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3. Aspirin Versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia

Author

Rolnik, Daniel L., Wright, David, Poon, Liona C., O’Gorman, Neil, Syngelaki, Argyro, de Paco Matallana, Catalina, Akolekar, Ranjit, Cicero, Simona, Janga, Deepa, Singh, Mandeep, Molina, Francisca S., Persico, Nicola, Jani, Jacques C., Plasencia, Walter, Papaioannou, George, Tenenbaum-Gavish, Kinneret, Meiri, Hamutal, Gizurarson, Sveinbjorn, Maclagan, Kate, and Nicolaides, Kypros H.

Published
2018
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4. Exenatide once weekly over 2 years as a potential disease-modifying treatment for Parkinson’s disease: protocol for a multicentre, randomised, double blind, parallel group, placebo controlled, phase 3 trial: The ‘Exenatide-PD3’ study

Author

Vijiaratnam, Nirosen, primary, Girges, Christine, additional, Auld, Grace, additional, Chau, Marisa, additional, Maclagan, Kate, additional, King, Alexa, additional, Skene, Simon, additional, Chowdhury, Kashfia, additional, Hibbert, Steve, additional, Morris, Huw, additional, Limousin, Patricia, additional, Athauda, Dilan, additional, Carroll, Camille B, additional, Hu, Michele T, additional, Silverdale, Monty, additional, Duncan, Gordon W, additional, Chaudhuri, Ray, additional, Lo, Christine, additional, Del Din, Silvia, additional, Yarnall, Alison J, additional, Rochester, Lynn, additional, Gibson, Rachel, additional, Dickson, John, additional, Hunter, Rachael, additional, Libri, Vincenzo, additional, and Foltynie, Thomas, additional

Published
2021
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5. Early vaginal progesterone versus placebo in twin pregnancies for the prevention of spontaneous preterm birth: a randomized, double-blind trial

Author

Rehal, Anoop, primary, Benkő, Zsófia, additional, De Paco Matallana, Catalina, additional, Syngelaki, Argyro, additional, Janga, Deepa, additional, Cicero, Simona, additional, Akolekar, Ranjit, additional, Singh, Mandeep, additional, Chaveeva, Petya, additional, Burgos, Jorge, additional, Molina, Francisca S., additional, Savvidou, Makrina, additional, De La Calle, Maria, additional, Persico, Nicola, additional, Quezada Rojas, Maria Soledad, additional, Sau, Ashis, additional, Greco, Elena, additional, O’Gorman, Neil, additional, Plasencia, Walter, additional, Pereira, Susana, additional, Jani, Jacques C., additional, Valino, Nuria, additional, del Mar Gil, Maria, additional, Maclagan, Kate, additional, Wright, Alan, additional, Wright, David, additional, and Nicolaides, Kypros H., additional

Published
2021
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7. Early Vaginal Progesterone Versus Placebo in Twin Pregnancies for Prevention of Spontaneous Preterm Birth (EVENTS): A Randomised Double-Blind Trial

Author

Rehal, Anoop, primary, Benkő, Zsófia, additional, De Paco Matallana, Catalina, additional, Syngelaki, Argyro, additional, Cicero, Simona, additional, Akolekar, Ranjit, additional, Singh, Mandeep, additional, Chaveeva, Petya, additional, Burgos, Jorge, additional, Molina, Francisca S., additional, Savvidou, Makrina, additional, De La Calle, Maria, additional, Persico, Nicola, additional, Quezada Rojas, Maria Soledad, additional, Sau, Ashis, additional, Greco, Elena, additional, O’Gorman, Neil, additional, Plasencia, Walter, additional, Pereira, Susana, additional, Jani, Jacques C, additional, Valino, Nuria, additional, del Mar Gil, Maria, additional, Maclagan, Kate, additional, Wright, Alan, additional, Wright, David, additional, and Nicolaides, Kypros H, additional

Published
2020
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9. Neprilysin inhibition for pulmonary arterial hypertension: a randomized, double‐blind, placebo‐controlled, proof‐of‐concept trial

Author

Hobbs, Adrian J., primary, Moyes, Amie J., additional, Baliga, Reshma S., additional, Ghedia, Dipa, additional, Ochiel, Rachel, additional, Sylvestre, Yvonne, additional, Doré, Caroline J., additional, Chowdhury, Kashfia, additional, Maclagan, Kate, additional, Quartly, Harriet L., additional, Sofat, Reecha, additional, Smit, Angelique, additional, Schreiber, Benjamin E., additional, Coghlan, Gerry J., additional, and MacAllister, Raymond J., additional

Published
2019
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11. Aspirin Versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia

Author

Rolnik, Daniel Lorber Orber D.L., Wright, David, Poon, Liona L.C., O'Gorman, Neil, Syngelaki, Argyro, de Paco Matallana, Catalina, Akolekar, Ranjit, Cicero, Simona, Janga, Deepa, Singh, Mandeep, Molina, Francisca Sonia, Persico, Nicola, Jani, Jacques, Plasencia, Walter, Papaioannou, George, Tenenbaum-Gavish, Kinneret, Meiri, Hamutal, Gizurarson, Sveinbjorn, Maclagan, Kate, Nicolaides, Kypros K.H., Rolnik, Daniel Lorber Orber D.L., Wright, David, Poon, Liona L.C., O'Gorman, Neil, Syngelaki, Argyro, de Paco Matallana, Catalina, Akolekar, Ranjit, Cicero, Simona, Janga, Deepa, Singh, Mandeep, Molina, Francisca Sonia, Persico, Nicola, Jani, Jacques, Plasencia, Walter, Papaioannou, George, Tenenbaum-Gavish, Kinneret, Meiri, Hamutal, Gizurarson, Sveinbjorn, Maclagan, Kate, and Nicolaides, Kypros K.H.

Abstract

SCOPUS: no.j, info:eu-repo/semantics/published

Published
2018

13. Aspirin versus placebo in pregnancies at high risk for preterm preeclampsia

Author

Rolnik, Daniel Lorber Orber D.L., Singh, Mandeep, Molina, Francisca Sonia, Persico, Nicola, Jani, Jacques, Plasencia, Walter, Papaioannou, George, Tenenbaum-Gavish, Kinneret, Meiri, Hamutal, Gizurarson, Sveinbjorn, Maclagan, Kate, Wright, David, Nicolaides, Kypros, Poon, Liona L.C., O'Gorman, Neil, Syngelaki, Argyro, de Paco Matallana, Catalina, Akolekar, Ranjit, Cicero, Simona, Janga, Deepa, Rolnik, Daniel Lorber Orber D.L., Singh, Mandeep, Molina, Francisca Sonia, Persico, Nicola, Jani, Jacques, Plasencia, Walter, Papaioannou, George, Tenenbaum-Gavish, Kinneret, Meiri, Hamutal, Gizurarson, Sveinbjorn, Maclagan, Kate, Wright, David, Nicolaides, Kypros, Poon, Liona L.C., O'Gorman, Neil, Syngelaki, Argyro, de Paco Matallana, Catalina, Akolekar, Ranjit, Cicero, Simona, and Janga, Deepa

Abstract

BACKGROUND: Preterm preeclampsia is an important cause of maternal and perinatal death and complications. It is uncertain whether the intake of low-dose aspirin during pregnancy reduces the risk of preterm preeclampsia. METHODS: In this multicenter, double-blind, placebo-controlled trial, we randomly assigned 1776 women with singleton pregnancies who were at high risk for preterm preeclampsia to receive aspirin, at a dose of 150 mg per day, or placebo from 11 to 14 weeks of gestation until 36 weeks of gestation. The primary outcome was delivery with preeclampsia before 37 weeks of gestation. The analysis was performed according to the intention-to-treat principle. RESULTS: A total of 152 women withdrew consent during the trial, and 4 were lost to follow up, which left 798 participants in the aspirin group and 822 in the placebo group. Preterm preeclampsia occurred in 13 participants (1.6%) in the aspirin group, as compared with 35 (4.3%) in the placebo group (odds ratio in the aspirin group, 0.38; 95% confidence interval, 0.20 to 0.74; P=0.004). Results were materially unchanged in a sensitivity analysis that took into account participants who had withdrawn or were lost to follow-up. Adherence was good, with a reported intake of 85% or more of the required number of tablets in 79.9% of the participants. There were no significant between-group differences in the incidence of neonatal adverse outcomes or other adverse events. CONCLUSIONS: Treatment with low-dose aspirin in women at high risk for preterm preeclampsia resulted in a lower incidence of this diagnosis than placebo., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2017

14. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia

Author

Rolnik, Daniel L., primary, Wright, David, additional, Poon, Liona C., additional, O’Gorman, Neil, additional, Syngelaki, Argyro, additional, de Paco Matallana, Catalina, additional, Akolekar, Ranjit, additional, Cicero, Simona, additional, Janga, Deepa, additional, Singh, Mandeep, additional, Molina, Francisca S., additional, Persico, Nicola, additional, Jani, Jacques C., additional, Plasencia, Walter, additional, Papaioannou, George, additional, Tenenbaum-Gavish, Kinneret, additional, Meiri, Hamutal, additional, Gizurarson, Sveinbjorn, additional, Maclagan, Kate, additional, and Nicolaides, Kypros H., additional

Published
2017
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15. Post hoc analysis of the Exenatide‐PD trial—Factors that predict response.

Author

Athauda, Dilan, Maclagan, Kate, Budnik, Natalia, Zampedri, Luca, Hibbert, Steve, Aviles‐Olmos, Iciar, Chowdhury, Kashfia, Skene, Simon S., Limousin, Patricia, and Foltynie, Thomas

Subjects
*TREMOR, *PARKINSON'S disease, *DISEASE duration, *GLUCAGON-like peptide-1 agonists, *BODY mass index, *DISEASES in older people, *TYPE 2 diabetes
Abstract

Exenatide, a glucagon‐like peptide‐1 agonist and a licensed treatment for Type 2 diabetes significantly reduced deterioration in motor symptoms in patients with Parkinson's disease in a randomized, placebo‐controlled trial. In addition, there were trends favouring the exenatide group in assessments of nonmotor symptoms, cognition, and quality of life. The aim of this exploratory post hoc analysis was to generate new hypotheses regarding (a) whether candidate baseline factors might predict the magnitude of response to exenatide; and (b) whether the beneficial effects of exenatide reported for the overall population are consistent in various subgroups of patients. Univariate and multivariate analyses were conducted to determine possible predictors of motor response to exenatide in this cohort. Potential treatment by subgroup interactions for changes in; motor severity, nonmotor symptoms, cognition, and quality of life after 48‐weeks treatment with exenatide were evaluated among post hoc subgroups defined by age, motor phenotype, disease duration, disease severity, body mass index (BMI), and insulin resistance. In the subgroup analyses, exenatide once‐weekly was associated with broadly improved outcome measures assessing motor severity, nonmotor symptoms, cognition, and quality of life across all subgroups, however, tremor‐dominant phenotype and lower Movement Disorder Society‐Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS‐UPDRS) Part‐2 scores predicted greatest motor response to exenatide and there was an indication that patients with older age of onset and disease duration over 10 years responded less well. While patients with a range of demographic and clinical factors can potentially benefit from exenatide once‐weekly, these data support an emphasis towards recruiting patients at earlier disease in future planned clinical trials of gluacagon‐like peptide‐1 (GLP‐1) receptor agonists in Parkinson's disease (PD). While patients with a wide range of demographic and clinical factors can potentially benefit from exenatide once‐weekly, and providing the results can be replicated our data support an emphasis towards recruitment of patients at earlier stages of the disease. These exploratory findings will contribute to the design of future trials that will confirm whether such heterogeneity of the effect of exenatide exists in a larger cohort of patients. [ABSTRACT FROM AUTHOR]

Published
2019
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19. Combinatorial Domain Hunting: An effective approach for the identification of soluble protein domains adaptable to high-throughput applications

Author

Reich, Stefanie, primary, Puckey, Loretto H., additional, Cheetham, Caroline L., additional, Harris, Richard, additional, Ali, Ammar A.E., additional, Bhattacharyya, Uma, additional, Maclagan, Kate, additional, Powell, Keith A., additional, Prodromou, Chrisostomos, additional, Pearl, Laurence H., additional, Driscoll, Paul C., additional, and Savva, Renos, additional

Published
2006
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20. Exploring Analysis Approaches for Using the Dopamine Transporter Striatal Binding Ratio in Early‐ to Mid‐Stage Parkinson's Disease Modification Trials.

Author

Vijiaratnam, Nirosen, Girges, Christine, Athauda, Dilan, King, Alexa, Auld, Grace, McComish, Rachel, Chowdhury, Kashfia, Skene, Simon, Maclagan, Kate, Chaudhuri, Kallol Ray, Libri, Vincenzo, Dickson, John, and Foltynie, Thomas

Subjects
*DOPAMINERGIC imaging, *PARKINSON'S disease, *DISEASE duration, *REGRESSION analysis, *HYPOKINESIA
Abstract

Background Objective Methods Results Conclusion The dopamine transporter striatal binding ratio (DAT SBR) has been used as an outcome measure in Parkinson's disease (PD) trials of potential disease‐modifying therapies; however, both patient characteristics and analysis approach potentially complicate its interpretation.The aim was to explore how well DAT SBR reflects PD motor severity across different striatal subregions and the relationship to disease duration, and side of onset.DAT SBR for the anterior and posterior putamen and caudate in both hemispheres was obtained using validated automated quantitative software on baseline scans of 132 patients recruited for the Exenatide PD2 and PD3 trials. Associations between mean and lateralized SBR subregions (posterior and anterior putamen and caudate) and summed and lateralized motor characteristics were explored using regression analysis. Analyses were repeated considering disease duration and limiting analysis to the less‐affected hemisphere.Lateralized bradykinesia was most consistently associated with the loss of DAT uptake in the contralateral anterior putamen. There was much higher variance in the posterior putamen, and in all regions in those with longer duration disease, although bradykinesia remained robustly associated with anterior putaminal DAT uptake even in longer‐duration patients. Restricting analyses to the less‐affected side did not usefully reduce the variance compared to the overall cohort.These data suggest that DAT SBR could be a useful biomarker in disease‐modifying trials, but a focus on anterior striatal subregions and incorporating disease duration into analyses may improve its utility. [ABSTRACT FROM AUTHOR]

Published
2024
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21. Aspirin Versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia

Author

Jacques Jani, Francisca S. Molina, Neil O'Gorman, Kinneret Tenenbaum-Gavish, Walter Plasencia, D. Janga, Nicola Persico, Liona C. Poon, Sveinbjörn Gizurarson, Ranjit Akolekar, Simona Cicero, Hamutal Meiri, Kate Maclagan, Kypros H. Nicolaides, Daniel L. Rolnik, David Wright, Catalina De Paco Matallana, Argyro Syngelaki, G. Papaioannou, Mandeep Singh, [Rolnik, Daniel L.] Kings Coll Hosp London, London, England, [Poon, Liona C.] Kings Coll Hosp London, London, England, [O'Gorman, Neil] Kings Coll Hosp London, London, England, [Syngelaki, Argyro] Kings Coll Hosp London, London, England, [Akolekar, Ranjit] Kings Coll Hosp London, London, England, [Nicolaides, Kypros H.] Kings Coll Hosp London, London, England, [Cicero, Simona] Homerton Univ Hosp, London, England, [Janga, Deepa] North Middlesex Univ Hosp, London, England, [Maclagan, Kate] UCL, Comprehens Clin Trials Unit, London, England, [Wright, David] Univ Exeter, Exeter, Devon, England, [Akolekar, Ranjit] Medway Maritime Hosp, Gillingham, England, [Singh, Mandeep] Southend Univ Hosp, Westcliff On Sea, England, [Poon, Liona C.] Chinese Univ Hong Kong, Hong Kong, Hong Kong, Peoples R China, [de Paco Matallana, Catalina] Hosp Clin Univ Virgen de la Arrixaca, Murcia, Spain, [Molina, Francisca S.] Hosp Univ San Cecilio, Granada, Spain, [Plasencia, Walter] Hospiten Grp, Tenerife, Spain, [Persico, Nicola] Osped Maggiore Policlin, Milan, Italy, [Jani, Jacques C.] Univ Libre Bruxelles, Univ Hosp Brugmann, Brussels, Belgium, [Papaioannou, George] Attikon Univ Hosp, Athens, Greece, [Tenenbaum-Gavish, Kinneret] Rabin Med Ctr, Petah Tiqwa, Israel, [Meiri, Hamutal] HyLabs Diagnost, Rehovot, Israel, and [Gizurarson, Sveinbjorn] Univ Iceland, Reykjavik, Iceland

Subjects
Adult, Risk, medicine.medical_specialty, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Placebo, Placebo group, Preeclampsia, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Pre-Eclampsia, Pregnancy, 030202 anesthesiology, Internal medicine, medicine, Humans, 030212 general & internal medicine, Lost to follow-up, reproductive and urinary physiology, Gynecology, Aspirin, Intention-to-treat analysis, 030219 obstetrics & reproductive medicine, Obstetrics, business.industry, Incidence, Infant, Newborn, Pregnancy Outcome, Obstetrics and Gynecology, Odds ratio, General Medicine, medicine.disease, female genital diseases and pregnancy complications, Intention to Treat Analysis, Pregnancy Complications, Platelet aggregation inhibitor, Gestation, Female, business, medicine.drug
Abstract

Since 1979, multiple studies have shown that low-dose aspirin in pregnancy can lower the occurrence of preeclampsia. Subsequent studies have shown that doses greater than 100 mg/d started before 16 weeks of gestation are most effective. Another recent study found that screening pregnant women for preeclampsia risk based on a combination of maternal factors and biochemical and physical measurements early in pregnancy could identify heightened risk of preeclampsia twice as well as predicting risk based on history alone. In this trial (the CombinedMultimarker Screening and Randomized Patient Treatment with Aspirin for Evidence-based Preeclampsia Prevention [ASPRE trial]), women identified as being at high risk of developing preeclampsia were treated with daily low-dose aspirin and compared with women who were treated with placebo. A double-blind randomized controlled trial was performed to assess the impact of 150 mg of aspirin daily from 11 to 14 weeks until 36 weeks of pregnancy in a group of women who were screened and found to be at high risk of preeclampsia. A total of 1776 women with singleton pregnancies were enrolled in the trial, which was analyzed on an intention-to-treat basis. After some women dropped out of the trial and some were lost to follow-up, there remained 822 participants in the placebo group and 798 in the aspirin group. Of these participants, 4.3% of the placebo group and 1.6% of the aspirin group developed preeclampsia before 37 weeks' gestation (odds ratio in the aspirin group, 0.38; 95% confidence interval, 0.20-0.74; P = 0.004). The occurrence of adverse outcomes such as miscarriage or stillbirth was not significantly different between the 2 groups. Sensitivity analyses showed that these results were not affected by the enrollees who dropped out of the trial by either choice or loss at follow-up. Compliance of participants was good, with nearly 80% taking 85% of their required aspirin doses. This study confirmed that a regimen of low-dose aspirin (150 mg/d) during pregnancy can lower the occurrence of preeclampsia in susceptible populations. In this trial, preeclampsia was reduced by more than half in women taking aspirin as compared with those taking a placebo.

Published
2018

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