Pharmacy & Therapeutics - September 2008 - (Page 546)

MEETING HIGHLIGHTS Digestive Disease Week and American Diabetes Association Walter Alexander Digestive Disease Week From May 17 to 22, 2008, in San Diego, Digestive Disease Week covered the latest advances in gastroenterology, hepatology, endoscopy, and surgery as well as the prevention, diagnosis, and treatment of digestive disorders. The meeting attracted thousands of physicians, researchers, and academics.The first portion of this month’s column addresses ulcerative colitis and Crohn’s disease. Assessment (PGA) scores (60% vs. 36%; P = 0.0004); mucosal appearance (53% vs. 37%; P = 0.02); and improvements in bowel frequency (49% vs. 37%; P = 0.08). Dr. Bosworth concluded: “As assessed by the MMDAI, balsalazide tablets, administered as 3.3 g twice daily, are effective in improving the signs and symptoms of mild-to-moderate ulcerative colitis. This new tablet formulation reduces both pill and dosing burden in patients with active ulcerative colitis and may improve patient compliance.” Infliximab (Remicade) • William J. Sandborn, MD, Mayo Clinic, Rochester, Minn. ULCERATIVE COLITIS Balsalazide (Colazal) • Brian Bosworth, MD, Assistant Professor of Medicine, WeillCornell Medical College of Cornell University, New York, New York A twice-daily formulation of balsalazide tablets (Colazal, Salix) improved signs and symptoms of mild-to-moderate ulcerative colitis, according to phase 3 clinical trial results presented by Dr. Bosworth. The reduced-dosing regimen, he stated, “has the potential for higher compliance with selfadministered treatment.” Poor compliance with the currently approved formulation of three doses per day, he added, is a major problem for these patients. Dr. Bosworth and co-investigators for the double-blind, placebo-controlled, multicenter trial enrolled 249 adults with symptoms of mild-to-moderate active ulcerative colitis with Modified Mayo Disease Activity Index (MMDAI) scores of 6 to 10 at baseline. Subjects had subscale ratings of 2 or higher for both rectal bleeding and mucosal appearance. Patients were randomly assigned to three 1,100-mg balsalazide tablets (n = 166) twice daily or three matching placebo tablets (n = 83) twice daily for eight weeks. Colonoscopy or sigmoidoscopy screening was conducted up to seven days before randomization and at the study’s end. Dr. Bosworth reported benefits for the balsalazide group across a wide range of endpoints. A significantly larger proportion of balsalazide patients achieved improvements in total MMDAI scores at the end of the study (67% vs. 47%, respectively; P = 0.004), and mean decreases in total MMDAI scores from baseline to week eight were significantly larger with balsalazide than with placebo (–3.4 ± 3.0 vs. –2.3 ± 3.0; P = 0.002). Benefits among the balsalazide subjects, compared with the patients receiving placebo, were also reported for rectal bleeding (59% vs. 42%, respectively; P = 0.01); Physician Global Mr. Alexander is a freelance medical writer living in New York City. An analysis of data from a clinical trial of infliximab (Remicade, Centocor) for ulcerative colitis demonstrated that substantial proportions of patients who do not respond to the agent following the first dose might ultimately respond to a second or third dose. In the large phase 3 registration trials of infliximab (Active Ulcerative Colitis Trials 1 and 2 [ACT 1 and ACT 2]), Dr. Sandborn stated, approximately two-thirds of patients responded to infliximab at the eighth week after three induction doses (5 or 10 mg/kg) given at weeks zero (baseline), two, and six. Onethird of the placebo patients responded in the same period. The objective of the current analysis of efficacy data from ACT 1 and ACT 2 was to determine, among patients not responding to their first or second induction infliximab dose, what proportion responded after the second and third induction doses. ACT 1 and ACT 2 each included 364 patients with active ulcerative colitis despite the use of corticosteroids, azathioprine (Azasan, Salix), and 6-mercaptopurine (6-MP) (Purinethol, Gate). All of the patients had endoscopic evidence of moderate or severe ulcerative colitis with endoscopy scores of 2 or above and total MMDAI scores of 6 to 12 inclusive. They had been randomly assigned to receive placebo (n = 242) or infliximab 5 or 10 mg/kg at weeks zero, two, and six and every eight weeks through week 46 in ACT 1 and through week 22 in ACT 2. The primary endpoint of clinical response was determined from the MMDAI score, which comprised stool frequency, rectal bleeding, PGA scores, and endoscopy findings. Using PGA subscores, Dr. Sandborn reported that about 50% of patients with moderate or severe disease at week zero had mild or no disease after their initial infliximab infusion; 247 patients had not responded by the second week. Among these, about one-third responded at week six following their second dose of infliximab. Of 169 patients who had not responded by week six after two doses, more than a fourth responded at week eight after receiving a third dose. By week eight, about 74% of the 464 infliximab-treated patients ultimately achieved 546 P&T® • September 2008 • Vol. 33 No. 9

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - September 2008

Pharmacy & Therapeutics - September 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Effect of Prescription Copays on Adherence and Treatment Failure with Oral Antidiabetic Medications Vaccine Declinations Present New Challenges for Public Health Universal Health Care in America Digestive Disease Week and American Diabetes Association Pharmaceutical Approval Update

Pharmacy & Therapeutics - September 2008

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.