Study Indicates Omalizumab Is Effective for Allergic Asthma

(American Academy of Allergy, Asthma, and Immunology Annual Meeting) Investigators report that long-term use of omalizumab (Xolair), the first in a new class of therapies that target IgE in the treatment of allergic disease, reduces the need for inhaled corticosteroid use in patients with moderate to severe asthma, can concomitantly reduce the need for other asthma medications and decreases the frequency of asthma exacerbations in patients whose allergic asthma is poorly controlled. The 12-month, randomized, double-blind, placebo-controlled, parallel group trial, comprising a four-week baseline phase, 28-week core phase and 26-week extension phase, included 546 subjects with allergic asthma who were symptomatic despite taking beclomethasone dipropionate (BDP) and albuterol (Ventolin). During the core phase, the BDP dose was reduced to zero in 43 percent of the subjects who received omalizumab and in 19.5 percent of the subjects who received placebo. For those who required BDP during the extension phase, the omalizumab-treated subjects required a significantly lower dose than those in the placebo group. Through the core and extension periods, exacerbation of symptoms occurred in 24 and 20.5 percent of the subjects in the omalizumab group, respectively, versus 42 and 32 percent in the placebo group, respectively. Omalizumab was safe and well tolerated with a similar incidence of adverse effects reported in both treatment groups.—dr. roland buhl, et al., Johannes-Gutenberg University, Mainz, Germany.

Low-Dose SSRI Is Promising in Treatment of Major Depressive Episodes

(American Psychiatric Association) Study investigators report that escitalopram, the isomer of citalopram (Celexa), was significantly more effective than citalopram relative to placebo across all study measures at a lower dose than indicated for any current selective serotonin reuptake inhibitors (SSRIs) in the treatment of patients with major depressive disorder, suggesting that escitalopram shows promise as a first-line treatment for this disorder. A total of 491 patients between 18 and 65 years of age with ongoing episodes of major depression were evaluated in a randomized, double-blind, placebo-controlled, multicenter study and were randomized for eight weeks to one of four trial arms: placebo, citalopram and two different dosages of escitalopram. The Montgomery-Asbert Depression Rating Scale (MADRs) was the prospective defined primary end point; other outcome measures included the Hamilton Depression Rating (HAMD) and HAMD item 1 scales, and the Clinical Global Impression (CGI) scale. At all time points throughout the study, patients randomized to the escitalopram trial arm showed significant improvement in the primary end point compared to the other trial arms. The investigators noted a low discontinuation rate due to adverse events, which they attributed to escitalopram's high tolerability —william burke, m.d., et al., University of Nebraska Medical School, Omaha, Nebraska.

Parecoxib Reduces Pain Following Total Hip Replacement

(20th Annual Scientific Meeting of the American Pain Society) Results of a Phase III, placebo-controlled, multicenter study evaluating pain management following total hip replacement in 175 patients reveal that parecoxib, the first injectable COX-2 inhibitor, significantly reduced the amount of morphine needed to manage postoperative pain. Patients receiving parecoxib required 39 percent less morphine during the first 24-hour postoperative period following hip replacement surgery than those receiving morphine. Adverse events were similar between the parecoxib and morphine groups; however; significantly fewer patients receiving parecoxib experienced fever and/or vomiting compared with those receiving placebo, and they also scored higher in Pain Intensity Difference scores at most assessment points. Investigators consider this an important step toward better acute pain management following hip replacement surgery in view of the challenge of achieving the best level of pain control and keeping side effects to a minimum.—t. philip malan, m.d., et al., University of Arizona Health Science Center, Tucson, Arizona.

Parecoxib Is Effective Pain Control After Knee Surgery

(20th Annual Scientific Meeting of the American Pain Society) Results of a second Phase III, multicenter, double-blind study evaluating pain management following total knee replacement in 208 patients reveal that 80 percent of the patients who received parecoxib rated their pain medication as good or excellent, compared with 70 percent of patients receiving ketorolac (Toradol) and 45 percent of those receiving morphine. The investigators consider these findings to be important because of the heightened attention pain management has received and the importance of reducing the need for opioids and improving overall pain relief.—g. lynn rasmussen, m.d., et al., Orthopedic Specialty Hospital, Salt Lake City, Utah.

Benefit of IL-2 Therapy in HIV Patients Confirmed

(40th Interscience Conference on Antimicrobial Agents and Chemotherapy [ICAAC]) Preliminary results from the largest randomized clinical trial conducted to-date evaluating the safety and efficacy of recombinant interleukin-2 (IL-2) confirmed that recombinant IL-2 produces a sustained increase in the CD4+ T-cell level for up to one year in some patients with human immunodeficiency virus (HIV) infection who are receiving antiretroviral drug therapy and demonstrated that the addition of recombinant IL-2 to that therapy does not significantly affect the viral load. Investigators evaluated 511 patients for a minimum of one year who received combination antiretroviral drug therapy with or without intermittent subcutaneous recombinant IL-2. Results from previous studies demonstrated that recombinant IL-2 boosted immunity levels in a small group of patients with HIV on antiretroviral drug therapy; however, concern was raised as to whether it increased the amount of HIV in the blood. According to the investigators, data from this trial allay the concern about any detrimental effects of recombinant IL-2 on the viral load and provide the basis for two large, ongoing, major Phase III trials evaluating the clinical outcomes of IL-2 treatment of patients with HIV.—donald abrams, m.d., et al., University of California, San Francisco.

Studies Report Paroxetine Effective in Treatment of PTSD

(15th Annual Meeting of the American Psychiatric Association) Data pooled from three 12-week, randomized, double-blind, placebo-controlled trials indicate that paroxetine (Paxil) is well tolerated, and safe and effective in the treatment of post-traumatic stress disorder (PTSD). Primary efficacy measurements for the 428 men and 752 women participating in the study included the Clinician Administered PTSD scale (CAPS-2) and the Global Improvement of the Clinical Global Impression (CGI-I) scale; secondary measurements included CAPS-2 symptom clusters, Davidson Trauma Scale (DTS) and the Sheehan Disability Scale (SDS). Total scores for the CAPS-2 scale decreased significantly (p<0.001) Secondary measurements produced similar results in favor of paroxetine versus placebo for both genders. However, this finding did not differ in regard to gender on the efficacy instruments. The U.S. Food and Drug Administration is currently reviewing paroxetine for the treatment of PTSD.—c.d.pitts, r.ph., et. al.,GlaxoSmithKline, Philadelphia, Pennsylvania.