使用来自私人心脏病专家实践的21年真实世界数据库来验证联合药物治疗(卡维地洛、螺内酯和他汀类药物)与减肥可能对HFpEF患者有益的假设

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Besides LV diastolic dysfunction, recent investigations\nsuggest a more complex and heterogeneous pathophysiology, including systolic reserve abnormalities, chronotropic incompetence, stiffening of\nventricular tissue, atrial dysfunction, secondary Pulmonary Arterial Hypertension (PAH), impaired vasodilatation and endothelial dysfunction.\nUnlike Heart Failure with Reduced Ejection Fraction (HFrEF), clinical trials over the years have not yet identified effective treatments that\nreduce mortality in patients with HFpEF. A database on use of carvedilol in a private cardiologist's practice was begun in 1997 and concluded at\nthe end of 2018. We used this database to test the hypothesis that combining pharmacological interventions to address diastolic dysfunction\n(carvedilol), volume overload (spironolactone/eplerenone) and endothelial dysfunction (statins) with weight loss may benefit patients with\nHFpEF. 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引用次数: 0

摘要

心力衰竭伴保留射血分数(HFpEF)是一种临床综合征,患者有心力衰竭(HF)症状,如呼吸困难和疲劳,左心室射血分数(LVEF)≥50%,心功能障碍作为症状的证据,如左心室(LV)舒张功能异常伴充血压力升高。除了左室舒张功能障碍外,最近的研究表明,左室舒张功能障碍还有更复杂和异质性的病理生理,包括收缩储备异常、变时性功能不全、心室组织硬化、心房功能障碍、继发性肺动脉高压(PAH)、血管舒张功能受损和内皮功能障碍。与心力衰竭伴射血分数降低(HFrEF)不同,多年来的临床试验尚未发现降低HFpEF患者死亡率的有效治疗方法。关于卡维地洛在私人心脏病专家实践中使用的数据库始于1997年,并于2018年底结束。我们使用这个数据库来验证这样的假设,即结合药物干预来解决舒张功能障碍(卡维地洛)、容量过载(安内酯/依普利酮)和内皮功能障碍(他汀类药物)与体重减轻可能对hfpef患者有益。我们报告了335例HFpEF患者的分析,其中61%为女性(平均年龄74±8岁),39%为男性(平均年龄72±7岁)。初始EF范围为50 - 77%,平均EF为57±6%。仅有15例患者因不良反应改用琥珀酸美托洛尔、维拉帕米或地尔噻嗪。220名患者在开始服用卡维地洛、螺内酯/依普利酮和他汀类药物治疗并进行减肥咨询时窦性心律正常。5年后,191例患者仍在接受联合治疗,只有31例(17%)发生房颤(AF)。与先前HFpEF试验报告的4年后发生房颤的风险为32%相比,我们的联合治疗显著降低了5年后发生房颤的风险(p < 0.05)。因此,无论年龄和性别是否伴有2型糖尿病(DM)和慢性肾脏疾病(CKD)的合并症,HFpEF患者都可以通过卡维地洛、旋内酯/依普利酮和他汀类药物成功治疗,其临床益处是降低了发生房颤的风险。我们认为这些数据产生了假设,并希望这些结果将在数据库分析和临床试验中得到进一步的验证。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Using A 21-Year Real-World Database from a Private Cardiologist's Practice to Test the Hypothesis that Combining Pharmacological Therapies (Carvedilol, Spironolactone and Statins) with Weight Loss May Benefit Patients with HFpEF
Heart Failure with preserved Ejection Fraction (HFpEF) is a clinical syndrome in which patients have symptoms of Heart Failure (HF), such as dyspnea and fatigue, a Left Ventricular Ejection Fraction (LVEF) ≥ 50% and evidence of cardiac dysfunction as a cause of symptoms, such as abnormal Left Ventricular (LV) diastolic dysfunction with elevated filling pressures. Besides LV diastolic dysfunction, recent investigations suggest a more complex and heterogeneous pathophysiology, including systolic reserve abnormalities, chronotropic incompetence, stiffening of ventricular tissue, atrial dysfunction, secondary Pulmonary Arterial Hypertension (PAH), impaired vasodilatation and endothelial dysfunction. Unlike Heart Failure with Reduced Ejection Fraction (HFrEF), clinical trials over the years have not yet identified effective treatments that reduce mortality in patients with HFpEF. A database on use of carvedilol in a private cardiologist's practice was begun in 1997 and concluded at the end of 2018. We used this database to test the hypothesis that combining pharmacological interventions to address diastolic dysfunction (carvedilol), volume overload (spironolactone/eplerenone) and endothelial dysfunction (statins) with weight loss may benefit patients with HFpEF. We report analysis of 335 patients with HFpEF comprised of 61% female (mean age 74 ± 8) and 39% males (mean age 72 ± 7). Initial EF ranged between 50 and 77% with mean EF of 57 ± 6%. Only 15 patients were changed to metoprolol succinate, verapamil or diltiazem because of adverse side effects. Two hundred and twenty of the patients were in normal sinus rhythm when started on carvedilol, spironolactone/eplerenone and statin therapy with weight loss counseling. After 5 years, 191 patients were still on combination therapy, and only 31 (17%) had developed Atrial Fibrillation (AF). Compared to previous HFpEF trials reporting a 32% risk of developing atrial fibrillation after 4 years, our combination therapy significantly (p < 0.05) reduced the risk of developing AF over 5 years. Thus, irrespective of age and sex with comorbidities of type 2 Diabetes Mellitus (DM) and Chronic Kidney Disease (CKD), patients with HFpEF can be managed successfully with carvedilol, spironolactone/eplerenone and statins with a clinical benefit being a reduced risk of developing AF. We consider these data hypothesis-generating and hope these results will be tested further in database analyses and clinical trials.
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