Therapeutic Research

Clinical usefulness of teneligliptin was evaluated in type 2 diabetic patients. The start of teneligliptin administration significantly lowered casual blood glucose levels by - 26.6mg/dL, HbA1c by - 1.71％, and decreased diastolic blood pressure, but did not affect body weight. There was a significant correlation of HbA1c improvement for 3 months to starting HbA1c, but not to body mass index. On the other hand, change to teneligliptin from other dipeptidyl peptidase –4 inhibitors did not cause any significant changes in HbA1c, but significantly decreased body weight and systolic blood pressure. Further studies should be necessary to clarify the differences in the effects on body weight and blood pressure among dipeptidyl peptidase –4 inhibitors.

目的：肥満を伴う2 型糖尿病患者に対するエキセナチド1 日2 回投与（BID）の有効性と安全性を検討するため，当院での治療成績を後ろ向きに調査，解析した。対象：2013 年8 月から2014 年1 月の間に当院にてエキセナチド10μg BIDの処方を受けた患者のうち，24週時のデータが解析可能であった29例。年齢54.8±11.1歳，BMI 34.2±6.4 kg/m2。10例はインスリン，9例はリラグルチドを使用。結果： エキセナチドの24 週投与により，HbA1cは投与前の7.98±0.27％から7.32±0.27％（p ＝ 0.004）に，体重は投与前の93.3±3.5 kg から87.9±3.3 kg（p ＜ 0.001）にそれぞれ有意に減少し，48 週後まで経過が観察できた22 例では，この改善が維持されていた。29例中25例（86％）が投与前に比べ24週後の体重が減少した。考察：エキセナチドBIDは，肥満を伴う2型糖尿病患者の糖代謝改善に加え，体重減少効果が期待できると考えられた。

Objectives: To investigate the safety and effectiveness of BI・Sifrol(R) （pramipexole） tablets in patients with idiopathic restless legs syndrome（RLS） for long –term real world use. Method: This post marketing surveillance（PMS） was an observational study under routine medical practice. This was a prospective study using a central registration method. Patients with idiopathic RLS were included in the PMS. No specific criteria（e.g.,demographics, baseline characteristics, concomitant drugs in use） were defined for patient enrolment. Safety: There were no new concerns for the safety profile of pramipexole in patients with RLS. The frequencies of patients with adverse events（AEs） and drug–related AEs were 19.4％ and 15.1％ , respectively. Nausea（2.7％） was the most frequent AE, followed by somnolence（2.0％）. Nausea（2.7％） was the most frequent drug– related AE as well, followed by somnolence（1.8％）. Serious AEs（SAEs） were experienced by 10（2.0％）patients. There were 3 drug–related SAEs in 3 patients: ileus, impulse control disorders, and somatic hallucination. Nausea and dizziness were experienced by 5 patients, respectively, followed by headache and RLS （aggravation of RLS） by 4 patients. One patient died by cerebral infarction and it was not drug– related. Augmentation occurred in 5（1.0％）patients, and sudden onset of sleep（SOOS） occurred in 2（0.4％） patients as an AE. In 4 out of 5 patients who experienced augmentation, and all patients who experienced SOOS, these AEs were drug–related. Efficacy: In this PMS, the mean change in International RLS rating scale（IRLS） total score from baseline at the end of obser vation was -15.1（Mixed–effect Model with Repeated Measures: MMRM）. Since the change in IRLS total score of 10 or more points indicates an improvement in at least one stage of RLS severity, the result of the PMS study confirmed an important finding that pramipexole treatment clinically improves the symptoms of RLS in a routine clinical practice. In addition, both Pittsburgh Sleep Quality Index（PSQI） total score for assessing quality of sleep, and the Japanese version of the Epworth Sleepiness Scale（JESS） total score for assessing sleepiness in daily activities showed reductions after 12 months of treatment with pramipexole. Overall conclusions: With the results of this PMS, pramipexole is concluded to be effective and safe in Japanese patients with idiopathic RLS for long –term real world use.

セレコキシブ（セレコックス(R)錠）の急性疼痛患者を対象とした使用成績調査における安全性解析対象730 例のうち，手術後の消炎・鎮痛の目的で使用された安全性解析対象336 例，有効性解析対象289例を解析対象とした。有効性に関して，疼痛全般改善度（著明＋中等度）の改善率は83.7％（242/289例）であり，手術別の改善率は，人工置換術（膝・股関節・骨頭）65.7％（44/67例），観血的整復固定術 90.9％（50/55 例），腫瘍切除・摘出術 83.3％（25/30 例），抜釘・金属・異物除去術 91.7％（22/24 例），脊椎固定・椎弓形成術 90.5％（19/21例）であった。疼痛VAS（Visual Analogue Scale；100 mm）の最終変化量（最小二乗平均±SE）は- 50.7±2.0 mm（n ＝ 210，p ＜ 0.001；t – 検定）であり，人工置換術（膝・股関節・骨頭）- 38.7±4.7 mm（n ＝52，p＜0.001），観血的整復固定術-65.5±3.6 mm（n ＝ 44，p ＜ 0.001），腫瘍切除・摘出術- 49.6±5.3 mm（n＝ 16，p ＜ 0.001），抜釘・金属・異物除去術- 44.6±7.1 mm（n ＝ 17，p ＜ 0.001），脊椎固定・椎弓形成術- 60.6±6.6 mm（n＝ 17，p ＜ 0.001）であった。本剤初回投与から5 分～20 分以内，20 分超～ 40 分以内および40 分超～60分以内のVAS変化量（最小二乗平均±SE）は，それぞれ- 18.5±3.4 mm（n ＝ 25，p ＜ 0.001），- 20.3±1.8 mm（n ＝ 105，p ＜ 0.001）， および- 20.2±3.3 mm（n＝64，p＜0.001）であった。安全性解析対象336 例中12 例（3.6％）に計12件の副作用が認められた。主な副作用は胃腸障害6件（1.8％）であった。以上のことから，手術後の急性疼痛に対するセレコキシブの有用性が示された。