Safety and Tolerability of Tegaserod
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.
OVERVIEW
IBS is a relatively common gastrointestinal (GI) disorder that affects up to 20% of the U.S. population, with more women affected than men, in a ratio of 2:1. Patients typically first seek medical care between ages 30 and 50 years, although the age of onset is generally younger.
The diagnosis of IBS is made in more than one quarter (28%) of patients who see gastroenterologists. The annual costs associated with the care of these patients in the eight major industrialized countries are approximately $41 billion (in U.S. dollars). The estimated annual total cost of IBS in the U.S., excluding the cost of prescription medications, is $30 billion.
IBS has a substantial negative impact on quality of life. Patients commonly report that symptoms cause them to miss work or school or to be less productive there. Symptoms may also limit patients’ participation in leisure activities and often have an adverse effect on their social and physical relation-ships. Studies using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), a generic quality-of-life measure, have shown that patients with IBS have poorer quality of life than the general U.S. population, and their scores on selected SF-36 subscales are lower than those of patients with other chronic conditions such as gastroesophageal reflux disease (GERD), asthma, migraine, diabetes mellitus, and end-stage renal disease.
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In the clinical setting, the diagnosis of IBS is usually confirmed according to the broad definition of abdominal pain or discomfort associated with altered bowel habits. More detailed symptom-based criteria, the Rome II criteria, are commonly used to identify patients for clinical trials. There are three major subtypes:
- IBS with constipation (IBS-C)
- IBS with diarrhea (IBS-D)
- IBS with alternating diarrhea and constipation (IBS-A)
TRADITIONAL TREATMENT OPTIONS
Until recently, IBS treatment options consisted of single agents—for specific individual symptoms—or various combinations of therapies (e.g., antispasmodics, fiber, laxatives, anti-diarrheal agents, and antidepressants)—targeted at multiple symptoms—in individual patients. However, data to support the efficacy and safety of these therapies in patients with IBS are generally lacking. Furthermore, patient surveys indicate that most patients are dissatisfied with traditional therapies because they are either ineffective or are associated with adverse drug effects (ADEs). Dissatisfaction commonly results in trials of multiple medications, either concurrently or consecutively, or in combination with other medications. Many patients also try alternative remedies when other options fail, although the effectiveness of these therapies is perceived as limited.
The ADEs that are associated with traditional therapies can be particularly troublesome, because they sometimes worsen or mimic IBS symptoms. Antispasmodics and tricyclic anti-depressants (TCAs) can cause or exacerbate constipation, fiber may increase symptoms of bloating and abdominal dis-comfort, antidiarrheal agents may provoke constipation in some patients, and laxatives may be associated with diarrhea, abdominal discomfort, and gas.
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In the IBS Medications Side Effects Study, 35% of survey respondents who had taken over-the-counter laxatives (n = 114) reported that they experienced abdominal discomfort while taking them. Furthermore, bloating was reported by 20% of survey respondents who had taken prescription laxatives (n = 59), by 21% who had taken nonprescription laxatives (n = 114), and by 26% who had taken fiber supplements (n = 263).
Ideally, IBS therapies should provide total relief of abdominal pain or discomfort, bloating, and altered bowel habits. Therapies that do not achieve this goal or that address only individual IBS symptoms should be considered suboptimal. Therapies that provide global relief have greater potential to alleviate symptoms and to improve overall well-being and quality of life. In addition to being effective, IBS treatment options should be safe and well tolerated and should produce a minimal number of ADEs and drug-drug interactions.
