Heather Wray

An open‐label randomized study of the relative absorption of gastro‐resistant risedronate taken fasted or with food versus immediate‐release risedronate

Diane Kleinermans, Andrew Joyson, Heather Wray

Abstract Patients with osteoporosis often take oral bisphosphonates with food, rendering these medications ineffective. This study compared the relative absorption of four formulations of gastro‐resistant (GR; formulations 1–4) risedronate 35 mg versus immediate‐release (IR) risedronate 35 mg taken fasted. Secondarily, it compared …

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A Post-Authorization Safety Study of Quetiapine as Antidepressant Treatment in Sweden: Nested Case–Control Analyses of Select Outcomes

Johan Reutfors, Philip Brenner, Bob Brody, Heather Wray et autres

INTRODUCTION: This post-authorization safety study (PASS) was a commitment to the European Medicines Agency. OBJECTIVE: This PASS investigated quetiapine as antidepressant treatment in Swedish registers with regard to the risk for all-cause mortality, self-harm and suicide, acute myocardial infarction, stroke, diabetes mellitus, …

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Pharmacokinetics of the Oral Selective CXCR2 Antagonist AZD5069: A Summary of Eight Phase I Studies in Healthy Volunteers

Marie Cullberg, Cecilia Arfvidsson, BENGT S. LARSSON, Anna Malmgren et autres

The aim of this study was to summarise the pharmacokinetic findings from eight phase I studies in healthy volunteers given oral AZD5069, a selective small-molecule CXCR2 antagonist. 240 healthy volunteers across eight phase I studies received single (0.1–200 mg) or multiple once- …

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Results from a drug utilization study of extended release quetiapine fumarate prescribed by psychiatrists as treatment for major depressive disorder in selected countries in the European Union

Robert S. Brody, Charles L. Liss, Heather Wray, Kari B. Kastango et autres

This multicenter, observational drug utilization (DU) study (NCT01594996) investigated the profile of patients and specialist providers who prescribed extended release quetiapine fumarate (quetiapine XR) for treatment of major depressive disorder (MDD) across five European countries (Germany, Italy, Romania, Spain, and Sweden). A …

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Efficacy of Zolmitriptan Nasal Spray for the Treatment of Acute Migraine in Adolescents: Subgroup analysis by Age (S52.005)

Paul K Winner, Robert Rubens, Nathan R. Rustay, Sarita Khanna et autres

Analyze the effect of patient age on the effectiveness of zolmitriptan nasal spray (ZNS) in adolescent migraine, using patient subgroups of younger (12–14 years) and older (15–17 years) adolescents.

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Physician Online Survey

Robert S. Brody, Charles L. Liss, Heather Wray, Ramon C Iovin et autres

Effectiveness of a risk-minimization activity involving physician education on metabolic monitoring of patients receiving quetiapine

Robert S. Brody, Charles L. Liss, Heather Wray, Ramon C Iovin et autres

Following Good Pharmacovigilance Practices Module XVI, two complementary studies were performed that included process and outcome measurements of the effectiveness of physician education on metabolic monitoring of patients receiving quetiapine. A multinational survey of 800 European Union physicians was utilized to assess …

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A randomised, placebo-controlled study of the CXCR2 antagonist AZD5069 in bronchiectasis

Anthony De Soyza, Ian Douglas Pavord, J.S. Elborn, David Lloyd Smith et autres

This randomised double-blind placebo-controlled parallel-group multicentre phase IIa study evaluated the effect of the CXCR2 antagonist AZD5069 on sputum neutrophil counts in adults with bronchiectasis.Patients were randomised 1:1 to receive AZD5069 80 mg or placebo orally twice daily for 28 days. Assessments …

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The safety and tolerability of oral AZD5069, a selective CXCR2 antagonist, in patients with moderate-to-severe COPD

A. Kirsten, Karin Förster, E. Radeczky, Anneliese Linnhoff et autres

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Effect of the CYP3A4 inhibitor ketoconazole on the pharmacokinetics and pharmacodynamics of AZD5069, an oral CXCR2 antagonist

Marie Cullberg, Heather Wray, BENGT S. LARSSON

Background: AZD5069 is an oral C-X-C chemokine receptor 2 (CXCR2) antagonist targeting neutrophil-driven inflammation and is in clinical evaluation for the treatment of inadequately controlled asthma. AZD5069 is primarily metabolised by CYP3A isoenzymes, 1 but the impact of CYP3A inhibition on systemic …

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The effect of tumour necrosis factor-α and insulin on equine digital blood vessel function in vitro

Nicola J. Menzies‐Gow, Heather Wray, Simon R. Bailey, Patricia A. Harris et autres

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Efficacy and safety of AZD5069, a CXCR2 antagonist, in adult bronchiectasis

Ian Douglas Pavord, Anthony De Soyza, J.S. Elborn, David Lloyd Smith et autres

Rationale: CXCR2 antagonist AZD5069 may be useful for neutrophilic airway diseases, including bronchiectasis. This early phase study assessed the effects of AZD5069 on sputum neutrophil numbers, a range of biomarkers, other variables and safety in bronchiectasis patients (pts). Methods: Pts with radiological …

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