Postgraduate medicine
-
Postgraduate medicine · Jan 2015
ReviewThe sunshine act and medical publications: Guidance from professional medical associations.
To review guidance from professional medical associations to physicians on the Sunshine Act, with a focus on industry support for medical publications. ⋯ There is a shortage of information for physicians from professional associations regarding the Sunshine Act and support for medical publications. Due to the lack of clear guidance regarding support for publications, there are presently varying interpretations of the Sunshine Act. The literature debates the potential impact of the Sunshine Act and expresses some concerns that physician-enabled innovation in drug development may be hindered.
-
Postgraduate medicine · Jan 2015
Randomized Controlled Trial Multicenter StudyEfficacy and safety of once-daily, extended-release hydrocodone in individuals previously receiving hydrocodone/acetaminophen combination therapy for chronic pain.
Hydrocodone/acetaminophen combination analgesics are frequently prescribed for chronic pain management; however, acetaminophen presents potential hepatotoxicity to patients and thus dose limitations. These opioid medications are also widely abused. Once-daily, single-entity hydrocodone (Hysingla™ ER tablets [HYD]) is a novel formulation with abuse-deterrent properties for the management of chronic pain and represents a suitable option for those patients receiving analgesics containing the same opioid analgesic, hydrocodone. This post-hoc analysis evaluated the efficacy and safety of HYD in patients whose primary pre-study analgesic was hydrocodone/acetaminophen analgesics (23-31% of the study populations). ⋯ In patients whose primary pretrial analgesic was hydrocodone/acetaminophen combination tablets, single-entity HYD was effective in reducing pain intensity and in maintaining analgesia over time without need for continued dose increase. HYD's safety and tolerability profiles were similar to other opioid analgesics.
-
Postgraduate medicine · Jan 2015
Randomized Controlled Trial Multicenter StudyBuprenorphine transdermal system compared with placebo reduces interference in functioning for chronic low back pain.
This study examines the efficacy of the buprenorphine transdermal system (BTDS) for reducing the interference of pain on physical and emotional functioning associated with chronic low back pain (CLBP). ⋯ Results indicate the efficacy of BTDS treatment, compared with placebo, for reducing the interference of pain on physical and emotional functioning in patients with moderate-to-severe CLBP. The advantage of BTDS was observed within 4 weeks of treatment, and was maintained throughout the 12-week treatment phase.
-
Postgraduate medicine · Jan 2015
Meta AnalysisSafety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Ibuprofen (IBU) is an efficacious over-the-counter analgesic/antipyretic with adverse event (AE) rates comparable to placebo. IBU sodium (IBU(Na)) is a newer, more soluble form that is absorbed faster than standard IBU, leading to more rapid analgesia. Although its safety and tolerability are expected to be comparable to standard IBU, this has not yet been reported. ⋯ IBU(Na) has a favorable safety profile comparable to those of standard IBU tablets and placebo in single-dose studies evaluating analgesic or antipyretic efficacy. ClinicalTrials.gov Registry Numbers: Dental pain studies: NCT01098747 and NCT01216163; headache studies: NCT01077973 and NCT01362491; pyresis study: NCT01035346.
-
Postgraduate medicine · Jan 2015
Randomized Controlled TrialHuman abuse potential of immediate-release/extended-release versus immediate-release hydrocodone bitartrate/acetaminophen: a randomized controlled trial in recreational users of prescription opioids.
The abuse potential of prescription opioids is well established. This study compared positive, subjective drug effects of single, equal doses of biphasic immediate release (IR)/extended release (ER) hydrocodone bitartrate (HB)/acetaminophen (acetyl-p-aminophenol [APAP]) 7.5/325 mg tablets versus IR HB/APAP 7.5/325-mg tablets and placebo. ⋯ This Phase I clinical trial conducted in the USA was not registered.