Comparative study of hypoglycaemia induced by opioids. Is it a class effect?

Chrétien, Basile; Dolladille, Charles; Hamel-Sénécal, Léa; Sassier, Marion; Faillie, Jean Luc; Miremont-Salamé, Ghada; Lelong‐Boulouard, Véronique; Boisselier, Reynald Le; Fédrizzi, Sophie; Alexandre, Jonas; Humbert, Xavier

doi:10.1080/14740338.2019.1646246

Cited by 21 publications

(25 citation statements)

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“…There is significant heterogeneity in the types of literature reporting tramadol-associated hypoglycemia especially with trial design, statistical tests, covariates, and study inclusion and exclusion criteria. 4,6-17 Two case-control studies of diabetic and nondiabetic patients by Golightly et al 13 and Fournier et al 9 support our findings that there is a stronger signal for tramadol-associated hypoglycemia in patients not taking diabetes medications. Golightly et al reported an increased risk of hypoglycemia in tramadol patients who were not diabetic compared with oxycodone patients with hypoglycemia who were not diabetic (RR = 3.12 [95% CI = 1.53-6.51]).…”

Section: Discussionsupporting

confidence: 72%

“…Chretien et al utilized the covariates of age, gender, and concurrent reporting of drugs used in diabetic patients in their multivariate logistic regression model to calculate aROR but did not report how each individual may have affected signal detection. 4 Direct comparisons between our study and Chretien et al should be avoided due to differences in statistical methods.…”

Section: Discussionmentioning

confidence: 82%

“…There is conflicting evidence in the literature to identify if dose or gender increase the potential for tramadol associated hypoglycemia. 4,9,13,16,17 Golightly et al observed that tramadol associated hypoglycemia was more likely to occur in younger patients (mean age 52.0 years versus 59.8 years; p=0.027) and not those with concurrent kidney disease. 13 These findings are consistent with our findings, but do not support that patients with renal insufficiency and increasing age are predisposed to There was a higher incidence of hypoglycemia with tramadol compared to oxycodone in type 1 and type 2 diabetics than non-diabetics, but the occurrence rate was only statistically significant in patients without diabetes (p<0.001).…”

Section: Discussionmentioning

confidence: 99%

“…The most comprehensive data to date includes analysis of opioid-associated hypoglycemia using the WHO’s VigiBase pharmacovigilance database for signal detection and the French Pharmacovigilance Database (FPVDB) for validation using descriptive statistics. 4 There were 100 472 reports of opioid-associated hypoglycemia and 28 113 cases of tramadol-related hypoglycemia in VigiBase between 1967 and April 1, 2018. Results of their analysis in VigiBase indicated an adjusted reporting odds ratio (aROR) of 1.53 (95% CI: 1.52-1.54) for opioid-associated hypoglycemia and an aROR of 1.28 (95% CI: 1.26-1.30) for tramadol-associated hypoglycemia.…”

Section: Discussionmentioning

confidence: 99%

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A Review of the Food and Drug Administration Adverse Event Reporting System for Tramadol-Related Hypoglycemia

Juba

Manen²,

Fellows

2019

Ann Pharmacother

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Background: Background: Hypoglycemia is a rare adverse effect of tramadol that is described in the medical literature and package insert. Objective: Objective: The purpose of this study was to review reports of tramadol and hypoglycemia in the Food and Drug Administration Adverse Event Reporting System (FAERS) database to determine a potential association. Methods: Methods: Disproportionality analysis with Bayesian correction was used to compare tramadol and hypoglycemia with other medications in FAERS. The results were considered significant if the fifth percentile of the Empirical Bayesian geometric mean distribution (EB05) >2. Logistic regression odds ratios was used to determine if age, diabetes medications, and renal insufficiency masked the disproportionality of hypoglycemia, with the fifth percentile of the logistic regression odds ratio (LR05) >2 indicating a potential signal. The Interaction Signal Score (INTSS) was computed to determine the influence of predisposing risk factors on the signal. Results: Results: A total of 605 cases of tramadol-associated hypoglycemia were reported, but our results were not significant (EB05: 1.590). Tramadol-associated hypoglycemia was significant in patients who did not take diabetes medications (EB05: 2.256; LR05: 2.2104). Renal insufficiency was not found to increase the risk of tramadol-associated hypoglycemia (INTSS: 0.865). There was a significant signal for tramadol-associated hypoglycemia in patients aged 0 to 1 year (LR05: 3.0240) and 2 to 4 years (LR05: 2.6853). Conclusion and Conclusion and Relevance: Relevance: Results of our analysis suggest a potential signal between hypoglycemia and tramadol use in patients not taking diabetes medications. Our results do not support a predisposition for tramadolassociated hypoglycemia in patients with renal insufficiency, increasing age, and/or diabetes as noted in the tramadol package insert. Abstract:Background: Hypoglycemia is a rare adverse effect (AE) of the central analgesic tramadol that is described in the medical literature and package insert.Objective: The purpose of this study was to review reports of tramadol and hypoglycemia in the Food and Drug Administration Adverse Event Reporting System (FAERS) database to determine a potential association. Methods: Disproportionality analysis with Bayesian correction was used to compare tramadol and hypoglycemia with other medications in FAERS using Empirica Signal Software. The results were considered significant if the fifth percentile of the Empirical Bayesian geometric mean (EBGM) distribution (EB05) > 2. Logistic regression odd-ratios (LROR) was used to determine if age, diabetes medications, and renal insufficiency masked the disproportionality of hypoglycemia with LR05 > 2 indicating a potential signal. The Interaction Signal Score (INTSS) was computed to determine the influence of predisposing risk factors' on the signal.Results: Six hundred and five cases of tramadol associated hypoglycemia were reported in the FAERS database, but our results were not significan...

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Section: Discussionsupporting

confidence: 72%

Section: Discussionmentioning

confidence: 82%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

A Review of the Food and Drug Administration Adverse Event Reporting System for Tramadol-Related Hypoglycemia

Juba

Manen²,

Fellows

2019

Ann Pharmacother

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“…Is it a class effect?" published online in this journal [1]. The authors performed a disproportionality analysis in the WHO global individual case safety report database and in the French PharmacoVigilance DataBase (FPVD) with nine opioids (codeine, fentanyl, hydromorphone, methadone, morphine, oxycodone, tramadol, buprenorphine, and nalbuphine) looking for any indications of hypoglycemia.…”

mentioning

confidence: 99%