Post Marketing Study Management Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Drugs R D. 2011;11(2):191-205. doi: 10.2165/11592460-000000000-00000.
In Japan, when pharmaceutical companies launch a new drug, they are obligated to conduct a post-marketing survey to evaluate the safety and efficacy of the drug in accordance with Good Post-Marketing Surveillance Practice under Article 14-4 (re-examination) of the Pharmaceutical Affairs Law at contracted medical institutions. We report the results of a long-term special survey that we conducted as a post-marketing survey.
The results of a prospective post-marketing survey that was conducted to assess the safety and efficacy of the β-adrenergic receptor antagonist (β-blocker) Artist® tablets 10 mg, 20 mg (carvedilol) in patients with hypertension in Japan, were investigated in order to examine the safety and efficacy of the drug during long-term treatment (18 months).
Patients were carvedilol-naive and had essential hypertension or renal parenchymal hypertension.
We performed this survey as a prospective cohort study (special survey) utilizing a centralized registration method over 3 years (starting from April 1994), for an observation period of 18 months of carvedilol treatment.
Sixty-one medical institutions across Japan collected 380 case report forms of patients who received long-term administration of carvedilol, with 363 and 341 cases evaluated for safety and efficacy, respectively. The discontinuation rate was 7.2% and the incidence of adverse drug reactions was 5.23% (19 of 363) in the safety population. There was no significant change in fasting plasma glucose levels from baseline (118.1 ± 46.5 mg/dL) to after carvedilol treatment (114.6 ± 43.3 mg/dL).[n = 141; p = 0.310]. In 341 evaluable patients in the efficacy population, decreases in both blood pressure and pulse rate were statistically significant at all assessment points in comparison with baseline data (p < 0.001). Similarly, in hypertensive patients with diabetes mellitus, decreases in blood pressure were statistically significant at all assessment points in comparison with baseline data (p < 0.001).
The results of this study show that carvedilol exerted stable antihypertensive effects leading to favorable blood pressure control throughout long-term treatment, without showing any safety concerns. It was concluded that there were no clinically significant issues in terms of safety or efficacy with the long-term treatment of carvedilol in patients with hypertension.
在日本，制药公司推出新药后，必须根据《药品管理法》第 14-4 条（复查）的良好上市后监测实践，在合同医疗机构中进行上市后调查，以评估药物的安全性和有效性。我们报告了我们作为上市后调查进行的一项长期特别调查的结果。
评估β肾上腺素能受体拮抗剂（β受体阻滞剂）Artist®片剂 10mg、20mg（卡维地洛）在日本高血压患者中的安全性和有效性的前瞻性上市后调查的结果，以检查药物在长期治疗（18 个月）期间的安全性和疗效。
患者为卡维地洛初治患者，患有原发性高血压或肾实质高血压。
我们进行了这项调查，作为一项前瞻性队列研究（特别调查），利用集中登记方法，历时 3 年（从 1994 年 4 月开始），对卡维地洛治疗 18 个月的观察期进行评估。
日本的 61 家医疗机构共收集了 380 份接受卡维地洛长期治疗的患者病例报告表，其中 363 例和 341 例分别进行了安全性和疗效评估。安全性人群中停药率为 7.2%，不良反应发生率为 5.23%（19/363）。与基线（118.1±46.5mg/dL）相比，空腹血糖水平无显著变化（114.6±43.3mg/dL）。[n=141；p=0.310]。在可评估疗效的 341 例患者中，与基线数据相比，所有评估点的血压和脉搏率均有统计学意义下降（p<0.001）。同样，在患有糖尿病的高血压患者中，与基线数据相比，所有评估点的血压下降均有统计学意义（p<0.001）。
这项研究的结果表明，卡维地洛在长期治疗期间发挥了稳定的降压作用，从而实现了有利的血压控制，没有显示出任何安全性问题。因此，卡维地洛长期治疗高血压患者在安全性或疗效方面没有临床意义的问题。
