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Outlook: Clinical Trials

Michele Reed, PharmD
Published Online: Monday, April 18, 2011   [ Request Print ]

Olmesartan Delays Onset of Microalbuminuria

In a recent randomized, doubleblind, multicenter, controlled trial, the efficacy of olmesartan in delaying or preventing the occurrence of microalbuminuria in patients with type 2 diabetes and normoalbuminuria was evaluated.1 The trial randomized patients (n = 4447) with type 2 diabetes to receive either olmesartan 40 mg once daily or placebo for a median of 3.2 years. The primary end point of the study was the time to the first onset of microalbuminuria.

Results showed that microalbuminuria developed in 8.2% of the patients in the olmesartan group and 9.8% in the placebo group. The primary end point, time to the onset of microalbuminuria, was increased by 23% with olmesartan (hazard ratio for onset of microalbuminuria, 0.77; 95% confidence interval [CI], 0.63 to 0.94; P = .01). 

Fidaxomicin For Clostridium Difficile Infection

A recent study of 629 patients evaluated the safety and efficacy of fidaxomicin in the treatment of Clostridium difficile (C difficile) infection.2 Patients received either fidaxomicin 200 mg twice daily or vancomycin 125 mg 4 times daily orally for 10 days. The primary end point of the study was clinical cure, defined as resolution of symptoms and no need for further therapy for C difficile infection as of the second day after the end of the course of therapy. The secondary end points were recurrence of C difficile infection, defined as diarrhea and a positive result on a stool toxin test within 4 weeks after treatment, and global cure, defined as cure with no recurrence.

Results demonstrated noninferiority between treatments with regard to clinical cure (88.2% with fidaxomicin vs 85.8% with vancomycin). Significantly fewer patients experienced infection recurrence in the fidaxomicin group compared with the vancomycin group (15.4% vs 25.3%, P = .005).

Effects of Glucose Lowering on Cardiovascular Outcomes 

A recently published study describes the 5-year outcomes of intensive glucose lowering on mortality and key cardiovascular events.3 Investigators randomly assigned subjects to receive either intensive therapy (glycated hemoglobin <6.0%) or standard therapy (glycated hemoglobin 7%-7.9%). After intensive therapy, all subjects had a glycated hemoglobin target of 7% to 7.9%. The primary outcome of the study was a composite of nonfatal myocardial infarction (MI), nonfatal stroke, or death from cardiovascular causes.

Results showed that, before the intensive therapy period ended (3.7 years), the intensive therapy group did not differ significantly from the standard therapy group in the rate of the primary outcome (P = .13). However, the intensive therapy group had more deaths from any cause (hazard ratio, 1.21; 95% CI, 1.02-1.44) and fewer nonfatal MIs (hazard ratio, 0.79; 95% CI, 0.66-0.95). Similar results were seen during the entire follow-up period of 5 years (hazard ratio for death, 1.19; 95% CI, 1.03-1.38; hazard ratio for nonfatal MI, 0.82; 95% CI, 0.70-0.96). Investigators concluded that the use of intensive therapy for 3.7 years reduced 5-year nonfatal MIs but increased 5-year mortality.

Diuretic Strategies in Acute Decompensated Heart Failure

In a recent double-blind, randomized clinical study, the use of furosemide via intravenous (IV) bolus dosing was compared with furosemide via continuous IV infusion in patients with acute decompensated heart failure. 4

A total of 308 patients were randomized to furosemide IV bolus every 12 hours or furosemide via continuous infusion and at either a low dose (patient’s previous oral dose) or a high dose (2.5 times the previous oral dose).

The study’s coprimary end points included patients’ global assessment of symptoms (area under the curve [AUC] of the score on a visual-analogue scale over the course of 72 hours) and change in the serum creatinine level from baseline to 72 hours.

Results demonstrated that the patients’ global assessment of symptoms resulted in a mean AUC of 4236 ± 1440 in the bolus group and 4373 ± 1404 in the infusion group (P = 47). Additionally, the mean change in the. creatinine level was 0.05 ± 0.3 mg per dL in the bolus group and 0.07 ± 0.3 mg per dL in the infusion group (P = .45). 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.





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