Palmer A J, Roze S, Rodby R A, Valentine W J, Ritz E, Lehnert H
CORE -- Center for Outcomes Research, A Unit of IMS, Binningen, Switzerland.
Dtsch Med Wochenschr. 2006 Aug 4;131(31-32):1721-6. doi: 10.1055/s-2006-947822.
It was the aim of this study to project the long-term clinical and cost outcomes of irbesartan treatment, based on data from the irbesartan in Reduction of Microalbuminuria-2 (IRMA-2) study and the irbesartan in Diabetic Nephropathy Trial (IDNT), in hypertensive patients with type 2 diabetes and renal disease in Germany.
A Markov model adapted to the German setting simulated progression of renal disease and associated changes in mortality in patients with hypertension, type 2 diabetes and microalbuminuria. Early irbesartan 300 mg daily (initiated at microalbuminuria) and late irbesartan (initiated at overt nephropathy) were compared to a control scheme of antihypertensive standard medications with comparable blood pressure control, initiated at microalbuminuria. Cumulative incidence of ESRD, time to onset of ESRD, life expectancy (LE), quality-adjusted life years (QALY) and costs were projected over 25 years for 1,000 simulated patients, from a third party payer perspective. Clinical and cost outcomes were discounted at 5% per annum.
When compared to standard blood pressure control, both early and late treatment with irbesartan were projected to reduce the cumulative incidence of ESRD fromm23.80.3% to 9.10.6% and 19.83%, increase discounted LE by 0.670.04 and 0.030.00 years, and improve QALY by 0.750.04 and 0.070.01 years per treated patient, respectively. Early irbesartan treatment was associated with a cost savings of i 12,658825 per patient while late irbesartan treatment was associated with a cost savings of i 4,116575 per patient compared to control over the 25-year time horizon.
Early irbesartan treatment was projected to improve LE and QALY, and reduce the onset of ESRD, with cost savings, in hypertensive patients with type 2 diabetes and microalbuminuria in Germany. Later use of irbesartan in overt nephropathy is also superior to standard care. These findings suggest that irbesartan should be started earlier and continued long-term.
本研究旨在根据厄贝沙坦减少微量白蛋白尿-2(IRMA-2)研究和厄贝沙坦糖尿病肾病试验(IDNT)的数据,预测德国2型糖尿病合并肾病的高血压患者接受厄贝沙坦治疗的长期临床和成本结局。
采用适应德国情况的马尔可夫模型模拟高血压、2型糖尿病和微量白蛋白尿患者的肾病进展及相关死亡率变化。将每日300毫克厄贝沙坦早期治疗(在微量白蛋白尿阶段开始)和晚期治疗(在显性肾病阶段开始)与在微量白蛋白尿阶段开始的具有可比血压控制效果的抗高血压标准药物对照方案进行比较。从第三方支付者的角度,对模拟的1000例患者在25年期间的终末期肾病(ESRD)累积发病率、ESRD发病时间、预期寿命(LE)、质量调整生命年(QALY)和成本进行预测。临床和成本结局按每年5%进行贴现。
与标准血压控制相比,厄贝沙坦早期和晚期治疗预计均可将ESRD累积发病率从23.8±0.3%降至9.1±0.6%和19.8±3%,每例接受治疗患者的贴现LE分别增加0.67±0.04年和0.03±0.00年,QALY分别改善0.75±0.04年和0.07±0.01年。与25年时间范围内的对照相比,厄贝沙坦早期治疗使每位患者节省成本12,658±825欧元,而厄贝沙坦晚期治疗使每位患者节省成本4,116±575欧元。
预计在德国2型糖尿病合并微量白蛋白尿的高血压患者中,早期使用厄贝沙坦可改善LE和QALY,减少ESRD的发生,并节省成本。在显性肾病阶段较晚使用厄贝沙坦也优于标准治疗。这些研究结果表明,厄贝沙坦应尽早开始并长期使用。