/publications/issue/2011/December2011/News-and-Views-Outlook-Clinical-Trials-

News & Views Outlook: Clinical Trials

Author: Michele Reed, PharmD

Budesonide in Preschool Children with Recurrent Wheezing

A recent clinical study assessed the efficacy of budesonide daily versus intermittent therapy for recurrent wheezing in preschool children.2

Study subjects (n = 278) were aged between 12 and 53 months and had positive values on the modified asthma predictive index, recurrent wheezing episodes, and at least 1 exacerbation in the previous year but a low degree of impairment. Subjects were randomized to receive a budesonide inhalation suspension for 1 year as either an intermittent high-dose regimen (1 mg twice daily for 7 days, starting early during a predefined respiratory tract illness) or a daily low-dose regimen (0.5 mg nightly) with corresponding placebos. The primary outcome was the frequency of exacerbations requiring oral glucocorticoid therapy.

The study demonstrated that there was no significant difference in the frequency of exacerbations between daily and intermittent regimens. The rate per patient-year for the daily regimen was 0.97 (95% CI, 0.76-1.22) compared with 0.95 (95% CI, 0.75-1.20) for the intermittent regimen (relative rate in the intermittent-regimen group, 0.99; 95% CI, 0.71-1.35; P = .60). Additionally, no significant differences were demonstrated between the 2 groups in other asthma severity measures, such as time to first exacerbation. The study authors concluded that there was no proven benefit of a daily low-dose regimen of budesonide over an intermittent high-dose regimen in reducing asthma exacerbations. 

 

Long-Term Mortality and Morbidity Effects of Simvastatin

Data from the extended follow-up of the Heart Protection Study (HPS) showed cause-specific mortality and major morbidity were associated with lowering low-density lipoprotein (LDL) cholesterol with simvastatin.1 Study subjects (n = 20,536) received either 40 mg simvastatin daily or placebo, and mean in-trial follow-up and post-trial follow-up of surviving patients was 5.3 years (standard deviation [SD] 1.2) and 11.0 years (SD 0.6), respectively. The primary end point of the long-term follow-up of the HPS was first post-randomization major vascular event.

Results showed that during the in-trial period, simvastatin demonstrated an average reduction in LDL cholesterol of 1.0 mmol/L and a 23% proportional decrease in major vascular events (95% confidence interval [CI] 19-28; P <.0001). Significant divergence each year after the first was observed. No further significant reductions were noted in either major vascular events (risk ratio [RR] 0.95 [0.89-1.02]) or vascular mortality (RR 0.98 [0.90-1.07]) during the post-trial period. Investigators concluded that more prolonged LDL-lowering statin treatment produces larger absolute reductions in vascular events. Additionally, these findings provide further support for the prompt initiation and long-term continuation of statin treatment.

 

Mycophenolate vs Azathioprine as Maintenance Therapy for Lupus Nephritis

In a recent 36-month, randomized, double-blind, doubledummy, phase 3 study, investigators compared oral mycophenolate mofetil (2 g per day) (n = 116) and oral azathioprine (2 mg per kg of body weight per day) (n = 111), plus placebo in each group, in patients with lupus nephritis who met response criteria during a 6-month induction trial. 3

The primary end point was the time to treatment failure, defined as death, end-stage renal disease, doubling of the serum creatinine level, renal flare, or rescue therapy for lupus nephritis.

Results showed that mycophenolate mofetil was superior to azathioprine in time to treatment failure (hazard ratio [HR], 0.44; 95% CI, 0.25-0.77; P = .003) and time to renal flare and rescue therapy (HR, <1.00; P <.05).

Investigators concluded that mycophenolate mofetil was superior to azathioprine in maintaining a renal response to treatment and in preventing relapse in patients with lupus nephritis who had a response to induction therapy.

 

Comparative Effectiveness of Weight-Loss Interventions

In a recent randomized, controlled trial, investigators examined the effects of 2 behavioral weight-loss interventions in obese patients with at least 1 cardiovascular risk factor (n = 415).4 Three groups were studied: 1 intervention provided remote weightloss support through the telephone, a study-specific website, and e-mail; another intervention provided in-person support during group and individual sessions plus the 3 remote means of support; and a third group was a control group in which weight loss was self-directed.

Results showed that the mean change in weight from baseline was -0.8 kg in the control group, -4.6 kg in the group receiving remote support only (P <.001 for the comparison with the control group), and -5.1 kg in the group receiving in-person support (P <.001 for the comparison with the control group). The change in weight from baseline did not differ significantly between the 2 intervention groups. The study authors concluded that both behavioral interventions resulted in significantly more weight loss than a self-directed weight loss program. PT


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.