The value of branded proton pump inhibitors: formulary considerations.

The prevalence of gastroesophageal reflux disease (GERD) continues to rise, placing an increasing burden on our health care system. Proton pump inhibitors (PPIs) are the most effective and widely used therapy for GERD. Many PPIs are now available in generic and over-the-counter forms, and managed care formularies often choose these as their preferred drug for GERD treatment. However, newer-generation branded PPIs, as a result of differences in their pharmacokinetic and pharmacodynamic profiles, may offer clinical advantages over generic PPIs. This article discusses these differences and the advantages they offer and suggests possible ways to incorporate the newer PPIs into formularies.

Cyclosporine for severe ulcerative colitis.

OBJECTIVE: To evaluate evidence for the use of cyclosporine in treating patients with severe ulcerative colitis. DATA SOURCES: A literature search was performed using MEDLINE, EMBASE, Cochrane Database, and ISI Web of Knowledge (1966-November 2005) with the search terms cyclosporine, cyclosporin A, CsA, ulcerative colitis, UC, inflammatory bowel disease, IBD, steroid-refractory, and immunosuppression. Additional papers were located by hand-searching relevant references. Only human studies in adults and literature published in English were included. DATA SYNTHESIS: Intravenous cyclosporine has been evaluated for the treatment of severe ulcerative colitis in 4 randomized, controlled trials, as well as in many open-label and retrospective studies. Studies that evaluated cyclosporine for severe ulcerative colitis were reviewed. All 4 controlled trials showed an initial positive clinical response as defined by the Crohn's Activity Index when intravenous cyclosporine 4 mg/kg/day was administered as monotherapy or combined with intravenous corticosteroids. One of the 4 trials indicated that high-dose cyclosporine (4 mg/kg/day) has no additional clinical benefit over the low-dose (2 mg/kg/day) and that the lower dose may improve safety related to dose-dependent adverse effects. CONCLUSIONS: There is evidence to support the use of intravenous cyclosporine for patients with severe ulcerative colitis who are refractory to corticosteroid therapy. Because most of the adverse effects associated with cyclosporine are dose dependent, therapy should be initiated with the lower 2 mg/kg/day dose. Subsequent doses should be adjusted based on cyclosporine blood concentrations of 150-250 ng/mL. Cyclosporine should be used only to induce remission and serve as a "bridge" to azathioprine or 6-mercaptopurine maintenance therapy. At this time, there are insufficient data to support the long-term use of cyclosporine monotherapy for avoidance of surgery or maintenance of remission.

Safety and tolerability of tegaserod in irritable bowel syndrome management.

OBJECTIVES: To discuss the need for safe and effective therapy for patients with irritable bowel syndrome (IBS) and to provide up-to-date information on the safety and tolerability profile of tegaserod, a novel treatment for women with IBS whose primary bowel symptom is constipation. DATA SOURCES: PubMed and abstracts from gastroenterology conferences were searched through October 2003 using the following search terms: irritable bowel syndrome, IBS, tegaserod, cisapride, alosetron, systematic review, safety, tolerability, serotonin, 5-HT, 5-HT3 receptor antagonist, and 5-HT4 receptor agonist; all information on the safety and tolerability of tegaserod published up to October 2003 is included. DATA SYNTHESIS: A comprehensive review of the medical literature (through 2001) finds no adequate therapies that address the multiple symptoms of IBS. Traditional agents, although occasionally effective, often cause adverse effects. Tegaserod, a selective serotonin type 4 receptor (5-HT4) partial agonist, overcomes a number of obstacles associated with traditional therapies. Important information for pharmacists about the safety and tolerability of tegaserod is presented. CONCLUSION: Tegaserod is effective in treating multiple IBS symptoms in women with IBS whose primary bowel symptom is constipation, and it is safe and well tolerated.