Noninferiority trials have serious inherent limitations , the main one being that (unlike in a superiority trial), given a finding of noninferiority, it is impossible to distinguish between true equivalence and poor execution or faulty pretrial a priori assumptions regarding expectations of benefit and event rates. In this particular trial, a 15% absolute difference in the primary outcome was arguably too large to use as a noninferiority threshold. That threshold implies acceptance of 1 additional COPD exacerbation for each 7 patients treated. If a superiority trial showed a week's extra steroids prevented 1 COPD exacerbation for 10 or even 20 patients treated (, a 5-10% noninferiority margin), I think many doctors and patients would endorse longer-course prednisone. This trial (as designed) would fail to detect that.
To minimize the risk of glucocorticoid-induced bone loss, should use the smallest possible effective dosage and duration and use topical and inhaled preparations whenever possible. Obtain baseline measurement of bone mineral density (BMD) at the lumbar spine and/or hip when initiating long-term (., exceeding 6 months) glucocorticoid therapy and initiate appropriate preventive therapy. May repeat longitudinal measurements as often as every 6 months to detect possible bone loss. Less frequent (., annually) follow-up probably is sufficient in patients who are receiving therapy to prevent bone loss.
Prednisone is a drug that belongs to the corticosteroid drug class, and is an
anti-inflammatory and immune system suppressant. It's used to treat a variety of diseases and conditions, for example: inflammatory bowel disease (Crohn's
disease and ulcerative colitis), lupus, asthma, cancers, and several types of
Common side effects are weight gain, headache, fluid retention, and muscle weakness. Other effects and adverse events include glaucoma, cataracts, obesity, facial hair growth, moon face, and growth retardation in children. This medicine also causes psychiatric problems, for example: depression, insomnia, mood swings, personality changes, and psychotic behavior. Serious side effects include reactions to diabetes drugs, infections, and necrosis of the hips and joints.
Corticosteroids like prednisone, have many drug interactions; examples include: estrogens, phenytoin (Dilantin), diuretics, warfarin (Coumadin, Jantoven), and diabetes drugs. Prednisone is available as tablets of 1, , 10, 20, and 50 mg; extended release tablets of 1, 2, and 5mg; and oral solution of 5mg/5ml. It's use during the first trimester of pregnancy may cause cleft palate. This medicine is secreted in breast milk and can cause side effects in infants who are nursing. You should not stop taking prednisone abruptly because it can cause withdrawal symptoms and adrenal failure. Talk with your doctor, pharmacist, or other medical professional if you have questions about beta-blockers. Talk with your doctor, pharmacist, or other medical professional if you have questions about prednisone.
If you notice other effects not listed above, contact your doctor or pharmacist. In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.