Maintenance of remission of ulcerative colitis: a comparison between balsalazide 3 g daily and mesalazine 1.2 g daily over 12 months. ABACUS Investigator group.
BACKGROUND
Despite widespread use of aminosalicylates as maintenance treatment for ulcerative colitis (UC), patients still report troublesome symptoms, often nocturnally.


OBJECTIVE
To compare the efficacy and safety of balsalazide (Colazide) with mesalazine (Asacol) in maintaining UC remission.


METHODS
A randomized, double-blind comparison of balsalazide 3 g daily (1.04 g 5-ASA) and mesalazine 1.2 g daily for 12 months, in 99 (95 evaluable) patients in UC remission.


RESULTS
Balsalazide patients experienced more asymptomatic nights (90% vs. 77%, P=0.0011) and days (58% vs. 50%, N.S.) during the first 3 months. Balsalazide patients experienced more symptom-free nights per week (6.4+/-1.7 vs. 4.7+/-2.8; P=0.0006) and fewer nights per week with blood on their stools or on the toilet paper, mucus with their stools or with sleep disturbance resulting from symptoms or lavatory visits (each P < 0.05). Fewer balsalazide patients relapsed within 3 months (10% vs. 28%; P=0.0354). Remission at 12 months was 58%, in both groups. Similar proportions of patients reported adverse events (61% balsalazide vs. 65% mesalazine). There were five serious adverse events (two balsalazide, three mesalazine) and four withdrawals due to unacceptable adverse events (three balsalazide, one mesalazine), of which one in each group was also a serious adverse event.


CONCLUSIONS
Balsalazide 3 g/day and mesalazine 1.2 g/ day effectively maintain UC remission and are equally well tolerated over 12 months. At this dose balsalazide prevents more relapses during the first 3 months of treatment and controls nocturnal symptoms more effectively.
Green
J R
JR
Gastroenterology unit, City General Hospital, Stoke-on-Trent, UK.
Gibson
J A
JA
Kerr
G D
GD
Swarbrick
E T
ET
Lobo
A J
AJ
Holdsworth
C D
CD
Crowe
J P
JP
Schofield
K J
KJ
Taylor
M D
MD
D000293:Adolescent; D000328:Adult; D000368:Aged; D000636:Aminosalicylic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003692:Delayed-Action Preparations / Q000493:pharmacokinetics; D004311:Double-Blind Method; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010659:Phenylhydrazines; D055502:Secondary Prevention; D013997:Time Factors; D017211:Treatment Failure
D000636:Aminosalicylic Acids; D000897:Anti-Ulcer Agents; D003692:Delayed-Action Preparations; D010659:Phenylhydrazines; D019804:Mesalamine; C038637:balsalazide