA-1273 vaccine from March 1st to April 30th, 2021. All AEs occurring after the first and the second doses were collected and classified as local or systemic. Results: Overall, 126 patients on chronic maintenance dialysis without a prior COVID-19 diagnosis were vaccinated with two doses of mRNA-1273 vaccine. Mean age was 68 (IQR, 54,7-76) years and 53.6% of patients were aged ≥65 years. During the observational period of 68 (IQR, 66-70) days, AEs occurred in 57.9% and 61.9% of patients after the first dose and second dose, respectively. The most common AEs were: injection-site pain (61.9%), erythema (4.8%), itching (4.8%), swelling (16.7%), axillary swelling/tenderness (2.4%), fever (17.5%) headache (7.9%), fatigue (23.8%), myalgia (17.5%), arthralgia (12.7%), dyspnoea (2.4%), nausea/vomiting (7.1%), diarrhoea (5.6%), shivers (4%) and vertigo (1.6%). The rates of local AEs were similar after the first and second doses (P=0.8), whereas systemic AEs occurred more frequently after the second dose (P=0.001). Fever (P=0.03), fatigue (P=0.02) and nausea/vomiting (P=0.03) were significantly more frequent after the second dose of the vaccine. There were no age-related differences in the rate of AEs. Overall, vaccine-related AEs in hemodialysis patients seem to be lower than in the general population. Conclusion: The RNA-1273 vaccine was associated with the development of transient AEs after the first and second doses in patients on chronic maintenance hemodialysis. They were mostly local, whereas systemic AEs were more prevalent after the second dose. Overall, all AEs lasted for a few days, without any apparent sequelae.


Subject(s)
COVID-19 Vaccines , COVID-19 , Aged , COVID-19/prevention & control , COVID-19 Testing , COVID-19 Vaccines/adverse effects , Fatigue/etiology , Humans , Nausea , Renal Dialysis , Retrospective Studies , SARS-CoV-2 , Vomiting
11.
BMC Gastroenterol ; 22(1): 106, 2022 Mar 07.
Article in English | MEDLINE | ID: covidwho-1731517

ABSTRACT

BACKGROUND: Gastrointestinal symptoms have been reported in patients with COVID-19. Several clinical investigations suggested that gastrointestinal symptoms were associated with disease severity of COVID-19. However, the relevance of gastrointestinal symptoms and mortality of COVID-19 remains largely unknown. We aim to investigate the relationship between gastrointestinal symptoms and COVID-19 mortality. METHODS: We searched the PubMed, Embase, Web of science and Cochrane for studies published between Dec 1, 2019 and May 1, 2021, that had data on gastrointestinal symptoms in COVID-19 patients. Additional literatures were obtained by screening the citations of included studies and recent reviews. Only studies that reported the mortality of COVID-19 patients with/without gastrointestinal symptoms were included. Raw data were pooled to calculate OR (Odds Ratio). The mortality was compared between patients with and without gastrointestinal symptoms, as well as between patients with and without individual symptoms (diarrhea, nausea/vomiting, abdominal pain). RESULTS: Fifty-three literatures with 55,245 COVID-19 patients (4955 non-survivors and 50,290 survivors) were included. The presence of GI symptoms was not associated with the mortality of COVID-19 patients (OR=0.88; 95% CI 0.71-1.09; P=0.23). As for individual symptoms, diarrhea (OR=1.01; 95% CI 0.72-1.41; P=0.96), nausea/vomiting (OR=1.16; 95% CI 0.78-1.71; P=0.46) and abdominal pain (OR=1.55; 95% CI 0.68-3.54; P=0.3) also showed non-relevance with the death of COVID-19 patients. CONCLUSIONS: Gastrointestinal symptoms are not associated with higher mortality of COVID-19 patients. The prognostic value of gastrointestinal symptoms in COVID-19 requires further investigation.


Subject(s)
COVID-19 , Gastrointestinal Diseases , COVID-19/complications , Gastrointestinal Diseases/diagnosis , Humans , Nausea/etiology , SARS-CoV-2 , Vomiting/etiology
12.
Homeopathy ; 111(3): 202-209, 2022 08.
Article in English | MEDLINE | ID: covidwho-1713256

ABSTRACT

INTRODUCTION/BACKGROUND: Nausea and vomiting in pregnancy are common physiological disturbances, causing physical, social and psychological symptoms in the affected women. Though it is difficult to draw absolute conclusions on whether or not pregnant women are at high risk of acquiring severe consequences from corona-virus disease 2019 (COVID-19), clinical experience has shown them to be potentially vulnerable to other coronaviruses. Lack of specific conventional therapy for these conditions called for a complementary and individualised homeopathy approach in the presented case. METHODS: The homeopathic medical management of early symptoms of nausea and vomiting in pregnancy (NVP) and the beginning of COVID-19 symptoms shortly before a scheduled Caesarean section is described. No ongoing specific treatments were discontinued. The connection between intervention with individualised homeopathy and clinical improvement was assessed by two independent reviewers using the MOdified NARanjo Criteria for Homeopathy (MONARCH) inventory. RESULTS: There was improvement of NVP symptoms in early pregnancy and in later-onset COVID-19 symptoms following an individually prescribed unipotent homeopathic medicine, Sepia officinalis, after tele-consultation during lockdown. The agreed MONARCH score was +8 points, suggesting that homeopathy contributed to clinical improvement. CONCLUSION: Individualised homeopathy may be a helpful complementary medical approach for managing symptoms associated with NVP and COVID-19 during pregnancy.


Subject(s)
COVID-19 , Homeopathy , Pregnancy Complications , COVID-19/therapy , Cesarean Section , Communicable Disease Control , Female , Humans , Nausea/drug therapy , Nausea/psychology , Pregnancy , Pregnancy Trimester, First , Pregnancy Trimester, Third , Vomiting/psychology
13.
Dig Dis Sci ; 67(11): 5034-5043, 2022 Nov.
Article in English | MEDLINE | ID: covidwho-1669857

ABSTRACT

BACKGROUND: We aimed to understand the association of gastrointestinal (GI) symptoms at initial presentation with clinical outcomes during COVID-19 hospitalization. METHODS: This retrospective, multicenter cohort study included consecutive hospitalized COVID-19 patients from a single, large health system. The presence of GI symptoms was assessed at initial presentation and included one or more of the following: nausea, vomiting, diarrhea and abdominal pain. Patients were divided into three cohorts: Only GI symptoms, GI and non-GI symptoms and only non-GI symptoms. The primary outcome was association of GI symptoms with mortality. Secondary outcomes included prevalence of GI symptoms and survival analysis. RESULTS: A total of 1672 COVID-19 patients were hospitalized (mean age: 63 ± 15.8 years, females: 50.4%) in our system during the study period. 40.7% patients had at least one GI symptom (diarrhea in 28.3%, nausea/vomiting in 23%, and abdominal pain in 8.8% patients), and 2.6% patients had only GI symptoms at initial presentation. Patients presenting with GI symptoms (with or without non-GI symptoms) had a lower mortality rate compared to patients presenting with only non-GI symptoms (20% vs. 26%; p < 0.05). The time from hospitalization to being discharged was less for patients presenting with only GI symptoms (7.4 days vs. > 9 days, p < 0.0014). After adjusting for other factors, the presence of GI symptoms was not associated with mortality (p > 0.05). CONCLUSION: Among a hospitalized COVID-19 positive Southern US population, 41% patients presented with either diarrhea, nausea, vomiting or abdominal pain initially. The presence of GI symptoms has no association with in-hospital all-cause mortality.


Subject(s)
COVID-19 , Gastrointestinal Diseases , Female , Humans , Middle Aged , Aged , COVID-19/complications , COVID-19/therapy , SARS-CoV-2 , Retrospective Studies , Cohort Studies , Gastrointestinal Diseases/diagnosis , Gastrointestinal Diseases/epidemiology , Nausea/epidemiology , Nausea/etiology , Vomiting/epidemiology , Vomiting/etiology , Diarrhea/epidemiology , Diarrhea/etiology , Abdominal Pain/epidemiology , Abdominal Pain/etiology
14.
PLoS Comput Biol ; 17(12): e1009629, 2021 12.
Article in English | MEDLINE | ID: covidwho-1581906

ABSTRACT

Identifying order of symptom onset of infectious diseases might aid in differentiating symptomatic infections earlier in a population thereby enabling non-pharmaceutical interventions and reducing disease spread. Previously, we developed a mathematical model predicting the order of symptoms based on data from the initial outbreak of SARS-CoV-2 in China using symptom occurrence at diagnosis and found that the order of COVID-19 symptoms differed from that of other infectious diseases including influenza. Whether this order of COVID-19 symptoms holds in the USA under changing conditions is unclear. Here, we use modeling to predict the order of symptoms using data from both the initial outbreaks in China and in the USA. Whereas patients in China were more likely to have fever before cough and then nausea/vomiting before diarrhea, patients in the USA were more likely to have cough before fever and then diarrhea before nausea/vomiting. Given that the D614G SARS-CoV-2 variant that rapidly spread from Europe to predominate in the USA during the first wave of the outbreak was not present in the initial China outbreak, we hypothesized that this mutation might affect symptom order. Supporting this notion, we found that as SARS-CoV-2 in Japan shifted from the original Wuhan reference strain to the D614G variant, symptom order shifted to the USA pattern. Google Trends analyses supported these findings, while weather, age, and comorbidities did not affect our model's predictions of symptom order. These findings indicate that symptom order can change with mutation in viral disease and raise the possibility that D614G variant is more transmissible because infected people are more likely to cough in public before being incapacitated with fever.


Subject(s)
COVID-19/diagnosis , COVID-19/virology , Models, Biological , SARS-CoV-2 , COVID-19/epidemiology , China/epidemiology , Computational Biology , Cough/etiology , Diarrhea/etiology , Fever/etiology , Humans , Japan/epidemiology , Mutation , Nausea/etiology , Pandemics , SARS-CoV-2/genetics , SARS-CoV-2/pathogenicity , Time Factors , United States/epidemiology , Vomiting/etiology
15.
J Nerv Ment Dis ; 210(2): 98-103, 2022 02 01.
Article in English | MEDLINE | ID: covidwho-1504110

ABSTRACT

ABSTRACT: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a highly contagious new ß-coronavirus that primarily affects the lungs. Because of its unprecedented spread, in a relatively short interval, it is declared a global pandemic. Binding to the angiotensin-converting enzyme 2 receptors, SARS-CoV-2 is easily disseminated through air. Apart from the established clinical panel, individuals exposed to prolonged chronic stress also manifest gastrointestinal (GI) symptoms similar to those exhibited by SARS-CoV-2-infected patients.The present study aims to assess the incidence of GI deficiencies and prevalence of anxiety among healthy medical staff by applying the Visual Analog Scale for Irritable Bowel Syndrome (VAS-IBS) and Hamilton Anxiety Rating Scale (HAM-A) during this global crisis.We found significant differences on several items of the VAS-IBS: regarding the incidence of diarrhea (p = 0.04), bloating/gases (p = 0.02), and nausea/vomiting (p = 0.01) from the physical spectrum. After stratification based on age of the participants and after we applied Kruskal-Wallis test because of heterogeneity between groups, we noted two situations in which the null hypothesis is rejected: nausea/vomiting in women between 20 and 30 years, and between 30 and 40, and between 40 and 50 years, respectively (p = 0.026/0.029). Anxiety was prevalent among young and middle-class people after the centralization of HAM-A data, where 40.4% of the participants had various forms of anxiety: mild (n = 13; 13.82%), severe (n = 13; 13.82%), and moderate (n = 12; 12.76%).This study demonstrates that VAS-IBS is a reliable tool for assessing the incidence of GI deficiencies, as well as HAM-A for anxiety.


Subject(s)
Abdominal Pain/epidemiology , Anxiety Disorders/epidemiology , COVID-19 , Constipation/epidemiology , Diarrhea/epidemiology , Irritable Bowel Syndrome/epidemiology , Nausea/epidemiology , Occupational Diseases/epidemiology , Personnel, Hospital/statistics & numerical data , Vomiting/epidemiology , Adult , Female , Humans , Middle Aged , Prevalence , Psychiatric Status Rating Scales , Psychometrics , Severity of Illness Index , Young Adult
16.
Dig Dis ; 40(4): 506-514, 2022.
Article in English | MEDLINE | ID: covidwho-1403144

ABSTRACT

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has had an unprecedented and catastrophic impact on humanity and continues to progress. In addition to typical respiratory symptoms such as fever, cough, and dyspnea, a large percentage of COVID-19 patients experience gastrointestinal (GI) complaints, with the most common symptoms being diarrhea, nausea, vomiting, and abdominal discomfort. SUMMARY: We comprehensively summarize the latest knowledge of the adverse effects of COVID-19 and therapeutic drugs on the GI system, as well as related disease pathogenesis, and then provide a discussion focusing on the management and vaccination of patients who have inflammatory bowel disease (IBD) and GI cancer. The virus can affect the digestive system via binding to ACE2 receptors and subsequent gut microbiome dysbiosis. Through a variety of molecular pathways and mechanisms, numerous drugs for the treatment of COVID-19 could interfere with GI function and lead to multiple clinical manifestations, which may further intensify the risk and severity of GI symptoms of COVID-19 infection, such as nausea, vomiting, gastroparesis, and gastric ulcers. KEY MESSAGES: We should monitor GI manifestations closely while managing COVID-19 patients and take timely measures to reduce the incidence of SARS-CoV-2 infections in GI cancer patients. IBD patients should receive vaccination timely, but corticosteroid use should be minimized when they are vaccinated. Simultaneously, for persons with IBD who have known or suspected COVID-19, immunosuppressive agents, especially thiopurines, should be avoided/minimized if possible.


Subject(s)
COVID-19 , Gastrointestinal Diseases , Inflammatory Bowel Diseases , Neoplasms , Gastrointestinal Diseases/diagnosis , Humans , Nausea/etiology , SARS-CoV-2 , Vomiting/etiology
17.
Eur Rev Med Pharmacol Sci ; 25(16): 5310-5317, 2021 08.
Article in English | MEDLINE | ID: covidwho-1395678

ABSTRACT

OBJECTIVE: The outbreak of coronavirus disease 2019 (COVID-19) has affected the treatment of cancer patients, with particular regard to the management of both chemotherapy and side effects. Chemotherapy-induced nausea and vomiting (CINV) are amongst the most troublesome side effects that impair patients' adherence to treatments and their quality of life (QoL). NEPA (Akynzeo®), is an oral fixed-dose combination of netupitant [a neurokinin-1 receptor antagonist (NK1RA), 300 mg] and palonosetron [(5-hydroxytryptamine (serotonin or 5HT) type3 receptor antagonist (5HT3RA), 0.5 mg] which has been shown to be effective in preventing CINV. PATIENTS AND METHODS: This prospective study started before the outbreak of COVID-19 and was carried out during the pandemic period. The aim was to evaluate the efficacy and safety of a single oral dose NEPA plus 12 mg of dexamethasone (DEX) in patients treated with Folfoxiri plus Bevacizumab and Folfirinox. The patients were diagnosed with advanced colorectal cancer (CRC) or advanced pancreatic ductal adenocarcinoma (PDAC). They were divided into two groups: naïve patients and patients previously treated with serotonin receptor antagonists (5HT3-RA) and neurokin-1 receptor antagonists (NK1-RA). RESULTS: During the overall phase, the complete response (CR) rate was 96.8% in naïve patients treated with Folfoxiri plus Bevacizumab, and 94.6% in patients treated with Folfirinox. During the acute and delayed phases, the CR rate was 92.8% and 94.2%, with Folfoxiri and Bevacizumab, as well as 96.2% and 94.6%, with Folfirinox. There was no adequate control of CINV events in patients on antiemetic prophylaxis with 5HT3-RA or NK1-RA associated with cortisone. During the overall phase, the CR rate was 74.6% with Folfoxiri plus Bevacizumab and 75.8% with Folfirinox. During the acute and delayed phases, the CR rate was 72.5% and 74.8% with Folfoxiri plus Bevacizumab, as well as 75.2% and 74.6% with Folfirinox. CONCLUSIONS: This study has shown the therapeutic benefits of NEPA in the management and prophylaxis of CINV events, both in naive patients and patients previously treated with 5HT3-RA and NK1-RA. In addition, NEPA has been shown to be safe, both before and during the COVID-19 pandemic.


Subject(s)
Antiemetics/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Bevacizumab/therapeutic use , Colorectal Neoplasms/drug therapy , Palonosetron/therapeutic use , Pyridines/therapeutic use , Aged , Antiemetics/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Bevacizumab/administration & dosage , COVID-19 , Female , Fluorouracil/administration & dosage , Fluorouracil/therapeutic use , Humans , Irinotecan/administration & dosage , Irinotecan/therapeutic use , Leucovorin/administration & dosage , Leucovorin/therapeutic use , Male , Middle Aged , Nausea/prevention & control , Oxaliplatin/administration & dosage , Oxaliplatin/therapeutic use , Palonosetron/administration & dosage , Pandemics , Prospective Studies , Pyridines/administration & dosage , Vomiting/prevention & control
18.
PLoS One ; 16(8): e0256429, 2021.
Article in English | MEDLINE | ID: covidwho-1367707

ABSTRACT

INTRODUCTION: Coronavirus disease 2019 (COVID-19) has emerged as a global pandemic since its outbreak in Wuhan, China. It is an urgent task to prevent and treat COVID-19 effectively early. In China's experience combating the COVID-19 pandemic, Chinese herbal medicine (CHM) has played an indispensable role. A large number of epidemiological investigations have shown that mild to moderate COVID-19 accounts for the largest proportion of cases. It is of great importance to treat such COVID-19 cases, which can help control epidemic progression. Many trials have shown that CHM combined with conventional therapy in the treatment of mild to moderate COVID-19 was superior to conventional therapy alone. This review was designed to evaluate the add-on effect of CHM in the treatment of mild to moderate COVID-19. METHODS: Eight electronic databases including PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the Clinical Trials.gov website, China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (VIP), Wanfang Database and China Biology Medicine (CBM) were searched from December 2019 to March 2021 without language restrictions. Two reviewers searched and selected studies, and extracted data according to inclusion and exclusion criteria independently. Cochrane Risk of Bias (ROB) tool was used to assess the methodological quality of the included RCTs. Review Manager 5.3.0 software was used for statistical analysis. RESULTS: Twelve eligible RCTs including 1393 participants were included in this meta-analysis. Our meta-analyses found that lung CT parameters [RR = 1.26, 95% CI (1.15, 1.38), P<0.00001] and the clinical cure rate [RR = 1.26, 95%CI (1.16, 1.38), P<0.00001] of CHM combined with conventional therapy in the treatment of mild to moderate COVID-19 were better than those of conventional therapy. The rate of conversion to severe cases [RR = 0.48, 95%CI (0.32, 0.73), P = 0.0005], TCM symptom score of fever [MD = -0.62, 95%CI (-0.79, -0.45), P<0.00001], cough cases [RR = 1.43, 95%CI (1.16, 1.75), P = 0.0006], TCM symptom score of cough[MD = -1.07, 95%CI (-1.29, -0.85), P<0.00001], TCM symptom score of fatigue[MD = -0.66, 95%CI (-1.05, -0.28), P = 0.0007], and CRP[MD = -5.46, 95%CI (-8.19, -2.72), P<0.0001] of combination therapy was significantly lower than that of conventional therapy. The WBC count was significantly higher than that of conventional therapy[MD = 0.38, 95%CI (0.31, 0.44), P<0.00001]. Our meta-analysis results were robust through sensitivity analysis. CONCLUSION: Chinese herbal medicine combined with conventional therapy may be effective and safe in the treatment of mild to moderate COVID-19. More high-quality RCTs are needed in the future.


Subject(s)
COVID-19/drug therapy , Drugs, Chinese Herbal/adverse effects , Drugs, Chinese Herbal/therapeutic use , COVID-19/diagnostic imaging , COVID-19/etiology , Cough/drug therapy , Cough/virology , Diarrhea/chemically induced , Drugs, Chinese Herbal/chemistry , Fever/drug therapy , Fever/virology , Humans , Lung/diagnostic imaging , Lung/virology , Nausea/chemically induced , Tomography, X-Ray Computed , Treatment Outcome , Vomiting/chemically induced
19.
N Engl J Med ; 385(8): 695-706, 2021 08 19.
Article in English | MEDLINE | ID: covidwho-1364626

ABSTRACT

BACKGROUND: Atogepant is an oral, small-molecule, calcitonin gene-related peptide receptor antagonist that is being investigated for the preventive treatment of migraine. METHODS: In a phase 3, double-blind trial, we randomly assigned adults with 4 to 14 migraine days per month in a 1:1:1:1 ratio to receive a once-daily dose of oral atogepant (10 mg, 30 mg, or 60 mg) or placebo for 12 weeks. The primary end point was the change from baseline in the mean number of migraine days per month across the 12 weeks. Secondary end points included headache days per month, a reduction from baseline of at least 50% in the 3-month average of migraine days per month, quality of life, and scores on the Activity Impairment in Migraine-Diary (AIM-D). RESULTS: A total of 2270 participants were screened, 910 were enrolled, and 873 were included in the efficacy analysis; 214 were assigned to the 10-mg atogepant group, 223 to the 30-mg atogepant group, 222 to the 60-mg atogepant group, and 214 to the placebo group. The mean number of migraine days per month at baseline ranged from 7.5 to 7.9 in the four groups. The changes from baseline across 12 weeks were -3.7 days with 10-mg atogepant, -3.9 days with 30-mg atogepant, -4.2 days with 60-mg atogepant, and -2.5 days with placebo. The mean differences from placebo in the change from baseline were -1.2 days with 10-mg atogepant (95% confidence interval [CI], -1.8 to -0.6), -1.4 days with 30-mg atogepant (95% CI, -1.9 to -0.8), and -1.7 days with 60-mg atogepant (95% CI, -2.3 to -1.2) (P<0.001 for all comparisons with placebo). Results for the secondary end points favored atogepant over placebo with the exceptions of the AIM-D Performance of Daily Activities score and the AIM-D Physical Impairment score for the 10-mg dose. The most common adverse events were constipation (6.9 to 7.7% across atogepant doses) and nausea (4.4 to 6.1% across atogepant doses). Serious adverse events included one case each of asthma and optic neuritis in the 10-mg atogepant group. CONCLUSIONS: Oral atogepant once daily was effective in reducing the number of migraine days and headache days over a period of 12 weeks. Adverse events included constipation and nausea. Longer and larger trials are needed to determine the effect and safety of atogepant for migraine prevention. (Funded by Allergan; ADVANCE ClinicalTrials.gov number, NCT03777059.).


Subject(s)
Calcitonin Gene-Related Peptide Receptor Antagonists/administration & dosage , Migraine Disorders/prevention & control , Piperidines/administration & dosage , Pyridines/administration & dosage , Pyrroles/administration & dosage , Spiro Compounds/administration & dosage , Adolescent , Adult , Aged , Calcitonin Gene-Related Peptide Receptor Antagonists/adverse effects , Calcitonin Gene-Related Peptide Receptor Antagonists/therapeutic use , Constipation/chemically induced , Dose-Response Relationship, Drug , Double-Blind Method , Female , Humans , Intention to Treat Analysis , Male , Middle Aged , Nausea/chemically induced , Piperidines/adverse effects , Piperidines/therapeutic use , Pyridines/adverse effects , Pyridines/therapeutic use , Pyrroles/adverse effects , Pyrroles/therapeutic use , Spiro Compounds/adverse effects , Spiro Compounds/therapeutic use , Young Adult
20.
Am J Clin Dermatol ; 22(5): 693-707, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1361347

ABSTRACT

BACKGROUND: Pivotal phase III studies demonstrated that abrocitinib, an oral, once-daily, JAK1-selective inhibitor, is effective treatment for moderate-to-severe atopic dermatitis (AD) as monotherapy and in combination with topical therapy. OBJECTIVE: The aim of this study was to evaluate the long-term safety of abrocitinib 200 mg and 100 mg in an integrated analysis of a phase IIb study, four phase III studies, and one long-term extension study. METHODS: Two cohorts were analyzed: a placebo-controlled cohort from 12- to 16-week studies and an all-abrocitinib cohort including patients who received one or more abrocitinib doses. Adverse events (AEs) of interest and laboratory data are reported. RESULTS: Total exposure in the all-abrocitinib cohort (n = 2856) was 1614 patient-years (PY); exposure was ≥ 24 weeks in 1248 patients and ≥ 48 weeks in 606 (maximum 108 weeks). In the placebo-controlled cohort (n = 1540), dose-related AEs (200 mg, 100 mg, placebo) were nausea (14.6%, 6.1%, 2.0%), headache (7.8%, 5.9%, 3.5%), and acne (4.7%, 1.6%, 0%). Platelet count was reduced transiently in a dose-dependent manner; 2/2718 patients (200-mg group) had confirmed platelet counts of < 50 × 103/mm3 at week 4. Incidence rates (IRs) were 2.33/100PY and 2.65/100 PY for serious infection, 4.34/100PY and 2.04/100PY for herpes zoster, and 11.83/100PY and 8.73/100PY for herpes simplex in the 200-mg and 100-mg groups, respectively. IRs for nonmelanoma skin cancer, other malignancies, and major adverse cardiovascular events were < 0.5/100PY for both doses. Five venous thromboembolism events occurred (IR 0.30/100PY), all in the 200-mg group. There were three deaths due to gastric carcinoma (diagnosed at day 43), sudden death, and COVID-19. CONCLUSION: Abrocitinib, with proper patient and dose selection, has a manageable tolerability and longer-term safety profile appropriate for long-term use in patients with moderate-to-severe AD. TRIAL REGISTRIES: ClinicalTrials.gov: NCT02780167, NCT03349060, NCT03575871, NCT03720470, NCT03627767, NCT03422822.


Subject(s)
Dermatitis, Atopic/drug therapy , Infections/epidemiology , Protein Kinase Inhibitors/adverse effects , Pyrimidines/adverse effects , Skin Neoplasms/epidemiology , Sulfonamides/adverse effects , Acne Vulgaris/chemically induced , Adolescent , Adult , Aged , Cardiovascular Diseases/epidemiology , Cholesterol, HDL/blood , Cholesterol, LDL/blood , Female , Headache/chemically induced , Herpes Simplex/epidemiology , Herpes Zoster/epidemiology , Humans , Incidence , Lymphocyte Count , Male , Middle Aged , Nausea/chemically induced , Platelet Count , Protein Kinase Inhibitors/administration & dosage , Pyrimidines/administration & dosage , Risk Factors , Sulfonamides/administration & dosage , Time Factors , Venous Thromboembolism/epidemiology , Young Adult
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