Treatment deviating from guidelines does not influence status epilepticus prognosis.

Status epilepticus (SE) prognosis is related to nonmodifiable factors (age, etiology), but the exact role of drug treatment is unclear. This study was undertaken to address the prognostic role of treatment adherence to guidelines (TAG). We prospectively studied over 26 months a cohort of adults with incident SE (excluding postanoxic). TAG was assessed in terms of drug doses (± 30 % of recommendations) and medication sequence; its prognostic impact on mortality and return to baseline conditions was adjusted for etiology, SE severity [Status Epilepticus Severity Score (STESS)], and comorbidities. Of 225 patients, 26 (12 %) died and 82 (36 %) were discharged with a new handicap; TAG was observed in 142 (63 %). On univariate analysis, age, etiology, SE severity, and comorbidities were significantly related to outcome, while TAG was associated with neither outcome nor likelihood of SE control. Logistic regression for mortality identified etiology [odds ratio (OR) 18.8, 95 % confidence interval (CI) 4.3-82.8] and SE severity (STESS ≥ 3; OR 1.7, 95 % CI 1.2-2.4) as independent predictors, and for lack of return to baseline, again etiology (OR 7.4, 95 % CI 3.9-14.0) and STESS ≥ 3 (OR 1.7, 95 % CI 1.4-2.2). Similar results were found for the subgroup of 116 patients with generalized-convulsive SE. Receiver operator characteristic (ROC) analyses confirmed that TAG did not improve outcome prediction. This study of a large SE cohort suggests that treatment adherence to recommendations using current medications seems to play a negligible prognostic role (class III), confirming the importance of the biological background. Awaiting further treatment trials, it appears mandatory to apply resources towards identification of new therapeutic approaches.

Orthopantomography contribution to prevent isquemic stroke

Objectives: The ortopantomography (OPG) can be a valuable way for an early detection of calcified atheroma plaques, thus contributing for a preliminary stroke risk evaluation. The study looks for the existence of calcified atheroma plates through the use of OPG, comparing the results with the stenosis percentage found through eco-doppler. It has been analyzed the correlation of the number of years as a smoker, arterial hypertension and body mass index, against the risk of having calcified atheroma plaques. Study Design: Observational, transversal and prospective study with 84 patients from the Dental Center of Hospital Particular de Lisboa. First the patients answered to an inquiry and them they were submitted to an OPG and an eco-doppler. Results and Conclusions: It is possible to detect calcified atheroma plaques in the carotid artery through an OPG and patients who have them have got a fifteen fold greater risk of suffering from carotid stenosis. In this study, it has been confirmed the increase in carotid stenosis for long term smokers (OR = 1,033, n=18, 42,9%). The study results show that hypertension patients have a probability 5,426 greater than normal of developing atheroma plaques (with sig=0,049). Amid analyzed patients, the correlation between obesity and the existence of carotid atheroma plaques was significant, although negative (sig=0,047). OPG can help find patients with higher risk of isquemic stroke

Can Orthopantomography be used as a tool for screening of carotid atheromatous pathology and thus be used to help reduce the prevalence of ischemic stroke within the population?

Objective: To assess the possibility of Dentists being able to screen patients with higher risk of vascular diseases. Materials: Kodak 8000C Orthopantomographer, eco-Doppler Logiq-500 General Electric at the Lisbon Hospital Particular. Methods: Assessment of orthopantomographies made to 142 patients aged 50 or more, as well as the existing risk factors. Conduction of carotid eco-Doppler to patients who appear to have calcified plaques of the atheroma. Results: Strong dependence between dichotomised age and having the pathology (p = 0.02).Smokers are twice more likely to present plaques (OR= 2). Being hypertensive increases in about 1.4 the likelihood of having a stroke (OR= 1.4). Of the 27 individuals who presented calcifications in the Orthopantomography, they were all submitted to an eco-Doppler and 21 had the pathology confirmed. 27 individuals, who did not show any plaques in the Orthopantomography, were randomly selected to be the control group. They were submitted to an eco-Doppler. And 23 confirmed the non-existence of plaques. Conclusions: Orthopantomography used for assessing the oral cavity reveals more information which should be the object of the Dentist"s attention

Genetic association analyses reveal a role for vitamin D insufficiency in hepatitis C virus-associated hepatocellular carcinoma development

Background: V itamin D insufficiency has been associated with the occurrence of various types of cancer, but causal relationships remain elusive. Methods: Associations between t he r isk o f HCV-related HCC development and CYP2R1 , GC, and DHCR7 genotypes, which are genetic determinants of reduced 25-OH-vitamin D3 (25[OH]D3) serum levels, were determined. Results: A t otal of 5604 HCV-infected patients, 1279 with a nd 4325 without progression to HCC, w ere identified. The well-known association between 25(OH)D3 s erum levels and variations in CYP2R1 ( rs1993116, rs10741657), GC ( rs2282679), a nd DHCR7 ( rs7944926, rs12785878) g enotypes was also apparent in patients w ith chronic hepatitis C. The same genotypes of t hese single nucleotide polymorphisms (SNPs), w hich are associated with reduced 25(OH)D3 s erum levels, were significantly associated with HCV-associated HCC (P=0.07 [OR=1.13] for CYP2R1 , P=0.007 [OR=1.56] for GC, P=0.003 [OR=1.42] for DHCR7; ORs for risk genotypes). In contrast, no association between t hese genetic variations and the o utcome of antiviral therapy with pegylated interferon-α and ribavirin ( P>0.2 for e ach SNP) or liver fibrosis progression rate (P>0.2 for each SNP) was observed, s uggesting a specific influence o f the genetic d eterminants of 25(OH)D3 s erum levels o n hepatocarcinogenesis. Conclusions: Our data suggest a relatively weak but functionally relevant role for vitamin D in the prevention of HCV-related HCC development. Controlled clinical trials to assess the benefit of vitamin D supplementation in HCVinfected patients with advanced liver fibrosis or cirrhosis are warranted.

Predictors of favourable outcome in first-episode patients who refuse medication: results from the FEPOS study

There are suggestions that some first-episode psychosis (FEP) patients can have favourable outcome without antipsychotic medication. However, there is very limited data regarding patients' characteristics on which the decision to propose medication free treatment could be based. FEPOS is a fi le-based study of an epidemiological sample of 704 FEP patients treated at EPPIC, Melbourne, between 1998 and 2000. Among the 661 patients where data was available, 108 consistently refused medication during the entire duration of their treatment at EPPIC. In this paper we compared, within this sub-group, patients who had a favourable outcome with those who did not. Patients were aged between 15 and 29 years (M = 21.9, SD = 3.40) and the majority were male (70.4%, n = 76). Symptomatic remission data was available on 105 patients; of these patients 41.0% (n = 41) had achieved remission. Functional remission data was available on 100 patients; of these patients 33.0% (n = 33) had achieved functional remission. Combined remission was evident in 23.0% (n = 23) of patients. Three factors were associated with symptomatic remission: better premorbid functioning (based on GAF, OR = 1.07, p = 0.006), higher number of years of education (OR = 1.43, p = 0.020), and being employed or studying at service entry (OR = 2.59, p = 0.034). Three factors were associated with functional remission: shorter duration of prodrome (OR = 0.50, p = 0.043), severity of psychopathology (CGI-S, OR = 0.51, p = 0.024), and vocational status at service entry (OR = 4.29, p = 0.003). While various aspects of pre-morbid functioning seem to correlate with the possibility of a favourable outcome in FEP patients who refuse medication, various limitations need to be taken into account in this study.

Alcohol consumption and binge drinking in young adult childhood cancer survivors.

BACKGROUND: This study compared frequency of alcohol consumption and binge drinking between young adult childhood cancer survivors and the general population in Switzerland, and assessed its socio-demographic and clinical determinants. PROCEDURE: Childhood cancer survivors aged <16 years when diagnosed 1976-2003, who had survived >5 years and were currently aged 20-40 years received a postal questionnaire. Reported frequency of alcohol use and of binge drinking were compared to the Swiss Health Survey, a representative general population survey. Determinants of frequent alcohol consumption and binge drinking were assessed in a multivariable logistic regression. RESULTS: Of 1,697 eligible survivors, 1,447 could be contacted and 1,049 (73%) responded. Survivors reported more often than controls to consume alcohol frequently (OR = 1.7; 95%CI = 1.3-2.1) and to engage in binge drinking (OR = 2.9; 95%CI = 2.3-3.8). Peak frequency of binge drinking in males occurred at age 24-26 years in survivors, compared to age 18-20 in the general population. Socio-demographic factors (male gender, high educational attainment, French and Italian speaking, and migration background from Northern European countries) were most strongly associated with alcohol consumption patterns among both survivors and controls. CONCLUSIONS: The high frequency of alcohol consumption found in this study is a matter of concern. Our data suggest that survivors should be better informed on the health effects of alcohol consumption during routine follow-up, and that such counseling should be included in clinical guidelines. Future research should study motives of alcohol consumption among survivors to allow development of targeted health interventions for this vulnerable group.

Outcome of intravenous thrombolysis in stroke patients weighing over 100 kg.

Background: Intravenous thrombolysis with alteplase for ischemic stroke is fixed at a maximal dose of 90 mg for safety reasons. Little is known about the clinical outcomes of stroke patients weighing >100 kg, who may benefit less from thrombolysis due to this dose limitation. Methods: Prospective data on 1,479 consecutive stroke patients treated with intravenous alteplase in six Swiss stroke units were analyzed. Presenting characteristics and the frequency of favorable outcomes, defined as a modified Rankin scale (mRS) score of 0 or 1, a good outcome (mRS score 0-2), mortality and symptomatic intracranial hemorrhage (SICH) were compared between patients weighing >100 kg and those weighing ≤100 kg. Results: Compared to their counterparts (n = 1,384, mean body weight 73 kg), patients weighing >100 kg (n = 95, mean body weight 108 kg) were younger (61 vs. 67 years, p < 0.001), were more frequently males (83 vs. 60%, p < 0.001) and more frequently suffered from diabetes mellitus (30 vs. 13%, p < 0.001). As compared with patients weighing ≤100 kg, patients weighing >100 kg had similar rates of favorable outcomes (45 vs. 48%, p = 0.656), good outcomes (58 vs. 64%, p = 0.270) and mortality (17 vs. 12%, p = 0.196), and SICH risk (1 vs. 5%, p = 0.182). After multivariable adjustment, body weight >100 kg was strongly associated with mortality (p = 0.007) and poor outcome (p = 0.007). Conclusion: Our data do not suggest a reduced likehood of favorable outcomes in patients weighing >100 kg treated with the current dose regimen. The association of body weight >100 kg with mortality and poor outcome, however, demands further large-scale studies to replicate our findings and to explore the underlying mechanisms.

Atypical depression and alcohol misuse are related to the cardiovascular risk in the general population.

OBJECTIVE: The aims of the present study were to assess the associations between mood, anxiety and substance use disorders, including their subtypes, and the prevalence of cardiovascular risk factors (CVRFs). METHOD: Thorough physical investigations, biological measures and standardized interview techniques were used to assess 3716 subjects of an urban area, aged 35-66 years. RESULTS: Atypical depression was associated with increased prevalence of overweight, diabetes and the metabolic syndrome (OR = 1.5, 95% C.I. 1.1-2.0; OR = 2.0, 95% C.I. 1.1-3.5, OR = 1.6, 95% C.I. 1.0-2.4 respectively), whereas decreased prevalence of overweight was found in melancholic (OR = 0.7, 95% C.I. 0.6-0.9) and unspecified depression (OR = 0.8, 95% C.I. 0.7-1.0). Alcohol abuse was associated with diabetes (OR = 1.8, 95% C.I. 1.1-2.9) and dyslipidemia (OR = 1.3, 95% C.I. 1.0-1.8), alcohol dependence with dyslipidemia only (OR = 1.4, 95% C.I. 1.0-2.0). Almost all mental disorders were associated with a lifetime history of regular cigarette smoking, and atypical depression, alcohol misuse and drug dependence were associated with inactivity. CONCLUSION: To conclude results emphasize the need to subtype depression and to pay particular attention to the atypical subtype. Comorbid alcohol misuse may further increase the cardiovascular risk. Efforts to diminish smoking in subjects with mental disorders could be crucial measures to reduce their high incidence of cardiovascular disease.

Résistance aux antibiotiques chez les pneumocoques.

In 1875, 7 years prior to the description of the Koch bacillus, Klebs visualized the first Streptococcus pneumoniae in pleural fluid. Since then, this organism has played a decisive role in biomedical science. From a biological point of view, it was extensively involved in the development of passive and active immunization by serotherapy and vaccination respectively. Genetic transformation was also first observed in S. pneumoniae, leading to the discovery of DNA. From a clinical point of view, S. pneumoniae is today still a prime cause of otitis media in children and of pneumonia in all age groups, as well as a predominant cause of meningitis and bacteremia. In adults, bacteremia still has a mortality of over 25%. Although S. pneumoniae remained very sensitive to penicillin for many years, penicillin-resistant strains have emerged and increased dramatically over the last 15 years. During this period the frequency of penicillin-resistant isolates has increased from < or = 1% to frequencies varying from 20 to 60% in geographic areas as diverse as South Africa, Spain, France, Hungary, Iceland, Alaska, and numerous regions of the United States and South America. In Switzerland, the current frequency of penicillin-resistant pneumococci ranges between 5 and > or = 10%. The increase in penicillin-resistant pneumococci correlates with the intensive use of beta-lactam antibiotics. The mechanism of resistance is not due to bacterial production of penicillinase but to an alteration of the bacterial target of penicillin, the so-called penicillin-binding proteins. Resistance is subdivided into (1) intermediate level resistance (minimal inhibitory concentration [MIC] of penicillin of 0.1-1 mg/l) and (2) high level resistance (MCI > or = 2 mg/l). The clinical significance of intermediate resistance remains poorly defined. On the other hand, highly resistant strains have been responsible for numerous therapeutic failures, especially in cases of meningitis. Antibiotics recommended against penicillin-resistant pneumococci include cefotaxime, ceftriaxone, imipenem and in some instances vancomycin. However, penicillin-resistant pneumococci tend to present cross-resistances to all the antibiotics of the beta-lactam family and could even become resistant to the last resort drugs mentioned above. Thus, the explosion of resistance to penicillin in pneumococci is a ubiquitous phenomenon which must be fought against by (1) avoiding excessive use of antibiotics, (2) the practice of microbiological sampling of infected foci before treatment, (3) the systematic surveillance of resistance profiles of pneumococci against antibiotics and (4) adequate vaccination of populations at risk.

Contribution of genetic background, traditional risk factors, and HIV-related factors to coronary artery disease events in HIV-positive persons.

BACKGROUND: Persons infected with human immunodeficiency virus (HIV) have increased rates of coronary artery disease (CAD). The relative contribution of genetic background, HIV-related factors, antiretroviral medications, and traditional risk factors to CAD has not been fully evaluated in the setting of HIV infection. METHODS: In the general population, 23 common single-nucleotide polymorphisms (SNPs) were shown to be associated with CAD through genome-wide association analysis. Using the Metabochip, we genotyped 1875 HIV-positive, white individuals enrolled in 24 HIV observational studies, including 571 participants with a first CAD event during the 9-year study period and 1304 controls matched on sex and cohort. RESULTS: A genetic risk score built from 23 CAD-associated SNPs contributed significantly to CAD (P = 2.9 × 10(-4)). In the final multivariable model, participants with an unfavorable genetic background (top genetic score quartile) had a CAD odds ratio (OR) of 1.47 (95% confidence interval [CI], 1.05-2.04). This effect was similar to hypertension (OR = 1.36; 95% CI, 1.06-1.73), hypercholesterolemia (OR = 1.51; 95% CI, 1.16-1.96), diabetes (OR = 1.66; 95% CI, 1.10-2.49), ≥ 1 year lopinavir exposure (OR = 1.36; 95% CI, 1.06-1.73), and current abacavir treatment (OR = 1.56; 95% CI, 1.17-2.07). The effect of the genetic risk score was additive to the effect of nongenetic CAD risk factors, and did not change after adjustment for family history of CAD. CONCLUSIONS: In the setting of HIV infection, the effect of an unfavorable genetic background was similar to traditional CAD risk factors and certain adverse antiretroviral exposures. Genetic testing may provide prognostic information complementary to family history of CAD.

Prevalencia de la discapacidad en España por comunidades autónomas: el papel de los factores individuales y del entorno geográfico en su variabilidad

Fundamento: La prevalencia de discapacidad en la población general presenta una gran variabilidad geográfica, de manera que identificar aquellos factores que pudieran explicarla será importante para la planificación de políticas sociales. En este trabajo se analiza la variabilidad de la discapacidad por comunidades autónomas desde una doble vertiente, los factores individuales y del entorno. Métodos: Los datos proceden principalmente de la Encuesta de Discapacidad, Deficiencias y Estado de Salud de 1999 y del Inebase, ambas del Instituto Nacional de Estadística (INE). Se calculó la prevalencia de discapacidad simple y ajustada por edad de las CCAA. Se analizan los factores individuales asociados a la discapacidad mediante una regresión logística y los factores individuales y de la comunidad autónoma conjuntamente con una regresión logística de dos niveles. Resultados: La prevalencia de discapacidad muestra una diferencia máxima de 5,75 puntos entre las comunidades autónomas. En la regresión logística la comunidad de residencia fue estadísticamente significativa (OR: 3,35 en la de mayor prevalencia respecto a la de menor) junto con otras variables individuales: edad (OR de 40-64= 1,78 OR de 65-79= 1,87 y OR de >79= 3,34), sexo (OR mujer= 0,66), situación laboral (OR sin trabajo=2,25 OR amas casa/estudiante=1,39 y OR otros=2,03), estado de salud (OR regular= 1,69 OR malo/muy malo= 2,05) y enfermedades crónicas (OR 1-3=1,56 OR4-6=1,82 OR>6=2,59). En la regresión de dos niveles las variables individuales explican poca varianza (s=0,261) y ninguna de las variables relativas a las CCAA mejora el modelo. Conclusiones: Las características individuales no explican suficientemente la variabilidad de la discapacidad entre CCAA y no se han identificado variables del entorno que sean significativas.

Percutaneous coronary interventions prior to coronary artery bypass surgery.

BACKGROUND AND AIM OF THE STUDY: Percutaneous coronary interventions (PCI) are frequently performed before coronary artery bypass graft (CABG) surgery. This study sought to evaluate postoperative outcomes, and incidence of recurrent target ischemia in vessels with prior PCI in patients who had PCI prior to CABG compared to only CABG patients. METHODS: A review included CABG patients operated from 2000 to 2012. PCI prior to CABG patients were compared with patients having had CABG on native coronary arteries. Demographic and risk factors, including hospital morbidity, mortality, and recurrent target vessel ischemia at follow-up (FU), were compared. Major end-points were statistical differences of postoperative morbidity and reintervention rates due to symptomatic graft failure or target vessel ischemia during FU. RESULTS: Twenty-four percent of 1669 isolated CABG patients had PCI prior to CABG, with an increasing percentage during recent years. Demographics, risk factors, comorbidities and mortality rates were similar. Incidence of postoperative hemorrhage (OR 1.9; 95% CI 1.1-3.2; p = 0.02), perioperative myocardial infarction rate (p = 0.02), neurological deficits (OR 3.5; 95% CI 1.2-9.7; p = 0.02) and re-intervention rate for symptomatic graft or target vessel occlusion were higher in pretreated patients (OR 1.8; 95% CI 1.1-3.0; p = 0.01). CONCLUSIONS: PCI prior to CABG increases the risk for postoperative morbidity. Increased postoperative hemorrhage could be attributed to ongoing double anti-platelet therapy. doi: 10.1111/jocs.12514 (J Card Surg 2015;30:313-318).

Preoperative nutritional screening by the specialist instead of the nutritional risk score might prevent excess nutrition: a multivariate analysis of nutritional risk factors.

BACKGROUND: The aim of the current study was to assess whether widely used nutritional parameters are correlated with the nutritional risk score (NRS-2002) to identify postoperative morbidity and to evaluate the role of nutritionists in nutritional assessment. METHODS: A randomized trial on preoperative nutritional interventions (NCT00512213) provided the study cohort of 152 patients at nutritional risk (NRS-2002 ≥3) with a comprehensive phenotyping including diverse nutritional parameters (n=17), elaborated by nutritional specialists, and potential demographic and surgical (n=5) confounders. Risk factors for overall, severe (Dindo-Clavien 3-5) and infectious complications were identified by univariate analysis; parameters with P<0.20 were then entered in a multiple logistic regression model. RESULTS: Final analysis included 140 patients with complete datasets. Of these, 61 patients (43.6%) were overweight, and 72 patients (51.4%) experienced at least one complication of any degree of severity. Univariate analysis identified a correlation between few (≤3) active co-morbidities (OR=4.94; 95% CI: 1.47-16.56, p=0.01) and overall complications. Patients screened as being malnourished by nutritional specialists presented less overall complications compared to the not malnourished (OR=0.47; 95% CI: 0.22-0.97, p=0.043). Severe postoperative complications occurred more often in patients with low lean body mass (OR=1.06; 95% CI: 1-1.12, p=0.028). Few (≤3) active co-morbidities (OR=8.8; 95% CI: 1.12-68.99, p=0.008) were related with postoperative infections. Patients screened as being malnourished by nutritional specialists presented less infectious complications (OR=0.28; 95% CI: 0.1-0.78), p=0.014) as compared to the not malnourished. Multivariate analysis identified few co-morbidities (OR=6.33; 95% CI: 1.75-22.84, p=0.005), low weight loss (OR=1.08; 95% CI: 1.02-1.14, p=0.006) and low hemoglobin concentration (OR=2.84; 95% CI: 1.22-6.59, p=0.021) as independent risk factors for overall postoperative complications. Compliance with nutritional supplements (OR=0.37; 95% CI: 0.14-0.97, p=0.041) and supplementation of malnourished patients as assessed by nutritional specialists (OR=0.24; 95% CI: 0.08-0.69, p=0.009) were independently associated with decreased infectious complications. CONCLUSIONS: Nutritional support based upon NRS-2002 screening might result in overnutrition, with potentially deleterious clinical consequences. We emphasize the importance of detailed assessment of the nutritional status by a dedicated specialist before deciding on early nutritional intervention for patients with an initial NRS-2002 score of ≥3.

Patterns of practice of regional nodal irradiation in breast cancer: results of the European Organization for Research and Treatment of Cancer (EORTC) NOdal Radiotherapy (NORA) survey.

BACKGROUND: Predicting outcome of breast cancer (BC) patients based on sentinel lymph node (SLN) status without axillary lymph node dissection (ALND) is an area of uncertainty. It influences the decision-making for regional nodal irradiation (RNI). The aim of the NORA (NOdal RAdiotherapy) survey was to examine the patterns of RNI. METHODS: A web-questionnaire, including several clinical scenarios, was distributed to 88 EORTC-affiliated centers. Responses were received between July 2013 and January 2014. RESULTS: A total of 84 responses were analyzed. While three-dimensional (3D) radiotherapy (RT) planning is carried out in 81 (96%) centers, nodal areas are delineated in only 51 (61%) centers. Only 14 (17%) centers routinely link internal mammary chain (IMC) and supraclavicular node (SCN) RT indications. In patients undergoing total mastectomy (TM) with ALND, SCN-RT is recommend by 5 (6%), 53 (63%) and 51 (61%) centers for patients with pN0(i+), pN(mi) and pN1, respectively. Extra-capsular extension (ECE) is the main factor influencing decision-making RNI after breast conserving surgery (BCS) and TM. After primary systemic therapy (PST), 49 (58%) centers take into account nodal fibrotic changes in ypN0 patients for RNI indications. In ypN0 patients with inner/central tumors, 23 (27%) centers indicate SCN-RT and IMC-RT. In ypN1 patients, SCN-RT is delivered by less than half of the centers in patients with ypN(i+) and ypN(mi). Twenty-one (25%) of the centers recommend ALN-RT in patients with ypN(mi) or 1-2N+ after ALND. Seventy-five (90%) centers state that age is not considered a limiting factor for RNI. CONCLUSION: The NORA survey is unique in evaluating the impact of SLNB/ALND status on adjuvant RNI decision-making and volumes after BCS/TM with or without PST. ALN-RT is often indicated in pN1 patients, particularly in the case of ECE. Besides the ongoing NSABP-B51/RTOG and ALLIANCE trials, NORA could help to design future specific RNI trials in the SLNB era without ALND in patients receiving or not PST.

Pregnancy outcome following maternal exposure to mirtazapine: a multicenter, prospective study.

This multicenter, observational prospective cohort study addresses the risk associated with exposure to mirtazapine during pregnancy. Pregnancy outcomes after exposure to mirtazapine were compared with 2 matched control groups: (1) exposure to any selective serotonin reuptake inhibitor (SSRI, control subjects with a psychiatric condition) and (2) no exposure to medication known to be teratogenic or any antidepressant (general control subjects). Data were collected by members of the European Network of Teratology Information Services between 1995 and 2011. Observations from 357 exposed pregnancies were compared with 357 pregnancies from each control group. The rate of major birth defects between the mirtazapine and the SSRI group did not differ significantly (4.5% vs 4.2%; odds ratio [OR], 1.1; 95% confidence interval [95% CI], 0.5-2.3; P = 0.9). A trend toward a higher rate of birth defects in the mirtazapine group compared with general control subjects (4.5% vs 1.9%; OR, 2.4; 95% CI, 0.9-6.3; P = 0.08) reached statistical significance after exclusion of chromosomal or genetic anomalies (4.1% vs 1.3%; OR, 3.3; 95% CI, 1.04-10.3; P = 0.03), but this difference became again nonsignificant if cases of exposure not comprising the first trimester were excluded from the analysis (3.4% vs 1.9%; OR, 1.8; 95% CI, 0.6-5.0; P = 0.26). The crude miscarriage rate did not differ significantly between the mirtazapine, the SSRI, and the general control groups (12.1% vs 12.0% vs 9.3%; P = 0.44). However, a higher rate of elective pregnancy termination was observed in the mirtazapine group compared with SSRI and general control subjects (7.8% vs 3.4% vs 5.6%; P = 0.03). This study did not observe a statistically significant difference in the rate of major birth defects after first-trimester exposure between mirtazapine, SSRI-exposed, and nonexposed pregnancies. A marginally higher rate of birth defects was, however, observed in the mirtazapine and SSRI groups compared with the low rate of birth defects in our general control subjects. Overall pregnancy outcome after mirtazapine exposure was similar to that of the SSRI-exposed control group.