Current medical research and opinion
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Randomized Controlled Trial
Assessment of potentially abuse-related events in two phase 3 studies of NKTR-181, a novel opioid analgesic, using the MADDERS® system (Misuse, Abuse, and Diversion Drug Event Reporting System).
Objective: To prospectively evaluate the abuse potential of NKTR-181, a novel opioid analgesic, in two phase 3 clinical trials using a newly developed reporting system: the Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS®). Methods: SUMMIT-07 was an enriched enrollment randomized withdrawal study that examined the safety and efficacy of NKTR-181 across 12 weeks in opioid-naïve subjects with chronic low back pain. SUMMIT-LTS was a 52 week open-label study in opioid-naïve and experienced subjects with chronic low back pain or noncancer pain rolled over from SUMMIT-07 or enrolled de novo. ⋯ Most events were attributed to "Withdrawal" and, primarily in SUMMIT-07, "Therapeutic Error" (unintentional overuse) or "Misuse" (intentional overuse for a therapeutic purpose) of study medication. Adjudicators identified five possible "Abuse" events (three NKTR-181, two placebo) in SUMMIT-07 and four possible "Abuse" events (all NKTR-181) in SUMMIT-LTS. Conclusions: The MADDERS® system discerns potentially abuse-related events and identified low rates of withdrawal and a low risk of abuse potential, diversion or addiction associated with NKTR-181 in phase 3 trials.
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Prediabetes is defined as a state of abnormal glucose homeostasis where blood glucose levels are elevated above those considered normal, but not as high as those required for a diagnosis of diabetes. As a condition intermediate between normal glucose homeostasis and the pathological condition of diabetes, the characterization of prediabetes as a distinct pathogenic condition is controversial. Emerging evidence suggests that the condition of prediabetes is associated with pathophysiological changes in several tissues and organs, which would support its recognition as a distinct pathological entity; the recent inclusion of prediabetes and associated billable conditions in the most recent ICD-10 codes provides additional credence to this position. This minireview summarizes our understanding of prediabetes and provides evidence that it should be considered a distinct and important clinical entity.
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Objective: To compare the multi-biomarker disease activity (MBDA) score with the DAS28-CRP and CRP for predicting risk of radiographic progression in patients with rheumatoid arthritis. Methods: Published studies of the MBDA score and radiographic progression with ≥100 patients per cohort were evaluated. Rates of radiographic progression over 1 year were determined across the low/moderate/high categories for MBDA score (low/moderate/high: <30, 30-44, >44), DAS28-CRP (low/moderate/high: ≤2.67, >2.67-4.09, >4.09) and CRP (low/moderate/high: ≤10, >10-30, >30 mg/L), with positive and negative predictive value (PPV, NPV) and relative risk (RR) determined for high vs. not-high (i.e. low and moderate combined) categories. ⋯ For patients cross-classified by MBDA score and DAS28-CRP, high vs. not-high MBDA score significantly predicted radiographic progression independently of DAS28-CRP. Conclusions: High and not-high MBDA scores were associated with increased and low risk, respectively, for radiographic progression over one year. MBDA score was a better predictor of radiographic progression than DAS28-CRP or CRP.
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Background and aims: Pentazocine remains a widely used opioid pre-anesthetic medication and post-operative analgesic in low- and middle-income countries despite concerns. We assessed the adverse events (AEs) associated with off-label use of pentazocine in pediatric surgical patients and determined the possible risk factors associated with slow respiratory AEs. Method: Children ≤18 years old were administered pentazocine IM/IV as a pre-anesthetic medication or post-operative analgesic. ⋯ None of the demographics and clinical variables significantly predicted the risk of slow respiratory AEs. Conclusion: Off-label use of pentazocine is common and associated with multiple AEs. Care is needed as no predictors of slow respiratory AEs were observed.
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Objectives: The study aimed to investigate risk factors for venous symptoms in Russian patients with chronic venous disease (CVD). Methods: Data on 487 patients with CVD aged 18 years and more were extracted from the database of a cross-sectional population-based study on the prevalence of CVD in a rural settlement. Risk factors for venous symptoms were calculated by multiple regression analysis. ⋯ Superficial venous reflux is a predictor only for venous pain (HR 2.4, p < .01). Conclusions: This study presents independent risk factors for venous symptoms in CVD patients. It demonstrates that different symptoms are associated with different factors.