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Research

Glucagon-like peptide-1 receptor agonists before upper gastrointestinal endoscopy and risk of pulmonary aspiration or discontinuation of procedure: cohort study

BMJ 2024; 387 doi: https://doi.org/10.1136/bmj-2024-080340 (Published 22 October 2024) Cite this as: BMJ 2024;387:e080340

Linked Editorial

Glucagon-like peptide-1 receptor agonists and aspiration risk
  1. Wajd Alkabbani, research fellow1,
  2. Karine Suissa, instructor in medicine1,
  3. Kristine D Gu, endocrinologist and instructor in medicine2,
  4. Sara J Cromer, endocrinologist and assistant professor2,
  5. Julie M Paik, nephrologist and associate professor134,
  6. Katsiaryna Bykov, assistant professor1,
  7. Ion Hobai, anesthesiologist5,
  8. Christopher C Thompson, gastroenterologist and professor6,
  9. Deborah J Wexler, endocrinologist and associate professor2,
  10. Elisabetta Patorno, associate professor1
  1. 1Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA
  2. 2Diabetes Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA
  3. 3Division of Renal (Kidney) Medicine, Department of Medicine, Brigham and Women’s Hospital, Boston, MA, USA
  4. 4New England Geriatric Research Education and Clinical Center, VA Boston Healthcare System, Boston, MA, USA
  5. 5Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, MA, USA
  6. 6Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA
  1. Correspondence to: E Patorno epatorno{at}bwh.harvard.edu
  • Accepted 13 August 2024

Abstract

Objective To assess whether use of glucagon-like peptide-1 (GLP-1) receptor agonists before upper gastrointestinal endoscopy is associated with increased risk of pulmonary aspiration or discontinuation of the procedure compared with sodium-glucose cotransporter-2 (SGLT-2) inhibitors.

Design Cohort study.

Setting Two deidentified US commercial healthcare databases.

Participants 43 365 adults (≥18 years) with type 2 diabetes who used a GLP-1 receptor agonist or SGLT-2 inhibitor within 30 days before upper gastrointestinal endoscopy.

Main outcome measures The primary outcome was pulmonary aspiration on the day of or the day after endoscopy, defined using diagnostic codes. The secondary outcome was discontinuation of endoscopy. Risk ratios and corresponding 95% confidence intervals (CIs) were estimated after fine stratification weighting based on propensity score.

Results After weighting, 24 817 adults used a GLP-1 receptor agonist (mean age 59.9 years; 63.6% female) and 18 537 used an SGLT-2 inhibitor (59.8 years; 63.7% female). Among users of GLP-1 receptor agonists and SGLT-2 inhibitors, the weighted risk per 1000 people was, respectively, 4.15 and 4.26 for pulmonary aspiration and 9.79 and 4.91 for discontinuation of endoscopy. Compared with SGLT-2 inhibitor use, GLP-1 receptor agonist use was not associated with an increased risk of pulmonary aspiration (pooled risk ratio 0.98, 95% CI 0.73 to 1.31), although it was associated with a higher risk for discontinuation of endoscopy (1.99, 1.56 to 2.53).

Conclusions In this comparative cohort study, no increased risk of pulmonary aspiration during upper gastrointestinal endoscopy was observed among adults with type 2 diabetes using GLP-1 receptor agonists compared with SGLT-2 inhibitors within 30 days of the procedure; however, GLP-1 receptor agonists were associated with a higher risk of discontinuation of endoscopy, possibly owing to a higher risk of retained gastric content. In the absence of evidence from randomized trials, these findings could inform future practice recommendations on the preprocedural protocol for patients requiring endoscopy.

Introduction

The use of glucagon-like peptide-1 (GLP-1) receptor agonists, a class of drugs used to treat type 2 diabetes and obesity,12 has increased rapidly over the past decade owing to evidence of cardiovascular benefit in these populations.34567 This rapid uptake has been further driven by evidence showing that high dose semaglutide and the dual glucose dependent insulinotropic polypeptide-GLP-1 receptor agonist tirzepatide reduce weight by 10-20% in people with obesity with or without diabetes.28910 GLP-1 receptor agonists exert glycemic and weight lowering effects through mechanisms that include delayed gastric emptying, which could have important implications in the perioperative setting.111213

Recently, several published case reports have described pulmonary aspiration or retained gastric contents during elective procedures in patients using semaglutide despite adherence to appropriate fasting protocols.141516 In small observational studies, use of GLP-1 receptor agonists in patients undergoing upper gastrointestinal endoscopy or elective procedures requiring anesthesia was associated with retained gastric content compared with patients not using GLP-1 receptor agonists, which can increase the risk of pulmonary aspiration.17181920

In light of these safety signals and in an effort to minimize this potential risk, the American Society of Anesthesiologists published consensus based guidance to withhold GLP-1 receptor agonists in all patients for one dose before an elective procedure (one day for drugs administered daily and one week for those administered weekly).21 In response, concerns about the potential harms of discontinuing GLP-1 receptor agonists, particularly among people with diabetes, have been raised,22 with the American Gastroenterological Association issuing a clinical practice update urging that well designed studies should investigate the risk of pulmonary aspiration in GLP-1 receptor agonist users who require endoscopy.23 More recently, a multisociety statement was published emphasizing the lack of data to support stopping GLP-1 receptor agonists in all patients before elective endoscopy procedures.24

Additional evidence from robust pharmacoepidemiologic studies on the association between GLP-1 receptor agonist use and risk of pulmonary aspiration during upper endoscopy is needed. Pharmacoepidemiologic studies can be useful for evaluating rare safety outcomes by using large claims databases while implementing design and analysis techniques to minimize bias, such as the active comparator design and propensity score weighting.25 In the current study, we assessed the risk of pulmonary aspiration and discontinuation of endoscopy associated with preprocedural use of GLP-1 receptor agonists compared with another antidiabetic drug class with similar indications to minimize confounding, in the real world clinical context of upper endoscopy.

Methods

Data sources

This nationwide cohort study used data from two databases: MarketScan Commercial Claims and Encounters, and Optum Clinformatics Data Mart to identify adults aged 18 years and older with type 2 diabetes who underwent upper endoscopy: between 1 January 2016 and 31 December 2021 in MarketScan and to 31 August 2023 in Optum Clinformatics Data Mart. Both databases provide deidentified longitudinal health claims data, including demographic information, visits to physicians, hospital admissions, diagnoses, procedures, and outpatient dispensations of prescription drugs.

Study design

The cohort entry date was the date of upper endoscopy, which was defined using current procedural terminology codes (see supplemental eTable 1). We did not include endoscopic retrograde cholangiopancreatography procedures owing to their increased complexity and distinct indications relative to routine upper endoscopy. We excluded patients aged <18 years at cohort entry and those without at least 365 days of continuous enrollment in an insurance plan before endoscopy. We also excluded those without a diagnosis code for type 2 diabetes, with a diagnosis code for type 1 diabetes, with any history of bariatric surgery, or admitted to a nursing home facility within 365 days before endoscopy. We also excluded those who underwent lower (colonoscopy) or upper endoscopy within the 365 days before cohort entry as they may have had a chronic gastrointestinal condition, further increasing their risk for pulmonary aspiration or complications during the procedure; additionally, including this population could introduce confounding by indication as these patients might be less likely to receive GLP-1 receptor agonists. Lastly, we excluded patients who had colonoscopy and upper endoscopy on the same day, given the different preprocedural protocol (fig 1).

Fig 1
Fig 1

Schematic illustration of study design

Drug use

Drug use was assessed within 30 days before upper endoscopy (fig 1). Patients with a dispensed GLP-1 receptor agonist during the 30 days before endoscopy or with a drug supply extending into the 30 day assessment period for drug use were considered to have used the drug; patients meeting the same criteria for sodium-glucose cotransporter-2 (SGLT-2) inhibitors were the referent group. SGLT-2 inhibitors are a class of diabetes drugs used for similar indications to GLP-1 receptor agonists and at a similar disease stage and are not known to affect gastric emptying; we therefore considered SGLT-2 inhibitors to be an appropriate comparator class to GLP-1 receptor agonists in this study. We excluded patients who used both drug classes. The GLP-1 receptor agonist class included dulaglutide, liraglutide, oral and subcutaneous semaglutide, exenatide, lixisenatide, and tirzepatide, and the SGLT-2 inhibitor class included empagliflozin, dapagliflozin, and canagliflozin.

Outcomes

The primary outcome was pulmonary aspiration on the day of or the day after endoscopy, defined using ICD-10 (international classification of diseases, 10th revision) codes (see supplemental eTable 1). We also assessed discontinuation of endoscopy as a secondary outcome. Discontinuation was captured using current procedural terminology modification code 53, which indicates that a surgical or diagnostic procedure was started but discontinued, and procedure codes Z53.X (procedure not carried out), in association with ICD-10 codes for the same endoscopy claim (see supplemental eTable 1).

Covariates

We considered several potential confounders, including personal characteristics (age, biological sex, region of residence, race/ethnicity), lifestyle factors (smoking, alcohol dependence, drug misuse, body mass index (BMI), comorbidities (eg, heart failure, coronary artery disease, gastroesophageal reflux disease, gastrointestinal cancer, peptic ulcer disease, gastroparesis, diabetic neuropathy, diabetic retinopathy), obesity related comorbidities (osteoarthritis, obstructive sleep apnea, non-alcoholic fatty liver disease), and drug use (eg, proton pump inhibitors, histamine receptor 2 antagonists (H2 blockers), opioids, antiemetics, benzodiazepines, beta blockers). We also included frailty level as measured by the validated claims based frailty index,2627 as well as measures of healthcare utilization, including number of distinct drugs, number of visits to an endocrinologist, and number and length of previous hospital admissions (see supplemental methods for list of covariates). All covariates were assessed within 335 days before the assessment period for drug use (fig 1).

Analyses

To mitigate confounding, we first estimated the propensity score of using a GLP-1 receptor agonist versus an SGLT-2 inhibitor using a multivariable logistic regression that included all the covariates relating to personal characteristics, diabetes severity and drugs, gastrointestinal conditions, other comorbidities, and healthcare utilization, and then used fine stratification weighting to balance the drug groups28 (see supplemental methods for details of propensity score model). We trimmed the study population that did not fall within overlapping regions of the propensity score distribution and then created 50 propensity score strata based on the distribution of the GLP-1 receptor agonist group. Patients in the GLP-1 receptor agonist group were assigned a weight of 1 and those in the SGLT-2 inhibitor group were weighted in proportion to the number of GLP-1 receptor agonist users in their corresponding stratum. We assessed for balance of covariates between the two groups using absolute standardized differences, with differences >0.1 considered to indicate substantial imbalance.29 For each drug group, we calculated the absolute risk of pulmonary aspiration and discontinuation of endoscopy and estimated the risk ratio and corresponding 95% confidence intervals (CIs) in generalized linear models (PROC GENMOD with weight statement and log-link function and binomial distribution).28

Subgroup and sensitivity analyses

We conducted three subgroup analyses. First, we stratified the analysis by type of sedation used during endoscopy, distinguishing between those who received anesthesia care services (current procedural terminology codes 00731 and 00740) and those who did not. Second, we evaluated BMI subgroups (<30 and ≥30), excluding individuals with missing BMI data. Third, given the differences in the half-life and frequency with which GLP-1 receptor agonists are administered, we stratified the analysis based on the specific GLP-1 receptor agonist (subcutaneous semaglutide, dulaglutide, liraglutide, exenatide-lixisenatide, and tirzepatide) used within 30 days before endoscopy. Exenatide and lixisenatide were combined in the agent specific analysis owing to small sample sizes and similar short half-life.

In sensitivity analyses, we first restricted the cohort to patients who received a prescription dispensation for a GLP-1 receptor agonist or SGLT-2 inhibitor within 30 days before endoscopy, excluding those who had drug supply from a previously filled prescription but did not receive a dispensing during the 30 day assessment period for drug use. Second, we restricted the cohort to short term new users of GLP-1 receptor agonists or SGLT-2 inhibitors, defined as receiving a prescription dispensation within 12 weeks before endoscopy after a washout (no drug use) period of six months. Third, we restricted the cohort to persistent users of GLP-1 receptor agonists or SGLT-2 inhibitors, defined as receiving at least two prescriptions dispensations within six months before endoscopy. Fourth, owing to different preparations required for procedures, we repeated the study in two additional cohorts: a cohort of patients who had colonoscopy only, and a cohort of patients who had colonoscopy and upper endoscopy on the same day. Fifth, we excluded patients who were intubated during endoscopy as the decision to use endotracheal intubation is rare and affected by the duration and complexity of a procedure as well as the presence of respiratory comorbidities, making it difficult to ascertain if intubation was an a priori decision or related to a complication of the procedure. Finally, since delayed recording of aspiration pneumonia is possible, we increased the follow-up period to assess pulmonary aspiration as an outcome from one day to three days. For each of these analyses, we re-estimated propensity scores and reweighted study participants.

Missing data

Given the nature of claims data, where the presence or absence of a specific billing code is interpreted as the presence or absence of a specific drug dispensation or clinical event, no data on drug use or outcomes were missing, and imputation was not required. BMI level was missing for >50% of patients, and given the high percentage of missingness, we used a missing indicator rather than imputation in the primary analysis. To deal with potential residual confounding from under-reporting of information on BMI, we included several proxies for obesity in the propensity score model. Additionally, we conducted a sensitivity analysis wherein we stratified patients based on the availability of BMI data and reconducted analyses to test the robustness of the primary findings. No other data were missing.

We conducted analyses separately for each database and then pooled the results using a Mantel-Haenszel fixed effect model. All analyses were conducted with Aetion Evidence Platform version 4.4830 and SAS version 9.4 (SAS Institute, Cary, NC). The study protocol was registered at institutional level. This manuscript is reported according to STROBE (strengthening the reporting of observational studies in epidemiology) guidelines.31

Patient and public involvement

Our study was based on analysis of secondary data. No patients were involved in setting the research question or the outcome measures, nor were they involved in the design and implementation of the study. As the study received no specific funding, it would not have been possible to engage patients or members of the public.

Results

A total of 5 212 871 individuals underwent upper endoscopy during the study period, of whom 24 824 used a GLP-1 receptor agonist and 18 541 used an SGLT-2 inhibitor within 30 days before the procedure and met the eligibility criteria (fig 2). Before weighting, both study groups were well balanced on many covariates; however, GLP-1 receptor agonist users were slightly younger and more likely to be female patients, had a higher BMI, and received antiemetics and opioids (table 1). After weighting, the groups were well balanced for all included covariates, with standardized differences <0.1 (see supplemental eTables 2-4 for list of characteristics overall and by database).

Fig 2
Fig 2

Flow of patients in study cohort pooled from MarketScan and Clinformatics Data Mart databases. *Assessed within 365 days before procedure. GLP-1=glucagon-like peptide-1; SGLT-2=sodium-glucose cotransporter-2

Table 1

Selected baseline characteristics among users of GLP-1 receptor agonists and SGLT-2 inhibitors undergoing upper gastrointestinal endoscopy, pooled from two US commercial healthcare databases.* Values are number (percentage) unless stated otherwise

View this table:

Pulmonary aspiration

Overall, GLP-1 receptor agonist use in the 30 days before upper endoscopy was not associated with an increased risk of pulmonary aspiration compared with SGLT-2 inhibitor use (weighted risk 4.15 v 4.26 per 1000 people, respectively; pooled risk ratio 0.98, 95% CI 0.73 to 1.31) (table 2).

Table 2

Crude and weighted risks of pulmonary aspiration and discontinuation of upper gastrointestinal endoscopy among users of GLP-1 receptor agonists and SGLT-2 inhibitors

View this table:

No difference in risk of pulmonary aspiration was observed between GLP-1 receptor agonists and SGLT-2 inhibitors in subgroup analyses based on type of anesthesia care used for endoscopy or obesity (fig 3). Neither was a difference in risk of pulmonary aspiration found between specific individual GLP-1 receptor agonists and SGLT-2 inhibitors, except for a higher risk of pulmonary aspiration with exenatide-lixisenatide (pooled risk ratio 2.49, 1.36 to 4.59), albeit with low precision owing to the small number of patients who used these agents (fig 3).

Fig 3
Fig 3

Subgroup analyses of association between use of GLP-1 receptor agonists and risk of pulmonary aspiration during upper gastrointestinal endoscopy and discontinuation of the procedure. BMI=body mass index; CI=confidence interval; GLP-1=glucagon-like peptide-1; SGLT-2=sodium-glucose cotransporter-2. *Fewer than 11 events

Results were consistent in the sensitivity analysis that redefined drug use as a prescription dispensation of GLP-1 receptor agonist or SGLT-2 inhibitor within 30 days before endoscopy, and when the cohort was restricted to new users of either GLP-1 receptor agonists or SGLT-2 inhibitors within 12 weeks before endoscopy, or to persistent users (table 2). Lastly, no increased risk of pulmonary aspiration was observed among GLP-1 receptor agonist users who underwent colonoscopy only (pooled risk ratio 1.57, 0.76 to 3.24) or colonoscopy and upper endoscopy on the same day (0.74, 0.35 to 1.56), compared with users of SGLT-2 inhibitors who underwent the same procedures (table 2).

Discontinuation of endoscopy

An increased risk for discontinuation of endoscopy was observed among GLP-1 receptor agonist users compared with SGLT-2 inhibitor users (9.79 v 4.91 per 1000 people; pooled risk ratio 1.99, 1.56 to 2.53) who underwent upper endoscopy (table 2). This increase did not appear to differ based on type of anesthesia care (fig 3). The risk of discontinuation among GLP-1 receptor agonist users compared with SGLT-2 inhibitor users did, however, appear to differ on the basis of obesity, with an increased risk observed among those with a BMI ≥30 (pooled risk ratio 2.60, 1.65 to 4.06) who used a GLP-1 receptor agonist compared with an SGLT-2 inhibitor, but not among those with a BMI <30 (0.99, 0.51 to 1.94) (fig 3). Additionally, we consistently observed a higher risk for discontinuation of endoscopy associated with use of specific GLP-1 receptor agonists, subcutaneous semaglutide, dulaglutide, exenatide-lixisenatide, and tirzepatide compared with SGLT-2 inhibitors (fig 3). The risk of discontinuation was attenuated in the cohort that underwent colonoscopy and upper endoscopy on the same day (pooled risk ratio 1.09, 0.95 to 1.24) and in the colonoscopy only cohort (1.16, 1.08 to 1.26). Results were consistent in all sensitivity analyses (table 2). Results were also consistent when we stratified by the presence or absence of data on BMI (see supplemental eTable5). Supplemental eTables 6 and 7 show the results of all analyses by database.

Discussion

This cohort study of people with type 2 diabetes found no association between use of GLP-1 receptor agonists before upper gastrointestinal endoscopy and increased risk of pulmonary aspiration compared with use of SGLT-2 inhibitors. Our findings provide real world evidence that despite delayed gastric emptying and concern about retained gastric contents with use of GLP-1 receptor agonists before endoscopy, pulmonary aspiration appeared to be rare, and the risk was not higher compared with use of SGLT-2 inhibitors.

Comparison with previous studies

Our findings are consistent with a previous chart review study that estimated the incidence rate of pulmonary aspiration in patients receiving GLP-1 receptor agonists, using electronic medical records from several Mayo Clinic sites, and reported a low rate of pulmonary aspiration similar to that of the general population.3233 Additionally, the rarity of pulmonary aspiration in our type 2 diabetes cohort is in line with the available evidence.34 Although data on the incidence of pulmonary aspiration in people with type 2 diabetes are not available, in previous studies conducted in the general population, the estimates ranged between 0.05% and 1.1%.3536373839 Although a 33% increased risk of pulmonary aspiration during endoscopy among GLP-1 receptor agonist users versus non-users was reported in a cohort study40 the lack of an active comparator design makes these findings prone to confounding by indication since diabetes and its related comorbidities can affect the risk of pulmonary aspiration.41 In our study, we minimized this risk by using an active comparator design with a clinically appropriate comparator at a similar disease stage.41 Indeed, recent findings showed the risk of pulmonary aspiration in an endoscopy cohort was no higher with use of GLP-1 receptor agonists than with use of DPP-4 inhibitors,42 although the latter might not be an ideal comparator class given their closely related incretin based mechanism of action, which theoretically could also affect gastric emptying.4344

Clinical implications

Importantly, we observed an increased risk for discontinuation of endoscopy among GLP-1 receptor agonist users compared with SGLT-2 inhibitor users (9.60 v 5.10 per 1000 people). The reason for discontinuation was not available in our data. Nonetheless this relative increase in risk among GLP-1 receptor agonist users suggests that to minimize the risk of pulmonary aspiration, endoscopists might be inclined to reschedule procedures when retained gastric contents are detected or suspected. Indeed, in a recent case report of retained gastric contents during elective endoscopy in preparation for bariatric surgery, the procedure was stopped owing to concerns about pulmonary aspiration.45 Although not a life threatening event, discontinuation of endoscopy can have several clinical and administrative implications, including delays in diagnosis and increased healthcare costs, as well as personal and societal economic costs such as missed workdays.23

We also found that the increased risk for discontinuation of endoscopy might be modified by obesity. A higher risk of discontinuation was observed among those with a BMI ≥30 compared with a BMI <30. GLP-1 receptor agonists have been on the market for nearly two decades, and concerns about the associated risk of pulmonary aspiration and retained gastric contents have surfaced only recently. Owing to their efficacy in lowering weight and their additional indication for the treatment of obesity, higher potency and higher dose GLP-1 receptor agonists are now being used specifically in patients with obesity. Given the inaccuracies in correctly identifying the dose regimen of GLP-1 receptor agonists from pharmacy dispensations, however, we were unable to conduct a subgroup analysis by dose of GLP-1 receptor agonist. Notably, the subgroup analyses suggested a higher risk for discontinuation of endoscopy associated with the higher potency GLP-1 receptor agonists subcutaneous semaglutide and tirzepatide. The risk of pulmonary aspiration and discontinuation of endoscopy should be assessed in future studies, with a focus on high potency GLP-1 receptor agonists.

Although most of the available evidence thus far has been restricted to semaglutide,14151617 the analysis stratified by specific GLP-1 receptor agonist showed a potentially increased risk of pulmonary aspiration associated only with the less commonly used exendin based short acting GLP-1 receptor agonist exenatide-lixisenatide; shorter acting GLP-1 receptor agonists are reported to be associated with a greater incidence of gastric side effects attributed to delayed gastric emptying, which could explain this phenomenon.46

It has been suggested that the potential increased risk of pulmonary aspiration is strictly associated with short term use of GLP-1 receptor agonists (ie, initiating the drug within 8-12 weeks before endoscopy), and that this risk might be mitigated with longer term use as gastric emptying might normalize as a result of tachyphylaxis; thus caution has been recommended only with short term use of GLP-1 receptor agonists.47 When we restricted the cohort to those initiating GLP-1 receptor agonists within 12 weeks before endoscopy, however, we did not detect a higher risk of pulmonary aspiration.

Our study focused on the risk of pulmonary aspiration during upper endoscopy. Importantly, the two concerns about the increased risk of pulmonary aspiration with GLP-1 receptor agonist use are interrelated. The first concern is among patients undergoing upper endoscopy, in which the risk of pulmonary aspiration is independent and the procedure often not performed under general anesthesia.4849 The second is among patients who undergo general anesthesia, regardless of procedure, as postulated by the American Society of Anesthesiologists consensus guidance and several other recent editorials.2150 Our findings need to be interpreted in the context of endoscopy only; this study did not investigate the association between GLP-1 receptor agonist use and risk of pulmonary aspiration during general anesthesia for other procedures, although a subgroup analysis by anesthesia care did not identify an increased risk among GLP-1 receptor agonist users compared with SGLT-2 inhibitor users even among those receiving anesthesia care. Specifically, we did not assess the risk of regurgitation or pulmonary aspiration in other elective procedures that require general anesthesia in which there is no direct inspection of gastric contents during the procedure, as is the case with upper endoscopy. Additional evidence is needed to understand the risk of pulmonary aspiration in non-endoscopic procedures that require general anesthesia.

Limitations of this study

Although the clinical findings were consistent across a range of subgroup and sensitivity analyses, our study does have several limitations. First, the primary and secondary outcome definitions were based on diagnostic codes from claims data, which have not been previously validated. Additionally, both outcomes may be under-reported in claims data. We do not expect this misclassification of measurement to differ between GLP-1 receptor agonists and SGLT-2 inhibitors because this study was conducted using data before the publication of any information on the potential safety signal of GLP-1RA and pulmonary aspiration. If more severe pulmonary aspiration events are likely to occur among GLP-1RA users and be recorded, however, this might have led to a biased higher risk of pulmonary aspiration in the GLP-1RA group versus SGLT-2 inhibitor group, which was not observed. Additionally, although we inferred that discontinuation of endoscopy might be related to concerns about retained gastric contents, the exact reason for discontinuation was unknown. Second, misclassification of drug use was possible given the use of claims data. Specifically, drug use before endoscopy was defined based on drug possession and supply of the dispensed prescription; whereas a sensitivity analysis restricting the cohort to patients dispensed a prescription within 30 days before endoscopy confirmed the primary findings, it is not possible to ascertain if patients prescribed GLP-1 receptor agonists were taking the drugs and whether they were instructed to stop treatment before endoscopy. Patients may have discontinued using GLP-1 receptor agonists before endoscopy, although the American Society of Anesthesiologists’ specific recommendation was only recently published (29 June 2023), and before this no specific recommendations were available on withholding GLP-1 receptor agonists before procedures. We were also unable to account for the specific dose of GLP-1 receptor agonist or any recent titration. Third, given the rarity of pulmonary aspiration, effect estimates comparing GLP-1 receptor agonists with SGLT-2 inhibitors were not precise owing to wide confidence intervals. Although our findings showing no difference in risk between use of GLP-1 receptor agonists and use of SGLT-2 inhibitors are consistent with those of other studies, with a 95% upper confidence limit of 1.31 we cannot rule out the possibility that GLP-1 receptor agonists may be associated with up to a 31% increase in relative risk of pulmonary aspiration, compared with SGLT-2 inhibitors. Fourth, despite the inclusion of a wide range of potential confounders, the restriction of the study population to people with type 2 diabetes using similar diabetes drugs, and the use of advanced adjustment techniques to balance covariates across drug use groups, residual confounding cannot be fully ruled out. Data on laboratory measures, including hemoglobin A1C and glomerular filtration rate were only available in a subset of the study population and thus were not included in the propensity score model. Additionally, the covariate assessment period was limited to one year before endoscopy and thus conditions not brought to medical attention during this time may not have been captured and accounted for in the analyses. We also did not have data on the specific indication for endoscopy, although we included a list of potential indications, such as gastroesophageal reflux disease and gastrointestinal cancer, in the propensity score model. Fifth, we did not have information on BMI for all patients (>50% missingness), therefore residual confounding by BMI is possible. Additionally, patients with missing information on BMI were excluded from the subgroup analysis exploring the potential modification of the GLP-1 receptor agonist effect by BMI, which could reduce precision of the estimates in this analysis or introduce bias if information on BMI was not missing at random. However, clinical findings were consistent in a sensitivity analysis stratified based on the presence of information on BMI. Similarly, our subgroup and sensitivity analyses might have had limited statistical power to detect small but clinically meaningful differences owing to the small number of events. Sixth, we did not have data on the specific healthcare provider or medical facility, therefore we were unable to account for potential clustering by these factors.51 Finally, to minimize threats to internal validity, we restricted the cohort to people with type 2 diabetes. We did not include patients receiving GLP-1 receptor agonists for weight loss without diabetes given that these patients have different characteristics and would not have a valid propensity score weighted cohort of SGLT-2 inhibitor users. We also excluded those who had undergone a previous endoscopy procedure. Therefore, the findings of this study might not be generalizable to all users of GLP-1 receptor agonists. A randomized controlled trial could potentially overcome several of these limitations that are inherent to the data and observational nature of the study; however, given the rarity of pulmonary aspiration, the feasibility of such a trial might be challenging (requiring >30 000 participants for 90% power and >23 000 for 80% power). Thus, while we wait for such trials to be conducted, real world evidence provides important information to guide clinical decision making in the setting of an urgent research question.

These limitations were balanced by several strengths. By using two national databases, we were able to go beyond case reports and small observational studies to estimate the risk of pulmonary aspiration as well as discontinuation of endoscopy. In addition, by using an active comparator design and rigorous pharmacoepidemiologic methods, we were able to reduce several of the biases inherent in many of the smaller observational reports.

Conclusions

Among adults with type 2 diabetes using GLP-1 receptor agonists before upper endoscopy, pulmonary aspiration was rare (4.2 per 1000 patients), and we did not observe an increased risk compared with those taking SGLT-2 inhibitors. Discontinuation of endoscopy occurred in less than 1% of procedures but was about twice as common among those using GLP-1 receptor agonists. Although the exact reason for discontinuation is unknown, it could indicate a higher risk of retained gastric content and concern about pulmonary aspiration. These findings, and those of future pharmacoepidemiologic analyses, may inform future practice recommendations on the preprocedural protocol for elective endoscopy in the absence of evidence from randomized trials.

What is already known on this topic

  • Pulmonary aspiration or retained gastric contents during upper gastrointestinal endoscopy have been reported among patients taking glucagon-like peptide-1 (GLP-1) receptor agonists before the procedure

  • Emerging data from cohort studies have been inconsistent about whether GLP-1 receptor agonist use before endoscopy is associated with a higher risk of pulmonary aspiration

  • The risk for discontinuation of endoscopy, which might indicate concern about retained gastric contents, is unknown

What this study adds

  • In this study of >43 000 adults with type 2 diabetes, GLP-1 receptor agonist use within 30 days before upper endoscopy was not associated with an increased risk of pulmonary aspiration compared with use of sodium-glucose cotransporter-2 (SGLT-2) inhibitors

  • Use of GLP-1 receptor agonists was, however, associated with a higher risk for discontinuation of endoscopy compared with SGLT-2 inhibitors

  • These findings may inform practice recommendations on the preprocedural protocol for patients requiring endoscopy

Ethics statements

Ethical approval

The study protocol was registered at institutional level, and the study was approved by the Mass General Brigham institutional review board (IRB 2023P003514), and signed data license agreements were in place for all data sources.

Data availability statement

A data use agreement is required for each of the data sources in this study. These data use agreements do not permit the authors to share patient level source data or data derivatives with individuals and institutions not covered under the data use agreements. The databases used in this study are accessible to other researchers by contacting the data providers and acquiring data use agreements or licenses.

Footnotes

  • Contributors: EP and DJW are co-senior authors and contributed equally. WA wrote the first draft of the manuscript and conducted all analyses. All authors contributed to the conception, design, and methodology of the study, and the final draft of the manuscript. EP acquired the data. EP and DJW supervised the study and are the guarantors. All authors approved the submitted version of the manuscript. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

  • Funding: This study was funded by the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA. EP was supported by research grants from the National Institute of Diabetes and Digestive and Kidney Diseases (R01DK138036), Patient Centered Outcomes Research Institute (PCORI, DB-2020C2-20326), and US Food and Drug Administration (5U01FD007213). DJW was supported by PCORI (DB-2020C2-20326). JMP was supported by a research grant from the National Institutes of Health (NIH, NIAMS R01AR075117). SJC was supported by the American Diabetes Association (7-21-JDFM-005). KDG was supported by a research grant from the NIH (NIDDK T32DK007028). KB was supported by a grant from the National Institute on Aging (K01AG068365). The funders had no role in considering the study design or in the collection, analysis, interpretation of data, writing of the report, or decision to submit the article for publication.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: SJC has a close family member employed by a Johnson & Johnson company and reports consultancy for Wolters-Kluwer and Alexion Pharmaceuticals. DJW reports consultancy for Novo Nordisk and serving as a data monitoring committee member for SOUL and FLOW trials. EP is principal investigator of a research grant to the Brigham and Women’s Hospital from Boehringer Ingelheim, not related to the topic of this work. CCT reports the following activities: Apollo Endosurgery – consultant/research support (consulting fees/institutional research grants); Bariendo – Founder/Board Member/Ownership Interest; BlueFlame Healthcare Venture Fund – Founder/General Partner; Boston Scientific – consultant (consulting fees)/research support (institutional research grant); Medtronic – consultant (consulting fees); ELLES – founder/board member/ownership interest; Endoquest Robotics – consultant, institutional research grant; Enterasense – founder, consultant, board member, ownership interest; EnVision Endoscopy – founder, board member, consultant, ownership interest; ERBE – institutional research grant; Fractyl – consultant/advisory board member (consulting fees)/research support; FujiFilm – consultant/institutional research grant; GI Dynamics – consultant (consulting fees)/ research support (institutional research grant); GI Windows – founder, board member, ownership interest; Lumendi – consultant/institutional research grant; Olympus/Spiration – consultant (consulting fees)/research support (Equipment Loans); Society for Metabolic and Bariatric Endoscopy (SMBE) – founder/president/ownership interest; Softac – consultant/ownership interest; USGI Medical – consultant (consulting fees)/advisory board member (consulting fees)/research support (institutional research grant); Xenter – consultant/SAB/ownership interest.

  • Transparency: The lead authors (the manuscript’s guarantors) affirm that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as originally planned (and, if relevant, registered) have been explained.

  • Dissemination to participants and related patient and public communities: The study results will be disseminated to the public through media releases and social media by the Media Relations office at Brigham and Women’s Hospital and on the author’s website (bwhpromise.org). Additionally, we will directly communicate our results to diabetes, anesthesia, and gastroenterology associations.

  • Provenance and peer review: Not commissioned; externally peer reviewed.

http://creativecommons.org/licenses/by-nc/4.0/

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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