Expert Review of Clinical Pharmacology




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Profile of estetrol, a promising native estrogen for oral contraception and the relief of climacteric symptoms of menopause

Céline Gérard , Jean-François Arnal , Maud Jost , Jonathan Douxfils ORCID Icon, Françoise Lenfant , Coralie Fontaine , René Houtman , David F. Archer

doi : 17512433.2022.2054413

Estrogens used in women’s healthcare have been associated with increased risks of venous thromboembolism (VTE) and breast cancer. Estetrol (E4), an estrogen produced by the human fetal liver, has recently been approved for the first time as a new estrogenic component of a novel combined oral contraceptive (E4/drospirenone [DRSP]) for over a decade. In phase 3 studies, E4/DRSP showed good contraceptive efficacy, a predictable bleeding pattern, and a favorable safety and tolerability profile.

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Evinacumab for the treatment of homozygous familial hypercholesterolemia

Yanli Gao , Baoqi Zhang & Junyi Yang

doi : 10.1080/17512433.2022.2047934

Hypercholesterolemia is mainly caused by abnormal lipoprotein metabolism and can increase the risk of cardiovascular disease. Angiopoietin-like protein 3 (ANGPTL3) can increase low-density lipoprotein cholesterol (LDL-C) and other lipids by inhibiting lipoprotein lipase activity. Evinacumab is a monoclonal antibody against ANGPTL3, it can decrease levels of LDL-C and has shown potential benefit in patients with homozygous familial hypercholesterolemia (HoFH).

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Growing role of SGLT2i in heart failure: evidence from clinical trials

Ajay Varadhan, Katarina Stephan, Rahul Gupta, Apurva V. Vyas, Purva Ranchal, Wilbert S. Aronow, Nael Hawwa & Gregg M. Lanier

doi : 10.1080/17512433.2022.2051480

There is an unmet need for therapies that improve overall mortality and morbidity for patients with preserved ejection fraction, who comprise roughly half of all heart failure (HF) cases. The growing role of sodium–glucose cotransporter-2 inhibitors (SGLT2is) in

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Emerging data on rifampicin pharmacokinetics and approaches to optimal dosing in children with tuberculosis

Kendra K. Radtke, Elin M. Svensson, Louvina E. van der Laan, Anneke C. Hesseling, Radojka M. Savic & Anthony J. Garcia-Prats

doi : 10.1080/17512433.2022.2053110

Despite its longstanding role in tuberculosis (TB) treatment, there continues to be emerging rifampicin research that has important implications for pediatric TB treatment and outstanding questions about its pharmacokinetics and optimal dose in children.

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Assessing the potential for drug interactions and long term safety of melatonin for the treatment of insomnia in children with autism spectrum disorder

Nava Zisapel

doi : 10.1080/17512433.2022.2053520

Melatonin preparations are emerging first-line pharmacotherapy for insomnia in children and adolescents with autism spectrum disorder (ASD), but quality, formulation, consistency, dosing, and limited long-term safety data are of concern. The recent approval of pediatric-appropriate prolonged-release melatonin (Ped-PRM) addresses these aspects.

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Recent pharmacological approaches for the treatment of renal cell carcinoma

Arman Alimohammadi, Harun Fajkovic, Mesut Remzi, Shahrokh Shariat & Manuela Schmidinger

doi : 10.1080/17512433.2022.2053521

Therapies combining either two immune check-point inhibitors (ICIs) or an ICI and a tyrosine kinase inhibitor (TKI) have been shown to improve overall survival (OS), progression-free survival (PFS) and objective response rates (ORR) in metastatic renal cell carcinoma (mRCC); moreover, unprecedented rates of complete remission (CR) have been reported.

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Alternate-day add-on therapy with dapagliflozin in patients with type 2 diabetes mellitus: potential benefits and concerns

Harmanjit Singh, Dinesh Joshi, Seerat Narula, Mandeep Singla, Ravi Rohilla & Jagjit Singh

doi : 10.1080/17512433.2022.2053111

Factors such as compliance, cost and safety play a major role in achieving the long-term goal in the management of type 2 diabetes mellitus (T2DM). Dapagliflozin carries a great potential of becoming an alternate-day therapy because of its favorable pharmacological properties.

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Pharmacological management of fibromyalgia: a Bayesian network meta-analysis

Filippo Migliorini, Nicola Maffulli, Jörg Eschweiler, Matthias Knobe, Markus Tingart & Giorgia Colarossi

doi : 10.1080/17512433.2022.2044792

The identification of the most effective therapy for patients with fibromyalgia (FM) remains controversial. Thus, we conducted a Bayesian network meta-analysis to compare several drugs employed as pharmacological management for FM.

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Biosimilar development and review process in the BRICS-TM countries: Proposal for a standardized model to improve regulatory performance

Hasumati Rahalkar, Alan Sheppard & Sam Salek

doi : 10.1080/17512433.2022.2034498

The current study is aimed at proposing a standardized regulatory model for biosimilar development and approval for adoption by BRICS-TM agencies, based on evaluation of regulatory guidelines and potential solutions to challenges.

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Safety assessment of propranolol for infantile hemangioma: a study in an Asian population

Lu Yu, Li Wei, Zigang Xu, Bin Zhang, Xiaofeng Han, Yujuan Sun, Yuanxiang Liu, Chen Wang, Lei Qiu, Bingyu Xiu, Rui He, Li Li & Lin Ma

doi : 10.1080/17512433.2022.2020638

To evaluate the safety of initiating and maintaining propranolol therapy for infantile hemangioma (IH) and the safety of different doses.

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Effects of body weight, smoking status, and sex on plasma concentrations of once-monthly paliperidone palmitate

Georgios Schoretsanitis, Ekkehard Haen, Daria Piacentino, Andreas Conca, Katharina Endres, Christoph Hiemke, Gerhard Gründer & Michael Paulzen

doi : 10.1080/17512433.2022.2020641

Knowledge about the impact of body composition features on pharmacokinetics of newer long-acting injectable antipsychotics is limited.

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