Although our data did not reach significance, they support a link between long-term tamoxifen and the development of endometrial cancer in Japanese women with breast cancer.
Methods:The home blood pressure control by a single-pill combination of cilnidipine and valsartan (HOPE-Combi) survey sought to evaluate the safety and efficacy of cilnidipine 10 mg/valsartan 80 mg single-pill combination (SPC of Cil/Val) treatment in patients with hypertension for over 12 months. Of 2622 subjects' data; we analyzed 2572 cases for safety and 2372 cases for efficacy. Results: Adverse drug reaction (ADR) incidence rate was 3.77% (97 of 2572 patients). The frequency of ADRs did not differ between patients aged <75 years and those aged ≥75 years (3.70% vs. 3.93%, respectively); between patients with and without chronic liver disease (CLD; 6.44% vs. 3.54%, respectively); and between patients with and without chronic kidney disease (CKD; 5.26% vs. 3.59%, respectively). Office systolic blood pressure (BP) was reduced from 149.5 ± 19.6 mmHg to 133.5 ± 14.8 mmHg (−15.8 mmHg, P < .01); pulse rate was also reduced 75.5 ± 12.2 bpm to 73.5 ± 11.3 bpm (−1.8 bpm, P < .01) after 12 months. Conclusions: The SPC of Cil/Val was safe and effective in treating BP of hypertensive patients in realworld settings.
Summary In a placebo-controlled double-blind study, we examined the effects on blood lipids during long-term consumption of mayonnaise containing phytosterolester in Japanese with borderline or mild hyperlipidemia. We also examined the safety of this mayonnaise. Fifty-five subjects were divided into 2 groups, one group of which was given for 3 months 15 g/day of a placebo mayonnaise (Placebo), and the other, 15 g/day of mayonnaise containing 884 mg/day of phytosterolester (MSE) for the same period of time. Hematological testing and confirmation of objective and subjective symptoms were conducted every month. Total cholesterol and LDL cholesterol levels did not change in the Placebo group throughout the study, but they did significantly decrease 1, 2, and 3 months after the start of intake in the MSE group. Significant differences were seen between Placebo group and MSE group in the amount of changes in total cholesterol 1, 2, and 3 months after the start of intake, and in LDL cholesterol 1 and 2 months after the start of intake. Furthermore, the results of hematological testing other than for blood lipids and physician interview revealed no adverse events caused by long-term consumption of the test foods. We thus concluded mayonnaise containing phytosterolester to be safe and to lower total serum cholesterol and LDL cholesterol levels.
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