Abstract
BackgroundDiabetes is a progressive disease needing multiple drugs for achieving and maintaining good glycemic control. Sodium-glucose co-transporter 2 inhibitors (SGLT2i) is a novel class of anti-diabetic agent which offers several beneficial effects. However, the long-term effectiveness in clinical practice and safety data of SGLT2 inhibitors is limited, especially in Asian patients. To better understand the effectiveness of SGLT2i in clinical practice, we conducted a retrospective evaluation of patients with diabetes on SGLT2i.MethodsThis retrospective observational study uses data of patients with diabetes who had been prescribed SGLT2i and continued to use at least 6 months at Theptarin Hospital, Bangkok. The characteristics of patients, changes in glycemic control and body weight at 3, 6, 12, 18, 24 months and the last follow-up were evaluated.ResultsA total of 189 patients with diabetes (females 50.3%, mean age 59.9 ± 12.3 years, T2DM 97.3%, duration of diabetes 16.3 ± 9.2 years, baseline BMI 29.9 ± 6.1 kg/m2, baseline HbA1c 8.8 ± 1.6%) were prescribed SGLT2i during the study period. At the time of first SGLT2i prescription, 80.4% used three or more other anti-diabetic agents concomitantly and 34.6% used insulin concomitantly. 151 patients who continue to use at least 6 months were included in analysis. At the last follow-up (median time 16 months), overall median HbA1c reduction and weight reduction were 1.0% and 1.5 kg, respectively. While glycemic control could maintain up to 18 months, weight loss gradually rebounded after the first 6 months and then backed to baseline body weight at 18 months (78.2 ± 18.0 kg vs. 78.0 ± 17.8, p value = 0.324). The incidence of adverse drug reactions of special interest (polyuria, volume depletion-related events, urinary tract infection, genital infection, and hypoglycemia) was 2.1, 1.6, 2.1, 2.6, and 7.9%, respectively.DiscussionThis real-world study confirmed long-term durability of glycemic control with SGLT2i in not only monotherapy, but also add-on studies with other oral anti-diabetic drugs and/or insulin treatment. However, weight loss became evident early after 6 weeks then reached slightly rebounds after 24 weeks until the end of follow-up. Further studies should be done towards a better understanding of treatment with SGLT2i in routine clinical practice.
Highlights
Diabetes is a progressive disease needing multiple drugs for achieving and maintaining good glycemic control
Despite advancement in the treatment of type 2 diabetes mellitus (T2DM), optimal glycemic control has not been achieved in almost half of patients in the US [2] or almost 70% of patients in Thailand [3]
Sodium-glucose co-transporter 2 inhibitors (SGLT2i) are the newest therapeutic option available for the treatment of T2DM which arrived into Thailand market at the end of 2014
Summary
Diabetes is a progressive disease needing multiple drugs for achieving and maintaining good glycemic control. Since the results of the EMPA-REG OUTCOME and CANVAS trials showed that this novel anti-diabetic agent reduced the incidence of cardiovascular events in patients with T2DM and established cardiovascular disease [7, 8], there has been great interest in expanding use of SGLT2i in treating heart diseases especially heart failure [9]. These benefits were observed unprecedentedly with less than 1 year of treatment. Risks and benefits should be assessed on a case-by-case basis because of its specific mechanism of action
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