教えて!　SGLT2阻害薬の使い方

出版社： 羊土社
著者：
発行日： 2017-02-15
分野： 臨床医学：内科  >  糖尿病
ISBN： 9784758118040
電子書籍版： 2017-02-15 （第1刷）
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大規模臨床試験などの多くのエビデンスに基づき，Q&Aとケーススタディで臨床の場における活用法を基礎から解説．また，心血管イベントリスク低下や腎保護作用など，本薬がもつ多面的作用の可能性も解説します．

目次

  • 教えて！　SGLT2阻害薬の使い方

    ―目次―

    第1章　SGLT2阻害薬への疑問に答えます
    　Q1　SGLT2阻害薬とは，どのような薬なのですか？
    　Q2　血糖降下作用の実際の程度は？ 糖毒性への影響は？
    　Q3　体重が減るのはなぜ？ 減量目的で使用してよいのですか？
    　Q4　お腹が空きやすくなるって本当？
    　Q5　血圧を改善するって本当？
    　Q6　脂質を改善するって本当？
    　Q7　結局どのような患者に適応になるの？
    　Q8　市販されているSGLT2阻害薬の種類と違いは？
    　Q9　1型糖尿病患者にも使用できるのでしょうか？
    　Q10　適正使用に関するRecommendationはなぜ出されたのですか？
    　　　　どう考えればよいのでしょうか？

    第2章　SGLT2阻害薬はこう使う
    　Case1　BMI 23〜25程度の患者
    　Case2　年齢65〜70歳程度の患者
    　Case3　ドラッグナイーブの患者
    　　　　　　〜DPP-4阻害薬か？ SGLT2阻害薬か？
    　Case4　他の糖尿病治療薬からの切り替えを検討中の患者
    　Case5　インスリンとの併用
    　Case6　SU薬との併用
    　Case7　ビグアナイド薬との併用
    　Case8　α-GI薬との併用
    　Case9　チアゾリジン薬との併用
    　Case10　速効型インスリン分泌促進薬（グリニド薬）との併用
    　Case11　DPP-4阻害薬との併用
    　Case12　GLP-1受容体作動薬との併用
    　Case13　生活指導との相乗効果を狙いたい患者
    　Case14　これまで他の糖尿病治療薬で効果が得られなかった患者

    第3章　多面的作用〜病態および糖尿病関連疾患への効果
    　1　病態改善作用とその機構
    　2　心血管疾患（脳卒中含む）
    　3　腎症
    　4　肝疾患
    　5　その他（がん，認知症）

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第1章 SGLT2阻害薬への疑問に答えます

P.12 掲載の参考文献
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PubMed
12) Forst T, et al:Efficacy and safety of canagliflozin over 52 weeks in patients with type 2 diabetes on background metformin and pioglitazone. Diabetes Obes Metab, 16:467-477, 2014
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13) Stenlof K, et al:Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetes Obes Metab, 15:372-382, 2013
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14) Cefalu WT, et al:Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU):52 week results from a randomised, doubleblind, phase 3 non-inferiority trial. Lancet, 382:941-950, 2013
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15) Haring HU, et al:Empagliflozin as add-on to metformin in patients with type 2 diabetes:a 24-week, randomized, doubleblind, placebo-controlled trial. Diabetes Care, 37:1650-1659, 2014
 
16) Zinman B, et al:Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med, 373:2117-2128, 2015
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17) Merovci A, et al:Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production. J Clin Invest, 124:509-514, 2014
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18) Jurczak MJ, et al:SGLT2 deletion improves glucose homeostasis and preserves pancreatic beta-cell function. Diabetes, 60:890-898, 2011
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19) Hansen HH, et al:The sodium glucose cotransporter type 2 inhibitor empagliflozin preserves β-cell mass and restores glucose homeostasis in the male zucker diabetic fatty rat. J Pharmacol Exp Ther, 350:657-664, 2014
 
P.25 掲載の参考文献
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2) Lambers Heerspink HJ, et al:Dapagliflozin a glucose-regulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes Obes Metab, 15:853-862, 2013
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3) Sha S, et al:Effect of the sodium glucose co-transporter 2 inhibitor canagliflozin on plasma volume in patients with type 2 diabetes mellitus. Diabetes Obes Metab, 16:1087-1095, 2014
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4) Ferrannini G, et al:Energy Balance After Sodium-Glucose Cotransporter 2 Inhibition. Diabetes Care, 38:1730-1735, 2015
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5) Ferrannini E, et al:The threshold shift paradigm of obesity:evidence from surgically induced weight loss. Am J Clin Nutr, 100:996-1002, 2014
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P.27 掲載の参考文献
1) Tang H, et al:Sodium-glucose co-transporter 2 inhibitors in addition to insulin therapy for management of type 2 diabetes mellitus:A meta-analysis of randomized controlled trials. Diabetes Obes Metab, 19:142-147, 2017
 
2) Monica Reddy RP & Inzucchi SE:SGLT2 inhibitors in the management of type 2 diabetes. Endocrine, 53:364-372, 2016
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P.32 掲載の参考文献
1) Baker WL, et al:Effects of sodium-glucose co-transporter 2 inhibitors on blood pressure:a systematic review and meta-analysis. J Am Soc Hypertens, 8:262-275.e9, 2014
 
2) Komoroski B, et al:Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus. Clin Pharmacol Ther, 85:513-519, 2009
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3) Tikkanen I, et al:EMPA-REG BP Investigators. Empagliflozin reduces blood pressure in patients with type 2 diabetes and hypertension. Diabetes Care, 38:420-428, 2015
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4) Sha S, et al:Effect of the sodium glucose co-transporter 2 inhibitor canagliflozin on plasma volume in patients with type 2 diabetes mellitus. Diabetes Obes Metab, 16:1087-1095, 2014
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5) Maliha G & Townsend RR:SGLT2 inhibitors:their potential reduction in blood pressure. J Am Soc Hypertens, 9:48-53, 2015
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6) Cherney DZ, et al:Renal hemodynamic effect of sodium-glucose cotransporter 2 inhibition in patients with type 1 diabetes mellitus. Circulation, 129:587-597, 2014
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7) Thomson SC, et al:Acute and chronic effects of SGLT2 blockade on glomerular and tubular function in the early diabetic rat. Am J Physiol Regul Integr Comp Physiol, 302:R75-83, 2012
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8) Nagata T, et al:Tofogliflozin, a novel sodium-glucose co-transporter 2 inhibitor, improves renal and pancreatic function in db/db mice. Br J Pharmacol, 170:519-531, 2013
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9) Terami N, et al:Long-term treatment with the sodium glucose cotransporter 2 inhibitor, dapagliflozin, ameliorates glucose homeostasis and diabetic nephropathy in db/db mice. PLoS One, 9:e100777, 2014
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10) Vallon V, et al:Knockout of Na-glucose transporter SGLT2 attenuates hyperglycemia and glomerular hyperfiltration but not kidney growth or injury in diabetes mellitus. Am J Physiol Renal Physiol, 304:F156-167, 2013
 
11) Cherney DZ, et al:The effect of empagliflozin on arterial stiffness and heart rate variability in subjects with uncomplicated type 1 diabetes mellitus. Cardiovasc Diabetol, 13:28, 2014
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P.37 掲載の参考文献
1) Schwartz GG, et al:Fasting triglycerides predict recurrent ischemic events in patients with acute coronary syndrome treated with statins. J Am Coll Cardiol, 65:2267-2275, 2015
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2) Hayashizaki-Someya Y, et al:Ipragliflozin, an SGLT2 inhibitor, exhibits a prophylactic effect on hepatic steatosis and fibrosis induced by choline-deficient l-amino aciddefined diet in rats. Eur J Pharmacol, 754:19-24, 2015
 
3) Obata A, et al:Tofogliflozin Improves Insulin Resistance in Skeletal Muscle and Accelerates Lipolysis in Adipose Tissue in Male Mice. Endocrinology, 157:1029-1042, 2016
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4) Bolinder J, et al:Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin. J Clin Endocrinol Metab, 97:1020-1031, 2012
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5) Ferrannini E, et al:Metabolic response to sodium-glucose cotransporter 2 inhibition in type 2 diabetic patients. J Clin Invest, 124:499-508, 2014
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6) Briand F, et al:Empagliflozin, via Switching Metabolism Toward Lipid Utilization, Moderately Increases LDL Cholesterol Levels Through Reduced LDL Catabolism. Diabetes, 65:2032-2038, 2016
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P.40 掲載の参考文献
1) 日本糖尿病学会SGLT2 阻害薬の適正使用に関する委員会:日本糖尿病学会SGLT2 阻害薬の適正使用に関するRecommendation. 2016年5月12日
 
P.47 掲載の参考文献
1) Zinman B, et al:Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med, 373:2117-2128, 2015
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2) 脇野 修:糖吸収・排泄調節系薬(SGLT2 阻害薬, α GI). 糖尿病の最新治療, 7:147-153, 2016
 
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5) Washburn WN & Poucher SM:Differentiating sodium-glucose co-transporter-2 inhibitors in development for the treatment of type 2 diabetes mellitus. Expert Opin Investig Drugs, 22:463-486, 2013
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6) 生井一之:他のSGLT2 阻害薬が夜間頻尿のため継続できず, トホグリフロジンに変更し, 夜間頻尿改善, HbA1c 低下, 体重も減少したインスリン併用の1例. Life Style Medicine, 9:138-140, 2015
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8) Strojek K, et al:Dapagliflozin added to glimepiride in patients with type 2 diabetes mellitus sustains glycemic control and weight loss over 48 weeks:a randomized, double-blind, parallel-group, placebo-controlled trial. Diabetes Ther, 5:267-283, 2014
 
9) Wilding JP, et al:Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea:a randomised trial. Int J Clin Pract, 67:1267-1282, 2013
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10) Haring HU, et al:Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes:a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Care, 36:3396-3404, 2013
 
11) Cefalu WT, et al:Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU):52 week results from a randomised, doubleblind, phase 3 non-inferiority trial. Lancet, 382:941-950, 2013
PubMed
12) Rosenstock J, et al:Effects of dapagliflozin, an SGLT2 inhibitor, on HbA(1c), body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. Diabetes Care, 35:1473-1478, 2012
PubMed
13) Kovacs CS, et al:Empagliflozin improves glycaemic and weight control as add-on therapy to pioglitazone or pioglitazone plus metformin in patients with type 2 diabetes:a 24-week, randomized, placebo-controlled trial. Diabetes Obes Metab, 16:147-158, 2014
PubMed
14) Forst T, et al:Efficacy and safety of canagliflozin over 52 weeks in patients with type 2 diabetes on background metformin and pioglitazone. Diabetes Obes Metab, 16:467-477, 2014
PubMed
15) Wanner C, et al:Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes. N Engl J Med, 375:323-334, 2016
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16) Ferrannini E, et al:CV Protection in the EMPA-REG OUTCOME Trial:A "Thrifty Substrate" Hypothesis. Diabetes Care, 39:1108-1114, 2016
 
17) Mudaliar S, et al:Can a Shift in Fuel Energetics Explain the Beneficial Cardiorenal Outcomes in the EMPA-REG OUTCOME Study? A Unifying Hypothesis. Diabetes Care, 39:1115-1122, 2016
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P.52 掲載の参考文献
1) 一般社団法人 糖尿病データマネジメント研究会:基礎集計資料(2013年度). http://jddm.jp/data/index-2013.html
 
2) Inagaki N, et al:Safety and efficacy of canagliflozin in Japanese patients with type 2 diabetes mellitus:post hoc subgroup analyses according to body mass index in a 52-week open-label study. Expert Opin Pharmacother, 16:1577-1591, 2015
 
3) FDA Drug Safety Communication:FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood. http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm
 
4) Ogawa W & Sakaguchi K:Euglycemic diabetic ketoacidosis induced by SGLT2 inhibitors:possible mechanism and contributing factors. J Diabetes Investig, 7:135-138, 2016
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5) Peters AL, et al:Euglycemic Diabetic Ketoacidosis:A Potential Complication of Treatment With Sodium-Glucose Cotransporter 2 Inhibition. Diabetes Care, 38:1687-1693, 2015
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6) 日本糖尿病学会SGLT2 阻害薬の適正使用に関する委員会:日本糖尿病学会SGLT2 阻害薬の適正使用に関するRecommendation. 2016年5月12日
 
7) Henry RR, et al:Exploring the potential of the SGLT2 inhibitor dapagliflozin in type 1 diabetes:a randomized, double-blind, placebo-controlled pilot study. Diabetes Care, 38:412-419, 2015
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8) Pieber TR, et al:Empagliflozin as adjunct to insulin in patients with type 1 diabetes:a 4-week, randomized, placebo-controlled trial (EASE-1). Diabetes Obes Metab, 17:928-935, 2015
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9) Henry RR, et al:Efficacy and Safety of Canagliflozin, a Sodium-Glucose Cotransporter 2 Inhibitor, as Add-on to Insulin in Patients With Type 1 Diabetes. Diabetes Care, 38:2258-2265, 2015
 
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P.60 掲載の参考文献
1) Kaku K, et al:Efficacy and safety of dapagliflozin as a monotherapy for type 2 diabetes mellitus in Japanese patients with inadequate glycaemic control:a phase II multicentre, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab, 15:432-440, 2013
PubMed
2) Kaku K, et al:Efficacy and safety of monotherapy with the novel sodium/glucose cotransporter-2 inhibitor tofogliflozin in Japanese patients with type 2 diabetes mellitus:a combined Phase 2 and 3 randomized, placebo-controlled, double-blind, parallel-group comparative study. Cardiovasc Diabetol, 13:65, 2014
PubMed
3) 日本糖尿病学会SGLT2 阻害薬の適正使用に関する委員会:日本糖尿病学会SGLT2 阻害薬の適正使用に関するRecommendation. http://www.jds.or.jp/
 
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5) Terauchi Y, et al:Safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER):Interim results of a post-marketing surveillance study. Expert Opin Pharmacother, 17:463-471, 2016
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6) Utsunomiya K, et al:Japanese study of tofogliflozin with type 2 diabetes mellitus patients in an observational study of the elderly (J-STEP/EL):A 12-week interim analysis. J Diabetes Investig, 7:755-763, 2016
 
7) 加来浩平:新たな作用機序による経口血糖効果薬(選択的SGLT2 阻害薬)の有効性と安全性. 診療と新薬, 50:607-614, 2013
 
8) Zinman B, et al:Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med, 373:2117-2128, 2015
PubMed
9) Wanner C, et al:Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes. N Engl J Med, 375:323-334, 2016
PubMed
10) Kaku K, et al:Empagliflozin and Cardiovascular Outcomes in Asian Patients with Type 2 Diabetes and Established Cardiovascular Disease:Results from EMPA-REG OUTCOME. Circ J, 2016 doi:10.1253/circj.CJ-16-1148
 

第2章 SGLT2阻害薬はこう使う

P.64 掲載の参考文献
1) Zinman B, et al:Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med, 373:2117-2128, 2015
PubMed
2) Sonesson C, et al:Cardiovascular effects of dapagliflozin in patients with type 2 diabetes and different risk categories:a metaanalysis. Cardiovasc Diabetol, 15:37, 2016
PubMed
P.67 掲載の参考文献
1) Terauchi Y, et al:Safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER):Interim results of a post-marketing surveillance study. Expert Opin Pharmacother, 17:463-471, 2016
PubMed
P.70 掲載の参考文献
1) Takihata M, et al:Comparative study of sitagliptin with pioglitazone in Japanese type 2 diabetic patients:the COMPASS randomized controlled trial. Diabetes Obes Metab, 15:455-462, 2013
 
2) Kashiwagi A, et al:Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes stratified by body mass index:A subgroup analysis of five randomized clinical trials. J Diabetes Investig, 7:544-554, 2016
PubMed
P.73 掲載の参考文献
1) Goto A, et al:Severe hypoglycaemia and cardiovascular disease:systematic review and meta-analysis with bias analysis. BMJ, 347:f4533, 2013
PubMed
2) Takihata M, et al:Comparative study of sitagliptin with pioglitazone in Japanese type 2 diabetic patients:the COMPASS randomized controlled trial. Diabetes Obes Metab, 15:455-462, 2013
 
3) Kahn SE, et al:Rosiglitazone-associated fractures in type 2 diabetes:an Analysis from A Diabetes Outcome Progression Trial (ADOPT). Diabetes Care, 31:845-851, 2008
PubMed
P.77 掲載の参考文献
1) Goto A, et al:Severe hypoglycaemia and cardiovascular disease:systematic review and meta-analysis with bias analysis. BMJ, 347:f4533, 2013
PubMed
P.83 掲載の参考文献
1) 日本糖尿病学会SGLT2 阻害薬の適正使用に関する委員会:日本糖尿病学会SGLT2 阻害薬の適正使用に関するRecommendation. 策定2014年6月13日;改訂2014年8月29日
 
P.90 掲載の参考文献
1) 栗原義夫:実臨床からみえてきたSGLT2 阻害薬の有用性. Therapeutic Research, 36:983-993, 2015
Medical*Online
P.93 掲載の参考文献
1) Wanner C, et al:Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes. N Engl J Med, 375:323-334, 2016
PubMed
P.97 掲載の参考文献
1) 加来浩平:新たな作用機序による経口血糖降下薬(選択的SGLT2 阻害薬)の有効性と安全性. 診療と新薬, 50:607-614, 2013
 
P.100 掲載の参考文献
1) 栗原義夫:実臨床からみえてきたSGLT2 阻害薬の有用性. Therapeutic Research, 36:983-993, 2015
Medical*Online
P.106 掲載の参考文献
1) 栗原義夫:実臨床からみえてきたSGLT2 阻害薬の有用性. Therapeutic Research, 36:983-993, 2015
Medical*Online
2) 加来浩平:新たな作用機序による経口血糖降下薬(選択的SGLT2 阻害薬)の有効性と安全性. 診療と新薬, 50:607-614, 2013
 
P.110 掲載の参考文献
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第3章 多面的作用～病態および糖尿病関連疾患への効果

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