Long-term safety and effectiveness of biosimilar insulin glargine in Japanese patients with diabetes mellitus in routine clinical practice: results of a post-marketing safety study

Abstract

Objective: To evaluate the long-term safety and effectiveness of biosimilar insulin glargine (GLY) in real-world clinical practice.

Methods: This prospective, non-interventional, multicenter, observational, post-marketing safety study (PMSS) enrolled Japanese patients with type 1 or 2 diabetes mellitus (T1DM or T2DM) starting GLY therapy, and was required by Japanese Pharmaceutical Affairs Law mandating post-marketing safety surveillance to acquire safety and effectiveness data of biosimilar products. Data collected from the 12-month observation included patient characteristics, adverse events, and blood glucose control.

Results: The study enrolled 141 patients with T1DM and 1104 patients with T2DM. Pre-study insulin was used by 94.1% of patients with T1DM and 75.0% with T2DM. 65.4% of patients with T1DM and 64.3% with T2DM switched from the reference product (GLY-switched), while 25.0% with T2DM were insulin-naive. Adverse events were reported by 5.7% and 8.5% in T1DM and T2DM, respectively. Similar incidences were reported in GLY-switched. Adverse events were reported by 10.7% in insulin-naive T2DM. Baseline mean hypoglycemic events/month were 1.8 and 0.1 in T1DM and T2DM, respectively: the mean change from baseline (CFB) was –1.2 (p?=?.066) and 0.0 (p?=?.915), respectively. Baseline mean HbA1c was 8.4% and 8.7% in T1DM and T2DM, respectively; the mean CFB was –0.5% (p?<?.001) and –0.9% (p?<?.001), respectively, and –1.5% (p?<?.001) in insulin-naive T2DM.

Conclusions: This first long-term Japanese PMSS of GLY demonstrated adverse events, hypoglycemia, and glycemic control consistent with the known GLY profile for T1DM and T2DM patients, in routine clinical practice.     

Sonodynamic Therapy: Advances and Challenges in Clinical Translation

Sonodynamic therapy (SDT) consists of the synergetic interaction between ultrasound and a chemical agent. In SDT, the cytotoxicity is triggered by ultrasonic stimuli, notably through cavitation. The unique features of SDT are relevant in the clinical context more than ever: the need for efficacy, accuracy, and safety while being noninvasive and preserving the patient's quality of life. However, despite the promising results of this technique, only a few clinical reports describe the use of SDT. The objective of this article is to provide an extensive overview of the clinical and preclinical research conducted in vivo on SDT, to identify the limitations, and to detail the developed strategies to overcome them.     

Protective Effects of a Hydrogen-Rich Preservation Solution in a Canine Lung Transplantation Model

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Keratocystic odontogenic tumor: a retrospective study of 183 cases

In 2005, the WHO Working Group considered odontogenic keratocyst (OKC) to be a tumor and recommended the term keratocystic odontogenic tumor (KCOT), separating the lesion from the orthokeratinizing variant, which is now considered an odontogenic cyst. We analyzed the clinicopathological features of KCOTs encountered over a period of 28 years at Meikai University Hospital. The diagnosis was confirmed by reevaluation of hematoxylin and eosin-stained slides on the basis of the 2005 WHO Classification. Clinical history was also taken into consideration. A total of 183 KCOTs were found, and the two genders were affected almost evenly (51.3% male; 48.7% female; male to female ratio 1.05 to 1). Patient age at the time of diagnosis ranged from 6 to 78 years, with a peak in the third decade of life (mean age: 32.8 years). The mandible was the site of occurrence of 70.5% of tumors; 16.4% occurred in the maxilla and 13.1% in both. Association with the nevoid basal cell carcinoma syndrome (NBCCS) was found in 6.0% of all tumors, and recurrence was found in 13.1% of patients. We found that tumors that initially appeared in the maxilla alone had a higher recurrence rate than those that first appeared in the mandible alone. Pathological examination of KCOT is important to avoid misdiagnosis and provide appropriate treatment and follow-up.     

Periodontal regeneration of transplanted rat teeth subcutaneously after cryopreservation

The periodontal regeneration of transplanted teeth after cryopreservation in liquid nitrogen overnight was previously examined using an animal model. The results showed that overnight cryopreservation did not have any severe adverse effects on periodontal healing. For clinical application, it is necessary to make the period of storage longer than in the preliminary study. In this study, the regeneration of periodontal tissues after cryopreservation for 4 weeks was examined. The maxillary molars of 4-week-old Wistar rats were extracted and transplanted into the abdominal subcutaneous tissue either immediately or after cryopreservation in a deep freezer at -80 degrees C. The donor teeth were frozen in a rate-controlling freezer. At 1, 2 and 4 weeks after transplantation, they were excised and observed under light microscopy. The cryopreserved teeth had acellular cementum with a rough surface at 1 week. With an increase in cementoblasts and the appearance of periodontal ligament and alveolar bone, the surface had become smooth at 2 weeks. There was no progressive root resorption. Although the process took somewhat more time, the teeth cryopreserved for 4 weeks showed regeneration that was similar to that of the immediately transplanted teeth.     

A case report of bilateral Brodie bite in early mixed dentition using bonded constriction quad-helix appliance

Brodie bite is a comparatively rare type of malocclusion found in primary and mixed dentition. It not only adversely affects chewing and muscle functions, but also impairs normal growth and development of the mandible. This report describes the therapeutic results of a patient with bilateral Brodie bite in early mixed dentition after using a bonded constriction quad-helix appliance. The patient, a boy aged 9 years and 2 months, first visited our hospital after occlusal abnormality in the molar region was detected at a local dental clinic. Case analysis resulted in a diagnosis of bilateral Brodie bite with slight mandibular retrognathism. Treatment objectives were to reduce the arch width of the maxillary dentition and expand the mandibular arch in order to establish and stabilize molar occlusion and to achieve a Class I molar relation and appropriate overbite and overjet. Treatment comprised covering the occlusal surface of the maxillary molars with resin and attaching a bonded constriction quad-helix appliance joined with a 0.040-inch quad-helix wire. A bi-helix appliance was also fixed to the mandibular dentition. Brodie bite visibly improved after 5 months. Cervical headgear was then fitted and the patient observed until eruption of the permanent dentition was complete. Class I molar relation was achieved after 2 years and 6 months, although spacing remained in the maxillary and mandibular dentitions. Treatment of bilateral Brodie bite in mixed dentition by means of a bonded constriction quad-helix appliance attached to the maxillary dentition enabled effective bite opening and reduction in the width of maxillary arch independent of the patient's cooperation, providing good therapeutic outcome in a short time period.