Current medical research and opinion
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The safety and tolerability of duloxetine for major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathic pain (DPNP), fibromyalgia, and lower urinary tract disorders (LUTD) (including female stress urinary incontinence [SUI] and other LUTDs) has been established in individual clinical studies. The objective of this manuscript is to characterize the overall safety profile of duloxetine, regardless of indication, based on data from the duloxetine exposures integrated safety database. ⋯ The safety profile for the molecule from the overall duloxetine exposures integrated safety database suggests that benign and common pharmacologic side effects occur with duloxetine treatment. Because these pooled analyses do not allow for statistical comparison to placebo or active comparator, and include data from five different studied indications, these data do not suggest causality for AEs, nor are they necessarily generalizable to each disease stated studied.
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Randomized Controlled Trial Multicenter Study Comparative Study
The efficacy of rofecoxib 50 mg and hydrocodone/acetaminophen 7.5/750 mg in patients with post-arthroscopic pain.
To compare the efficacy and tolerability of rofecoxib, hydrocodone/acetaminophen 7.5 mg/750 mg (H/A) and placebo in treating pain after arthroscopy of the knee. ⋯ Rofecoxib 50 mg did not provide significantly different pain relief than placebo at 6 h, and the primary endpoint TOPAR was not attained, although it did show several efficacy benefits at 24 h, including a significant opioid-sparing effect. All treatments were well tolerated, with no significant differences observed. The limited efficacy of rofecoxib in this study contrasts to the results of previous surgical studies evaluating rofecoxib, and may be partially explained by the postoperative dosing in this arthroscopic surgical model.
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Randomized Controlled Trial Multicenter Study
Fentanyl buccal tablet (FBT) for relief of breakthrough pain in opioid-treated patients with chronic low back pain: a randomized, placebo-controlled study.
Short-acting opioids are commonly used to treat breakthrough pain (BTP) and rapid-onset formulations are being developed to improve the effectiveness of this approach. Fentanyl buccal tablet (FBT) is a new formulation of fentanyl that enhances transbuccal drug delivery via an effervescent reaction and may provide relatively rapid-onset analgesia. FBT was evaluated for BTP in opioid-treated patients with chronic low back pain--the first such study in a population with chronic non-cancer pain. ⋯ FBT was efficacious and well tolerated in the treatment of BTP in opioid-treated patients with chronic low back pain.
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Randomized Controlled Trial
Cost-effectiveness of linezolid and vancomycin in the treatment of surgical site infections.
This decision-analytic study was intended to determine the expected cost-effectiveness of linezolid compared to vancomycin for treating surgical site infections (SSIs) caused by methicillin-resistant Staphyloccocus aureus (MRSA) from the perspective of a tertiary-care academic medical center. ⋯ Using decision-analytic modeling, treatment with oral linezolid during hospitalization and after discharge is expected to be the most cost-effective approach for treating SSIs caused by MRSA.
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Randomized Controlled Trial Multicenter Study
Randomized study of tramadol/acetaminophen versus placebo in painful diabetic peripheral neuropathy.
To examine the efficacy and safety of tramadol/acetaminophen (APAP) for the management of painful diabetic peripheral neuropathy (DPN). ⋯ Tramadol/APAP was more effective than placebo and was well tolerated in the management of painful DPN.