Safety and Effectiveness of Alirocumab, a Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor, in Patients With Familial or Non-Familial Hypercholesterolemia - A Post-Marketing Survey (J-POSSIBLE).

Background: This study evaluated the safety and effectiveness of alirocumab in Japanese patients with familial hypercholesterolemia (FH) or non-FH in a real-world clinical setting.

Methods and results: This post-marketing surveillance study had a 2-year standard observation period. The study included Japanese patients with hypercholesterolemia who were treatment naïve to alirocumab, had a high risk of developing cardiovascular events, and had an insufficient response to, or were unsuitable for, treatment with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors.

Efficacy and Safety of Alirocumab in Japanese Patients with Diabetes Mellitus: Post-hoc Subanalysis of ODYSSEY Japan.

Aim: To examine the efficacy and safety of alirocumab in Japanese patients with dyslipidemia with or without diabetes mellitus (DM).

Methods: Patients (n=216) with heterozygous familial hypercholesterolemia (heFH), non-FH at high cardiovascular risk with coronary artery disease (CAD), or category III (primary prevention) were enrolled; 148 (68.5%) patients had a diagnosis of DM at baseline.

Distribution of Ankle-Brachial Index among Inpatients with Cardiovascular Disease: Analysis Using the Kumamoto University Hospital Medical Database.

Objective: To describe the distribution of ankle-brachial index (ABI) among Japanese cardiovascular inpatients and to explore risk factors of peripheral arterial disease (PAD) associated with ABI ≤0.9.

Materials And Methods: This study was a retrospective analysis using clinical record databases of patients with cardiovascular disease admitted to the Department of Cardiovascular Medicine, Kumamoto University Hospital between 2007 and 2014.

Japanese postmarketing surveillance of clopidogrel in patients with non-ST-segment elevation acute coronary syndrome, stable angina, old myocardial infarction, and ST-segment elevation myocardial infarction after percutaneous coronary intervention in a real-life setting: the final report (J-PLACE Final).

The present postmarketing surveillance investigated the safety and efficacy of clopidogrel for prevention of cardiovascular events following percutaneous coronary intervention (PCI) in a real-life setting with a large patient population. This study included patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) who had unstable angina, and patients with non-ST-segment elevation myocardial infarction, stable angina, and old myocardial infarction (SA/OMI), or ST-segment elevation myocardial infarction (STEMI). For safety assessment in 4049 patients, the incidence of adverse drug reactions (ADR) and bleeding adverse events (AE), and for efficacy assessment in 3900 patients, that of major adverse cardiovascular events (MACE) and MACE and cerebrovascular events (MACCE), was calculated in the primary diagnosis groups (NSTE-ACS, SA/OMI, or STEMI).

Buserelin acetate microparticle dispersion effects drug release and plasma E(1) levels.

We investigated the effect of different dispersion methods on release behavior and efficacy onset following microparticle administration of buserelin acetate (BA) sustained-release injection. In this in vitro release study, the initial dispersion of BA increased with increased stirring speed (p<0.01).

Skin tests of a novel nicotine patch, PHK-301p, in healthy male volunteers: phase I, placebo-controlled study.

Major local adverse reactions in the nicotine patches are skin reactions. To assess the skin reaction of PHK-301p, a newly developed nicotine patch, we conducted a phase I study that consisted of 2 parts: a skin irritation test (48-h closed patch test) and a photosensitivity test (24-h closed patch test + Ultraviolet A irradiation). Twenty healthy men were treated with PHK-301p and placebo.

Computational consideration of cisplatin hydrolysis and acid dissociation in aqueous media: effect of total drug concentrations.

Cisplatin (cis-DDP) is subject to nucleophilic displacement of chloride in water, forming aquated species, subsequently liberating hydrogen ion(s) with increasing pH. This study intends to theoretically analyze the hydrolysis and polyprotic dissociation behavior of cis-DDP in various aqueous media. A mathematical model was expressed by nonlinear simultaneous equations in terms of the total drug concentration, pH and pCl based on the hydrolysis and acid dissociation constants already published.