No substantial gender differences in suspected adverse reactions to ACE inhibitors and ARBs: results from spontaneous reporting system in Campania Region

Sportiello, Liberata; Rafaniello, Concetta; Sullo, Maria Giuseppa; Nica, Mihaela; Scavone, Cristina; Bernardi, Francesca Futura; Colombo, Delia; Rossi, Francesco

doi:10.1080/14740338.2016.1225720

Cited by 11 publications

(10 citation statements)

References 39 publications

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“…In the Italian study, the fact that ACE-Is and ARBs were prescribed to a greater extent in men during the study period was discussed [14], and the lack of adjustment to prescription data may explain why their results differ from ours. The results from our study are in line with the literature referring to pharmacokinetic and pharmacodynamic differences, giving relatively higher exposure in women to a given dose [3].…”

Section: Discussionmentioning

confidence: 80%

“…However, in a regional pharmacovigilance center in France, there was no sex difference in the incidence of reporting of ADRs overall [ 13 ]. Furthermore, no sex difference was seen in suspected ADRs to ACE inhibitors and ARBs in spontaneous reports in the Campania region, Italy [ 14 ]. Spontaneous reporting of ADEs is an important tool in obtaining better knowledge about sex differences in ADEs, in addition to the information from the clinical trials conducted before the drug has been introduced on the market.…”

Section: Introductionmentioning

confidence: 99%

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Sex differences in spontaneous reports on adverse drug events for common antihypertensive drugs

Rydberg

Mejyr

Loikas

et al. 2018

Eur J Clin Pharmacol

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PurposeTo explore sex differences in spontaneously reported adverse drug events (ADEs) for antihypertensives in routine care.MethodsA cross sectional analysis combining number of reports from the national pharmacovigilance database with data from the Swedish Prescribed Drug Register, from 2005 to 2012 for ACE inhibitors (ACE-I) and angiotensin receptor blockers (ARB), with or without thiazide, diuretics (thiazides, potassium-sparing agents, sulfonamides, aldosterone antagonists), selective betablockers, and dihydropyridine calcium-channel-blockers (DHPs). The total number of reports was adjusted to exposed patients and dispensed DDDs among women and men. Dose exposures, co-medications, and co-prescriptions were also analyzed.ResultsIn women, a higher prevalence of ADE-reports was seen in ACE-I (odds ratio, OR 1.21; 95% CI 1.09–1.35), ACE-I-combinations (OR 1.61; 1.44–1.79), ARB-combinations (OR 2.12; 1.47–3.06), thiazides (OR 1.78; 1.33–2.39), diuretics and potassium-sparing agents (OR 1.62; 1.22–2.17), and DHPs (OR 1.40; 1.17–1.67), with a potential linkage to dose exposure. For aldosterone antagonists, we observed a higher prevalence of ADE reports in men (OR 0.75; 0.59–0.97) but without any sex difference in dose exposure.ConclusionsThis ecological study of reported ADEs showed a higher prevalence of reports in women in six out of ten groups of antihypertensive drugs, and this may potentially be linked to dose exposure. Aldosterone antagonists was the only group with a higher prevalence of ADE-reports in men with a similar dose exposure between women and men.Electronic supplementary materialThe online version of this article (10.1007/s00228-018-2480-y) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 80%

Section: Introductionmentioning

confidence: 99%

Sex differences in spontaneous reports on adverse drug events for common antihypertensive drugs

Rydberg

Mejyr

Loikas

et al. 2018

Eur J Clin Pharmacol

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“…Whilst men have an increased risk of gout and hyperuricemia and, therefore, are more prone to be treated with allopurinol, we found that ADRs, especially serious cutaneous ADRs, were more common in women. This is not surprising because females seem to be more likely at risk to experience ADRs due to sex-specific differences in the pharmacokinetics and pharmacodynamics of drugs [34][35][36][37]. Furthermore, literature data confirm that both SJS and TEN could occur at any age, but appear to be more prevalent in adults, with a slight predominance in women [38,39].…”

Section: Overall Resultsmentioning

confidence: 94%

Severe Cutaneous Adverse Drug Reactions Associated with Allopurinol: An Analysis of Spontaneous Reporting System in Southern Italy

Scavone

Mauro

Ruggiero

et al. 2019

Drugs - Real World Outcomes

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Background Allopurinol can induce severe cutaneous adverse reactions (SCARs), including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Aims and Methods We analyzed the Individual Case Safety Reports (ICSRs) sent from January 2001 until April 2019 to the Campania regional Center of Pharmacovigilance (Southern Italy) that reported allopurinol as suspected, with a focus on those reporting at least one serious cutaneous adverse drug reaction (ADR). This study was aimed to describe the main characteristics of all ADRs associated with allopurinol, analyze the proportion of serious cutaneous ADRs of total ICSRs related to allopurinol and to compare the main features (age, sex, seriousness and outcome) of ICSRs that reported serious cutaneous ADRs with those that did not. Results The Campania regional Center of Pharmacovigilance received 108 ICSRs that reported allopurinol as suspected. ADRs occurred more frequently in the elderly (median age: 71 years) and female patients (53.7%). Fifty-seven percent of all ADRs were classified as serious and 58% had a favorable outcome. Fifty-six ICSRs reported at least one serious cutaneous ADR; among these ICSRs, 37 cases of SCARs were found [DRESS syndrome (n = 3; 5.4%), SJS (n = 8; 14.3%) and TEN (n = 26; 46.4%)]. Serious cutaneous ADRs commonly occurred in the elderly (median age: 73 years) and female patients (62.5%). They frequently required hospitalization (75%) and had an unfavorable outcome (46%). No statistically significant differences were found between ICSRs that reported serious cutaneous ADRs and ICSRs that did not report serious cutaneous ADRs except for the seriousness degree "Hospitalization or its prolongation" and the outcome degrees "Unfavorable" and "Favorable". Conclusion This study found that 52% (56/108) of all ICSRs having allopurinol as a suspected drug were serious cutaneous ADRs. Serious cutaneous ADRs associated with allopurinol frequently required hospitalization or prolonged hospitalization, and almost half had an unfavorable outcome.

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“…Our study represents one of the activities performed in Campania Region in the field of pharmacovigilance (Rafaniello et al, 2016a ; Sessa et al, 2016a , b ; Sportiello et al, 2016a , b ) with the aim to better define the safety profile of drugs and to improve their safe use in routine clinical practice. The results of our study demonstrated that biotech drugs used in several clinical settings in Campania Region showed overall good tolerability profiles.…”

Section: Discussionmentioning

confidence: 99%

Safety Profile of Anticancer and Immune-Modulating Biotech Drugs Used in a Real World Setting in Campania Region (Italy): BIO-Cam Observational Study

et al. 2017

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Objectives: To investigate the occurrence of adverse events (AEs) in naïve patients receiving biotech drugs.Design: A prospective observational study.Setting: Onco-hematology, Hepato-gastroenterology, Rheumatology, Dermatology, and Neurology Units in Campania Region (Italy).Participants: 775 patients (53.81% female) with mean age 56.0 (SD 15.2). The mean follow-up/patient was 3.48 (95% confidence interval 3.13–3.84).Main outcome measures: We collected all AEs associated to biotech drugs, including serious infections and malignancies. Serious AEs were defined according to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, clinical safety data management: definitions and standards for expedited reporting E2A guideline.Results: The majority of the study population was enrolled in Onco-hematology and Rheumatology Units and the most common diagnosis were hematological malignancies, followed by rheumatoid arthritis, colorectal cancer, breast cancer, and psoriatic arthritis. The most commonly prescribed biotech drugs were rituximab, bevacizumab, infliximab, trastuzumab, adalimumab, and cetuximab. Out of 775 patients, 320 experienced at least one AE. Most of patients experienced AEs to cetuximab therapy, rituximab and trastuzumab. Comparing female and male population, our findings highlighted a statistically significant difference in terms of AEs for adalimumab (35.90% vs. 7.41%, p < 0.001) and etanercept (27.59% vs. 10.00%, p = 0.023). Considering all biotech drugs, we observed a peak for all AEs occurrence at follow-up 91–180 days category. Bevacizumab, brentuximab, rituximab, trastuzumab and cetuximab were more commonly associated to serious adverse events; most of these were possibly related to biotech drugs, according to causality assessment. Three cases of serious infections occurred.Conclusions: The results of our study demonstrated that the majority of AEs were not serious and expected. Few cases of serious infections occurred, while no case of malignancy did. Overall, the safety profile of biotech drugs used in our population was similar to those observed in pivotal trials. Notwithstanding the positive results of our study, some safety concerns still remain unresolved. In order to collect more effectiveness and safety data on biotech drugs, the collection and analysis of real world data should be endorsed as well as the management of post-authorization studies.

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No substantial gender differences in suspected adverse reactions to ACE inhibitors and ARBs: results from spontaneous reporting system in Campania Region

Abstract: This analysis suggested no substantial gender differences. Further studies such as randomized population studies or meta-analysis of ACE inhibitors and ARBs randomized studies are needed to clarify whether gender differences exist in the safety profile of these drugs.

Cited by 11 publications

References 39 publications

Sex differences in spontaneous reports on adverse drug events for common antihypertensive drugs

Sex differences in spontaneous reports on adverse drug events for common antihypertensive drugs

Severe Cutaneous Adverse Drug Reactions Associated with Allopurinol: An Analysis of Spontaneous Reporting System in Southern Italy

Safety Profile of Anticancer and Immune-Modulating Biotech Drugs Used in a Real World Setting in Campania Region (Italy): BIO-Cam Observational Study

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