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Study Title and Description

Mesalamine did not prevent recurrent diverticulitis in phase 3 controlled trials. -B(PREVENT2)



Key Questions Addressed
4 KEY QUESTION 4 KQ 4: What are the effects, comparative effects, and harms of pharmacological interventions (e.g., mesalamine), non-pharmacological interventions (e.g., medical nutrition therapy), and elective surgery to prevent recurrent diverticulitis? • Do the (comparative) effects and harms vary by patient characteristics, course of illness, or other factors?
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Primary Publication Information
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TitleData
Title Mesalamine did not prevent recurrent diverticulitis in phase 3 controlled trials. -B(PREVENT2)
Author Raskin JB., Kamm MA., Jamal MM., Márquez J., Melzer E., Schoen RE., Szalóki T., Barrett K., Streck P.
Country University of Miami Miller School of Medicine, Miami, Florida. Electronic address: JRaskin@med.miami.edu.
Year 2014
Numbers Pubmed ID: 25038431

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Extraction Form for KQs 2 and 4
Arms
Number Title Description Comments
1 Placebo
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2 Pharm: 5-ASA AKA mesalazine, mesalamine 1.2 g/d
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3 Pharm: 5-ASA AKA mesalazine, mesalamine 2.4 g/d
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4 Pharm: 5-ASA AKA mesalazine, mesalamine 4.8 g/d
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 2b: Antibiotics (acute)
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Study Design RCT
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Country USA
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Canada
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Germany
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Other ... Brazil, Finland, Hungary, Italy, Netherlands, Romania, South Africa (from NCT)
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Funder Industry (fully or in part)
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Study name PREVENT2
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Associated articles
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ClinicalTrials.gov identifier NCT00545103
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Start and end years of the Study 2007
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2011
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Inclusion criteria >= 18 years. 1 documented episodes of acute diverticulitis in the previous 24 months that resolved w/o colonic resection, and w/o signs/symptoms of diverticulitis within 6 wks of enrollment. Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon w/ at >= 3 diverticula noted.
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Exclusion criteria Previous colorectal surgery, surgical intervention for diverticular disease (w/ exceptions of hemorrhoidectomy, colonic removal of polyps, appendectomy); no complicated diverticulitis (no perforation or fistulization present on CT); right-sided diverticulosis only; active peptic ulcer disease; history or current IBD. Active irritable bowel syndrome, GI bleeding, endometriosis or dysmenorrhea (6 months before baseline), or current or historical use of biologic drugs, immunomodulators, or systemic/rectal steroids (6 wks before baseline) (from NCT).
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Specific population? No (all comers)
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Was diverticulitis diagnosed with CT? CT
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If NRCS, what analytic method was used to account for differences between study arms?
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How was diverticulitis diagnosed CT, MRI, ultrasound, colonoscopy, sigmoidoscopy, and barium enema. Endoscopic confirmation of 3 diverticula was required.
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Note/Comment about Design (or overall study)
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Baseline Characteristics
Question Placebo Pharm: 5-ASA Pharm: 5-ASA Pharm: 5-ASA Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant race/ethnicity characteristics Male 49.3 Male 43.9 Male 51.7 Male 40.9 Male 46.4
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White 94.4 White 93.9 White 93.2 White 94.6 White 94
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Black 3.5 Black 3.4 Black 3.4 Black 4.7 Black 3.8
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Hispanic/Latino 19 Hispanic/Latino 13.5 Hispanic/Latino 18.4 Hispanic/Latino 15.4 Hispanic/Latino 16.6
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Asian 0 Asian 0 Asian 0.7 Asian 0.7 Asian 0.3
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Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses 2.1 Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses 2.7 Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses 2.7 Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses 0 Other (or specific) race/ethnicity 1 - include race/ethnicity in parentheses 1.9
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Participant Age - Continuous data (in years) Mean 55.7 Mean 57.8 Mean 54.2 Mean 56.7 Mean 56.1
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SD SD 10.88 SD 10.10 SD 11.76 SD 11.04
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Participant Age - Categorical data No data entered.
Participants with Un/Complicated Diverticulitis No data entered.
Specific Complications of Diverticulitis No data entered.
Number of Prior Episodes of Diverticulitis (categorical) 0 0.7 0 0 0 0 0 1.3 0 0.5
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1 61.3 1 64.2 1 56.5 1 57 1 59.7
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2 22.5 2 20.3 2 25.2 2 22.8 2 22.7
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Other_1 (include definition in %) 4-5: 4.9 Other_1 (include definition in %) 4-5: 5.4 Other_1 (include definition in %) 4-5: 4.1 Other_1 (include definition in %) 4-5: 8.7 Other_1 (include definition in %) 4-5: 5.8
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Other_2 (include definition in %) 6-10: 2.1 Other_2 (include definition in %) 6-10: 2 Other_2 (include definition in %) 6-10: 2.7 Other_2 (include definition in %) 6-10: 0.7 Other_2 (include definition in %) 6-10: 1.9
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History of (Prior) Complicated Diverticulitis No data entered.
KQ 4: Time Since Last Episode of Diverticulitis Mean 17.9 weeks Mean 16.5 weeks Mean 18.3 weeks Mean 13.9 weeks Mean 16.5 weeks
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Range 2-100 weeks Range 0-101 weeks Range 1-122 weeks Range 2-93 weeks Range 0-122 weeks
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Note/Comment about baseline characteristics No data entered.
Number of Prior Episodes of Diverticulitis (continuous) No data entered.



Results & Comparisons


Results Data
P-Value
Outcome: Without recurrence      Population: All Participants Between-Arm Comparisons
Time Point Measure Placebo Pharm: 5-ASA Pharm: 5-ASA Pharm: 5-ASA Comparison Measure Placebo vs. Pharm: 5-ASA Placebo vs. Pharm: 5-ASA Placebo vs. Pharm: 5-ASA


104 weeks

 N Analyzed 142 148 147 149 0.368 0.159 0.778
Counts 96 93 87 103
Percentage 67.6 62.8 59.2 69.1
Outcome: AE - Infection requiring Abx (CD II)      Population: All Participants
Time Point Measure Placebo Pharm: 5-ASA Pharm: 5-ASA Pharm: 5-ASA


104 weeks

 N Analyzed 142 148 147 149
Counts 7 11 14 10
Percentage 4.9 7.4 9.5 6.7
Outcome: Adverse event - any      Population: All Participants
Time Point Measure Placebo Pharm: 5-ASA Pharm: 5-ASA Pharm: 5-ASA


104 weeks

 N Analyzed 142 148 147 149
Counts 105 108 111 110
Percentage 73.9 73 75.5 73.8
Outcome: AE - Serious (SAE)      Population: All Participants
Time Point Measure Placebo Pharm: 5-ASA Pharm: 5-ASA Pharm: 5-ASA


104 weeks

 N Analyzed 142 148 147 149
Counts 15 9 13 14
Percentage 10.56 6.08 8.84 9.40


Quality Dimensions
Dimension Value Notes Comments
Q14: Cochrane - Random sequence generation (selection bias): Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence Low Patients were randomly assigned in a 1:1:1:1 ratio.
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Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment Low Intervention assigned to each patient was determined by a computer generated fixed-block randomization schedule.
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Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study Low Double-blind
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Q17: Cochrane - Blinding of personnel/ care providers (performance bias): Performance bias due to knowledge of the allocated interventions by personnel/care providers during the study. Low Double-blind
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Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. Yes Low risk of detection bias because outcome assessors were blinded (NCT).
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Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Low Patients who completely withdrew from the study before week 104 without a protocol-defined recurrent of diverticulitis were considered dropouts and assumed to be treatment failures for the inter-to-treat primary analysis. Additional sensitivity analyses were performed using different methods for handling dropouts. Reasons for withdrawals are provided in Figure 1.
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Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting Low Study protocol is unavailable, but expected results
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Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. Low Study appears to be free of other sources of bias.
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Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study?
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Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains?
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Q4: ROBINS-I 1.5. If Y/PY to 1.4: Were confounding domains that were controlled for measured validly and reliably by the variables available in this study?
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Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention?
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Q6: ROBINS-I - Risk of bias judgement for BIAS DUE TO CONFOUNDING
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Q7: ROBINS-I 2.1. Was selection of participants into the study (or into the analysis) based on participant characteristics observed after the start of intervention?
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Q8: ROBINS-I 2.2. If Y/PY to 2.1: Were the post-intervention variables that influenced selection likely to be associated with intervention?
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Q9: ROBINS-I 2.3 If Y/PY to 2.2: Were the post-intervention variables that influenced selection likely to be influenced by the outcome or a cause of the outcome?
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Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants?
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Q12: ROBINS-I 2.5. If Y/PY to 2.2 and 2.3, or N/PN to 2.4: Were adjustment techniques used that are likely to correct for the presence of selection biases?
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Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY
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Q2: Did the study divide the follow up time of each individual participant into the different interventions?
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Q11: Did the start and follow up calendar years coincide for most participants in the study?
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Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. Yes Low risk of detection bias in patient-reported outcomes because participants were blinded.
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Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described?
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Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population?
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Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants?
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Quality Rating
No quality rating data was found.