Outlook: Clinical Trials

AUGUST 10, 2011
Michelle Reed, PharmD

Effect of Dexamethasone on Hospital Stay in CAP 
A recent double-blind, placebo-controlled trial evaluated the effect of dexamethasone on length of hospital stay for patients with community-acquired pneumonia (CAP).1 Investigators randomized adults 18 years or older (n = 304) with confirmed CAP who presented to emergency departments of 2 teaching hospitals in the Netherlands to receive either intravenous dexamethasone 5 mg once a day or placebo. Exclusion criteria were immunocompromised status, need for immediate transfer to an intensive-care unit, or current use of corticosteroids or immunosuppressive drugs. Study subjects received their respective treatments for 4 days from admission, and the primary outcome of the study was length of hospital stay.

Results showed that the median length of stay was 6.5 days (range: 5.0-9.0) in the dexamethasone group compared with 7.5 days (range: 5.3-11.5) in the placebo group (95% confidence interval [CI] of difference in medians 0-2 days; P = .0480). The rates of severe adverse events and in-hospital mortality were similar between groups. However, 44% of patients in the dexamethasone group had hyperglycemia, compared with 23% of patients in the placebo group (P <.0001). Investigators concluded that dexamethasone can reduce length of hospital stay when added to antibiotic treatment in nonimmunocompromised patients with CAP.

Probiotics and Diarrhea Prevention
A recent double-blind, randomized, controlled field trial of children (n = 3758) aged 1 to 5 years was conducted in an urban slum community in Kolkata, India.4 Study subjects were randomized to receive either a probiotic drink containing Lactobacillus casei strain Shirota or a nutrient drink daily for 12 weeks. The primary outcome of this study was the occurrence of first episodes of diarrhea, which was assessed during 12 weeks of intake of the study agent and during a 12-week follow-up period.

Results showed that there were 608 subjects with diarrhea in the probiotic group and 674 subjects with diarrhea in the nutrient group during the study period of 24 weeks. The level of protective efficacy for the probiotic was 14% (95% CI 4-23, P <.01). Investigators concluded that daily intake of a probiotic drink can play a role in prevention of acute diarrhea in young children in a community setting of a developing country.

Comparison of Asthma Treatment in Young and Elderly Patients
A recent, randomized, 6-month study compared 2 maintenance doses of budesonide/formoterol maintenance and reliever therapy 160/4.5 mcg 1 × 2 and 2 × 2 in patients with asthma (n = 8053) with symptoms despite treatment with inhaled corticosteroids ± inhaled long-acting beta2-agonists.2

Investigators compared response to the 2 treatments in elderly patients (≥65 years) with that of younger patients using Fiveitem Asthma Control Questionnaire (ACQ-5) scores. At baseline, the predicted normal post-bronchodilator forced expiratory volume in 1 second percentage was lower in elderly patients compared with younger patients (85.6% vs 91.0%, respectively).

Results showed that the elderly had more exacerbations, and that the risk of first severe exacerbation was increased by 55.3% (hazard ratio 1.553; 95% CI: 1.249- 1.931, P <.0001) compared with younger patients. However, no differences in exacerbations were seen between 1 × 2 or 2 × 2 budesonide/formoterol maintenance and reliever therapy treatment in the elderly. ACQ-5 scores improved equally in the 2 age groups. Investigators concluded that budesonide/formoterol maintenance and reliever therapy (1 × 2 or 2 × 2) is effective and well tolerated in elderly and younger asthmatic patients.

Predictive Nature of Early Response to Antipsychotic Therapy
A recent study evaluated whether early response to antipsychotic medication can predict later response to continued use of the same treatment for patients with first episode psychosis.3 In a randomized, double-blind trial of olanzapine versus haloperidol for treatment of patients with first episode psychosis (n = 225), investigators used a data-driven threshold for early response of greater than or equal to 26.2% improvement from baseline on the Positive and Negative Syndrome Scale (PANSS[0-6]) total score to determine whether response at Week 2 of treatment may predict response at Week 12.

At Week 2, 43% (97/225) of patients were identified as early responders. The threshold for later response was defined as greater than or equal to 50% improvement in PANSS(0-6) total score. Early nonresponse most strongly predicted later nonresponse, demonstrating high specificity (74%) and high negative predictive value (80%). Investigators concluded that, similar to results seen in the treatment of chronic schizophrenia, early nonresponse was a robust predictor of subsequent nonresponse in the treatment of patients with first episode psychosis.

Dr. Reed received her doctor of pharmacy degree from the University of the Sciences in Philadelphia, Pennsylvania, and currently works as a medical editor in the greater Philadelphia area.



1. Meijvis SC, Hardeman H, Remmelts HH, et al. Dexamethasone and length of hospital stay in patients with community-acquired pneumonia: a randomised, double-blind, placebo-controlled trial. Lancet. 2011;377(9782):2023-2030.

2. Haughney J, Aubier M, Jørgensen L, et al. Comparing asthma treatment in elderly versus younger patients. Respir Med. 2011;105(6):838-845.

3. Stauffer VL, Case M, Kinon BJ, et al. Early response to antipsychotic therapy as a clinical marker of subsequent response in the treatment of patients with first-episode psychosis. Psychiatry Res. 2011;187(1-2):42-48.

4. Sur D, Manna B, Niyogi SK, et al. Role of probiotic in preventing acute diarrhoea in children: a community-based, randomized, double-blind placebo-controlled field trial in an urban slum. Epidemiol Infect. 2011;139(6):919-926.

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