[Show abstract][Hide abstract] ABSTRACT: This long-term event monitoring (LEM) study was designed to evaluate the long-term lipid-lowering efficacy and safety of fluvastatin (Lochol®, Novartis A.G.) along with the incidence of cardiac and other events, and safety of fluvastatin in Japanese patients with hypercholesterolemia.
Patients (n = 21,139) who started fluvastatin between April 1, 2000 and March 31, 2002, across 2563 centers in Japan were prospectively registered and followed up for 3 years (secondary prevention cohort) or 5 years (primary prevention cohort).
Of the patients registered, 19,084 were included in this analysis. Levels of low-density lipoprotein-cholesterol (LDL-C) and total cholesterol (TC) decreased significantly in the primary (-27.1% and -18.8%) and secondary (-25.3% and -18.4%) prevention cohorts. Reductions in LDL-C (-22.1 vs. -18.2%, p < 0.0001) and TC (-16.1 vs. -13.1%, p < 0.0001) levels were significantly greater among patients aged ≥ 65 than < 65 years old. Overall, 1.7% (146/8563) and 1.1% (93/8563) of patients aged ≥ 65 years old experienced confirmed cardiac and cerebral events, compared with 1.1% (112/10,517) and 0.3% (28/10,517) of patients aged < 65 years old (p = 0.0002 and < 0.0001, respectively). Incidence of cardiac and cerebral events was lowest in patients aged < 65 years old in the primary prevention cohort and highest among patients aged ≥ 65 years old in the secondary prevention cohort. Adverse events were reported in 7.9% (1501/19,084) of patients.
This large-scale, prospective, uncontrolled study confirmed the lipid-lowering efficacy and safety of long-term fluvastatin treatment for hypercholesterolemia in Japanese patients aged ≥ 65 years old. The higher incidence of cardiac and cerebral events in patients aged ≥ 65 years old in the secondary prevention cohort reflects a high-risk clinical profile with multiple classic risk factors warranting multifactorial interventions.
Journal of Cardiology 11/2010; 57(1):77-88. · 2.30 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background: Various rating scales for post-stroke psychiatric symptoms such as cognitive impairment have long been used in drug efficacy trials in Japan. However, their reliability has not been established. The purpose of the present study was to examine the inter-rater and intra-rater reliability of a rating scale, which has been conventionally used in Japan.Methods: The most frequent symptoms, including apathy, emotional and cognitive impairment, found in post-stroke patients were assessed using a rating scale comprising 17 items and 4 global assessment scales. Semi-structured interviews of 18 patients with symptoms with various degrees of severity were videotaped. Twelve physicians who were not interviewers independently assessed the severity of symptoms in the 18 patients by replaying the videotapes. This procedure was repeated twice with an interval of two months to examine inter-rater and test-retest reliability.Results: The results revealed almost satisfactory reliability. Intraclass correlation coefficients were over 0.6 in the inter-rater analysis for most items and the concordance correlation coefficients were over 0.7 in the intra-rater analysis. The rating scale was considered to be reliable, although some items showed relatively low agreement.Conclusion: The conventional rating scale to assess post-stroke psychiatric symptoms showed satisfactory inter-rater and intra-rater reliability by the videotape method. The validity study should be further investigated.
[Show abstract][Hide abstract] ABSTRACT: The Japanese version of the Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-plus J) consists of 3 subscales: Disability Assessment of Dementia Scale (DAD), Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD), and Mental Function Impairment Scale (MENFIS), as well as the Clinician's Global Impression of Change (CGIC). While the interrater reliability of CGIC has already been reported, that of the 3 subscales has not. The aim of the present report was to examine the reliabilities of the subscale items and investigate their relationships with CGIC.
Eleven raters who were clinical physicians watched videotapes of 20 patients with Alzheimer's disease, completed the CIBIC-plus J assessment form, and assigned a CGIC score to the patients. Reliability was assessed using the kappa coefficient.
The kappa coefficient of the subscale items was in most instances higher than that of CGIC (0.453) and substantial reliability was observed. The Spearman rank correlation that was calculated between CGIC and the total score change of items was very high for MENFIS (0.990) and DAD (0.910), and moderate for Behave-AD items (0.576). The incidence of comments by the raters was highest for MENFIS (89%), followed by DAD (70%). The incidence was low for Behave-AD items (48%).
Based on the results, it is concluded that DAD, Behave-AD, and MENFIS are necessary constituents of CIBIC-plus J, and indispensable for the reliability of CGIC.
[Show abstract][Hide abstract] ABSTRACT: The Japanese version of the Clinician's Interview-Based Impression of Change (CIBIC-plus J) is a semistructured interview format including a 7-point Likert type scale for the Clinician's Global Impression of Change. It comprises subscales of DAD for ADL, Behave-AD for behavioral and psychiatric symptoms and MENFIS for cognitive and emotional impairment. DAD and Behave-AD are used for caregivers and MENFIS for both caregivers and patients. The objective of this study was to examine the interrater reliability of the CIBIC-plus J by the videotape method. Twenty videotaped patients including 13 real and 7 virtual patients were independently assessed by 11 raters. The kappa coefficient from the full set of data of 20 patients and 11 raters was 0.453, and from the limited data of 13 real patients, 0.383. By permitting one-point disagreements on the 7-point scale or by collapsing it into the 3-point scale (improved, no change, or worsened), kappa improved to 0.894 and 0.731, or 0.734 and 0.504, respectively. From these results, it was concluded that the reliability of a 7-point Clinician's Global Impression of Change was halfway, i.e., neither sufficient nor insufficient. However, if one-point disagreements or collapsing into 3-point scale are allowable, the CIBIC-plus J will be sufficiently reliable.