Gabapentin for Off-Label Use: Evidence-Based or Cause for Concern?
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ABSTRACT:
SUBMITTER: Peckham AM
PROVIDER: S-EPMC6153543 | biostudies-other | 2018
REPOSITORIES: biostudies-other
Publications
Gabapentin for Off-Label Use: Evidence-Based or Cause for Concern?
Peckham Alyssa M AM Evoy Kirk E KE Ochs Leslie L Covvey Jordan R JR
Substance abuse : research and treatment 20180923
Gabapentin is widely used in the United States for a number of off-label indications, often as an alternative to opioid therapy. Increasing evidence has emerged suggesting that gabapentin may not be as benign as once thought and may be associated with substance abuse in concert with opioids. With concerns for safety mounting, it is prudent to examine the efficacy of gabapentin across its many uses to understand the risk-benefit balance. Reviews on off-label indications such as migraine, fibromya ...[more]
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Project description:IntroductionGabapentin is commonly prescribed as an off-label adjunct to opioids because of its safer risk profile. Recent evidence has shown an increased risk of mortality when coprescribed with opioids. Therefore, we aimed to evaluate whether the addition of off-label gabapentin in patients with chronic opioid use is associated with a reduction in opioid dosage.MethodsWe performed a retrospective cohort study of patients with chronic opioid use with a new off-label gabapentin prescription (2010-2019). Our primary outcome of interest was a reduction in opioid dosage measured via oral morphine equivalents (OME) per day after the addition of a new off-label gabapentin prescription.ResultsIn our cohort of 172,607 patients, a new off-label gabapentin prescription was associated with a decrease in opioid dosage in 67,016 patients (38.8%) (median OME/day reduction:13.8), with no change in opioid dosage in 24,468 patients (14.2%), and an increase in opioid dosage in 81,123 patients (47.0%) (median OME/day increase: 14.3). A history of substance/alcohol use disorders was associated with a decrease in opioid dosage after the addition of a new off-label gabapentin (aOR 1.20, 95% CI 1.16 to 1.23). A history of pain disorders was associated with a decrease in opioid dosage after the initiation of a new gabapentin prescription including arthritis (aOR 1.12, 95% CI 1.09 to 1.15), back pain (aOR 1.10, 95% CI 1.07 to 1.12), and other pain conditions (aOR 1.08, 95% CI 1.06 to 1.10).ConclusionsIn this study of patients with chronic opioid use, an off-label gabapentin prescription did not reduce opioid dosage in the majority of patients. The coprescribing of these medications should be critically evaluated to ensure optimal patient safety.
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Project description: Not available
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Project description:AimsThe aim of this study was to assess the use and factors associated with the misuse of gabapentin and pregabalin in the general French population, through a cohort study in the EGB (General Sample of Beneficiaries), a national representative sample of the French general population.MethodsNew users of gabapentin and pregabalin were identified from June 2006 to December 2014, and new users of duloxetine served as control group. Misuse was defined as a use of higher daily doses than recommended. Cox proportional hazard regression models were performed to identify associated factors of misuse.ResultsMisuse was more frequent in the 8692 new users of pregabalin (12.8%) than in the 1963 gabapentin (6.6%) or the 3214 duloxetine new users (9.7%) (P < 0.001). Factors associated with misuse were pregabalin (hazard ratio [HR] 1.48; 95% confidence interval [CI] [1.29-1.69]), age (HR[18-45] versus > 70 years 1.98 [1.70-2.31] and HR[58-70] versus > 70 years 1.25 [1.06-1.47]), multiple prescribers (HR2 or 3 versus 1 prescriber 1.29 [1.15-1.45]; HR4 or more versus 1 prescriber 1.54 [1.30-1.83]), cancer (1.28 [1.11-1.47]), multiple sclerosis (1.53 [1.07-2.18]), neuropathy (1.85 [1.19-2.89]), depression (1.26 [1.07-1.49]) and methadone (2.61 [1.16-5.84]). After this first episode of drug misuse, 11.6% of gabapentin and 10.7% of pregabalin misusers developed a primary addiction.ConclusionIn a cohort of new users, misuse is more likely to occur in new users of pregabalin, with different associated factors of misuse compared to gabapentin and duloxetine. Health professionals and prescribers must be aware of this misuse potential, which could lead to abuse and dependence.
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Project description:Purpose: Cancer is a leading cause of morbidity and mortality worldwide. Off-label (OL) use of antineoplastic drugs to treat malignancies is prevalent. In this study, we quantified and characterized OL use of antineoplastic drugs to treat malignancies in China. Methods: This was a retrospective study using nationwide data collected from 2008 to 2010. Use of antineoplastic drugs was considered OL if they were used for indications not reflected in the package insert published by the National Medical Products Administration at the time of prescription. Descriptive analysis and Spearman rank correlation were used to evaluate the frequency and pattern of OL drug use. Results: In total, 51,382 patients with malignancies, 24 categories of antineoplastic drugs, and 77 types of malignancies treated with OL drugs were included in this study. Twenty commonly used antineoplastic drugs (ICD encoded as L01) were used OL in 10-61% of cases, and four commonly used endocrine therapy antineoplastic drugs (ICD encoded as L02) were used OL in 10-19% of cases. There was a significant negative correlation between the disease constituent ratio and the average OL use rate of antineoplastic drugs for various malignancies. In contrast, there was a significant positive correlation between the average OL use rate of antineoplastic drugs and the number of malignancies treated with OL drugs. Conclusion: This study provided information regarding OL use of antineoplastic drugs for treatment of malignancies, and showed that OL use was prevalent. In addition, uncommon malignancies were more likely to be treated with OL antineoplastic drugs. Furthermore, more commonly used antineoplastic drugs were more likely to be used OL.
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