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. 2012 Jul 25;4:41–50. doi: 10.2147/CPAA.S26556

Table 2.

Clinical efficacy of MMX mesalamine (MES) in induction (8 weeks) of remission in patients with mild to moderate ulcerative colitis

Study N Doses Clinical and endoscopic remission (%) (OR, 95% CI) Failure rates (%)
Kamm et al39 84 MMX mesalamine 2.4 g daily 40.5** (2.40; 1.23–4.69) 21.4***
85 MMX mesalamine 4.8 g daily 41.2** (2.47; 1.15–5.30) 20.0***
86 Asacola 800 mg three times daily 32.6 (1.70; 0.86–3.36) 27.9**
86 Placebo 22.1 47.7
Lichtenstein et al56 88 MMX mesalamine 1.2 g twice daily 34.1*** (3.48; 1.44–8.41) 28.4***
85 MES 4.8 g daily 29.2** (2.78; 1.27–6.06) 24.7***
89 Placebo 12.9 54.1
Kamm et al58,b 197 MMX mesalamine 2.4 g twice daily (No response to MMX mesalamine previously) 59.5 _
107 MMX mesalamine 2.4 g twice daily (Placebo previously) 57 _

Notes:

*

P < 0.05;

**

P < 0.01;

***

P < 0.001 vs placebo.

a

Included as an internal reference arm; no comparative statistical analyses with the mesalamine treatment arms were reported;

b

patients who did not achieve the primary endpoint of clinical and endoscopic remission in the 8-week Phase III trials35,51 were eligible for enrolment in the noncomparative extension study (4.8 g MMX mesalamine for 8 weeks).54

Abbreviation: OR, odds ratio.