Effect of CPAP on Blood Pressure in Patients With Obstructive Sleep Apnea and Resistant Hypertension The HIPARCO Randomized Clinical Trial
Effect of CPAP on Blood Pressure in Patients With Obstructive Sleep Apnea and Resistant Hypertension The HIPARCO Randomized Clinical Trial
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DOI：
10.1001/jama.2013.281250
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发表时间：
2013-12-11
影响因子：
120.7
通讯作者：
Montserrat, Josep Maria
中科院分区：
文献类型：
--
作者：
Martinez-Garcia, Miguel-Angel;Capote, Francisco;Montserrat, Josep Maria
重要性 超过 70% 的顽固性高血压患者患有阻塞性睡眠呼吸暂停 (OSA)。然而，关于持续气道正压通气 (CPAP) 治疗对难治性高血压患者血压的影响的证据很少。 目的 评估 CPAP 治疗对难治性高血压和 OSA 患者的血压值和夜间血压模式的影响。 设计、地点和参与者 在西班牙 24 家教学医院进行的开放标签、随机、多中心平行组临床试验，采用盲法终点设计，涉及 194 名难治性高血压患者和呼吸暂停低通气指数 (AHI) 为 15 或更高。数据收集时间为 2009 年 6 月至 2011 年 10 月。 干预措施 持续气道正压通气 (CPAP) 或不治疗，同时维持常规血压控制药物。 主要结果和措施 主要终点是 12 周后 24 小时平均血压的变化。次要终点包括其他血压值的变化和夜间血压模式的变化。进行了意向治疗 (ITT) 和符合方案分析。 结果 共有 194 名患者被随机分配接受 CPAP 治疗 (n = 98) 或不接受 CPAP 治疗（对照；n = 96）。平均 AHI 为 40.4（SD，18.9），每位患者平均服用 3.8 种抗高血压药物。基线24小时平均血压为103.4毫米汞柱；收缩压（SBP），144.2 毫米汞柱；舒张压 (DBP) 83 毫米汞柱。在基线时，25.8% 的患者表现出北斗型血压（与白天平均血压相比，夜间平均血压至少下降 10%）。每天使用 CPAP 4 小时或以上的患者比例为 72.4%。当通过 ITT 比较研究期间各组之间的血压变化时，CPAP 组在 24 小时平均血压（3.1 mm Hg [95% CI，0.6 至 5.6]；P = .02）和 24 小时 DBP（3.2 mm Hg [95% CI，1.0 至 5.4]；P = .005）方面实现了更大的下降，但在 24 小时内没有出现这种情况。与对照组相比，SBP（3.1 mm Hg [95% CI，-0.6 至 6.7]；P = .10）。此外，在 12 周随访中，CPAP 组出现夜间血压呈斗形模式的患者比例高于对照组（35.9% vs 21.6%；调整优势比 [OR]，2.4 [95% CI，1.2 至 5.1]；P = 0.02）。使用 CPAP 的时间与 24 小时平均血压 (r = 0.29，P = .006)、SBP (r = 0.25；P = .02) 和 DBP (r = 0.30，P = .005) 的下降呈显着正相关。 结论和相关性 在 OSA 合并顽固性高血压的患者中，与对照组相比，CPAP 治疗 12 周导致血压下降24 小时平均血压和舒张压降低，夜间血压模式改善。有必要进行进一步的研究来评估长期健康结果。
IMPORTANCE More than 70% of patients with resistant hypertension have obstructive sleep apnea (OSA). However, there is little evidence about the effect of continuous positive airway pressure (CPAP) treatment on blood pressure in patients with resistant hypertension.OBJECTIVE To assess the effect of CPAP treatment on blood pressure values and nocturnal blood pressure patterns in patients with resistant hypertension and OSA.DESIGN, SETTING, AND PARTICIPANTS Open-label, randomized, multicenter clinical trial of parallel groups with blinded end point design conducted in 24 teaching hospitals in Spain involving 194 patients with resistant hypertension and an apnea-hypopnea index (AHI) of 15 or higher. Data were collected from June 2009 to October 2011.INTERVENTIONS CPAP or no therapy while maintaining usual blood pressure control medication.MAIN OUTCOMES AND MEASURES The primary end point was the change in 24-hour mean blood pressure after 12 weeks. Secondary end points included changes in other blood pressure values and changes in nocturnal blood pressure patterns. Both intention-to-treat (ITT) and per-protocol analyses were performed.RESULTS A total of 194 patients were randomly assigned to receive CPAP (n = 98) or no CPAP (control; n = 96). The mean AHI was 40.4 (SD, 18.9) and an average of 3.8 antihypertensive drugs were taken per patient. Baseline 24-hour mean blood pressure was 103.4 mm Hg; systolic blood pressure (SBP), 144.2 mm Hg; and diastolic blood pressure (DBP), 83 mm Hg. At baseline, 25.8% of patients displayed a dipper pattern (a decrease of at least 10% in the average nighttime blood pressure compared with the average daytime blood pressure). The percentage of patients using CPAP for 4 or more hours per day was 72.4%. When the changes in blood pressure over the study period were compared between groups by ITT, the CPAP group achieved a greater decrease in 24-hour mean blood pressure (3.1 mm Hg [95% CI, 0.6 to 5.6]; P = .02) and 24-hour DBP (3.2 mm Hg [95% CI, 1.0 to 5.4]; P = .005), but not in 24-hour SBP (3.1 mm Hg [95% CI, -0.6 to 6.7]; P = .10) compared with the control group. Moreover, the percentage of patients displaying a nocturnal blood pressure dipper pattern at the 12-week follow-up was greater in the CPAP group than in the control group (35.9% vs 21.6%; adjusted odds ratio [OR], 2.4 [95% CI, 1.2 to 5.1]; P = .02). There was a significant positive correlation between hours of CPAP use and the decrease in 24-hour mean blood pressure (r = 0.29, P = .006), SBP (r = 0.25; P = .02), and DBP (r = 0.30, P = .005).CONCLUSIONS AND RELEVANCE Among patients with OSA and resistant hypertension, CPAP treatment for 12 weeks compared with control resulted in a decrease in 24-hour mean and diastolic blood pressure and an improvement in the nocturnal blood pressure pattern. Further research is warranted to assess longer-term health outcomes.