Dataset Information

Comparative Effectiveness and Harms of Antibiotics for Outpatient Diverticulitis : Two Nationwide Cohort Studies.

ABSTRACT:

Background

Outpatient diverticulitis is commonly treated with either a combination of metronidazole and a fluoroquinolone (metronidazole-with-fluoroquinolone) or amoxicillin-clavulanate alone. The U.S. Food and Drug Administration advised that fluoroquinolones be reserved for conditions with no alternative treatment options. The comparative effectiveness of metronidazole-with-fluoroquinolone versus amoxicillin-clavulanate for diverticulitis is uncertain.

Objective

To determine the effectiveness and harms of metronidazole-with-fluoroquinolone versus amoxicillin-clavulanate for outpatient diverticulitis.

Design

Active-comparator, new-user, retrospective cohort studies.

Setting

Nationwide population-based claims data on U.S. residents aged 18 to 64 years with private employer-sponsored insurance (2000 to 2018) or those aged 65 years or older with Medicare (2006 to 2015).

Participants

Immunocompetent adults with diverticulitis in the outpatient setting.

Intervention

Metronidazole-with-fluoroquinolone or amoxicillin-clavulanate.

Measurements

1-year risks for inpatient admission, urgent surgery, and Clostridioides difficile infection (CDI) and 3-year risk for elective surgery.

Results

In MarketScan (IBM Watson Health), new users of metronidazole-with-fluoroquinolone (n = 106 361) and amoxicillin-clavulanate (n = 13 160) were identified. There were no differences in 1-year admission risk (risk difference, 0.1 percentage points [95% CI, -0.3 to 0.6]), 1-year urgent surgery risk (risk difference, 0.0 percentage points [CI, -0.1 to 0.1]), 3-year elective surgery risk (risk difference, 0.2 percentage points [CI, -0.3 to 0.7]), or 1-year CDI risk (risk difference, 0.0 percentage points [CI, -0.1 to 0.1]) between groups. In Medicare, new users of metronidazole-with-fluoroquinolone (n = 17 639) and amoxicillin-clavulanate (n = 2709) were identified. There were no differences in 1-year admission risk (risk difference, 0.1 percentage points [CI, -0.7 to 0.9]), 1-year urgent surgery risk (risk difference, -0.2 percentage points [CI, -0.6 to 0.1]), or 3-year elective surgery risk (risk difference, -0.3 percentage points [CI, -1.1 to 0.4]) between groups. The 1-year CDI risk was higher for metronidazole-with-fluoroquinolone than for amoxicillin-clavulanate (risk difference, 0.6 percentage points [CI, 0.2 to 1.0]).

Limitation

Residual confounding is possible, and not all harms associated with these antibiotics, most notably drug-induced liver injury, could be assessed.

Conclusion

Treating diverticulitis in the outpatient setting with amoxicillin-clavulanate may reduce the risk for fluoroquinolone-related harms without adversely affecting diverticulitis-specific outcomes.

Primary funding source

National Institutes of Health.

SUBMITTER: Gaber CE

PROVIDER: S-EPMC9035276 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Comparative Effectiveness and Harms of Antibiotics for Outpatient Diverticulitis : Two Nationwide Cohort Studies.

Gaber Charles E CE Kinlaw Alan C AC Edwards Jessie K JK Lund Jennifer L JL Stürmer Til T Peacock Hinton Sharon S Pate Virginia V Bartelt Luther A LA Sandler Robert S RS Peery Anne F AF

Annals of internal medicine 20210223 6

<h4>Background</h4>Outpatient diverticulitis is commonly treated with either a combination of metronidazole and a fluoroquinolone (metronidazole-with-fluoroquinolone) or amoxicillin-clavulanate alone. The U.S. Food and Drug Administration advised that fluoroquinolones be reserved for conditions with no alternative treatment options. The comparative effectiveness of metronidazole-with-fluoroquinolone versus amoxicillin-clavulanate for diverticulitis is uncertain.<h4>Objective</h4>To determine the ...[more]

PMID: 33617725

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Project description:ImportanceDiverticulitis of the colon is an increasingly prevalent disease with significant implications for patient quality of life and health system resource expenditure. Although several randomized clinical trials and meta-analyses of Hartman procedure (HP) and primary anastomosis and proximal diversion (PAPD) have found surgical equipoise, questions regarding the relative performance of these treatments when applied broadly remain.ObjectiveTo examine use of and outcomes after urgent sigmoid colectomy with end colostomy (ie, HP) vs PAPD in management of complicated diverticulitis.Design, setting, and participantsThis retrospective cross-sectional study was a multicenter, population-based examination of inpatient hospitalizations, not including long-term rehabilitation facilities, using data from the 2014 to 2017 Nationwide Readmissions Database. It was performed from November 2020 to January 2021. Included patients were adults admitted with acute diverticulitis requiring HP or PAPD within 48 hours of admission.ExposuresUndergoing HP vs PAPD.Main outcomes and measuresInverse probability treatment analysis was used to compare outcomes, including index mortality, composite complications (ie, neurologic, infectious, and cardiovascular complications), length of stay, and readmissions within 90 days.ResultsDuring the study period, an estimated 1 072 395 adults (615 954 [57.4%] women; median [IQR] age, 64 [52-76] years) required nonelective hospitalization for acute colonic diverticulutus. A total of 34 126 patients required diversion, with 32 326 patients (94.7%) undergoing HP and 1800 patients (5.3%) undergoing PAPD within 48 hours of admission. Patients undergoing PAPD had a decreased median (IQR) age (60 [51-70] years vs 65 [54-74] years; P < .001) and decreased rates of end organ dysfunction (520 patients [28.9%] vs 11 514 patients [35.6%]; P < .001). In inverse probability treatment weight analysis, the odds of mortality (adjusted odds ratio [aOR], 0.63; 95% CI, 0.32-1.40), complications (aOR, 0.86; 95% CI, 0.66-1.13), and nonhome discharge (aOR 1.15; 95% CI, 0.83-1.60) were similar for PAPD compared with HP. Among 1772 patients who underwent PAPD and survived index hospitalization, there was an increased incidence of 90-day readmission compared with 30 851 patients who underwent HP and survived index hospitalization (393 patients [22.2%] vs 4384 patients [14.2%]; P < .001) with increased hazard of ostomy reversal (hazard ratio, 1.46; 95% CI, 1.08-1.99).Conclusions and relevanceThis study found that the use of PAPD was associated with comparable index hospitalization outcomes vs use of HP, while readmission rate and ostomy risk were statistically significantly increased among patients who underwent PAPD compared with patients who underwent HP. These findings suggest that further delineation of criteria for appropriate application of PAPD in the urgent setting are warranted.

Dataset Information

Comparative Effectiveness and Harms of Antibiotics for Outpatient Diverticulitis : Two Nationwide Cohort Studies.

Background

Objective

Design

Setting

Participants

Intervention

Measurements

Results

Limitation

Conclusion

Primary funding source

Publications

Comparative Effectiveness and Harms of Antibiotics for Outpatient Diverticulitis : Two Nationwide Cohort Studies.

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