Current medical research and opinion
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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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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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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.
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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
Efficacy and safety of the once-daily human GLP-1 analogue, liraglutide, vs glibenclamide monotherapy in Japanese patients with type 2 diabetes.
Liraglutide is a once-daily human glucagon-like peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes mellitus (T2DM). In Phase 2 and Phase 3 trials, largely conducted in populations of European descent, liraglutide has been shown to lower HbA(1C), weight and systolic blood pressure with a low risk of hypoglycaemia. This Phase 3, 24-week, multi-centre, double-blind, double dummy, randomised parallel-group trial compared the efficacy and safety of liraglutide and glibenclamide monotherapy in Japanese subjects with T2DM, inadequately controlled with diet therapy or oral antidiabetic drug (OAD) monotherapy. ⋯ Liraglutide monotherapy, administered once daily for 24 weeks in Japanese subjects with T2DM, was well tolerated. Compared with glibenclamide monotherapy, liraglutide achieved superior glycaemic control and weight outcome, and a significantly lower incidence of hypoglycaemia. Future studies, comprising a greater proportion of true therapy-naïve Japanese patients, will be beneficial in order to establish the true add-on efficacy of liraglutide monotherapy in patients with T2DM.