Assessment of quality of life on 4-year growth hormone therapy in Japanese patients with adult growth hormone deficiency: A post-marketing, multicenter, observational study.

OBJECTIVE: Improvement of quality of life (QOL) by growth hormone (GH) therapy was not demonstrated in Japanese adult growth hormone deficiency (AGHD) patients by either the QOL Assessment of Growth Hormone Deficiency in Adults or the Questions on Life Satisfaction-Hypopituitarism, which are widely used to evaluate QOL in Western AGHD patients. We therefore evaluated QOL in Japanese AGHD patients receiving recombinant GH, Norditropin® (Novo Nordisk A/S, Denmark), using the newly developed Adult Hypopituitarism Questionnaire (AHQ). DESIGN: This multicenter, non-interventional, observational study in Japanese patients with severe AGHD was conducted from 1 October 2009 to 30 September 2014. Patients with severe AGHD already receiving somatropin and somatropin-naïve patients were included. GH therapy (Norditropin®) was initiated as injections of 0.021mg/kg/week divided into 6-7 doses/week, and was adjusted according to clinical responses. Demographic/clinical data were obtained from medical records or by patient recall. QOL was assessed using the AHQ at baseline; 3, 6, and 12months; and annually up to 4years. RESULTS: Of 387 registered patients, 161 were eligible for QOL analysis. AHQ scores significantly improved after 3months of treatment. Improvements in the psycho-social and physical domains were statistically significant throughout the 4-year study period. Although the GH dose was increased in females such that insulin-like growth factor-1 levels reached those of males, QOL improvements in females did not reach those of males. Despite the greater GH dose in child-onset patients, limited QOL improvements were observed in child-onset vs adult-onset cases. CONCLUSIONS: Four-year GH treatment in Japanese AGHD patients elicits sustained improvement in QOL as assessed by AHQ scores.

Safety and effectiveness of long-term growth hormone therapy in Japanese patients with adult growth hormone deficiency: a postmarketing, multicenter, observational study.

We aimed to evaluate the long-term safety and effectiveness of growth hormone (GH) therapy in Japanese patients with adult growth hormone deficiency (AGHD). In this observational, multicenter study, Norditropin® (Novo Nordisk A/S, Bagsvaerd, Denmark) was administered as injections of 0.021 mg/kg/week as a starting dose divided into 6-7 doses/week. The dose was increased according to clinical response. Patients' data were obtained from medical records. Measurements (lipids, glucose metabolism, and body composition) taken at baseline; 3, 6, and 12 months; and yearly until the end of the study were collected. Adverse drug reactions (ADRs), serious ADRs, and serious adverse events (SAEs) were evaluated. Of 387 registered patients, 334 were eligible for safety. After GH treatment initiation, a marked decrease in total cholesterol was observed earlier in the child-onset group than in the adult-onset group. LDL-cholesterol also decreased, but no significant differences in changes in LDL-cholesterol between adult-onset and child-onset groups were found. A significant increase in HDL-cholesterol starting 1 year after GH treatment initiation was found in the adult-onset group. There was no effect of GH treatment on glucose metabolism. Because of the small number of dual-energy X-ray absorptiometry data, the overall assessment of changes of body composition was difficult. Fifty-six (16.8%), 12 (3.6%), and 35 (10.5%) patients experienced ADRs, serious ADRs, and SAEs, respectively. This study demonstrated a favorable long-term safety and effectiveness profile of GH therapy in AGHD patients in the real-life Japanese clinical practice setting.

A case of repeated occlusion in the common iliac artery due to an unexpected stent deformation.

We report a case experiencing repeated common iliac artery (CIA) occlusion due to an unexpected stent deformation. A 74-year-old man with intermittent claudication had undergone balloon-expandable stenting for the left CIA. Six years after his first stent implantation, his left CIA was totally occluded inside the stent. We performed revascularization for the left CIA and achieved sufficient balloon inflation and balloon-expandable stenting. Then, one and a half years later, his left CIA was re-occluded. CT angiography showed compression by the protruding hyperostotic lumbar vertebral body, such that both stents had become deformed into a crescent shape. We were told that he had been using a powerful massage machine to stretch and relieve his spondylotic back pain. We suspected that the external pressure of the hyperostotic spondylosis and massage might have caused the CIA compression and repeated crush of the stents.

Improvement of pustulosis palmaris et plantaris by periodontal infection control in a patient with chronic periodontitis.

BACKGROUND: Pustulosis palmaris et plantaris (PPP) is a chronic, inflammatory, autoimmune-type disease characterized by sterile pustules of skin. The skin inflammation is influenced by several factors such as drugs, sunlight, metabolic and psychogenic factors as well as metal allergy. Here, we report a rare case that intensive periodontal treatment might have contributed to the improvement of skin inflammation. RESULTS: Skin inflammation regressed 1 month after intensive periodontal treatment. Both CD4/CD8 ratio and % of B cells in the blood sample were slightly decreased corresponding to the improvement of periodontal inflammation. CONCLUSIONS: Infection control of periodontal lesions might be one of attractive therapeutic targets in management of PPP.

Efficacy of metal tip catheter for chronic total occlusion lesions in peripheral arterial disease.

We performed several techniques for chronic total occlusion (CTO) lesions in peripheral arterial disease (PAD). We evaluated the cases using the metal tip catheter (MT). We performed peripheral endovascular therapy (EVT) using MT in 31 cases 32 lesions of PAD from March 2007 to March 2011. Twenty-nine cases were CTO lesions using MT for back up of guidewire or MT alone in order to penetrate like a bougie with the blunt tip of MT. Two cases were acute arterial thrombosis for thrombectomy. Seven cases were CTO of the iliac artery (IA) and 25 cases were of the femoral artery (FA). Seven cases were in-stent restenosis. All 7 cases of IA were successfully treated with the initial techniques. We were unable to penetrate by MT(MT-) in 7 cases of FA, and in 2 cases out of the 7, we were even unable to cross the guidewire. Mean lesion length was 80 ± 42 mm in IA and 188 ± 88 mm in SFA. Among them, MT- was 164 ± 67 mm with no significant differences. Procedure time of EVT for CTO using MT was significantly shorter than other strategies. We had no complications such as perforation by using MT. MT provides high initial success rate by spectacular penetration performance and pushability. MT is a safe and effective device for CTO in PAD.

Cathepsin B, D, and L regulation in cyclosporin A-mediated gingival hyperplasia of a patient with sarcoidosis.

BACKGROUND: Cyclosporin A (CsA) is an immunosuppressant with side effects including gingival hyperplasia. Sarcoidosis is a systemic disease characterized by granulomas. Here, we report on a rare case of sarcoidosis with gingival hyperplasia to clarify whether clinical observation corresponds to in vitro results. METHODS: Gingival fibroblasts (HGFs) were isolated from healthy gingiva and cultured with CsA. Total RNA was collected and expression of mRNAs examined using semi-quantitative RT-PCR analysis. Cathepsin B, D, and L expression in overgrown gingiva of the patient was examined by immunohistochemistry. RESULTS: Cathepsin D, L, and vascular endothelial growth factor (VEGF)165 mRNA were markedly suppressed in CsA-treated HGFs, whereas cathepsin B, matrix metalloproteinase-1 (MMP-1) and tissue inhibitor of metalloproteinase-1 (TIMP-1) mRNA were not reduced. Next, the decrease of cathepsin B and L expression in enlarged gingiva was observed, whereas an increase of cathepsin D expression was observed. Clinically, the enlarged gingival lesions were fully resolved by performing oral infection control. CONCLUSIONS: Cathepsins regulation might be an important factor in the development of CsA-mediated gingival hyperplasia.