Current medical research and opinion
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Randomized Controlled Trial
Omalizumab in children with inadequately controlled severe allergic (IgE-mediated) asthma.
Many children with severe persistent allergic (IgE-mediated) asthma remain inadequately controlled despite treatment with high-dose inhaled corticosteroids (ICS) plus a long-acting beta(2)-agonist (LABA). ⋯ Add-on omalizumab is well-tolerated and reduces exacerbations in children (6-<12 years) with severe persistent allergic asthma, inadequately controlled despite high-dose ICS plus a LABA. It should be noted that the sample size was not based on providing statistical power in the severe subgroup, and no corrections were made for multiple comparisons; however, outcomes consistently favoured omalizumab.
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During subcutaneous insulin therapy, inadvertent intramuscular (IM) injections may increase pain and/or adversely affect glucose control. The most appropriate needle length for patients depends on skin thickness (ST) and the distance to muscle fascia. ST and subcutaneous adipose layer thickness (SCT) were measured in adults with diabetes. ⋯ Injection site ST does not differ by clinically significant degrees in demographically diverse adults with diabetes; SCT has a wider range. Needles >or=8 mm, inserted perpendicularly, may frequently enter muscle in limbs of males and those with BMI <25 kg/m(2). With 90 degrees insertion, needles 4-5 mm enter the subcutaneous tissue with minimal risk of IM injection in virtually all adults. These data will assist recommending appropriate length needles for subcutaneous insulin injections in adults.
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Randomized Controlled Trial Multicenter Study Comparative Study
Once-daily OROS hydromorphone ER compared with placebo in opioid-tolerant patients with chronic low back pain.
This multicenter, double-blind, placebo-controlled study using a randomized withdrawal design evaluated the efficacy and safety of once-daily OROS hydromorphone ER in the treatment of opioid-tolerant patients with chronic moderate-to-severe low back pain (LBP). ⋯ These results provide evidence for the efficacy and safety of hydromorphone ER in opioid-tolerant patients with chronic moderate-to-severe LBP. Potential limitations include the shortened dose-conversion/titration phase, limiting the daily allowable dose of hydromorphone ER to 64 mg, and the allowance of limited rescue medication throughout the entire double-blind phase. Other trial design elements such as the use of an enrichment phase and the inclusion of only opioid tolerant patients may limit the generalizability of these results.
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Multicenter Study
Innovative pain therapy with a fixed combination of prolonged-release oxycodone/naloxone: a large observational study under conditions of daily practice.
Chronic pain has a marked negative impact on quality of life. Opioid treatment is often effective in controlling this pain, but it has numerous side-effects, particularly affecting bowel function. ⋯ This is a multi-center, prospective, non-interventional, observational study. Analgesic efficacy and bowel function were assessed in patients suffering from long-lasting, severe chronic pain of different etiology (cancer and non-cancer) treated with combined PR oxycodone/PR naloxone and observed for 4 weeks. Pain was evaluated using the Brief Pain Inventory (BPI-SF) and constipation symptoms due to opioid treatment using the Bowel Function Index (BFI). Descriptive data are presented based on observed cases, efficacy and tolerability data additionally based on completely documented patients (for each parameter at least more than 2000 patients).
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Randomized Controlled Trial Multicenter Study
A 26-week, placebo- and pioglitazone-controlled, dose-ranging study of rivoglitazone, a novel thiazolidinedione for the treatment of type 2 diabetes.
To examine the efficacy and general safety of rivoglitazone, a novel thiazolidinedione, as a treatment for type 2 diabetes in a dose-ranging study over a period of up to 6 months. ⋯ Rivoglitazone is a potent thiazolidinedione agent with demonstrated glycemic benefits over a 6-month period in subjects with type 2 diabetes. Once-daily doses of 1, 2, and 3 mg rivoglitazone demonstrated HbA(1c) reduction similar or superior to those observed for pioglitazone 45 mg. Limitations in generalizing from this study include a modest sample size and a high rate of discontinuation prior to the last scheduled visit.