Outlook: Clinical Trials

Michele Reed, PharmD
Published Online: Monday, May 16, 2011
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Growth Hormone Treatment and Adult HeIght In Patients wIth Turner’s Syndrome

A randomized, controlled trial evaluated the effects of growth hormone and ultra low-dose estrogen therapy on adult height in 149 young women aged 5 to 12.5 years with Turner’s syndrome.1 Study subjects were randomized into 4 groups: double placebo (placebo injection plus childhood oral placebo, n = 39), estrogen alone (placebo injection plus childhood oral low-dose estrogen, n = 40), growth hormone alone (growth hormone injection plus childhood oral placebo, n = 35), and growth hormone–estrogen (growth hormone injection plus childhood oral low-dose estrogen, n = 35). Growth hormone was dosed at 0.1 mg/ kg 3 times per week and was discontinued when adult height was reached. The ethinyl estradiol dose was adjusted for chronologic age and pubertal status.

Results showed that the overall effect of growth hormone treatment on adult height was a 0.78 ± 0.13 increase in the height standard-deviation (SD) score (5.0 cm) compared with placebo (P <.001). The mean SD scores for adult height, attained at an average age of 17.0 ± 1.0 years, after an average study period of 7.2 ± 2.5 years, were -2.81 ± 0.85, -3.39 ± 0.74, -2.29 ± 1.10, and -2.10 ± 1.02 for the double-placebo, estrogen-alone, growth hormone–alone, and growth hormone– estrogen groups, respectively (P <0.001). Investigators concluded that growth hormone treatment increases adult height in patients with Turner’s syndrome.

ImmunogenIcIty and SmokIng AbstInence Rates for a Novel NicotIne Vaccine

A randomized, double-blind, placebocontrolled, multicenter clinical trial evaluated the effect on smoking abstinence of 2 doses of a novel nicotine vaccine (3’AmNic-rEPA).2 Study subjects (n = 301) were administered 3’AmNic-rEPA at 200- and 400-mcg doses or placebo 4 or 5 times over a period of 6 months.

Results showed that the 400-mcg dose, 5-injection regimen resulted in the greatest antibody response. Additionally, subjects receiving 3’AmNic-rEPA with the highest serum antinicotine antibody response (top 30% by area under the curve) were significantly more likely to attain 8 weeks of continuous nicotine abstinence from weeks 19 through 26 compared with the placebo group (24.6% vs 12.0%, respectively; P = .(024, odds ratio = 2.69, 95% CI, 1.14-6.37. Investigators concluded that further evaluation and development of 3’AmNic-rEPA is warranted.

OmalIzumab for Asthma Control In Inner-cIty children 

In a 60-week, randomized, double-blind, placebo-controlled, parallel-group trial, the efficacy of omalizumab when added to guidelines-based therapy was evaluated in inner-city children, adolescents, and young adults (n = 419).3 The primary outcome of the study was the number of days with asthma symptoms during the previous 2 weeks.

Results demonstrated that omalizumab reduced the number of days with asthma symptoms by 24.5% (from 1.96 to 1.48 days per 2-week interval; P <.001). Omalizumab also significantly reduced the proportion of subjects with 1 or more asthma exacerbations (from 48.8% to 30.3%; P <.001). Of note, omalizumab demonstrated asthma symptom improvement despite reductions in the use of inhaled glucocorticoids and long-acting beta-agonists.

Effect of NItroglycerin Ointment on Bone Health 

A single-center, double-blind, placebocontrolled randomized trial evaluated the effect of nitroglycerin ointment on bone mineral density (BMD) in postmenopausal women (n = 243).4 Study subjects were randomized to apply nitroglycerin ointment (15 mg/day) or placebo at bedtime for 24 months. The primary end point of the study was areal BMD at the lumbar spine, femoral neck, and hip. 

The study demonstrated that women randomized to the nitroglycerin group had a 6.7% (95% confidence interval [CI], 5.2%-8.2%) increase in areal BMD at the lumbar spine (from 1.05 to 1.14 g/cm2 vs placebo from 1.06 to 1.08 g/cm2 ; P <.001). Additionally, women in the nitroglycerin group had a 6.2% (95% CI, 5.6%-7.0%) increase in areal BMD at total hip (from 0.92 to 0.97 g/cm2 vs placebo from 0.93 to 0.92 g/cm2 ; P <.001) and a 7.0% (95% CI, 5.5%- 8.5%) increase at femoral neck (from 0.88 to 0.93 g/cm2 vs placebo from 0.87 to 0.86 g/cm2 ; P <.001). 

Investigators concluded that nitroglycerin ointment modestly increased BMD and decreased bone resorption in postmenopausal women.

 


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.


References

1. Ross JL, Quigley CA, Cao D, et al. Growth hormone plus childhood low-dose estrogen in Turner’s syndrome. N Engl J Med. 2011;364(13):1230-1242.

2. Hatsukami DK, Jorenby DE, Gonzales D, et al. Immunogenicity and smoking-cessation outcomes for a novel nicotine immunotherapeutic. Clin Pharmacol Ther. 2011;89(3):392-399.

3. Busse WW, Morgan WJ, Gergen PJ, et al. Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. N Engl J Med. 2011;364(11):1005-1015.

4. Jamal SA, Hamilton CJ, Eastell R, Cummings SR. Effect of nitroglycerin ointment on bone density and strength in postmenopausal women: a randomized trial. JAMA. 2011;305(8):800-807.

 

 




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