EFFECT OF AEROSOLIZED RECOMBINANT HUMAN DNase ON EXACERBATIONS OF RESPIRATORY SYMPTOMS AND ON PULMONARY FUNCTION IN PATIENTS WITH CYSTIC FIBROSIS
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Fuchs HJ, et al. "Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis. The Pulmozyme Study Group". New England Journal of Medicine. 1994. 331(10):637-642.
PubMed • Full text
PubMed • Full text
[[Category:]]
Clinical Question
Bottom Line
Major Points
Several small and large randomized trials in diabetics had previously suggested a sizable benefit of tight glycemic control in reducing cardiovascular risk. The ACCORD trial was the largest study of its kind and demonstrated that not only does euglycemia (ie, HbA1c <6%) not reduce cardiovascular risk, it also is associated with a trend towards increased mortality.
Guidelines
Design
- Multicenter,randomized, placebo-controlled trial over 24 weeks
- N=968
- Daily (n=322)
- Twice Daily (n=321)
- Placebo (n=325)
- Setting: 51 centers
- Enrollment: Not described
- Mean follow-up: N/A
- Analysis: Intention-to-treat
- Primary outcome: Maintain improvement in FEV1 and reduce the risk of pulmonary exacerbations requiring parenteral antibiotics
Population
Inclusion Criteria
- Diagnosis of Cystic Fibrosis - sweat chloride > 60 mmol/L)
- Forced Vital Capacity (FVC) > 40% predicted
- Age [[>]] 5
- Clinically Stable: receiving baseline regimen of antibiotics or no antimicrobial therapy 14 days prior to randomization
Exclusion Criteria
- None Listed
Baseline Characteristics
- Mean age: 72 years
- Mean BMI: 28
- Mean HbA1c: 8.8%
- Units of insulin: 14 units/day
Interventions
- Randomized to intensive (targeting HbA1c <6%) or standard (HbA1c 7-7.9%) glycemic therapy
- Then 46% were randomized to intensive (SBP <120) vs. standard (SBP <140) blood pressure therapy
- Remaining 54% randomized to fenofibrate vs. placebo; all received statin
- Intensive glycemic control group attended monthly visits for 4 months, then every 2 months, with additional visits and telephone calls as needed
- Standard therapy group had glycemic control visits every 4 months
Outcomes
Comparisons are intensive therapy vs. standard therapy.
Primary Outcomes
- PRIMARY OUTCOME
- ##% vs. ##% (HR ##; 95% CI ##-##; P=##)