بررسي اثر مصرف ايمپاگليفلوزين در پروفايل ليپيدي بيماران ديابتي با سندرم كرونري حاد پس از PCI

The effect of empagliflozin administration on lipid profile in diabetic patients with acute coronary syndrome after PCI

اثرات اضافه كردن مهاركننده‌هاي انتخابي انتقال‌دهنده سديم-گلوكز (SGLT2) به درمان استاندارد استاتين‌ها در بيماران با سندرم كرونري حاد (ACS) متناقض مي‌باشد. همچنين تاكنون اثرات درمان ايمپاگليفلوزين پس از مداخله زير جلدي كرونري (PCI) بر پروفايل ليپيدي بيماران ديابتي تيپ دو بررسي نشده است. روش بررسي: اين كارآزمايي باليني كنترل شده دوسويه‌كور بر روي 93 بيمار (56 مرد و 37 زن، ميانگين سني 55/56 سال) انجام شد. بيماران از بين مراجعه‌كنندگان ديابتي تيپ دو تحت PCI در بازه زماني فروردين 1399 تا دي 1399 انتخاب شدند. بيماران به‌صورت تصادفي در دو گروه دريافت‌كننده ايمپاگليفلوزين (mg 10 يك بار در روز) يا پلاسبو با دوز مشابه در كنار درمان‌هاي استاندارد براي مدت شش ماه قرار گرفتند. تغييرات پارامترهاي متابوليك از جمله پروفايل ليپيدي پيش و شش ماه پس از مداخله بررسي شد. يافته‌ها: در گروه پلاسبو پس از درمان سطوح LDL-C (متوسط mg/dl 90/0 به 82/0، 0/008=P) و HDL-C (متوسط mg/dl 40/0 به 35/0، 090/0=P) كاهش يافت، در حالي‌كه در گروه ايمپاگليفلوزين سطح LDL-C (متوسط mg/dl 87/0 به 96/0، 875/0=P) و HDL-C (متوسط mg/dl 38/0 به 48/0، 0/007=P) افزايش يافت. درمان با ايمپاگليفلوزين و پلاسبو تاثير معناداري در تغيير سطوح توتال كلسترول، تري‌گليسيريد و eGFR نداشت (0/05

Diabetes mellitus is associated with an increased risk of cardiovascular disease. The effects of add-in Sodium-glucose cotransporter 2 (SGLT2) inhibitors to standard statin treatments in acute coronary syndrome (ACS) patients remains controversial. The effects of the empagliflozin treatment after percutaneous coronary intervention (PCI) on the lipid profile of patients with type 2 diabetes mellitus (T2DM) have not been investigated yet. This study aimed to evaluate the efficacy of empagliflozin administration on lipid profile in diabetic patients with ACS after PCI. Methods: This randomized, double-blind, placebo-controlled trial study was conducted from March until December 2020 on type 2 diabetes patients who underwent PCI and were referred to the Golestan and Imam Khomeini Hospitals. 93 patients (56 males and 37 females, mean age of 56.55 years old) were included. The patients were randomly assigned into two groups of receiving empagliflozin (10 mg, once daily) or a matching placebo, in addition to standard therapies for 6 months. The changes in metabolic parameters including lipid profile before and 6 months after interventions were assessed. Results: After treatment in placebo group the level of LDL-C (median 0.90 mg/dl to 0.82, P=0.008) and HDL-C (median 0.40 mg/dl to 0.35, P=0.090) were decreased, while in the empagliflozin group the levels of LDL-C (median 0.87 mg/dl to 0.96, P=0.875) and HDL-C (median 0.38 mg/dl to 0.48), P=0.007) increased. Treatment with Empagliflozin and placebo had no significant effect on changing the levels of total cholesterol, TG and eGFR (P>0.05). The weight loss and FBS reduction in the empagliflozin group were significantly higher than placebo (P=0.001 and P=0.048, respectively). Conclusion: Our results showed that adding Empagliflozin to standard treatment compared with a placebo for 6 months significantly increased LDL-C and significantly increased HDL-C. Also, except for weight loss and FBS, Empagliflozin was not more effective in improving the metabolic parameters of diabetic patients after PCI compared with placebo, so it seems that the use of this drug in diabetic patients with ACS after PCI is not very cost-effective.