Outlook: Clinical Trials

OCTOBER 10, 2011
Michele Reed, PharmD

Stenting vs Medical Therapy For Intracranial Arterial Stenosis

In a recent, randomized, controlled trial, patients who had a recent transient ischemic attack or stroke attributed to stenosis of 70% to 99% of the diameter of a major intracranial artery were randomized to either aggressive medical management alone or aggressive medical management plus percutaneous transluminal angioplasty and stenting (PTAS) with the use of the Wingspan stent system. 1 The primary efficacy end point was stroke or death within 30 days after enrollment or after a revascularization procedure for the qualifying lesion during the follow-up period or stroke in the territory of the qualifying artery beyond 30 days.

Due to the 30-day rate of stroke or death reaching 14.7% in the PTAS group (nonfatal stroke, 12.5%; fatal stroke, 2.2%) and 5.8% in the medical management group (nonfatal stroke, 5.3%; nonstrokerelated death, 0.4%; P = .002), enrollment was stopped after 451 patients were randomized. One-year rates of the primary end point were 20.0% in the PTAS group and 12.2% in the medical management group (P = .009).

Investigators concluded that in patients with intracranial arterial stenosis, aggressive medical management was superior to PTAS with the use of the Wingspan stent system.

Azithromycin For Prevention of COPD Exacerbations 

A recent, randomized, controlled trial evaluated whether azithromycin decreased the frequency of exacerbations in subjects with chronic obstructive pulmonary disease (COPD) with an increased risk of exacerbations.2

A total of 1142 subjects were randomized to receive azithromycin in addition to their usual care, at a dose of 250 mg daily (n = 570) or placebo (n = 572) for 1 year. The rate of 1-year follow-up was 89% in the azithromycin group and 90% in the placebo group. 

Results showed that the median time to the first exacerbation was 266 days (95% confidence interval [CI], 227-313) in the azithromycin group, as compared with 174 days (95% CI, 143-215) in the placebo group (P <.001). The frequency of exacerbations was 1.48 exacerbations per patient-year in the azithromycin group, as compared with 1.83 per patient-year in the placebo group (P = .01), and the hazard ratio for having an acute exacerbation of COPD per patient-year in the azithromycin group was 0.73 (95% CI, 0.63-0.84; P <.001). 

Investigators concluded that, among selected subjects with COPD, azithromycin taken daily for 1 year, when added to usual treatment, decreased the frequency of exacerbations.

Cholesterol-Lowering Foods and Hyperlipidemia

A recent study was conducted to assess the effect of a dietary portfolio administered at 2 levels of intensity on percentage change in low-density lipoprotein cholesterol (LDL-C) among participants following self-selected diets.3 Study subjects (n = 351) received dietary advice for 6 months on either a low saturated fat therapeutic diet (control) or a dietary portfolio emphasizing incorporation of plant sterols, soy protein, viscous fibers, and nuts. The routine dietary portfolio involved 2 clinic visits over 6 months and the intensive dietary portfolio involved 7 clinic visits over 6 months. The primary end point was percentage change in serum LDL-C.

Results showed that, in the modified intention-to-treat analysis (n = 345), the overall attrition rate was not significantly different between treatments (18% for intensive dietary portfolio, 23% for routine dietary portfolio, and 26% for control; P = .33). Percentage LDL-C reductions for each dietary portfolio were significantly more than the control diet (P <.001). The 2 dietary portfolio interventions did not differ significantly (P = .66). Among participants randomized to one of the dietary portfolio interventions, percentage reduction in LDL-C on the dietary portfolio was associated with dietary adherence (r = -0.34, n = 157, P <.001). Investigators concluded that use of a dietary portfolio compared with the low saturated fat dietary advice resulted in greater LDL-C lowering during 6 months of follow-up.

FA Intravitreal Implant For Diabetic Macular Edema

A recent controlled, multicenter clinical trial evaluated the efficacy and safety of fluocinolone acetonide (FA) intravitreal implants in eyes (n = 196) with persistent or recurrent diabetic macular edema (DME).4

Patients were randomized 2:1 to receive a 0.59-mg FA implant (n = 127) or standard of care (SOC; additional laser or observation; n = 69). The primary efficacy end point was a 15-letter or greater improvement in visual acuity (VA) at 6 months.

Results showed that VA improved greater than or equal to 3 lines in 16.8% of implanted eyes at 6 months (P = .0012; SOC, 1.4%); in 16.4% at 1 year (P = .1191; SOC, 8.1%); in 31.8% at 2 years (P = .0016; SOC, 9.3%); and in 31.1% at 3 years (P = .1566; SOC, 20.0%). Intraocular pressure greater than or equal to 30 mm Hg was recorded in 61.4% of implanted eyes (SOC, 5.8%) at any time and 33.8% required surgery for ocular hypertension by 4 years. Investigators concluded that the FA intravitreal implant significantly improved VA and reduced DME. 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.


1. Chimowitz MI, Lynn MJ, Derdeyn CP, et al. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011;365(11):993-1003.

2. Albert RK, Connett J, Bailey WC, et al. Azithromycin for prevention of exacerbations of COPD. N Engl J Med. 2011;365(8):689-698.

3. Jenkins DJ, Jones PJ, Lamarche B, et al. Effect of a dietary portfolio of cholesterol-lowering foods given at 2 levels of intensity of dietary advice on serum lipids in hyperlipidemia: a randomized controlled trial. JAMA. 2011;306(8):831-839.

4. Pearson PA, Comstock TL, Ip M, et al. Fluocinolone acetonide intravitreal implant for diabetic macular edema: a 3-year multicenter, randomized, controlled clinical trial. Ophthalmology. 2011;118(8):1580-1587.


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