Gorgojo-Martinez Juan J, Ferreira-Ocampo Pablo José, Galdón Sanz-Pastor Alba, Cárdenas-Salas Jersy, Antón-Bravo Teresa, Brito-Sanfiel Miguel, Almodóvar-Ruiz Francisca
Department of Endocrinology and Nutrition, Hospital Universitario Fundación Alcorcón, 28922 Madrid, Spain.
Department of Endocrinology and Nutrition, Hospital Universitario Gregorio Marañón, 28007 Madrid, Spain.
J Clin Med. 2023 Jun 25;12(13):4248. doi: 10.3390/jcm12134248.
This study aimed to evaluate the effectiveness and tolerability of intensifying the dose of canagliflozin from 100 mg/day (CANA100) to 300 mg/day (CANA300) in patients with type 2 diabetes (T2DM) and suboptimal metabolic control in a real-world setting. A multicenter observational study was conducted on adult patients with T2DM who initiated treatment with CANA100 and subsequently required intensification to CANA300. The primary outcome measures were changes in HbA1c and weight at 6 months after the switch and at the end of the follow-up period. A total of 317 patients met the inclusion criteria (59.6% male, mean age 62.2 years, baseline HbA1c 7.55%, weight 88.6 kg, median duration of treatment with CANA100 9.9 months). Switching to CANA300 resulted in a significant reduction in HbA1c (6 months: -0.33%; last visit: -0.47%, both < 0.0001) and weight (6 months: -1.8 kg; last visit: -2.9 kg, both < 0.0001) over a median follow-up period of 20.8 months. The proportion of patients that achieved HbA1c < 7% increased from 26.7% with CANA100 to 51.6% with CANA300 ( < 0.0001). Among individuals with poor baseline glycemic control (HbA1c > 8%, mean 9.0%), HbA1c was significantly reduced by -1.24% ( < 0.0001). Furthermore, significant improvements were observed in fasting plasma glucose (FPG), blood pressure (BP), liver enzymes, and albuminuria. No unexpected adverse events were reported. : Intensifying the treatment to CANA300 in a real-world setting resulted in further significant and clinically relevant reductions in FPG, HbA1c, weight, and BP in patients with T2DM. The switch was particularly effective in patients with higher baseline HbA1c levels.
本研究旨在评估在现实环境中，将卡格列净剂量从100毫克/天（CANA100）增加至300毫克/天（CANA300）对2型糖尿病（T2DM）且代谢控制欠佳患者的有效性和耐受性。对开始使用CANA100治疗且随后需要强化至CANA300的成年T2DM患者进行了一项多中心观察性研究。主要结局指标为换药后6个月及随访期末糖化血红蛋白（HbA1c）和体重的变化。共有317例患者符合纳入标准（男性占59.6%，平均年龄62.2岁，基线HbA1c为7.55%，体重88.6千克，使用CANA100治疗的中位时长为9.9个月）。在中位随访期20.8个月内，换用CANA300导致HbA1c显著降低（6个月时：-0.33%；末次访视时：-0.47%，均P<0.0001）以及体重降低（6个月时：-1.8千克；末次访视时：-2.9千克，均P<0.0001）。实现HbA1c<7%的患者比例从使用CANA100时的26.7%增至使用CANA300时的51.6%（P<0.0001）。在基线血糖控制不佳（HbA1c>8%，平均9.0%）的个体中，HbA1c显著降低了-1.24%（P<0.0001）。此外，空腹血糖（FPG）、血压（BP）、肝酶和蛋白尿也有显著改善。未报告意外不良事件。在现实环境中将治疗强化至CANA300可使T2DM患者的FPG、HbA1c、体重和BP进一步显著降低且具有临床意义。换药对基线HbA1c水平较高的患者尤其有效。
