Sex differences in type and occurrence of adverse reactions to opioid analgesics: a retrospective cohort study

Lopes, Guilherme S.; Bielinski, Suzette J.; Moyer, Ann M.; Jacobson, Debra J.; Wang, Liwei; Jiang, Ruoxiang; Larson, Nicholas B.; Miller, Virginia M.; Zhu, Ye; Cavanaugh, Dana C; Sauver, Jennifer St.

doi:10.1136/bmjopen-2020-044157

Cited by 23 publications

(14 citation statements)

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“…On the whole, a higher number of AEs was observed for females except for the sexual area, in line with previous evidence [ 3 , 20 , 47 , 48 ]. In general, women were more likely to report gastrointestinal and nervous systems issues compared with men, which can lead to the higher female hospital frequentation observed in this study.…”

Section: Discussionsupporting

confidence: 91%

“…OXN and TAP are two new-generation opioids, which apparently show a better safety profile and greater effectiveness compared to Other Prescribed Opioids (OPO) in real-world pain units (PU) [ 18 , 19 ]. There are some data related to the sex differences in OXN [ 8 , 20 ] mostly due to gastrointestinal AEs [ 8 , 20 ] but not as much as with TAP or comparing both opioids.…”

Section: Introductionmentioning

confidence: 99%

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Sex Differences in Oxycodone/Naloxone vs. Tapentadol in Chronic Non-Cancer Pain: An Observational Real-World Study

et al. 2022

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Despite the large body of research on sex differences in pain, there is a lack of translation to real-world pain management. Our aim was to analyse the sex differences in the analgesic response to oxycodone/naloxone (OXN) and tapentadol (TAP), in comparison with other opioids (OPO) commonly prescribed for chronic non-cancer pain (CNCP). An observational and cross-sectional study was conducted on ambulatory CNCP patients (n = 571). Sociodemographic, clinical (pain intensity, relief, and quality of life), safety (adverse events (AEs), adverse drug reactions), hospital frequentations and pharmacological (morphine equivalent daily dose (MEDD)) variables were collected. Multiple linear regressions were carried out to assess the association between sex and outcomes. Sex differences were observed, with lower female tolerability and higher hospital frequentation, especially in the OXN group (OR AEs report = 2.8 [1.8–4.4], p < 0.001). Here, females showed higher hospital use (23% hospital admission, 30% prescription change, p < 0.05), requiring a higher MEDD (127 ± 103 mg/day, p < 0.05), compared to OXN men. Regardless of the opioid group, CNCP women were significantly older than men (three years), with significantly higher benzodiazepine use (OR = 1.6 [1.1–2.3]), more constipation (OR = 1.34 [0.93–1.90]) and headache (OR = 1.45 [0.99–2.13]) AEs, than men who were more likely to refer sexual dysfunction (OR = 2.77 [1.53–5.01]), and loss of libido (OR = 1.93 [1.22–3.04]). Sex-differences were found related to poorer female drug tolerability and higher hospital resources, even worst in OXN female users. Other differences related to older female ages and benzodiazepine prescription, need to be further analysed from a gender perspective.

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Section: Discussionsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Sex Differences in Oxycodone/Naloxone vs. Tapentadol in Chronic Non-Cancer Pain: An Observational Real-World Study

et al. 2022

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“…The worse analgesic tolerability in females -related to gastrointestinal and nervous systems- and 10% more emergency department visits, falls in line with previously published scientific literature [ 34 , 35 , 36 , 37 ]. However, in spite of male cases having the lowest number of AEs, they arose the highest ADRs notification.…”

Section: Discussionsupporting

confidence: 88%

Sex-Differences in Pain and Opioid Use Disorder Management: A Cross-Sectional Real-World Study

Escorial

Muriel²,

Ferrí

et al. 2022

Biomedicines

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(1) Background: It is essential to focus attention on sex-specific factors which are clinically relevant in pain management, especially with regards to opioid use disorder (OUD) risk. The aim of this study was to explore potential sex-differences in chronic non-cancer pain (CNCP) outpatients. (2) Methods: An observational cross-sectional study was conducted under CNCP outpatients with long-term prescribed opioids (n = 806), wherein 137 patients had an OUD diagnosis (cases, 64% females) and 669 did not (controls, 66% females). Socio-demographic, clinical, and pharmacological outcomes were analyzed. (3) Results: Female controls presented an older age and less intensive pain therapy but higher psychotropic prescriptions and emergency department visits compared to male controls. Meanwhile, cases demonstrated a younger age, higher work disability, double morphine equivalent daily dose, and benzodiazepine use compared with controls. Here, female cases showed an 8% greater substance use disorder (OR 2.04 [1.11–3.76]) and 24% lower tramadol use, while male cases presented a 22% higher fentanyl use (OR 2.97 [1.52–5.81]) and reported the highest number of adverse drug reactions (24%, OR 2.40 [1.12–5.16]) compared with controls. (4) Conclusions: An OUD individual risk profile was evidenced with sex-differences to take into consideration to design equal prevention programs.

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“…In the case of women, adverse reactions following antibiotic administration were most frequently reported, for example, after using ceftriaxone and for anti-tuberculosis drugs [14]. In a retrospective cohort study evaluating the incidence of adverse reactions after analgesics, women reported such symptoms almost twice as often as men [15].…”

Section: Discussionmentioning

confidence: 99%

The occurrence of drug-induced side effects in women and men with arterial hypertension and comorbidities

et al. 2022

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Background:Women have been underrepresented in large clinical trials in hypertension, and the incidence of adverse drug reactions by sex has been not sufficiently described. Aims:The aim of the study was to determine the prevalence of adverse drug reactions in women and men with arterial hypertension and comorbidities and to assess the specific predisposing factors for adverse drug reactions by sex. Methods:The study population comprised consecutive hospitalized patients diagnosed with arterial hypertension and patients treated in an outpatient clinic, whose recruitment started in January 2019 aiming to reach 1000 participants. A structured questionnaire was used to gather the patients' demographic and clinical data and current or past cases of adverse drug reactions. Results:The study included 560 women and 440 men, with mean (standard deviation) age of 62.84 (14.96) years. Women were older than men, had a longer hypertension history, and suffered less frequently from other cardiovascular diseases. Women reported more frequently adverse drug reactions. The risk of drug-induced side effects in women increased with age (P = 0.03) and with coexistence of any respiratory disease (P = 0.04). In the case of male sex, the risk of adverse drug reactions increased with the occurrence of hypercholesterolemia (P = 0.03), and coexistence of any analyzed metabolic diseases (P = 0.04).Conclusions: Adverse drug reactions were reported more frequently by women. Older age and the presence of any respiratory disease increased the risk of adverse drug reactions in women, while in men, the risk was increased mainly by the presence of hypercholesterolemia or other metabolic diseases.

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Sex differences in type and occurrence of adverse reactions to opioid analgesics: a retrospective cohort study

Cited by 23 publications

References 46 publications

Sex Differences in Oxycodone/Naloxone vs. Tapentadol in Chronic Non-Cancer Pain: An Observational Real-World Study

Sex Differences in Oxycodone/Naloxone vs. Tapentadol in Chronic Non-Cancer Pain: An Observational Real-World Study

Sex-Differences in Pain and Opioid Use Disorder Management: A Cross-Sectional Real-World Study

The occurrence of drug-induced side effects in women and men with arterial hypertension and comorbidities

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