Failure of the emergency contraceptive levonorgestrel and the risk of adverse effects in pregnancy and on fetal development: an observational cohort study

2005 ◽  
Vol 84 (2) ◽  
pp. 296-299 ◽  
Author(s):  
Marco De Santis ◽  
Anna Franca Cavaliere ◽  
Gianluca Straface ◽  
Brigida Carducci ◽  
Alessandro Caruso
2014 ◽  
Vol 23 (4) ◽  
pp. 329-331 ◽  
Author(s):  
C. Barbui ◽  
S.B. Patten

Although the mechanism by which antidepressants (ADs) may increase the risk of suicide-related outcomes is unknown, it has been hypothesised that some adverse effects, including akathisia, insomnia and panic attacks, as well as an early energising effect that might allow patients with depression to act on suicidal impulses, may have a key role. Considering that these adverse effects are dose-related, it might be hypothesised that the risk of suicidal behaviour is similarly related to the AD dose. This research question has recently been addressed by a propensity score-matched observational cohort study that involved 162 625 patients aged 10–64 years with a depression diagnosis who initiated therapy with citalopram, sertraline or fluoxetine. In this commentary, we discuss the main findings of this study in view of its methodological strengths and limitations, and we suggest possible implications for day-to-day clinical practice.


The Lancet ◽  
2007 ◽  
Vol 369 (9561) ◽  
pp. 578-585 ◽  
Author(s):  
Joseph R Hibbeln ◽  
John M Davis ◽  
Colin Steer ◽  
Pauline Emmett ◽  
Imogen Rogers ◽  
...  

Author(s):  
Deonne Dersch-Mills ◽  
Belal Alshaikh ◽  
Amuchou S Soraisham ◽  
Albert Akierman ◽  
Kamran Yusuf

<p><strong>ABSTRACT</strong></p><p><strong>Background: </strong>There is no injectable ibuprofen product marketed to treat patent ductus arteriosus (PDA) in newborns in Canada. The authors’ institution has used ibuprofen arginine in the past. In the absence of published evidence supporting use of this salt form of ibuprofen for neonatal PDA, a retrospective analysis was undertaken.</p><p><strong>Objective: </strong>To compare the effectiveness and adverse effects of ibuprofen arginine, ibuprofen tromethamine, and indomethacin in the treatment of PDA.</p><p><strong>Methods: </strong>This retrospective observational cohort study, for patients admitted between 2009 and 2015, included preterm infants with symptomatic PDA who received at least one dose of injectable indomethacin, ibuprofen tromethamine, or ibuprofen arginine. Three effectiveness end points were analyzed: closure after one course of treatment, repeat medical treatment, and surgical ligation. The secondary end points included acute kidney injury, necrotizing enterocolitis, chronic lung disease, and time to full enteral feeding.</p><p><strong>Results: </strong>A total of 179 infants were included. There were no differences among groups in terms of closure after one course of treatment (37/54 [69%] with indomethacin, 42/70 [60%] with ibuprofen tromethamine, and 28/55 [51%] with ibuprofen arginine; <em>p </em>= 0.21) or surgical ligation (10/54 [19%] with indomethacin, 13/70 [19%] with ibuprofen tromethamine, and 12/55 [22%] with ibuprofen arginine; <em>p </em>= 0.88). However, there was a difference regarding use of a repeat course of treatment, ibuprofen arginine having the highest rate (8/54 [15%] with indomethacin, 18/70 [26%] with ibuprofen tromethamine, and 20/55 [36%] with ibuprofen arginine; <em>p </em>= 0.04). After adjustment for gestational age, the association between ibuprofen arginine and increased use of a repeat course of treatment remained significant. The groups did not differ with respect to adverse effects.</p><p><strong>Conclusion: </strong>These results highlight the potential for differences in effectiveness among various salt forms of injectable ibuprofen and indomethacin. Because of the small sample size and retrospective methodology, confirmation of the present results through a larger prospective study is needed.</p><p><strong>RÉSUMÉ</strong></p><p><strong>Contexte : </strong>Il n’y a pas sur le marché de produit injectable à base d’ibuprofène pour traiter la persistance du canal artériel (PCA) chez le nouveau-né au Canada. L’ibuprofène arginine a été utilisé auparavant dans l’établissement de santé des auteurs. En l’absence de données publiées appuyant l’utilisation de ce médicament sous forme de ce sel pour traiter la PCA chez le nouveau-né, une analyse rétrospective a été réalisée.</p><p><strong>Objectif : </strong>Comparer l’efficacité et les effets indésirables de l’ibuprofène arginine, de l’ibuprofène trométhamine et de l’indométhacine dans le traitement de la PCA.</p><p><strong>Méthodes : </strong>Cette étude de cohorte observationnelle rétrospective, au sujet de patients hospitalisés entre 2009 et 2015, incluait des nourrissons prématurés atteints d’une PCA symptomatique ayant reçu par injection au moins une dose d’indométhacine, d’ibuprofène trométhamine ou d’ibuprofène arginine. Trois paramètres d’évaluation de l’efficacité ont été analysés : la fermeture après un seul traitement, la répétition du traitement médical et la ligature chirurgicale. Les paramètres d’évaluation secondaires étaient les cas d’insuffisance rénale aiguë, d’entérocolite nécrosante et de maladie pulmonaire chronique ainsi que le temps pour atteindre l’alimentation entérale complète.</p><p><strong>Résultats : </strong>Au total, 179 nourrissons ont été admis à l’étude. Aucune différence n’a été relevée entre les groupes en ce qui touche à la fermeture après un seul traitement (37/54 [69 %] pour l’indométhacine, 42/70 [60 %] pour l’ibuprofène trométhamine et 28/55 [51 %] pour l’ibuprofène arginine; <em>p </em>= 0,21) ou à la ligature chirurgicale (10/54 [19 %] pour l’indométhacine, 13/70 [19 %] pour l’ibuprofène trométhamine et 12/55 [22 %] pour l’ibuprofène arginine; <em>p </em>= 0,88). Cependant, une différence a été observée pour ce qui est de la répétition du traitement et l’ibuprofène arginine a obtenu le taux le plus élevé (8/54 [15 %] pour l’indométhacine, 18/70 [26 %] pour l’ibuprofène trométhamine et 20/55 [36 %] pour l’ibuprofène arginine; <em>p </em>= 0,04). Après ajustement pour l’âge gestationnel, l’association entre l’utilisation de l’ibuprofène arginine et une augmentation du recours à un second traitement demeurait significative. Il n’y avait pas de différence entre les groupes en ce qui touche aux effets indésirables.</p><p><strong>Conclusion : </strong>Ces résultats soulignent la possible différence d’efficacité parmi les divers sels d’ibuprofène injectable et l’indométhacine. Cependant, en raison de la petite taille de l’échantillon et de l’emploi d’une méthodologie rétrospective, une étude prospective plus importante doit être menée pour confirmer les résultats de la présente étude.</p>


2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii14-ii14
Author(s):  
P B van der Meer ◽  
L Dirven ◽  
M Fiocco ◽  
M Vos ◽  
M C M Kouwenhoven ◽  
...  

Abstract BACKGROUND About 30% of glioma patients need an add-on antiepileptic drug (AED) due to uncontrolled seizures on AED monotherapy. This study aimed to determine whether levetiracetam combined with valproic acid (LEV+VPA), a commonly prescribed duotherapy, is more effective than other duotherapy combinations including either LEV or VPA in glioma patients. MATERIAL AND METHODS In this multicenter retrospective observational cohort study, treatment failure (i.e. replacement by or addition of a new AED, or withdrawal of an AED) for any reason was the primary outcome. Secondary outcomes included: 1) treatment failure due to uncontrolled seizures; and 2) treatment failure due to adverse effects. Time to treatment failure was defined as the time from the start of AED duotherapy until the time of treatment failure. Multivariable Cox proportional hazard models were estimated to study the association between risk factors and treatment failure. The maximum duration of follow-up was 36 months. RESULTS A total of 1435 patients were treated with first-line monotherapy LEV or VPA, of which 355 patients received AED duotherapy after they had treatment failure due to uncontrolled seizures on monotherapy. LEV+VPA was prescribed in 66% (236/355) and other AED duotherapy combinations including LEV or VPA in 34% (119/355) of patients. Patients using other duotherapy versus LEV+VPA had higher risk of treatment failure for any reason (cause-specific hazard ratio [csHR]=1.50 [95%CI=1.07–2.12], p=0.020), treatment failure due to uncontrolled seizures (csHR=1.73 [95%CI=1.10–2.73], p=0.018). There were no differences in failure due to adverse effects (csHR=0.88 [95%CI=0.47–1.67]), p=0.703) between the two groups. CONCLUSION This observational cohort study suggests that LEV+VPA has better efficacy than other AED combinations. Similar toxicities were experienced in the two groups.


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