用于强化收缩压治疗的抗高血压方案的单片复方制剂的可获得性：收缩压干预试验。
Single-Pill Combination Product Availability of the Antihypertensive Regimens Used for Intensive Systolic Blood Pressure Treatment in the Systolic Blood Pressure Intervention Trial.
机构信息
Intermountain Healthcare Department of Population Health Sciences, Spencer Fox Eccles School of Medicine, University of Utah, Salt Lake City (J.B.K., C.G.D., J.A.J., M.B.C., A.P.B.).
Institute for Health Research, Kaiser Permanente Colorado, Aurora (J.B.K.).
出版信息
Hypertension. 2023 Aug;80(8):1749-1758. doi: 10.1161/HYPERTENSIONAHA.123.21132. Epub 2023 Jun 8.
BACKGROUND
Single-pill combination (SPC) antihypertensive products improve blood pressure control and medication adherence among patients with hypertension. It is unknown to what degree commercially available SPC products could be used to target an intensive systolic blood pressure goal of <120 mm Hg.
METHODS
This cross-sectional analysis included participants randomized to the intensive treatment arm (goal systolic blood pressure <120 mm Hg) of the Systolic Blood Pressure Intervention Trial (SPRINT) using ≥2 antihypertensive medication classes at the 12-month postrandomization visit. Antihypertensive medication data were collected using pill bottle review by research coordinators, and regimens were categorized by the unique combinations of antihypertensive classes. We calculated the proportion of regimens used, which are commercially available as one of the 7 SPC class combinations in the United States as of January 2023.
RESULTS
Among the 3833 SPRINT intensive arm participants included (median age, 67.0 years; 35.5% female), participants were using 219 unique antihypertensive regimens. The 7 regimens for which there are class-equivalent SPC products were used by 40.3% of participants. Only 3.2% of all medication class regimens used are available as a class-equivalent SPC product (7/219). There are no SPC products available with 4 or more medication classes, which were used by 1060 participants (27.7%).
CONCLUSIONS
Most SPRINT participants in the intensive arm used an antihypertensive medication regimen, which is not commercially available as a class equivalent SPC product. To achieve the SPRINT results in real-world settings, maximize the potential benefit of SPCs, and reduce pill burden, improvements in the product landscape are needed.
REGISTRATION
URL: https://www.
CLINICALTRIALS
gov/ct2/show/NCT01206062; Unique identifier: NCT01206062.
背景
单片复方（SPC）降压产品可改善高血压患者的血压控制和药物依从性。目前尚不清楚在多大程度上可以使用市售的 SPC 产品来实现收缩压目标＜120mmHg 的强化治疗。
方法
本横断面分析纳入了在 Systolic Blood Pressure Intervention Trial（SPRINT）中随机分配至强化治疗组（目标收缩压＜120mmHg）且在随机分组后 12 个月的随访时使用≥2 种降压药物类别的参与者。研究协调员通过查看药瓶对降压药物数据进行收集，并根据降压药物类别的独特组合对方案进行分类。我们计算了使用方案的比例，这些方案均为截至 2023 年 1 月在美国上市的 7 种 SPC 类组合中的一种。
结果
在纳入的 3833 名 SPRINT 强化组参与者中（中位年龄 67.0 岁，35.5%为女性），参与者使用了 219 种独特的降压方案。有 7 种方案可使用具有等效类别的 SPC 产品，有 40.3%的参与者使用了这些方案。使用的所有药物类方案中，仅有 3.2%（7/219）可作为等效类别的 SPC 产品。没有包含 4 种或更多药物类别的 SPC 产品，而有 1060 名参与者（27.7%）使用了这些方案。
结论
SPRINT 强化组中的大多数参与者使用的降压药物方案在商业上不可作为等效类别的 SPC 产品。为了在实际环境中实现 SPRINT 的结果，最大限度地发挥 SPC 的潜在益处并减少用药负担，需要改善产品种类。
注册信息
临床试验
ClinicalTrials.gov/ct2/show/NCT01206062；唯一标识符：NCT01206062。
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