Tegaserod Demonstrates Efficacy in Improving IBS Symptoms
(32nd Annual Digestive Disease Week [DDW] Meeting) Results of a multicenter, placebo-controlled, double-blind study evaluating 1,519 women with irritable bowel syndrome (IBS) demonstrate that tegaserod (Zelnorm) significantly relieves (P < 0.05) the symptoms (abdominal discomfort/pain, bloating, impaired bowel function) associated with IBS, and improves the overall sense of well being. Improvement in symptoms was reported during the first week of therapy, with the most pronounced relief occurring during the initial four to six weeks of treatment and continuing throughout the study, with rapid return of symptoms occurring during the withdrawal period. Study participants were randomized to receive 6 mg of tegaserod or placebo for 12 weeks followed by a four-week withdrawal period. The Subject's Global Assessment served as the primary efficacy measurement, plus participants kept a daily diary of symptoms. Tegaserod, a 5-HT4 partial agonist with promotile properties and modulating effects on visceral sensitivity, is currently under review by the U.S. Food and Drug Administration as a treatment for the relief of symptoms associated with IBS.—martin p. lefkowitz, m.d., et al., East Hanover, New Jersey.
Study Compares Antidepressant Therapies and Depression-Free Days
(154th Annual Meeting of the American Psychiatric Association) Pooled data from eight active-controlled clinical trials conducted in the United States, Europe and Canada involving 2,046 patients with moderate-to-severe depression indicate that during an eight-week period, patients taking extended-release venlafaxine (Effexor XR) experienced 18.8 depression-free days (DFDs), those taking a selective serotonin reuptake inhibitor (SSRI) had 13.6 DFDs and those receiving placebo had 7.4 DFDs (based on a difference between median scores). Compared with placebo, venlafaxine and the SSRIs (paroxetine [Paxil], fluoxetine [Prozac] or fluvoxamine [Luvox]) were associated with sustained low rating on the Clinical Global Impressions-Severity of Illness (CGI-SI) scale as well. The 17-item Hamilton Rating Scale for Depression (HAM-17) was used to estimate the DFDs; this instrument, along with the CGI-SI, was used at baseline and then weekly during the eight-week period, and cumulative DFDs were compared across treatment groups. While antidepressant therapy is considered effective if a patient's symptoms of depression are reduced by at least 50 percent, and while clinical trials typically base the efficacy of antidepressant therapy on patient response to the HAM-17, the DFD scale, developed in 1998, provides an additional method of quantitating the efficacy of antidepressant therapy.—rajiv mallick, ph.d., et al., Radnor, Pennsylvania.
Study Evaluates NSAID in Treatment of Chronic Low Back Pain
(20th Annual Scientific Meeting of the American Pain Society) Results of two randomized, placebo-controlled, four-week multicenter studies evaluating 690 patients who routinely took analgesic medications for chronic low back pain demonstrate that 25 or 50 mg of rofecoxib (Vioxx) once daily is safe and effective across the majority of outcomes measures. Baseline characteristics of the patients were similar, with 12.1 years' mean duration of back pain and 82.8 percent having taken nonsteroidal anti-inflammatory drugs (NSAIDs) and 17.2 percent non-NSAIDs as prestudy pain analgesic. After meeting pain-worsening criteria following discontinuation of prestudy analgesics, 223, 229 and 228 patients were randomized to receive 25 mg, 50 mg or placebo, respectively. Efficacy end point data were combined; the primary end point was the Low Back Pain Intensity Scale. The efficacy of 25- and 50-mg dosages is comparable and is significantly superior to placebo—nathanial katz, m.d., et al., Brigham and Women's Hospital, Boston, Massachusetts.
Researchers Report Relief of IC Symptoms with Pentosan Polysulfate
(96th Annual American Urological Association Meeting) The findings of the first study conducted to evaluate the onset of effect and dose-response relationship of pentosan polysulfate sodium (Elmiron) in the treatment of interstitial cystitis (IC) indicate that significant improvement of symptoms occurrs with duration of therapy in relation to differences in dosages. The 32-week, randomized, double-blind, multicenter study enrolled 380 patients with a positive cystoscopic examination or a history of IC symptoms of at least six months' duration. Patients were randomized to receive 100, 200 or 300 mg of pentosan or placebo three times daily. Measurement tools included the Patient's Overall Rating of Symptom Index (PORIS) and the O'Leary-Sant Interstitial Cystitis Symptom Index. Patients who showed 50 percent or more improvement on PORIS were considered responders. Of the 230 patients who completed the study, 23.1 percent who received 300 mg per day, 16.5 percent who received 600 mg per day and 16.9 percent who received 900 mg per day were responders. At 32 weeks, the percentages rose to 67.1, 59.5 and 60.1 percent, respectively, leading investigators to suggest that while no significant measure of efficacy was evident between dosages, improvement in symptoms had not plateaued at 32 weeks, and further improvement may be obtained with long-term therapy. Pentosan polysulfate sodium is the only oral medication approved by the U.S. Food and Drug Administration for the treatment of IC.—J. curtis nickel, m.d., et al., Kingston General Hospital, Ontario, Canada.
Foradil Aerolizer Shows Promise in Treatment of Children with Asthma
(97th Annual American Thoracic Society Meeting) Formoterol fumarate inhalation powder (Foradil Aerolizer), taken in addition to standard inhaled corticosteroid therapy, reduces day and nighttime asthma symptoms and the need for rescue medication in children with persistent asthma uncontrolled by inhaled corticosteroid therapy alone, according to investigators. Patients enrolled in the double-blind, placebo-controlled, 12-month study received 12 μg, 24 μg or placebo twice daily via the inhaler, along with their established anti-inflammatory therapy. Investigators report that rapid bronchodilation occurred within five minutes and was maintained over a 12-hour period. Patients showed significant improvement in forced expiratory volume, the primary outcome measure, at three and 12 months (P < 0.0062 for the 12-μg dose and P < 0.0001 for the 24-μg dose), compared with placebo. The incidence of adverse effects were comparable with that of placebo. The U.S. Food and Drug Administration approved formoterol fumerate inhalation powder in February 2001.—george bensch, m.d., et al., Allergy, Immunology and Asthma Medical Group, Stockton, California.