Tegaserod has demonstrated significant beneficial effects in patients (primarily women) with IBS-C. In large, controlled, randomized, phase 3 studies, tegaserod provided significantly greater overall improvement over placebo in relieving multiple and single symptoms of IBS-C, as described next.
Brain-Gut Axis Dysfunction
Symptoms of IBS arise from three main physiological abnormalities: altered GI motility, altered intestinal secretion, and enhanced visceral sensitivity. Although the motor, secretory, and sensory activities of the gut are under the direct control of the enteric nervous system (ENS), the central nervous system (CNS) contributes indirectly by modulating the activities of the ENS through sympathetic and parasympathetic pathways. This bidirectional communication pathway is referred to as the brain-gut axis. The ENS controls intestinal motility and secretion and visceral sensation via neuro-transmitters such as serotonin (5-hydroxytryptamine [5-HT]), norepinephrine, dopamine, acetylcholine, and calcitonin generelated peptide (CGRP).
INTRODUCTION
Canadian tegaserod maleate (Zelnorm generic, Novartis) is a unique pharmacological agent for the treatment of patients with irritable bowel syndrome (IBS) with constipation (IBS-C). Unlike traditional IBS therapies, which target only single IBS symptoms, tegaserod drug has provided global relief of the multiple symptoms of IBS, including abdominal pain and discomfort, bloating, and constipation. It has also been found to be safe and well tolerated in both short-term (three-month) and long-term (12-month) clinical trials.
The CEI is a sophisticated integrated analysis of data from commonly available sources that addresses this question: Did the use of a new medication (e.g., LMWH) increase or decrease the overall cost of caring for inpatients who received it compared with similar patients who received an older medication (e.g., UFH)?
A Comparison of Actual and Expected Treatment Rates
Because the CEI involved multiple hospitals, the data were pooled and used for comparison with treatment patterns at individual hospitals. These comparisons were adjusted to the case mix for each hospital to allow the individual hospital to be compared with the pooled data. To accomplish this, the CEI project team used the pooled data to develop expected utilization rates for each CEI-DRG based on averages for all of the hospitals. These expected rates were applied to the numbers of patients by the CEI-DRG at a hospital to calculate an expected number of patients. This number was compared with the actual number to determine whether the rate of utilization at a hospital was above or below the group as a whole (the pooled hospital data).
Case Mix Adjusted Savings Achieved Savings
Savings calculated at the CEI-DRG level were summed by patient category. Savings per case in each CEI-DRG could not be simply summed to provide an overall savings estimate for a patient category. A weighted average was needed that reflected the case mix of patients receiving the drugs. Because the patients receiving drug 2 had already “achieved” the savings estimated for each CEI-DRG, per-case savings were multiplied by the number of patients who received drug 2 (n2) to calculate the achieved savings: Read More…
Data Editing and Outlier Identification
To help ensure the credibility of the results, data used in the CEI were subjected to a series of steps involving screening, edits, and measures to identify outliers (data values that stand out from others in a set).
