Objective
This study aims to assess the efficacy and safety of Gelesis100, a novel, nonsystemic, superabsorbent hydrogel to treat overweight or obesity.
Methods
The Gelesis Loss Of Weight (GLOW) study was a 24‐week, multicenter, randomized, double‐blind, placebo‐controlled study in patients with BMI ≥ 27 and ≤ 40 kg/m2 and fasting plasma glucose ≥ 90 and ≤ 145 mg/dL. The co‐primary end points were placebo‐adjusted weight loss (superiority and 3% margin super‐superiority) and at least 35% of patients in the Gelesis100 group achieving ≥ 5% weight loss.
Results
Gelesis100 treatment caused greater weight loss over placebo (6.4% vs. 4.4%, P = 0.0007), achieving 2.1% superiority but not 3% super‐superiority. Importantly, 59% of Gelesis100‐treated patients achieved weight loss of ≥ 5%, and 27% achieved ≥ 10% versus 42% and 15% in the placebo group, respectively. Gelesis100‐treated patients had twice the odds of achieving ≥ 5% and ≥ 10% weight loss versus placebo (adjusted OR: 2.0, P = 0.0008; OR: 2.1, P = 0.0107, respectively), with 5% responders having a mean weight loss of 10.2%. Patients with prediabetes or drug‐naive type 2 diabetes had six times the odds of achieving ≥ 10% weight loss. Gelesis100 treatment had no apparent increased safety risks.
Conclusions
Gelesis100 is a promising new nonsystemic therapy for overweight and obesity with a highly desirable safety and tolerability profile.
Chronic opioid treatment is a highly effective method to treat chronic pain; however, the prevalence of abuse of opioids can make treating patients with these agents difficult for clinicians. The objective of this study was to describe rates of inappropriate utilization, abuse, and diversion in a population of patients who were prescribed chronic opioids, as measured by urine drug testing in the clinical setting. A retrospective analysis was conducted of results from all urine drug tests conducted by Ameritox, Ltd. between January 2006 and January 2009, for patients whose physicians ordered the test in order to screen for noncompliance. Data from 938,586 patient test samples showed that 75% of patients were unlikely to be taking their medications in a manner consistent with their prescribed pain regimen. Thirty-eight percent of patients were found to have no detectable level of their prescribed medication, 29% had a nonprescribed medication present, 27% had a drug level higher than expected, 15% had a drug level lower than expected, and 11% had illicit drugs detected in their urine. Note that all categories add to a total greater than 100% as each category is not mutually exclusive, and a single patient could fall into multiple categories. The high observed rate of noncompliance demonstrates a significant clinical concern and confirms the importance of periodic urine drug screening for the population prescribed long-term opioid therapy.
In contrast to raw FPIA values, an algorithm that normalizes hydrocodone urine drug levels for PH, specific gravity and lean body mass discriminates well between all three of the daily doses of hydrocodone tested (20, 60 and 120 mg), even when correcting for multiple analyses.
Disease management (DM) is a compelling concept. For many chronic conditions, DM programs can simultaneously improve clinical outcomes and patient satisfaction while reducing the net cost of medical care. However, many programs are ultimately abandoned or fail to achieve their full potential due to difficulties encountered in implementing what seems like a sound program design. Implementation issues and barriers can be grouped into three major categories: (1) lack of strong physician leadership; (2) failure to align incentives; and (3) failure to identify and address operational issues. Organizations that wish to implement DM programs should develop a comprehensive plan that fosters physician leadership, rewards all stakeholders, and proactively identifies and resolves operational issues. By addressing these critical areas, organizations will greatly increase the likelihood that their programs will succeed and be implemented in a reasonable period of time. 111
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