Postgraduate medicine
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Postgraduate medicine · Jan 2017
Comparative StudyAssessing the impact of abuse-deterrent opioids (ADOs): identifying epidemiologic factors related to new entrants with low population exposure.
Prescription opioid misuse and abuse is a serious public health concern that can lead to overdose, addiction, and death. The development of opioid formulations designed to deter misuse and abuse is considered an important step towards addressing the problem, but the extent to which abuse-deterrent opioids (ADOs) actually deter abuse in the community requires confirmation through epidemiologic studies. Epidemiologic evaluations of misuse and abuse present several unique challenges related to study design, sources of data, and methodology, particularly for new entrant ADOs with low population exposure. The purpose of this article is to review the critical methodologic issues that must be considered when designing an epidemiologic evaluation of prescription opioid misuse and abuse, and deterrence for new entrant ADOs. ⋯ Given the low population exposure of new entrant ADOs, there is limited feasibility in conducting the epidemiologic studies necessary to evaluate the effectiveness of these products in deterring abuse. Clear regulatory guidance is needed.
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Postgraduate medicine · Jan 2017
Comparative StudyComparison of abuse, suspected suicidal intent, and fatalities related to the 7-day buprenorphine transdermal patch versus other opioid analgesics in the National Poison Data System.
Prescription opioid related abuse, suicide and death are significant public health problems. This study compares rates of poison center calls categorized as intentional abuse, suspected suicidal intent or fatality for the 7-day buprenorphine transdermal system/patch (BTDS) with other extended-release and long-acting (ER/LA) opioids indicated for chronic pain. ⋯ This post-marketing evaluation of BTDS indicates infrequent poison center calls for intentional abuse and suspected suicidal intent events, suggesting lower rates of these risks with BTDS compared to other ER/LA opioids.
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Naloxone is indicated for reversal of opioid-induced respiratory depression. The objective of this study is to evaluate patterns of naloxone use in hospitalized patients. ⋯ In our study, naloxone was more often used for reversal of sedation than for respiratory depression. Gabapentin may pose a risk factor for oversedation when combined with opioids, leading to increased naloxone use. Further studies are needed to explore these patterns.
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Postgraduate medicine · Nov 2016
Randomized Controlled Trial Multicenter Study Comparative StudyCanagliflozin provides greater attainment of both HbA1c and body weight reduction versus sitagliptin in patients with type 2 diabetes.
To evaluate the proportion of patients with type 2 diabetes mellitus (T2DM) achieving reductions in both glycated hemoglobin (HbA1c) and body weight with canagliflozin, a sodium glucose co-transporter 2 inhibitor, versus sitagliptin over 52 weeks. ⋯ www.ClinicalTrials.gov identifiers are NCT01106677; NCT01137812.
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Postgraduate medicine · Nov 2016
Randomized Controlled Trial Multicenter StudyImpact of bromocriptine-QR therapy on cardiovascular outcomes in type 2 diabetes mellitus subjects on metformin.
Type 2 diabetes mellitus (T2DM) is associated with a substantially increased risk of cardiovascular disease (CVD). Bromocriptine-QR (B-QR), a quick release sympatholytic dopamine D2 receptor agonist, is a FDA-approved therapy for T2DM which may provide CVD risk reduction. Metformin is considered to be an agent with a potential cardioprotective benefit. This large placebo controlled clinical study assessed the impact of B-QR addition to existing metformin therapy on CVD outcomes in T2DM subjects. ⋯ These findings suggest that in T2DM subjects on metformin, BQR therapy may represent an effective strategy for reducing CVD risk. Cycloset Safety Trial registration: ClinicalTrials.gov Identifier: NCT00377676.