Mizuno Y.,Juntendo University |
Hasegawa K.,National Hospital Organization |
Kondo T.,Wakayama Medical University |
Kondo T.,National Hospital Organization |
And 44 more authors.
Movement Disorders | Year: 2010
The objectives of this study were to evaluate the efficacy of istradefylline at an oral dose of 20 mg or 40 mg once daily for 12 weeks in Parkinson's disease (PD) patients with motor complications on levodopa therapy based on the change in the daily OFF time compared with placebo and to assess the safety at these doses. A total of 363 subjects were randomly assigned to receive 20 mg/day istradefylline (n = 119), 40 mg/day istradefylline (n = 125), or placebo (n = 119). The primary outcome variable was the change from baseline at endpoint in daily OFF time based on patients' ON/OFF diaries. At endpoint, the daily OFF time reduced from baseline by 1.31 hours for 20 mg/day istradefylline (P = 0.013 as compared to the placebo), 1.58 hours for 40 mg/day istradefylline (P < 0.001), and 0.66 hours for placebo; istradefylline significantly reduced the daily OFF time compared with placebo. The UPDRS Part III subscale score (ON state) reduced by 5.7 at endpoint in both istradefylline groups and 3.7 in the placebo group (P = 0.006 for 20 mg/day and P = 0.006 for 40 mg/day group as compared with placebo). The most commonly reported drug-related treatment emergent adverse event (TEAE) was dyskinesia, which occurred in 2.5% (3/119) of subjects receiving placebo, 8.5% (10/118) receiving 20 mg/day istradefylline, and 6.4% (8/125) receiving 40 mg/day istradefylline. We conclude that istradefylline at 20 mg and 40 mg once daily is effective in relieving wearing-off fluctuations of PD patients. In addition, istradefylline was well tolerated at both doses. © 2010 Movement Disorder Society.
PubMed | Jichi Medical School Hospital and Jichi Medical School
Type: Journal Article | Journal: Journal of medical ultrasonics (2001) | Year: 2016
To (1) assess the accuracy of the ultrasound velocity profiling (USVP) technique of renal blood flow (RBF) measurement in normal subjects and (2) compare renal blood flow measurements obtained using USVP and renal clearance rate in patients with renal diseases.First, we calculated unilateral renal blood flow (unil-RBF) using USVP and the clearance rate of para-aminohippuric acid (CPAH) simultaneously in six healthy male subjects. We then compared unil-RBFUSVP and unil-RBFPAH in nine patients with chronic glomerulonephritis (CGN).In the first study, the limits of agreement in a Bland-Altman plot ranged from -325.3 to 32.0ml/min per 1.48m(2). The mean bias was -146.7ml/min per 1.48m(2). Subdivision for values of unil-RBFUSVP by flow showed small discrepancies in values above 280ml/min per 1.48 m(2): mean bias, -98.2ml/min per 1.48m(2); limits of agreement, -223.3 to 26.8ml/min per 1.48m(2). The three patients in the second study had immunoglobulin A (IgA) nephropathy, in whom unil-RBFPAH was estimated as being markedly lower than unil-RBFUSVP, contrary to the primary result.Despite its consistent negative bias, USVP may be a reliable method of quantifying renal blood flow noninvasively when measured values exceed 280ml/min per 1.48 m(2). We assumed that the p-aminohippurate extraction rate (EPAH) was profoundly impaired in the three patients with IgA nephropathy.