Safety and Efficacy of Mirogabalin in Lumbar Spinal Stenosis Patients with Peripheral Neuropathic Pain on NSAIDs: Post Hoc Analysis of the MiroTAS Study.

Introduction: The primary analysis of the MiroTAS study in patients with lumbar spinal stenosis (LSS) taking non-steroidal anti-inflammatory drugs showed that mirogabalin add-on therapy further improved pain and quality of life (QOL) without new safety concerns.

Methods: This post hoc analysis of the MiroTAS study examined the timing of onset of mirogabalin-related adverse drug reactions (mrADRs) (composite of somnolence, dizziness, edema, and peripheral edema), factors affecting safety and efficacy, and the relationships between baseline numbness severity (by spine painDETECT questionnaire [SPDQ] score), EQ-5D-5L scores, leg pain improvement (by visual analogue scale [VAS]), and patient satisfaction (by Patient Global Impression of Change [PGIC] scores).

Results: Among 110 patients, there were no significant differences in the incidence rates of mrADRs by patient characteristics.

A multicenter randomized open-label phase 2 study investigating optimal antiemetic therapy for patients with advanced/recurrent gastric cancer treated with trastuzumab deruxtecan: the EN-hance study.

Background: Trastuzumab deruxtecan (T-DXd) has been approved for the treatment of human epidermal growth factor receptor-2 (HER2)-positive gastric cancer and other indications in several countries and is considered moderately or highly emetogenic. The management of nausea and vomiting associated with T-DXd treatment has not been fully evaluated and the effectiveness of conventional prophylaxis remains unknown.

Methods: This open-label, randomized, multicenter, phase 2 study aimed to investigate the optimal antiemetic therapy for Japanese patients with gastric cancer undergoing T-DXd treatment.

A subgroup analysis of the MiroCIP study to evaluate chemotherapy-induced peripheral neuropathy: symptom profile, severity, and analgesia efficacy depending on type of chemotherapy.

Background: The multicenter, prospective MiroCIP observational study investigated the incidence, risk factors, and outcomes of chemotherapy-induced peripheral neuropathy (CIPN) by oxaliplatin- and taxane-based chemotherapies but did not examine their differences in detail. This post hoc subanalysis explored the differences between oxaliplatin- and taxane-based chemotherapy, in terms of CIPN symptom profile, severity, and response to analgesics.

Research Design And Methods: Patients with colorectal, gastric, non-small cell lung, or breast cancer, scheduled to receive oxaliplatin- or taxane-based chemotherapy, were followed for 12 months to assess the severity of sensory CIPN, by the Common Terminology Criteria for Adverse Events, and associated subjective and objective symptoms.

Efficacy and Safety of Mirogabalin in Patients with Neuropathic Pain Due to Cervical Spondylotic Radiculopathy: Miro-Cens, A Randomized, Controlled, Interventional Study.

Introduction: There are few studies of pharmacotherapy of neuropathic pain in cervical spondylotic radiculopathy (CSR). Miro-Cens aimed to examine the efficacy and safety of mirogabalin for treating pain in patients with CSR on non-steroidal anti-inflammatory drugs (NSAIDs), compared with NSAIDs alone.

Methods: Miro-Cens was a 12-week, multicenter, randomized, controlled, open-label, interventional study in Japan.

One-year incidence of chemotherapy-induced peripheral neuropathy in oxaliplatin- or taxane-based chemotherapy: a multicenter, prospective registry study (MiroCIP study).

Background: Chemotherapy-induced peripheral neuropathy (CIPN) and its associated pain negatively affect patient outcomes and quality of life (QoL). The two-part MiroCIP study included interventional and prospective observational studies. Here, we report the latter, describing CIPN incidence, risk factors, and outcomes.

Trastuzumab deruxtecan for the treatment of patients with HER2-positive breast cancer with brain and/or leptomeningeal metastases: an updated overall survival analysis using data from a multicenter retrospective study (ROSET-BM).

We provide updated results (median follow-up duration: 20.4 months) of a retrospective study on the effectiveness of trastuzumab deruxtecan (T-DXd) in patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer with brain metastases (BM) and/or leptomeningeal disease (ROSET-BM). Median progression-free survival (PFS) was 14.

Antihypertensive effect of esaxerenone and correlation between brachial and wrist home monitoring devices in patients with nocturnal hypertension: A post hoc analysis of the EARLY-NH study.

Adequate management of nocturnal hypertension is crucial to reduce the risk of organ damage and cardiovascular events. The EARLY-NH study was a prospective, open-label, multicenter study conducted in Japanese patients with nocturnal hypertension who received esaxerenone treatment for 12 weeks. This post hoc analysis aimed to assess (1) the relationship between changes in morning home systolic blood pressure (SBP), bedtime home SBP, and nighttime home SBP based on changes in SBP and achievement rates of target SBP levels; and (2) the correlation between nighttime home SBP measurements using brachial and wrist home BP monitoring (HBPM) devices.

Efficacy and safety of add-on mirogabalin to conventional therapy for the treatment of peripheral neuropathic pain after thoracic surgery: the multicenter, randomized, open-label ADMIT-NeP study.

Background: For chronic pain after thoracic surgery, optimal timing of its diagnosis and effective treatment remains unresolved, although several treatment options are currently available. We examined the efficacy and safety of mirogabalin, in combination with conventional pain therapy (nonsteroidal anti-inflammatory drugs and/or acetaminophen), for treating peripheral neuropathic pain (NeP) after thoracic surgery.

Methods: In this multicenter, randomized, open-label, parallel-group study, patients with peripheral NeP were randomly assigned 1:1 to mirogabalin as add-on to conventional therapy or conventional treatment alone.

Efficacy and safety of mirogabalin for chemotherapy-induced peripheral neuropathy: a prospective single-arm trial (MiroCIP study).

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a painful, dose-limiting adverse effect of commonly used chemotherapeutic agents. The purpose of this exploratory study was to evaluate the efficacy and safety of mirogabalin in patients with moderate to severe CIPN during chemotherapy and the effects of 12 weeks' intervention on chemotherapy completion and CIPN severity.

Methods: Patients experiencing moderate to severe CIPN while undergoing oxaliplatin- or taxane-containing chemotherapy for colorectal, gastric, non-small-cell lung, or breast cancer received mirogabalin at between 5 and 15 mg twice daily.

Efficacy and Safety of Esaxerenone in Hypertensive Patients with Diabetes Mellitus Undergoing Treatment with Sodium-Glucose Cotransporter 2 Inhibitors (EAGLE-DH).

Introduction: The EAGLE-DH study assessed the efficacy and safety of esaxerenone in hypertensive patients with diabetes mellitus receiving sodium-glucose cotransporter 2 (SGLT2) inhibitors.

Methods: In this multicenter, open-label, prospective, interventional study, esaxerenone was started at 1.25 or 2.

Nighttime home blood pressure lowering effect of esaxerenone in patients with uncontrolled nocturnal hypertension: the EARLY-NH study.

There is limited evidence on the blood pressure (BP)-lowering effect of esaxerenone on home BP, including nighttime BP. Using two newly developed nocturnal home BP monitoring devices (brachial and wrist), this multicenter, open-label, prospective study investigated the nighttime home BP-lowering effect of esaxerenone in patients with uncontrolled nocturnal hypertension being treated with an angiotensin receptor blocker (ARB) or calcium-channel blocker (CCB). In total, 101 patients were enrolled.

Steady-State Pharmacokinetics of Intravenous Hydromorphone in Japanese Patients With Renal Impairment and Cancer Pain.

The opioid analgesic hydromorphone has a low renal excretion ratio; however, exposure after oral administration is several times higher in those with moderate or severe renal impairment. We evaluated the impact of renal impairment on the steady-state pharmacokinetics of intravenously administered hydromorphone in patients with cancer being treated for pain. This was an open-label, prospective, parallel-comparison, interventional clinical pharmacology study.

Relationship between the dose titration and adherence of mirogabalin in patients with peripheral neuropathic pain depending on renal function: a nationwide electronic medical record database study.

Background: Mirogabalin has been attracting attention for treating peripheral neuropathic pain. The package insert recommends that mirogabalin should be titrated depending on renal function. Here, we investigated the relationship between dose titration patterns and adherence, and persistence of mirogabalin treatment.

Efficacy and Safety of Esaxerenone in Hypertensive Patients with Diabetic Kidney Disease: A Multicenter, Open-Label, Prospective Study.

Introduction: Clinical data of esaxerenone in hypertensive patients with diabetic kidney disease (DKD) are lacking. We evaluated the efficacy and safety of esaxerenone in patients with DKD and an inadequate response to blood pressure (BP)-lowering treatment.

Methods: In this multicenter, open-label, prospective study, patients were divided into urinary albumin-to-creatinine ratio subcohorts (UACR < 30, 30 to < 300, and 300 to < 1000 mg/gCr).

Efficacy and Safety of Add-on Mirogabalin to NSAIDs in Lumbar Spinal Stenosis with Peripheral Neuropathic Pain: A Randomized, Open-Label Study.

Introduction: In Japan, conservative therapy for patients with lumbar spinal stenosis (LSS) includes non-steroidal anti-inflammatory drugs (NSAIDs), prostaglandin E1, tramadol, physical/exercise therapy, and nerve blocks. Mirogabalin, a selective oral α2δ ligand, is approved for treating peripheral neuropathic pain, though data regarding visual analog scores (VAS) for pain in patients with LSS are limited. We investigated the efficacy and safety of mirogabalin as an add-on treatment in patients with LSS taking NSAIDs compared with patients taking NSAIDs only.

Rationale and Design of the Efficacy and Safety of Esaxerenone in Hypertensive Patients With Left Ventricular Hypertrophy (ESES-LVH) Study - Protocol for a Multicenter, Open-Label, Exploratory Interventional Study.

The complication of left ventricular (LV) hypertrophy (LVH) is associated with increased incidence of major cardiovascular events. Hypertension is an independent risk factor among several factors contributing to the development of LVH, and thus appropriate treatment of both hypertension and LVH reduces the risk of developing heart failure. Mineralocorticoid-receptor blockers (MRBs) have been reported to improve the prognosis of LVH, but use of currently available MRBs is limited by adverse events.

A large-scale database study for the prescription status of a new voltage-gated Ca channel αδ ligand, mirogabalin, in Japan.

Background: A new voltage-gated Ca channel αδ ligand, mirogabalin, was first approved for treating peripheral neuropathic pain in Japan in 2019. This is the first report on the prescription status of mirogabalin using a large-scale prescription database.

Research Design And Methods: The authors analyzed the prescription data of 12,924 patients prescribed mirogabalin between 1 June and 31 August 2020.

Mirogabalin treatment of postoperative neuropathic pain after thoracic surgery: study protocol for a multicenter, randomized, open-label, parallel-group, interventional trial.

Background: Intercostal nerve damage due to thoracotomy or thoracoscopic manipulation is a major contributor to chronic postsurgical pain after pulmonary resection. Chronic postsurgical pain may last for months or years and can negatively impair physical functioning and daily activities. Global consensus on severe postoperative pain management is lacking, and chronic pain incidence after thoracic surgery remains high.

An exploratory assessment of the applicability of direct-to-consumer genetic testing to translational research in Japan.

Objective: In order to assess the applicability of a direct-to-consumer (DTC) genetic testing to translational research for obtaining new knowledge on relationships between drug target genes and diseases, we examined possibility of these data by associating SNPs and disease related phenotype information collected from healthy individuals.

Results: A total of 12,598 saliva samples were collected from the customers of commercial service for SNPs analysis and web survey were conducted to collect phenotype information. The collected dataset revealed similarity to the Japanese data but distinguished differences to other populations of all dataset of the 1000 Genomes Project.

A Cross-Sectional Web Survey of Satisfaction with Treatment for Pain in Participants with Suspected Diabetic Peripheral Neuropathic Pain in Both Feet.

Introduction: Diabetic peripheral neuropathic pain (DPNP), a symptom of diabetic polyneuropathy (DPN), is underdiagnosed in people with diabetes. To date, no studies have determined the relationship between diagnosis of DPN and satisfaction with treatment for pain. Additionally, the factors that influence satisfaction with treatment for pain remain unknown.

The safety and efficacy of the long-acting neuraminidase inhibitor laninamivir octanoate hydrate for Inhalation Suspension Set in children under the age of 5 in a post-marketing surveillance.

Introduction: We conducted a post-marketing surveillance of laninamivir octanoate hydrate for Inhalation Suspension Set in patients under the age of 5 infected with the influenza virus to evaluate safety and efficacy of the drug.

Methods: Subjects enrolled by the centralized enrollment system were administered laninamivir once using a nebulizer based on the package insert.

Results: Safety was evaluated in 1104 patients.