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新型固定剂量复方单片Synjardy由empagliflozin和盐酸二甲双胍组成，二种联合具有独特的降血糖机制
2015年8月28日，勃林格殷格翰-礼来糖尿病联合研发的2型糖尿病复方新药Synjardy（empagliflozin/盐酸二甲双胍）获FDA批准，用于2型糖尿病（T2D）成人患者的治疗，该药于今年6月也获得了欧盟的批准。Synjardy是勃林格-礼来糖尿病联盟在过去4年中获得FDA批准的第5款产品，也是获批的第3款包含empagliflozin（恩格列净）的产品，另外2款产品为Jardiance（empagliflozin）和Glyxambi（empagliflozin/linagliptin）。
Synjardy是由empagliflozin（恩格列净）和盐酸二甲双胍组成的复方单片，具有2种独特的降血糖机制。empagliflozin属于新兴的钠-葡萄糖协同转运蛋白-2（SGLT-2）抑制剂类降糖药，能够阻断肾脏中葡萄糖的再吸收作用，将过多的葡萄糖排泄到体外，达到降血糖疗效，而且该降糖效果不依赖于β细胞功能和胰岛素抵抗。盐酸二甲双胍则是一种常见的2型糖尿病初始治疗药物，可降低肝糖的产生，降低小肠对葡萄糖的吸收，并可通过增加外周组织对葡萄糖的摄取和利用而提高胰岛素的敏感性。
Synjardy适应症为结合饮食及运动，用于改善2型糖尿病成人患者的血糖控制，适用人群为：（1）接受含empagliflozin或二甲双胍方案仍不能充分控制血糖水平的2型糖尿病患者；（2）正在接受empagliflozin和二甲双胍联合治疗的2型糖尿病患者。
Synjardy不适用于1型糖尿病或糖尿病酮症酸中毒（血液或尿液中酮体升高）的治疗，该药的产品标签上含有一个警示框，提示该药的乳酸性酸中毒风险，这是一种严重的代谢性并发症，是由于Synjardy治疗期间可能出现的二甲双胍积累所致。
Synjardy的获批，是基于多个临床试验的强劲数据，这些试验调查了empagliflozin联合二甲双胍单独治疗或与其他降糖药（吡格列酮、磺脲类、DPP-4抑制剂、胰岛素）联合治疗时的疗效和安全性。
SYNJARDY Rx
Generic Name and Formulations:
Empagliflozin, metformin HCl; 5mg/500mg, 12.5mg/500mg, 5mg/1000mg, 12.5mg/1000mg; tabs.
Company:
Boehringer Ingelheim and Lilly
Therapeutic Use:Diabetes
Drug News:
•Severe, Persistent Joint Pain Warning Issued for Diabetes Drug Class•Synjardy Tabs Approved for Type 2 DiabetesClinical Charts:
•Diabetes TreatmentsEndocrine Disorders Resource Center » Indications for SYNJARDY:
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are not adequately controlled on metformin or empagliflozin regimen, or who are already being treated with both.
Limitations Of use:
Not for treating type 1 diabetes or diabetic ketoacidosis.
Adult:
See full labeling. Individualize. Take twice daily with meals; increase dose gradually. Max daily dose: 25mg/2000mg.
Children:
<18yrs: not established.
Contraindications:
Renal impairment (SCr ≥1.5mg/dL [men], ≥1.4mg/dL [women], or eGFR <45mL/min/1.73m2), ESRD, or on dialysis. Metabolic acidosis, diabetic ketoacidosis.
Warnings/Precautions:
Confirm normal renal function before starting and monitor thereafter (esp. in elderly). Discontinue if lactic acidosis, renal impairment, shock, acute MI or CHF, hypoxemia, dehydration, or sepsis occur. Avoid in hepatic disease. Discontinue prior to any intravascular radiocontrast study or surgery; withhold for 48hrs after procedure. Correct volume depletion before initiating. Monitor for symptomatic hypotension after starting therapy (esp. elderly, renal impairment, low systolic BP, on diuretics). Elderly, debilitated, uncompensated strenuous exercise, malnourished, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. Monitor for genital mycotic infections, UTIs, Vit. B12 deficiency, increases in LDL-C; treat if occur. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions:
Cationic drugs eliminated by renal tubular secretion (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin); may increase metformin levels; monitor. Increased risk of lactic acidosis with topiramate or other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide). Diuretics, steroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, sympathomimetics, nicotinic acid, CCBs, and isoniazid may cause hyperglycemia. Avoid excessive alcohol. Concomitant drugs that may affect renal function or metformin disposition; monitor. Concomitant insulin or insulin secretagogue: consider a lower dose of insulin/insulin secretagogue to reduce risk of hypoglycemia. β-blockers may mask hypoglycemia. May cause false (+) urine glucose tests or unreliable measurements of 1, 5-AG assay; use alternative methods to monitor glycemic control.
Pharmacological Class:
Sodium-glucose co-transporter 2 inhibitor + biguanide.
Adverse Reactions:
UTI, female genital mycotic infections, diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, headache; lactic acidosis (rare), hypotension, hepatic or renal impairment.
Generic Availability:
NO
How Supplied:
Tabs—60, 180 |
