Current medical research and opinion
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of luseogliflozin monotherapy in Japanese patients with type 2 diabetes mellitus: a 12-week, randomized, placebo-controlled, phase II study.
Luseogliflozin is a novel sodium glucose cotransporter 2 inhibitor for type 2 diabetes mellitus (T2DM) treatment. An exploratory Phase II study was conducted to assess the efficacy and safety of several doses of luseogliflozin in Japanese T2DM patients. ⋯ Japanese T2DM patients aged 20-74 years with hemoglobin A1c (HbA1c) of 6.9-10.5%, fasting plasma glucose (FPG) ≥126 mg/dL and on diet therapy were randomized in a double-blind manner to receive luseogliflozin (0.5, 2.5, or 5 mg) or placebo once daily for 12 weeks (n = 61, 61, 61, and 56, respectively). The primary endpoint was the change in HbA1c from baseline to end of treatment. Other endpoints included FPG, 2 h postprandial plasma glucose (PPG) in a meal tolerance test (MTT), and body weight. Drug safety was also assessed.
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Randomized Controlled Trial Multicenter Study
Saxagliptin versus glipizide as add-on therapy to metformin: assessment of hypoglycemia.
To compare characteristics of hypoglycemic episodes in patients with type 2 diabetes receiving saxagliptin or glipizide add-on therapy to metformin. ⋯ Saxagliptin + metformin was associated with fewer patients reporting hypoglycemia and fewer and less severe hypoglycemic events in those experiencing hypoglycemia compared with glipizide + metformin. ClinicalTrials.gov registration number: NCT00575588.
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Multicenter Study Clinical Trial Observational Study
Weight loss through adjustable gastric banding and improvement in daytime sleepiness: 2 year interim results of APEX study.
Obesity is one factor associated with an increased risk of obstructive sleep apnea (OSA). This study reports the investigator-reported resolution or improvement of OSA and improvements in sleep-related quality of life (QOL) 2 years after surgical placement of the LAP-BAND AP * (LBAP) system. ⋯ These data support that surgically facilitated weight loss can improve sleep-related QOL and may result in resolution or improvement of OSA; the degree of weight loss may be related to these changes.
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Multicenter Study Clinical Trial
High concentration capsaicin for treatment of peripheral neuropathic pain: effect on somatosensory symptoms and identification of treatment responders.
Pain is usually assessed by spontaneous pain ratings. Time-dependent (brief attacks) or evoked (allodynia) phenomena, common in neuropathic pain, are not captured. To evaluate the overall effectiveness of a treatment, improvement of all sensory symptoms should be measured. Since the pattern of sensory abnormalities might hint at the underlying mechanisms of pain, this baseline information may aid in predicting the treatment effect. Data on sensory neuropathic abnormalities (painDETECT questionnaire) were analyzed aiming to (1) evaluate the frequency of neuropathic symptoms in different peripheral neuropathic pain syndromes, (2) assess the effect of capsaicin 8% patch on neuropathic symptoms and (3) identify treatment responders based on baseline values. ⋯ Completion of painDETECT was optional and therefore data was not available for all patients. Further studies for confirmation of these results are needed.
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A recent pharmacokinetic study with buprenorphine transdermal patches showed similar systemic exposures of buprenorphine in subjects aged ≥75 and 50-60 years. The current prospective, open-label study aimed to verify this in a clinical setting by evaluating efficacy and safety of buprenorphine patches in patients with chronic osteoarthritis (OA) pain. ⋯ Efficacy and tolerability of buprenorphine patches was demonstrated in chronic pain patients, regardless of age, supporting the conclusion that no age-related dose adjustment of transdermal buprenorphine is needed. A study limitation is lack of active control but no other opioid was appropriate in elderly patients or this indication.