Koh Naoki, Sakamoto Shigeru, Chino Fumio
Koh Medical Clinic, Nagoya, Japan.
Tohoku J Exp Med. 2008 Nov;216(3):249-57. doi: 10.1620/tjem.216.249.
Good compliance with hypoglycemic therapy is important for diabetes treatment, since positive relationship between medication compliance and glycemic control has been reported. To improve medication compliance, the oral disintegrating tablet technology that facilitates drug administration without water has been employed in various drugs, including voglibose, an alpha glucosidase inhibitor. In the present survey, we investigated safety profile of voglibose oral disintegrating tablet (VODT), and whether treatment with VODT results in improvement of medication compliance and glycemic control. Patients with diabetes received VODT 0.6 or 0.9 mg/day for 12 weeks. Among 2,930 eligible patients, adverse drug reactions were observed in 3.6%, with the most common being abdominal distension, flatulence, diarrhea, and increased alanine aminotransferase levels. In 1,067 patients who received conventional voglibose tablet (CVT) prior to VODT, 53.1% reported that taking VODT was easier than taking CVT. Medication compliance was improved after switching to VODT in 28.4% of patients who missed taking tablets more than one time a week during CVT treatment. A significant decrease in HbA(1C) levels was observed in patients whose medication compliance was improved after switching to VODT (P = 0.033), but there was no significant reduction in HbA(1C) levels in patients whose medication compliance did not change. In conclusion, the present survey suggests that the safety profile of VODT is comparable with that of CVT, and switching from CVT to VODT has positive impact on medication compliance which may lead to an improvement in glycemic control.
良好的降糖治疗依从性对糖尿病治疗很重要,因为已有报道称药物依从性与血糖控制之间存在正相关关系。为提高药物依从性,无需用水即可方便给药的口腔崩解片技术已应用于包括伏格列波糖(一种α-葡萄糖苷酶抑制剂)在内的多种药物中。在本次调查中,我们研究了伏格列波糖口腔崩解片(VODT)的安全性,以及VODT治疗是否能提高药物依从性和血糖控制。糖尿病患者接受0.6或0.9毫克/天的VODT治疗,为期12周。在2930名符合条件的患者中,观察到3.6%的患者出现药物不良反应,最常见的是腹胀、肠胃胀气、腹泻和丙氨酸转氨酶水平升高。在1067名在接受VODT之前服用传统伏格列波糖片(CVT)的患者中,53.1%的患者报告服用VODT比服用CVT更容易。在CVT治疗期间每周漏服药物超过一次的患者中,28.4%的患者在换用VODT后药物依从性得到改善。换用VODT后药物依从性得到改善的患者中,糖化血红蛋白(HbA1C)水平显著下降(P = 0.033),但药物依从性未改变的患者中HbA1C水平没有显著降低。总之,本次调查表明,VODT的安全性与CVT相当,从CVT换用VODT对药物依从性有积极影响,这可能会改善血糖控制。