Statistic Dance on Diverticular Disease Dr Walter Elisei

U.O.C. Gastreonterologia ed Endoscopia Digestiva

ASL_Roma 6 – Albano Laziale (Roma)

Main Topics on Treatment of Diverticular Disease

How to treat Symptomatic Uncomplicated Diverticular Disease (SUDD)

How to prevent the first attack of diverticulitis ( Diverticulitis Occurrence )

How to treat Acute Uncomplicated Diverticulitis

How to prevent Acute Diverticulitis Recurrence

Main Topics on Treatment of Diverticular Disease

How to treat Symptomatic Uncomplicated Diverticular Disease (SUDD)

How to prevent the first attack of diverticulitis ( Diverticulitis Occurrence )

How to treat Acute Uncomplicated Diverticulitis

How to prevent Acute Diverticulitis Recurrence

Symptom Relief NNT:3 Complications Occurrence NNT:59

Diverticulitis Occurrence NNT:50

SUDD and Diverticulitis Occurrence_Rifaximin based treatment

3 RT Open Label

1 DB-RT_PC

(1992-2003_1660 pts)

SUDD and Diverticulitis Occurrence_Mesalamine based treatment

4 RT Open Label (1999-2007)

Mesalamine vs Other Therapy

(694 pts)

Symptom Relief

Diverticulitis Occurrence

… we still have non meta-analysis

because the data are not omogeneous…

3 RT Open Label (1999-2007)

Mesalamine vs Other Therapy

(524 pts)

SUDD and Diverticulitis Occurrence_Mesalamine based treatment

Pain control

117 pts

ITT ARR (95% CI): 7.6% (6,2 % - 29,5%)

NNT = 13.1

PP ARR (95% CI): 17.8% (0,16 % - 35,4%)

NNT = 5.6

Symptom relief

250 pts

ARR (95% CI): 39.3 % (24.7-53.9)

NNT = 2.5

Diverticulitis Occurrence (1st)

250 pts

ARR (95% CI): 12 % (2.9-21)

NNT = 8.3

Main Topics on Treatment of Diverticular Disease

How to treat Symptomatic Uncomplicated Diverticular Disease (SUDD)

How to prevent the first attack of diverticulitis ( Diverticulitis Occurrence )

How to treat Acute Uncomplicated Diverticulitis

How to prevent Acute Diverticulitis Recurrence

Antibiotics for Acute Uncomplicated Diverticulitis

Chabok A et al. Br J Surg. 2012 Apr;99(4):532-9

AVOD Trial (2012)_RCT

623 patients randomized to treatment with (314 pts) or without (309 pts) antibiotics.

CT proven diverticulitis: Ambrosetti mild

Primary Endpoint: Recovery without complications at 12 months follow-up

Complications ( 1,9% vs 1%; p= ns)

Recurrent diverticulitis at 1-year Follow-Up (16% vs 16%; p= ns).

DIABOLO Trial (2010)_RCT

528 patients randomized to treatment with or without antibiotics.

CT proven diverticulitis: Hinchey 1a or 1b

Primary Endpoint: Time-to-full-recovery al 6 months follow-up

At 6 months follow-up recovery occurred in 234 (89.3%) patients assigned to observation

and in 248 (93.2%) patients assigned to antibiotics (P=0.183).

Median time-to-recovery was comparable among observational and antibiotic treatment

strategies (14 days [IQR, 6 to 35] vs. 12 days [IQR, 7 to 30]; P=0.291 by the Log-Rank

test), with a hazard ratio for recovery of 0.910 (upper limit one-sided 95 % CI, 1.059;

P=0.151).

UEG Journal. October 2014 vol 2 n 1 suppl

Chabok A et al. Br J Surg. 2012 Apr;99(4):532-9

… it should be reserved for the treatment of complicated diverticulitis

Main Topics on Treatment of Diverticular Disease

How to treat Symptomatic Uncomplicated Diverticular Disease (SUDD)

How to prevent the first attack of diverticulitis ( Diverticulitis Occurrence )

How to treat Acute Uncomplicated Diverticulitis

How to prevent Acute Diverticulitis Recurrence

Prevention of Acute Diverticulitis Recurrence_Rifaximin

No Placebo Controlled data

Prevention of Acute Diverticulitis Recurrence_Mesalamine

PREVENT 1_2 (RT_DB_PC)

590 + 592 pts

> 1 episodes of acute diverticulitis in the previus 24 months

Mesalamine MMX vs Placebo

Mesalamine (MMX) was not superior to placebo in preventig recurrent diverticulitis.

For a portion of the study recurrence of diverticulitis was diagnosed without CT.

Raskin JB et al Gastroenterology 2014 Oct;147(4):793-802.

DIVA Trial (RT_DB_PC)

117 pts (ITT)

1-3 episodes of acute diverticulitis in the previus 14 days

3 arms: Placebo vs Mesalazine vs Mesalazine + Probiotics (12 w)

Mesalamine (MMX) was not superior to placebo in preventig recurrent diverticulitis.

The rate of complete response (GSS=0) was significantly higher with mesalamine than

placebo at weeks 6 and 52 (P

Statistical Issues in Treatment of Diverticular Disease

The published Placebo Controlled Trials were not many

The published Trials had a limited number of patients

Some enrolment criteria should be more specific for SUDD

Useful End-Points are needed

International Guidelines on Diverticular Disease

Some of them don’ t recommend treatment to prevent the first

attack of diverticulitis

Most of them don’ t recommend treatment to prevent the

Recurrence of diverticulitis.

… Only the recent guidelines suggest that antibiotics should be

used selectively, rather than routinely, in patients with acute

uncomplicated diverticulitis.

… Thank You !!!