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30. Bioavailability and cardiovascular effects of adrenaline administered by Anapen 500 μg auto‐injector in healthy volunteers.

Author

Duvauchelle, Thierry, Robert, Philippe, Donazzolo, Yves, Loyau, Sabrina, Orlandini, Bernard, Lehert, Philippe, Lecomte, Jeanne‐Marie, and Schwartz, Jean‐Charles

Subjects
WEIGHT loss, ADRENALINE, INTRAMUSCULAR injections, SYSTOLIC blood pressure, SUBCUTANEOUS injections
Abstract

Aims: Anaphylaxis guidelines recommend intramuscular adrenaline, commonly 300 μg administered using an auto‐injector device. However, overweight/obese patients may require a higher adrenaline dose for adequate cardiovascular (CV) response. This study evaluated the pharmacokinetics (PK) and pharmacodynamic (PD) CV profiles after a single 500 μg adrenaline injection via Anapen auto‐injector in healthy normal weight males and otherwise healthy, overweight or obese females. Methods: In this exploratory open‐label, single‐centre study, 54 healthy volunteers aged 18‐50 years received a single 500 μg adrenaline injection (Anapen auto‐injector) in the thigh (antero‐lateral middle third [18 males] or antero‐inferior third [36 females]). Assessments included depot depth (ultrasonography), plasma adrenaline levels (liquid chromatography‐tandem mass spectrometry) and heart rate (HR; ECG Holter monitor). Results: Ultrasonography showed that 82.4% of normal weight males received intramuscular injections; all overweight and obese females received subcutaneous injections. Anapen injection produced rapid increases in circulating adrenaline levels and significant increases in systolic blood pressure (SBP) and HR. Second peak plasma adrenaline concentrations (Cmax2) were reduced, and time to Cmax2 increased in overweight and obese females compared with males with normal body mass index; area under the curve (0–240 min) (AUC(0‐240)) was increased in overweight and obese females. Obese females had reduced maximal SBP values compared with normal weight males or overweight females; overweight and obese females had markedly different HR time courses compared with normal weight males. Conclusion: A 500 μg adrenaline injection via Anapen produced rapid PK/PD changes in normal weight, overweight and obese subjects, irrespective of intramuscular or subcutaneous injection, and was well tolerated. [ABSTRACT FROM AUTHOR]

Published
2023
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33. Additional file 3 of Metformin and high-sensitivity cardiac troponin I and T trajectories in type 2 diabetes patients: a post-hoc analysis of a randomized controlled trial

Author

Stultiens, Johanna M. G., Top, Wiebe M. C., Kimenai, Dorien M., Lehert, Philippe, Bekers, Otto, Stehouwer, Coen D. A., Kooy, Adriaan, and Meex, Steven J. R.

Abstract

Additional file 3: Table S1. Troponin I and Troponin T linear mixed-effects model metrics. Table S2. Sex-stratified mixed models of Troponin I and Troponin T. Table S3. Prevalence of elevated cardiac troponins in placebo vs. metformin. Table S4. Random slope/random intercept models as sensitivity analysis for Troponin I. Table S5. Random slope/random intercept models as sensitivity analysis for Troponin T.

Published
2022
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44. sj-docx-2-tag-10.1177_17562848211033740 – Supplemental material for Efficacy of pinaverium bromide in the treatment of irritable bowel syndrome: a systematic review and meta-analysis

Author

Bor, Serhat, Lehert, Philippe, Chalbaud, Adriana, and Tack, Jan

Subjects
FOS: Clinical medicine, 111199 Nutrition and Dietetics not elsewhere classified, FOS: Health sciences, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 111299 Oncology and Carcinogenesis not elsewhere classified
Abstract

Supplemental material, sj-docx-2-tag-10.1177_17562848211033740 for Efficacy of pinaverium bromide in the treatment of irritable bowel syndrome: a systematic review and meta-analysis by Serhat Bor, Philippe Lehert, Adriana Chalbaud and Jan Tack in Therapeutic Advances in Gastroenterology

Published
2021
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45. Efficacy of pinaverium bromide in the treatment of irritable bowel syndrome: a systematic review and meta-analysis

Author

Bor, Serhat, Lehert, Philippe, Chalbaud, Adriana, and Tack, Jan

Subjects
irritable bowel syndrome, meta-analysis, treatment, efficacy, pinaverium bromide, Otilonium Bromide, Smooth-Muscle Relaxants
Abstract

Background: Spasmolytic agents are an attractive first line treatment option for irritable bowel syndrome (IBS). Pinaverium bromide (pinaverium) has antispasmodic effects on gastrointestinal smooth muscle and can relieve major IBS symptoms, but an up-to-date meta-analysis comparing the efficacy of pinaverium with placebo is lacking. The aim is to perform a systematic review and meta-analysis to assess the efficacy of pinaverium compared with placebo for IBS treatment. Methods: All placebo-controlled trials evaluating pinaverium for IBS treatment were included, up to October 2019. Treatment efficacy was evaluated by overall patient IBS symptoms. Individual symptoms were also evaluated. The effect of pinaverium versus placebo was expressed as standardized mean difference (SMD) and risk ratio (RR). Odds ratio (OR) and number needed to treat (NNT) were also calculated. Results: Eight studies were included for analysis. Pinaverium treatment had a beneficial effect on overall IBS symptom relief with a positive SMD of 0.64 [95% confidence interval (CI) 0.45-0.82, p < 0.0001] and a positive RR of 1.75 (1.26-2.43, p < 0.0008). No significant difference was found by publication year, gender, age, methodological quality score (MQS), or sample size. No publication bias was detected. OR was 3.43 (2.00-5.88, p < 0.0001), and NNT was 4. Pinaverium also demonstrated a beneficial treatment effect for abdominal pain, stool change, and bloating improvement or resolution. Conclusion: Pinaverium is superior to placebo for the treatment of IBS symptoms, irrespective of patient age or gender, study publication year, sample size, or MQS. The NNT in this meta-analysis is amongst the lowest for studies and meta-analyses of antispasmodics versus placebo in IBS.

Published
2021

46. Survival without Bronchopulmonary Dysplasia of Extremely Preterm Infants: A Predictive Model at Birth

Author

Baud, Olivier, Laughon, Matthew, and Lehert, Philippe

Subjects
Extremely preterm infants, Risk, ddc:618, Prediction model, Bronchopulmonary dysplasia
Abstract

Early prediction of survival without bronchopulmonary dysplasia (BPD) at 36 weeks of postmenstrual age remains challenging for infants born extremely preterm. We aimed to provide a new predictive model including variables available only at or soon after birth based on the literature and existing models.

Published
2021

47. sj-docx-1-tag-10.1177_17562848211033740 – Supplemental material for Efficacy of pinaverium bromide in the treatment of irritable bowel syndrome: a systematic review and meta-analysis

Author

Bor, Serhat, Lehert, Philippe, Chalbaud, Adriana, and Tack, Jan

Subjects
FOS: Clinical medicine, 111199 Nutrition and Dietetics not elsewhere classified, FOS: Health sciences, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 111299 Oncology and Carcinogenesis not elsewhere classified
Abstract

Supplemental material, sj-docx-1-tag-10.1177_17562848211033740 for Efficacy of pinaverium bromide in the treatment of irritable bowel syndrome: a systematic review and meta-analysis by Serhat Bor, Philippe Lehert, Adriana Chalbaud and Jan Tack in Therapeutic Advances in Gastroenterology

Published
2021
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