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2.
Sci Rep ; 12(1): 7596, 2022 05 09.
Article in English | MEDLINE | ID: covidwho-1830105

ABSTRACT

Proton Pump Inhibitors (PPI) are one of the most prescribed medications in the United States. However, PPIs have been shown to increase the risk of enteric infections. Our study aims to evaluate the correlation between PPI and COVID-19 severity. We performed a retrospective cohort study on patients who tested positive for SARS-CoV-2 from March to August 2020. Patients were categorized based on PPI user status. Primary outcomes included need for hospital or ICU admission and 30-day mortality. Secondary outcomes looked to determine the severity of COVID-19 infection and effect of comorbid conditions. 2,594 patients were reviewed. The primary outcomes of our study found that neither active nor past PPI use was associated with increased hospital admission or 30-day mortality following completion of multivariate analysis. Additionally, there was no association between COVID-19 infection and the strength of PPI dosing (low, standard, high). However, the following covariates were independently and significantly associated with increased admission: age, male gender, diabetes, COPD, composite cardiovascular disease, kidney disease, and obesity. The following covariates were associated with increased mortality: age, male gender, COPD, and kidney disease. In conclusion, the high risk features and comorbidities of PPI users were found to have a stronger correlation to severe COVID-19 infection and poor outcomes as opposed to the use of PPI therapy.


Subject(s)
COVID-19 , Pulmonary Disease, Chronic Obstructive , COVID-19/drug therapy , Critical Care Outcomes , Hospitalization , Humans , Male , Proton Pump Inhibitors/adverse effects , Pulmonary Disease, Chronic Obstructive/drug therapy , Retrospective Studies , SARS-CoV-2
3.
Trials ; 23(1): 302, 2022 Apr 12.
Article in English | MEDLINE | ID: covidwho-1789128

ABSTRACT

BACKGROUND: Proton-pump inhibitors (PPI) are liberally prescribed in patients with liver cirrhosis. Observational studies link PPI therapy in cirrhotic patients with an increased risk for infectious complications, hepatic encephalopathy and an increased risk for hospitalization and mortality. However, patients with liver cirrhosis are also considered to be at risk for peptic ulcer bleeding. The STOPPIT trial evaluates if discontinuation of a pre-existing PPI treatment delays a composite endpoint of re-hospitalization and/or death in patients (recently) hospitalized with liver cirrhosis compared to patients on continued PPI medication. METHODS: The STOPPIT-trial is a prospective, multicentre, randomized, double-blinded, placebo-controlled, parallel-group trial. In total, 476 patients with complicated liver cirrhosis who already receive long-term PPI therapy without evidence-based indication are 1:1 randomized to receive either esomeprazole 20 mg (control group) or placebo (intervention group) for 360 days. Patients with an indication for PPI therapy (such as a recent diagnosis of peptic ulcers, severe reflux esophagitis, severe hemorrhagic gastritis, recent endoscopic therapy for oesophageal varices) are excluded. The primary composite endpoint is the time-to re-hospitalization and/or death. Secondary endpoints include rates of re-hospitalization, mortality, occurrence of infections, hepatic decompensation and acute-on-chronic liver failure. The safety endpoint is defined as manifestation of an evidence-based indication for PPI re-therapy. The impact of PPI continuation or discontinuation on the intestinal microbiota will be studied. The recruitment will take place at 18 study sites throughout Germany. Recruitment has started in April 2021. DISCUSSION: The STOPPIT trial is the first clinical trial to study the effects of PPI withdrawal on relevant outcome variables in patients with complicated liver cirrhosis. If the hypothesis that PPI withdrawal improves clinical outcomes of cirrhosis patients is confirmed, this would argue for a strong restriction of the currently liberal prescription practice of PPIs in this population. If, on the other hand, the trial demonstrates an increased risk of gastrointestinal bleeding events in patients after PPI withdrawal, this could create a rationale for a more liberal, prophylactic PPI treatment in patients with liver cirrhosis. TRIAL REGISTRATION: EU clinical trials register EudraCT 2019-005008-16 (registered December 27, 2019). CLINICALTRIALS: gov NCT04448028 (registered June 25, 2020). German Clinical Trials Register DRKS00021290 (registered March 10, 2021).


Subject(s)
COVID-19 , Proton Pump Inhibitors , Humans , Liver Cirrhosis/complications , Liver Cirrhosis/diagnosis , Liver Cirrhosis/drug therapy , Multicenter Studies as Topic , Prospective Studies , Proton Pump Inhibitors/adverse effects , Randomized Controlled Trials as Topic , SARS-CoV-2
4.
Br J Clin Pharmacol ; 88(5): 2452-2453, 2022 05.
Article in English | MEDLINE | ID: covidwho-1788831
5.
J Glob Health ; 12: 05005, 2022.
Article in English | MEDLINE | ID: covidwho-1699578

ABSTRACT

BACKGROUND: The adverse effects of proton pump inhibitors (PPIs) on pneumonia have been well reported. However, the relationship between the use of PPIs and the adverse outcomes of coronavirus disease 2019 (COVID-19) is currently inconclusive. In this study, we aimed to explore the relationship between the use of PPIs and the in-hospital mortality among patients who were laboratory-confirmed SARS-CoV-2. METHODS: Data was derived from 2 hospitals which both were the first batch of SARS-CoV-2 specialist hospitals with four types of sensitivity analyses. This cohort included 4634 patients older than 18 years who were laboratory-confirmed SARS-CoV-2. Endpoints were death in hospital (primary) and the recovery of COVID-19 (secondary: the time of COVID-19 nucleic acid testing turning negative). RESULTS: In the entire cohort, there were 3588 non-users, 399 ≤ 0.5 defined daily dose (DDD) PPIs users, 483 1 DDD users, and 164 ≥ 1.5 DDD users. The multivariate logistic regression analysis (odds ratio (OR) = 3.63, 95% confidence interval (CI) = 1.83-7.23, P = 0.0002) and four types of sensitivity analyses showed higher mortality in patients using PPIs during hospitalization, while the relationship between different PPIs dosages and the hospital mortality remained insignificant. Usage of the PPIs significantly prolongs the time of COVID-19 nucleic acid testing turning negative. CONCLUSIONS: The use of PPIs may increase the risk of in-hospital death of patients who were laboratory-confirmed SARS-CoV-2, which means that physicians may need to re-evaluate the benefit-risk assessment of the use of PPIs during the COVID-19 pandemic.


Subject(s)
COVID-19 , COVID-19 Testing , Hospital Mortality , Humans , Pandemics , Proton Pump Inhibitors/adverse effects , SARS-CoV-2
6.
Obes Surg ; 32(5): 1451-1458, 2022 05.
Article in English | MEDLINE | ID: covidwho-1681711

ABSTRACT

PURPOSE: To compare sleeve gastrectomy (SG) to SG associated with Rossetti fundoplication (SG + RF) in terms of de novo gastro-esophageal reflux disease (GERD) after surgery, weight loss, and postoperative complications. MATERIALS AND METHODS: Patients affected by morbid obesity, without symptoms of GERD, who were never in therapy with proton pump inhibitors (PPIs), were randomized into two groups. One group underwent SG and the other SG + RF. The study was stopped on February 2020 due to the COVID pandemic. RESULTS: A total of 278 patients of the programmed number of 404 patients were enrolled (68.8%). De novo esophagitis was considered in those patients who had both pre- and postoperative gastroscopy (97/278, 34.9%). Two hundred fifty-one patients (90.3%) had completed clinical follow-up at 12 months. SG + RF resulted in an adequate weight loss, similar to classic SG at 12-month follow-up (%TWL = 35. 4 ± 7.2%) with a significantly better outcome in terms of GERD development. One year after surgery, PPIs were necessary in 4.3% SG + RF patients compared to 17.1% SG patients (p = 0.001). Esophagitis was present in 2.0% of SG + RF patients versus 23.4% SG patients (p = 0.002). The main complication after SG + RF was wrap perforation (4.3%), which improved with the surgeon's learning curve. CONCLUSION: SG + RF seemed to be an effective alternative to classic SG in preventing de novo GERD. More studies are needed to establish that an adequate learning curve decreases the higher percentage of short-term complications in the SG + RF group.


Subject(s)
COVID-19 , Esophagitis , Gastroesophageal Reflux , Laparoscopy , Obesity, Morbid , Esophagitis/etiology , Fundoplication/adverse effects , Gastrectomy/adverse effects , Gastrectomy/methods , Gastroesophageal Reflux/diagnosis , Humans , Laparoscopy/adverse effects , Obesity, Morbid/surgery , Postoperative Complications/etiology , Proton Pump Inhibitors/therapeutic use , Retrospective Studies , Treatment Outcome , Weight Loss
7.
Eur J Gastroenterol Hepatol ; 34(2): 137-141, 2022 02 01.
Article in English | MEDLINE | ID: covidwho-1672393

ABSTRACT

INTRODUCTION: Severe acute respiratory syndrome coronavirus-2 may escape the inactivation by gastric acid because of hypochlorhydria caused by proton pump inhibitors (PPIs), which could predispose the patients to severe COVID-19. METHODS: We studied the association between prehospitalization PPI exposure and clinical outcomes among hospitalized COVID-19 patients. RESULTS: A total of 295 hospitalized COVID-19 patients were included in the study. 15.6% of hospitalized COVID-19 patients were on PPIs at home. Mortality among PPI-users was 2.3 times higher than non-users, along with 2.3 times higher risk of acute respiratory distress syndrome after adjusting for confounding variables. CONCLUSION: We found that prehospitalization PPI-exposure is independently associated with worse clinical outcomes, including mortality in COVID-19 patients, regardless of the presence of cardiovascular comorbidities.


Subject(s)
COVID-19 , Proton Pump Inhibitors , Hospitalization , Humans , Proton Pump Inhibitors/adverse effects , SARS-CoV-2
9.
Jpn J Infect Dis ; 75(1): 10-15, 2022 Jan 24.
Article in English | MEDLINE | ID: covidwho-1649030

ABSTRACT

The findings of previous research on the association between proton pump inhibitor (PPI) use and the treatment and prevention of coronavirus disease 2019 (COVID-19) are inconsistent. Therefore, this meta-analysis was conducted to clarify the outcomes of patients taking PPIs. This analysis included 14 articles with more than 268,683 subjects. PPI use was not associated with increased or decreased risk of COVID-19 infection (odds ratio [OR] 1.64, 95% confidence interval [CI] = 0.54-5.00, P = 0.39) or mortality (OR = 1.91, 95% CI = 0.86-4.24, P = 0.11). However, PPI use increased the risks of severe disease (OR 1.67, 95% CI = 1.37-2.02, P < 0.00001) and secondary infection (OR 4.62, 95% CI = 2.55-8.39, P < 0.00001). In summary, PPI use was not associated with an increased risk of infection and mortality in COVID-19 but appeared to be associated with an increased risk of progression to severe disease and secondary infection. However, more original studies are urgently needed to further clarify the relationship between PPI use and COVID-19.


Subject(s)
COVID-19 , Proton Pump Inhibitors , Humans , Proton Pump Inhibitors/adverse effects , SARS-CoV-2
10.
BMC Pharmacol Toxicol ; 23(1): 9, 2022 01 17.
Article in English | MEDLINE | ID: covidwho-1636310

ABSTRACT

BACKGROUND: This study aimed to evaluate incidence risk and adverse clinical outcomes in COVID-19 disease among short-term users of acid-suppressants in South Korea. METHODS: This retrospective cohort study, conducted using a nationwide claims database for South Korea, used data from patients with COVID-19 tested between January 1 and May 15, 2020. Patients aged over 18 years and prescribed proton pump inhibitors (PPI) or histamine-2 receptor antagonist (H2RA) for more than 7 days were identified. Primary outcome was COVID-19 while secondary outcomes were all-cause mortality, hospitalization with respiratory disease, or intensive respiratory intervention. Large-scale propensity scores were used to match patients, while the Cox proportional hazard model was utilized to evaluate any association between exposure and outcome(s). The risk estimates were calibrated by using 123 negative control outcomes. RESULTS: We identified 26,166 PPI users and 62,117 H2RA users. After propensity score matching, compared to H2RA use, PPI use was not significantly associated with lower risk of COVID-19 (calibrated hazard ratio [HR], 0.81 [95% confidence interval (CI), 0.30-2.19]); moreover, PPI use was not associated with adverse clinical outcomes in COVID-19, namely, hospitalization with respiratory disease (calibrated HR, 0.88 [95% CI, 0.72-1.08]), intensive respiratory interventions (calibrated HR, 0.92 [95% CI, 0.46-1.82]), except for all-cause mortality (calibrated HR, 0.54 [95% CI, 0.31-0.95]). CONCLUSIONS: In this study, we found that the PPI user was not associated with risk of COVID-19 compared to H2RA users. There was no significant relationship between severe clinical outcomes of COVID-19 and exposure to PPI compared with H2RA, except for all-cause mortality.


Subject(s)
COVID-19/epidemiology , Histamine H2 Antagonists/therapeutic use , Proton Pump Inhibitors/therapeutic use , SARS-CoV-2 , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/complications , COVID-19/therapy , Female , Hospitalization/statistics & numerical data , Humans , Incidence , Male , Middle Aged , Republic of Korea/epidemiology , Retrospective Studies , Risk Factors , Treatment Outcome , Young Adult
12.
Eur J Clin Pharmacol ; 78(3): 383-391, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1530284

ABSTRACT

PURPOSE: Several observational studies have presented conflicting results on the association between the use of proton pump inhibitors (PPIs) or histamine H2 receptor antagonist (H2RA) and the risk of coronavirus disease 2019 (COVID-19). This systematic review and meta-analysis aimed to examine this association. METHODS: In July 2021, PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science were searched for articles investigating the relationship between the two main acid suppressants and COVID-19. Studies showing the effect estimates as hazard ratio (HR) for severe outcomes or incidence of COVID-19 were evaluated using a random-effects model. RESULTS: A total of 15 retrospective cohort studies with 18,109 COVID-19 cases were included in the current meta-analysis. PPI use was significantly associated with severe outcomes of COVID-19 (hazard ratio [HR] = 1.53; 95% confidence interval [CI]: 1.20-1.95) but not with the incidence of COVID-19, whereas H2RA use was significantly associated with decreased incidence (HR = 0.86, 95% CI: 0.76-0.97). For subgroup analyses of PPIs, increased severe outcomes of COVID-19 were observed in < 60 years, active use, in-hospital use, and Asians. For subgroup analyses of H2RAs, decreased severe outcomes of COVID-19 were observed in > 60 years, while in-hospital use and use in Asia were associated with higher disease severity. CONCLUSIONS: Close observation can be considered for COVID-19 patients who use PPIs to prevent severe outcomes. However, caution should be taken because of substantial heterogeneity and plausible protopathic bias.


Subject(s)
COVID-19/epidemiology , COVID-19/pathology , Histamine H2 Antagonists/administration & dosage , Proton Pump Inhibitors/administration & dosage , Age Factors , Humans , Incidence , Retrospective Studies , Risk Factors , SARS-CoV-2 , Severity of Illness Index , Sex Factors
14.
Sci Rep ; 11(1): 20987, 2021 10 25.
Article in English | MEDLINE | ID: covidwho-1483149

ABSTRACT

Acid suppressants are widely-used classes of medications linked to increased risks of aerodigestive infections. Prior studies of these medications as potentially reversible risk factors for COVID-19 have been conflicting. We aimed to determine the impact of chronic acid suppression use on COVID-19 infection risk while simultaneously evaluating the influence of social determinants of health to validate known and discover novel risk factors. We assessed the association of chronic acid suppression with incident COVID-19 in a 1:1 case-control study of 900 patients tested across three academic medical centers in California, USA. Medical comorbidities and history of chronic acid suppression use were manually extracted from health records by physicians following a pre-specified protocol. Socio-behavioral factors by geomapping publicly-available data to patient zip codes were incorporated. We identified no evidence to support an association between chronic acid suppression and COVID-19 (adjusted odds ratio 1.04, 95% CI 0.92-1.17, P = 0.515). However, several medical and social features were positive (Latinx ethnicity, BMI ≥ 30, dementia, public transportation use, month of the pandemic) and negative (female sex, concurrent solid tumor, alcohol use disorder) predictors of new infection. These findings demonstrate the value of integrating publicly-available databases with medical data to identify critical features of communicable diseases.


Subject(s)
COVID-19/epidemiology , COVID-19/therapy , Gastroesophageal Reflux/complications , Social Determinants of Health , Aged , Behavior , COVID-19/psychology , California , Case-Control Studies , Computational Biology/methods , Databases, Factual , Female , Gastroenterology , Gastroesophageal Reflux/drug therapy , Geography , Histamine H2 Antagonists/pharmacology , Humans , Incidence , Male , Middle Aged , Odds Ratio , Proton Pump Inhibitors/pharmacology , Risk Factors , Social Class
15.
Monaldi Arch Chest Dis ; 91(4)2021 Oct 19.
Article in English | MEDLINE | ID: covidwho-1478189

ABSTRACT

Identification of risk factors for severe outcome of SARS-CoV-2 infection is an important issue in COVID-19 management. Much attention has been focused on comorbidities as well as drugs taken by patients. Usage of proton pump inhibitors (PPIs) appears to potentially influence disease course. These drugs are known to reduce stomach acid and also modulate the immune system. Their use, prior to and during COVID-19 infection, seems to predispose to the development of more severe pneumonia and therefore to a greater risk of mortality. Instead, the use of histamine receptor 2 antagonists (H2RAs) seems to be associated with a better outcome in patients with COVID-19, in terms of symptoms, risk of intubation and death. As PPIs are essential for treatment of many disorders, usage of these drugs should be balanced considering the benefits and risk ratio, in order to guarantee their correct use for the necessary time. It remains to be clarified whether the detrimental effects, in terms of COVID-19 severe outcome, are due to PPIs or to the underlying disease for which they are administered. New controlled-randomized trials are required to better understand their impact in SARS-CoV-2 infections. *Vanvitelli/Monaldi COVID Group: Adriano Cristinziano, Carolina Delle Donne, Cecilia Calabrese, Fabio Perrotta, Filippo Scialò, Francesco Lassandro, Gennaro Mazzarella, Giorgio Paoli, Leonardo De Luca, Maria Galdo, Miriam Buonincontro, Roberta Cianci, Rosalba Donizzetti, Stefano Sanduzzi Zamparelli, Tullio Valente, Vito D'Agnano, Vittorio Bisogni.


Subject(s)
COVID-19 , Proton Pump Inhibitors , Humans , Proton Pump Inhibitors/adverse effects , Risk Factors , SARS-CoV-2
16.
Br J Clin Pharmacol ; 88(4): 1551-1566, 2022 02.
Article in English | MEDLINE | ID: covidwho-1462736

ABSTRACT

AIMS: The aim was to perform an umbrella review to summarise the existing evidence on proton-pump inhibitor (PPI) use and adverse outcomes and to grade the certainty of evidence. METHODS: Electronic databases were searched up to July 2021 for meta-analyses of cohort studies and/or randomised controlled trials (RCTs). Summary effect sizes from a random-effects model, between-study heterogeneity, 95% prediction interval, small-study effect, excess significance and credibility ceilings were devised to classify the credibility of evidence from meta-analyses of cohort studies, whereas the GRADE approach was used for meta-analyses of RCTs. RESULTS: In meta-analyses of cohort studies, 52 of the 91 examined associations were statistically significant (P ≤ .05). Convincing evidence emerged from main analysis for the association between PPI use and risk of all-site fracture and chronic kidney disease in the elderly population. However, none of these associations remained supported by convincing evidence after sensitivity analyses. The use of PPI is also associated with an increased risk of mortality due to COVID-19 infection and other related adverse outcomes, but the quality of evidence was weak. In meta-analyses of RCTs, 38 of the 63 examined associations were statistically significant. However, no associations were supported by high or moderate-quality evidence. CONCLUSION: This study's findings imply that most putative adverse outcomes associated with PPI use may not be supported by high-quality evidence and are likely to have been affected by underlying confounding factors. Future research is needed to confirm the causal association between PPI use and risk of fracture and chronic kidney disease.


Subject(s)
COVID-19 , Renal Insufficiency, Chronic , Aged , Cohort Studies , Humans , Meta-Analysis as Topic , Proton Pump Inhibitors/adverse effects , Randomized Controlled Trials as Topic
17.
Int Microbiol ; 25(1): 217-222, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1397016

ABSTRACT

Infectious diseases are among the main causes of morbidity and mortality today. In facing this crisis, the development of new drug options and combat strategies is necessary. In this sense, drug repositioning or drug redirection has emerged for the faster identification of effective drugs. In this "Commentary," the anti-infective properties of the class of proton pump inhibitors (PPIs) are emphasized. Studies report activities against bacterial, fungal, parasitic, and viral agents. In addition, we have provided in a table a summary of the specific characteristics of PPIs and some of their anti-infective activities.


Subject(s)
Anti-Infective Agents , Proton Pump Inhibitors , Anti-Infective Agents/pharmacology
20.
Am J Gastroenterol ; 116(10): 2153, 2021 10 01.
Article in English | MEDLINE | ID: covidwho-1357673
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