Maternal Serum Lipid Trajectories and Association with Pregnancy Loss and Length of Gestation

Objective We characterized lipid trajectories and investigated lipids and rate of pregnancy lipid change with the risk of pregnancy loss or preterm delivery <37 weeks. Study Design In a secondary analysis of 337 women with one to two prior losses assigned to placebo in a randomized controlled trial at four centers (2007–2012), cholesterol, low- and high-density lipoprotein cholesterol (HDL-C), and triglycerides were measured up to 6 months prepregnancy (time 0) and pregnancy up to 7 visits. Trajectories were created using linear mixed models. Multivariable logistic regression with adjustment for maternal characteristics and cholesterol was performed. Results Lipids decreased from prepregnancy to 4 to 5 weeks, followed by an increase, and were biphasic or triphasic depending on the lipid component. Between 4 and 8 weeks, for every 1-unit increase in HDL-C, there was a 22% decreased odds of loss <14 weeks (odds ratio: 0.78; 95% confidence interval: 0.60, 0.99) and 24% decreased odds of loss or preterm delivery 14 to <37 weeks (odds ratio: 0.76; 95% confidence interval: 0.60, 0.96). Conclusion There were no associations with other lipid components or other time points. An impaired rise of HDL-C early in pregnancy may signal maladaptation to pregnancy that is associated with pregnancy loss or preterm delivery.

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Efficacy of two-week therapy with doxycycline-based quadruple regimen versus levofloxacin concomitant regimen for helicobacter pylori infection: a prospective single-center randomized controlled trial

BMC Infectious Diseases ◽

10.1186/s12879-021-06356-5 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Marouf Alhalabi ◽

Mohammed Waleed Alassi ◽

Kamal Alaa Eddin ◽

Khaled Cheha

Keyword(s):

Clinical Trial ◽

Helicobacter Pylori ◽

Confidence Interval ◽

Odds Ratio ◽

Controlled Trial ◽

Helicobacter Pylori Infection ◽

First Line ◽

Link Type ◽

Syrian Population

Abstract Background Antibiotic-resistance reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, which necessitates using various treatment protocols. We used two protocols, doxycycline-based quadruple regimen and concomitant levofloxacin regimen. The aim was to assess the effectiveness of doxycycline-based quadruple regimen for treating Helicobacter Pylori infections compared with levofloxacin concomitant regimen as empirical first-line therapy based on intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population. Settings and design An open-label, randomised, parallel, superiority clinical trial. Methods We randomly assigned 78 naïve patients who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (D-group) which received (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for 2 weeks), or (L-group) which received (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test 8 weeks after completing the treatment. Results Thirty-nine patients were allocated in each group. In the D-group, 38 patients completed the follow-up, 30 patients were cured. While in the L-group, 39 completed the follow-up, 32patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the D-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454–4.146]. According to PPA, the eradication rates were 78.9%, and 82.05% for the D-group and L-group respectively. The odds ratio with 95% confidence interval was 1.219 [0.394–3.774]. We didn’t report serious adverse effects. Conclusions Levofloxacin concomitant therapy wasn’t superior to doxycycline based quadruple therapy. Further researches are required to identify the optimal first-line treatment for Helicobacter-Pylori Infection in the Syrian population. Trial registration We registered this study as a standard randomized clinical trial (Clinicaltrial.gov, identifier-NCT04348786, date:29-January-2020).

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Translational delivery of Cool Little Kids to prevent child internalising problems: Randomised controlled trial

Australian & New Zealand Journal of Psychiatry ◽

10.1177/0004867417726582 ◽

2017 ◽

Vol 52 (2) ◽

pp. 181-191 ◽

Cited By ~ 14

Author(s):

Jordana K Bayer ◽

Ruth Beatson ◽

Lesley Bretherton ◽

Harriet Hiscock ◽

Melissa Wake ◽

...

Keyword(s):

Standard Deviation ◽

Confidence Interval ◽

Anxiety Disorders ◽

Odds Ratio ◽

Adjusted Odds Ratio ◽

Controlled Trial ◽

Secondary Outcomes ◽

Randomised Controlled ◽

Internalising Problems

Objective: To determine whether a population-delivered parenting programme assists in preventing internalising problems at school entry for preschool children at-risk with temperamental inhibition. Methods: Design: a randomised controlled trial was used. Setting: the setting was 307 preschool services across eight socioeconomically diverse government areas in Melbourne, Australia. Participants: a total of 545 parents of inhibited 4-year-old children: 498 retained at 1-year follow up. Early intervention: Cool Little Kids parenting group programme was implemented. Primary outcomes: the primary outcomes were child DSM-IV anxiety disorders (assessor blind) and internalising problems. Secondary outcomes: the secondary outcomes were parenting practices and parent mental health. Results: At 1-year follow up (mean (standard deviation) age = 5.8 (0.4) years), there was little difference in anxiety disorders between the intervention and control arms (44.2% vs 50.2%; adjusted odds ratio = 0.86, 95% confidence interval = [0.60, 1.25], p = 0.427). Internalising problems were reduced in the intervention arm (Strengths and Difficulties Questionnaire: abnormal – 24.2% vs 33.0%; adjusted odds ratio = 0.56, 95% confidence interval = [0.35, 0.89], p = 0.014; symptoms – mean (standard deviation) = 2.5 (2.0) vs 2.9 (2.2); adjusted mean difference = –0.47, 95% confidence interval = [–0.81, –0.13], p = 0.006). Parents’ participation in the intervention was modest (29.4% attended most groups, 20.5% used skills most of the time during the year). A priori interaction tests suggested that for children with anxious parents, the intervention reduced anxiety disorders and internalising symptoms after 1 year. Conclusion: Offering Cool Little Kids across the population for inhibited preschoolers does not impact population outcomes after 1 year. Effects may be emerging for inhibited children at highest risk with parent anxiety. Trial outcomes will continue into mid-childhood.

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Increasing response rates to follow-up questionnaires in health intervention research: Randomized controlled trial of a gift card prize incentive

Clinical Trials ◽

10.1177/1740774517703320 ◽

2017 ◽

Vol 14 (4) ◽

pp. 381-386 ◽

Cited By ~ 2

Author(s):

Amy J Morgan ◽

Ronald M Rapee ◽

Jordana K Bayer

Keyword(s):

Randomized Controlled Trial ◽

Confidence Interval ◽

Odds Ratio ◽

Response Rate ◽

Controlled Trial ◽

Response Rates ◽

Health Intervention ◽

Randomized Controlled ◽

Gift Card

Background/aims Achieving a high response rate to follow-up questionnaires in randomized controlled trials of interventions is important for study validity. Few studies have tested the value of incentives in increasing response rates to online questionnaires in clinical trials of health interventions. This study evaluated the effect of a gift card prize-draw incentive on response rates to follow-up questionnaires within a trial of an online health intervention. Method The study was embedded in a host randomized controlled trial of an online parenting program for child anxiety. A total of 433 participants were randomly allocated to one of two groups: (1) being informed that they would enter a gift card prize-draw if they completed the final study questionnaire (24-week follow-up) and (2) not informed about the prize-draw. All participants had a 1 in 20 chance of winning an AUD50 gift card after they completed the online questionnaire. Results The odds of the informed group completing the follow-up questionnaire were significantly higher than the uninformed group, (79.6% vs 68.5%, odds ratio = 1.79, 95% confidence interval = 1.15–2.79). This response rate increase of 11.1% (95% confidence interval = 2.8–19.1) occurred in both intervention and control groups in the host randomized controlled trial. The incentive was also effective in increasing questionnaire commencement (84.6% vs 75.9%, odds ratio = 1.74, 95% confidence interval = 1.07–2.84) and reducing the delay in completing the questionnaire (19.9 vs 22.6 days, hazard ratio = 1.34, 95% confidence interval = 1.07–1.67). Conclusion This study adds to evidence for the effectiveness of incentives to increase response rates to follow-up questionnaires in health intervention trials.

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Association between Platelet-Specific Collagen Receptor Glycoprotein 6 Gene Variants, Selected Biomarkers, and Recurrent Pregnancy Loss in Korean Women

Genes ◽

10.3390/genes11080862 ◽

2020 ◽

Vol 11 (8) ◽

pp. 862

Author(s):

Hui Jeong An ◽

Eun Hee Ahn ◽

Jung Oh Kim ◽

Chang Soo Ryu ◽

Han Sung Park ◽

...

Keyword(s):

Polymerase Chain Reaction ◽

Confidence Interval ◽

Odds Ratio ◽

Pregnancy Loss ◽

Adjusted Odds Ratio ◽

Recurrent Pregnancy Loss ◽

Korean Women ◽

Chain Reaction ◽

Genotype Frequencies ◽

Polymerase Chain

This paper investigates whether glycoprotein 6 (GP6) gene polymorphisms are a risk factor for recurrent pregnancy loss (RPL) in Korean women. Genotypes were determined by polymerase chain reaction-restriction fragment length polymorphism and real-time polymerase chain reaction amplification. We identified five polymorphisms in the GP6 gene: rs1654410 T>C, rs1671153 T>G, rs1654419 G>A, rs12610286 A>G, and rs1654431 G>A. GP6 rs1654410 CC was associated with decreased RPL risk (adjusted odds ratio = 0.292, 95% confidence interval = 0.105–0.815, p = 0.019), and recessive genotypes were also significantly associated with decreased RPL risk (adjusted odds ratio = 0.348, 95% confidence interval = 0.128−0.944, p = 0.038). GP6 rs1654419 GA was associated with decreased RPL risk (adjusted odds ratio = 0.607, 95% confidence interval = 0.375-0.982, p = 0.042), and dominant genotypes were significantly associated with decreased RPL risk (adjusted odds ratio = 0.563, 95% confidence interval = 0.358−0.885, p = 0.013). Altogether, the genotype frequencies of GP6 rs1654410 T>C and GP6 rs1654419 G>A were significantly different between RPL patients and control participants. Therefore, although GP6 polymorphisms may be useful as biomarkers of RPL, additional studies with heterogeneous cohorts are required to better understand the influence of GP6 and assess its performance as a biomarker.

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Association Study between the Polymorphisms of Matrix Metalloproteinase (MMP) Genes and Idiopathic Recurrent Pregnancy Loss

Genes ◽

10.3390/genes10050347 ◽

2019 ◽

Vol 10 (5) ◽

pp. 347 ◽

Cited By ~ 2

Author(s):

Han Sung Park ◽

Ki Han Ko ◽

Jung Oh Kim ◽

Hui Jeong An ◽

Young Ran Kim ◽

...

Keyword(s):

Confidence Interval ◽

Odds Ratio ◽

Pregnancy Loss ◽

Adjusted Odds Ratio ◽

Recurrent Pregnancy Loss ◽

Proteolytic Enzymes ◽

Nucleotide Polymorphisms ◽

Genotype Combination ◽

History Of ◽

Consecutive Pregnancy

Recurrent pregnancy loss (RPL) refers to two or more consecutive pregnancy losses. It is estimated that fewer than 5% of women experience RPL. Matrix metalloproteinases (MMPs) are a family of proteolytic enzymes that play important roles in providing a safe and conducive environment for the stable development of the fetus. In this case-control study, we evaluated the associations between RPL and single nucleotide polymorphisms (SNPs) in MMP-8 and MMP-27. We recruited 375 Korean women with a history of RPL and 240 ethnically-matched healthy parous controls, and we performed genotyping for the MMP-8 rs2509013 C>T, MMP-8 rs11225395 G>A, and MMP-27 rs3809017 T>C polymorphisms. All SNPs were genotyped via the polymerase chain reaction–restriction fragment length polymorphism (PCR-RFLP) assay. In the genotype frequency analyses, the TT genotype of the MMP-8 rs2509013 C>T (age-adjusted odds ratio, 0.415; 95% confidence interval, 0.257–0.671; P = 0.0003) and TC genotype of MMP-27 rs3809017 T>C (age-adjusted odds ratio, 0.681; 95% confidence interval, 0.483–0.961; P = 0.029) were associated with decreased RPL susceptibility. Moreover, these trends were maintained in the haplotype and genotype combination analyses. Interestingly, amongst the RPL patients, higher levels of homocysteine (P = 0.042) and uric acid (P = 0.046) were associated with MMP-27 rs3809017 T>C. In conclusion, the two polymorphisms of MMP-8 and MMP-27 were significantly associated with RPL risk, both individually and in combination. Therefore, these two polymorphisms are potential biomarkers for RPL susceptibility.

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A Multicenter Case-Control Prospective Study to Assess the Risk of Immune Thrombocytopenia (ITP) Associated with Vaccines in Adults Using the PGRx-ITP Registry

Blood ◽

10.1182/blood.v118.21.1169.1169 ◽

2011 ◽

Vol 118 (21) ◽

pp. 1169-1169 ◽

Cited By ~ 1

Author(s):

Lamiae Grimaldi-Bensouda ◽

Marc Michel ◽

Jean-François Viallard ◽

Daniel Adoue ◽

Nadine Magy-Bertrand ◽

...

Keyword(s):

Confidence Interval ◽

Odds Ratio ◽

Immune Thrombocytopenia ◽

Index Date ◽

Adjusted Odds Ratio ◽

Time Window ◽

Case Reports ◽

Secondary Analysis ◽

Case Control ◽

Research Fellowship

Abstract Abstract 1169 Background and objectives Immune thrombocytopenia (ITP) is thought to result from an autoimmune mechanism, and some case-reports have suggested that immunizations could be involved and trigger the autoimmune process. This prospective multicenter case-control study investigated for the first time associations between ITP and vaccination in adults, particularly between ITP and influenza vaccinations. Methods Over a three year period, a network of 15 physicians from hematology and internal medicine referral centers across France recruited newly diagnosed cases of primary ITP in patients aged over 15 years fulfilling the ITP standardized criteria of the American Society of Hematology. Recruiting physicians completed standardized forms for each patient and every patient underwent a standardized 1 hour-interview focused on previous medications and vaccinations in the last 12 months. Incident ITP cases were compared to sex and age-matched controls selected and recruited from general practice settings, also from the same geographically areas of France. The method of referent recruitment has been described elsewhere (Grimaldi-Bensouda et al. 2010 Pharmacoepidemiol Drug Saf 2010;19(6):591–5). Controls were also interviewed in the same standardized way as cases. Cases and control were compared in respect of various descriptive factors and potential risk factors for ITP. Written or other confirmation of vaccinations was sought from both the patient and his/her physician. The time window defining exposure to vaccines was 12 months before the index date. In secondary analysis, the most prevalent vaccines in adults were analyzed. Results Two hundred and twenty four cases fulfilling the inclusion criteria and 4412 were included in the study. Seventy eight of the 224 cases (34.8%) and 1566 of 4412 controls (35.5%) received a vaccination within this time window [adjusted odds ratio 0.97, 95% confidence interval 0.70–1.33]. Twenty percent of the cases and 26% of controls received an influenza vaccine [adjusted odds ratio 0.66, 95% confidence interval 0.45–0.98]. Other prevalent vaccines in adult are currently under study. Conclusions This systematic case-control design is well-suited to study rare disorders such as ITP and few such studies have been conducted. Another advantage was the minimization of recall bias because questions about vaccinations were included in a standardized interview focusing on exposure to all medications. When all vaccines were considered, we found no association between vaccination and the incidence of ITP in either crude or adjusted analyses. Moreover, cases were less likely than controls to have been vaccinated against influenza in the 12 months before the index date. Disclosures: Grimaldi-Bensouda: LA-SER: Employment; INSERM: I was the recipient of a research fellowship from the INSERM (French National Institute for Health and Medical Research) at the time of the study. Leighton:LA-SER Europe Ltd: Employment. Aubrun:LA-SER Europe Ltd: Employment. Abenhaim:LA-SER Europe Ltd: I'm a stock owner and chairman of LA-SER, the company conducting the study.

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Acupuncture Efficacy on Ischemic Stroke Recovery

Stroke ◽

10.1161/strokeaha.114.007659 ◽

2015 ◽

Vol 46 (5) ◽

pp. 1301-1306 ◽

Cited By ~ 48

Author(s):

Shihong Zhang ◽

Bo Wu ◽

Ming Liu ◽

Ning Li ◽

Xianrong Zeng ◽

...

Keyword(s):

Ischemic Stroke ◽

Confidence Interval ◽

Odds Ratio ◽

Standard Care ◽

Controlled Trial ◽

Health Gain ◽

Institutional Care ◽

Stroke Recovery ◽

Control Group ◽

Clinical Trial Registration

Background and Purpose— Acupuncture is a frequently used complementary treatment for ischemic stroke in China but the evidence available from previous randomized trials is inconclusive. The objective of this study was to assess the efficacy and safety of acupuncture in a more robustly designed larger scale trial. Methods— This is a multicenter, single-blinded, randomized controlled trial. Eight hundred sixty-two hospitalized patients with limb paralysis between 3 to 10 days after ischemic stroke onset were allocated acupuncture plus standard care or standard care alone. The acupuncture was applied 5 times per week for 3 to 4 weeks. The primary outcomes were defined as follows: (1) death/disability according to Barthel index and (2) death/institutional care at 6 months. Results— There was a tendency of fewer patients being dead or dependent in acupuncture group (80/385, 20.7%) than in control group (102/396, 25.8%) at 6 months (odds ratio, 0.75; 95% confidence interval, 0.54–1.05). The benefit was noted in subgroup receiving ≥10 sessions of acupuncture (odds ratio, 0.68; 95% confidence interval, 0.47–0.98). There was no statistical difference in death or institutional care between the 2 groups (odds ratio, 1.06; 95% confidence interval, 0.63–1.79). Severe adverse events occurred in 7.6% and 8.3% of patients in the 2 groups, respectively. Conclusions— Acupuncture seemed to be safe in the subacute phase of ischemic stroke. If the potential benefits observed are confirmed in future larger study, the health gain from wider use of the treatment could be substantial. Clinical Trial Registration— URL: http://www.chictr.org/en/ . Unique identifier: ChiCTR-TRC-11001353.

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Network Meta-Analysis of Novel Glucose-Lowering Drugs on Risk of Acute Kidney Injury

Clinical Journal of the American Society of Nephrology ◽

10.2215/cjn.11220720 ◽

2020 ◽

Vol 16 (1) ◽

pp. 70-78 ◽

Cited By ~ 1

Author(s):

Min Zhao ◽

Shusen Sun ◽

Zhenguang Huang ◽

Tiansheng Wang ◽

Huilin Tang

Keyword(s):

Type 2 Diabetes ◽

Confidence Interval ◽

Odds Ratio ◽

Lower Risk ◽

Meta Analysis ◽

Secondary Analysis ◽

Sglt2 Inhibitors ◽

Glucose Lowering ◽

Event Driven

Background and objectivesLittle is known about the comparative effects of dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 receptor agonists (GLP-1RAs), or sodium glucose cotransporter-2 (SGLT2) inhibitors on risk of AKI. This study aimed to compare the effects of these three novel classes of glucose-lowering drugs on AKI risk in patients with or without type 2 diabetes, by network meta-analysis of event-driven cardiovascular or kidney outcome trials.Design, setting, participants, & measurementsWe systematically searched electronic databases up to September 2020, and included 20 event-driven cardiovascular or kidney outcome trials (18 trials included patients with type 2 diabetes only, and two trials included patients with or without type 2 diabetes). A network meta-analysis using a frequentist approach was performed to compare the effects of DPP-4 inhibitors, GLP-1RAs, or SGLT2 inhibitors on risk of AKI, and estimate the probability for each intervention as the safest one. The primary analysis included 18 trials with type 2 diabetes only, and a secondary analysis included 20 trials.ResultsIn the 18 trials with a total of 2051 AKI events (range: 1–300) among 156,690 patients with type 2 diabetes only, our network meta-analysis showed that SGLT2 inhibitors were associated with a lower risk of AKI compared with placebo (odds ratio, 0.76; 95% confidence interval, 0.66 to 0.88), whereas both DPP-4 inhibitors and GLP-1RAs had neutral effects on risk of AKI. Moreover, SGLT2 inhibitors were significantly associated with a lower risk in AKI than both GLP-1RAs (odds ratio, 0.79; 95% confidence interval, 0.65 to 0.97) and DPP-4 inhibitors (odds ratio, 0.68; 95% confidence interval, 0.54 to 0.86). SGLT2 inhibitors have the highest probability of being the safest intervention (84%). The results were similar in the secondary analysis.ConclusionsCurrent evidence indicates that SGLT2 inhibitors have a lower risk of AKI than both DPP-4 inhibitors and GLP-1RAs.

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Preferential Metabolic Improvement by Intermittent Fasting in People with Elevated Baseline Red Cell Distribution Width: A Secondary Analysis of the WONDERFUL Randomized Controlled Trial

Nutrients ◽

10.3390/nu13124407 ◽

2021 ◽

Vol 13 (12) ◽

pp. 4407

Author(s):

Benjamin D. Horne ◽

Joseph B. Muhlestein ◽

Heidi T. May ◽

Viet T. Le ◽

Tami L. Bair ◽

...

Keyword(s):

Metabolic Syndrome ◽

Controlled Trial ◽

Low Density Lipoprotein ◽

Secondary Analysis ◽

Density Lipoprotein ◽

Red Cell Distribution Width ◽

Intermittent Fasting ◽

Red Cell ◽

Cell Distribution ◽

Distribution Width

Red cell distribution width (RDW) predicts cardiovascular outcomes, but it is unstudied with regard to intermittent fasting. In WONDERFUL trial subjects, the effect of the interaction between baseline RDW and intermittent fasting on changes in insulin and other cardiometabolic endpoints and the effect of fasting on changes in RDW were evaluated. The subjects enrolled were aged 21–70 years and were free of statins, anti-diabetes medications, and chronic diseases, and had ≥1 metabolic syndrome feature, as well as elevated low-density lipoprotein cholesterol. Subjects were randomized to 24-h, water-only fasting (twice per week for 4 weeks, once per week for 22 weeks) or 26 weeks of ad libitum eating. Subjects (N = 71; n = 38 intermittent fasting, n = 33 controls) had more substantial changes in insulin in intermittent fasting vs. controls (−3.45 ± 2.27 vs. 0.48 ± 3.55 mIU/L) when baseline RDW size distribution (RDW-SD) was ≥median (42.6 fL) than <median (−1.99 ± 2.80 vs. −1.08 ± 3.40 mIU/L) (p-interaction = 0.039). Results were similar but weaker for glucose, HOMA-IR, and metabolic syndrome score. RDW-SD (intermittent fasting: 1.27 ± 9.6 fL vs. control: −0.37 ± 1.76 fL, p = 0.34) was unchanged by fasting at 26 weeks. Intermittent fasting decreased insulin more in subjects with higher baseline RDW. RDW may identify individuals who derive the most health benefits from intermittent fasting and who have the most cause to adhere to a fasting regimen.

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Erenumab versus topiramate for the prevention of migraine – a randomised, double-blind, active-controlled phase 4 trial

Cephalalgia ◽

10.1177/03331024211053571 ◽

2021 ◽

pp. 033310242110535

Author(s):

Uwe Reuter ◽

Marc Ehrlich ◽

Astrid Gendolla ◽

Axel Heinze ◽

Jan Klatt ◽

...

Keyword(s):

Confidence Interval ◽

Odds Ratio ◽

Controlled Trial ◽

Double Blind ◽

Peptide Receptor ◽

Medication Discontinuation ◽

Calcitonin Gene ◽

The Individual ◽

Efficacy Profile ◽

Monoclonal Antibody Binding

Background We compared the tolerability and efficacy of erenumab, a monoclonal antibody binding to the calcitonin gene-related peptide receptor, to topiramate for migraine prophylaxis in adults. Methods HER-MES was a 24-week, randomised, double-blind, double-dummy, controlled trial conducted in 82 sites in Germany. Patients with ≥4 migraine days per month and naïve to study drugs were randomly assigned (1:1) to either subcutaneous erenumab (70 or 140 mg/month) plus topiramate placebo (erenumab group) or oral topiramate at the individual dose with optimal efficacy (50–100 mg/day) plus erenumab placebo (topiramate group). The primary endpoint was medication discontinuation due to an adverse event during the double-blind phase. The proportion of patients that achieved ≥50% reduction from baseline in monthly migraine days during the last 3 months of the double-blind phase was a secondary endpoint. Results Seven hundred and seventy-seven patients were randomised (from 22 February 2019 to 29 July, 2020) and 95.1% completed the study. In the erenumab group, 10.6% discontinued medication due to adverse events compared to 38.9% in the topiramate group (odds ratio, 0.19; 95% confidence interval 0.13–0.27; p < 0.001). Significantly more patients achieved a ≥50% reduction in monthly migraine days from baseline with erenumab (55.4% vs. 31.2%; odds ratio 2.76; 95% confidence interval 2.06–3.71; p < 0.001). No new safety signals occurred. Conclusions Erenumab demonstrated a favourable tolerability and efficacy profile compared to topiramate. Trial registration: ClinicalTrials.gov NCT03828539, URL: https://clinicaltrials.gov/ct2/show/NCT03828539

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