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Pitavastatin Is Well-Tolerated With no Detrimental Effects on Physical Function
Clinical Infectious Diseases ( IF 8.2 ) Pub Date : 2024-08-16 , DOI: 10.1093/cid/ciae422
Kristine M Erlandson 1 , Triin Umbleja 2 , Heather J Ribaudo 2 , Jennifer A Schrack 3 , Edgar T Overton 4, 5 , Carl J Fichtenbaum 6 , Kathleen V Fitch 7 , Jhoanna C Roa 8 , Marissa R Diggs 7 , Kenneth Wood 9 , Markella V Zanni 7 , Gerald S Bloomfield 10 , Carlos Malvestutto 11 , Judith A Aberg 12 , Maria C Rodriguez-Barradas 13, 14 , Rosalba Gomez Morones 13, 14 , Katherine Breaux 13, 14 , Pamela S Douglas 15 , Steven K Grinspoon 7 , Todd T Brown 16
Affiliation  

Background Little is known about the potential benefits or harms of statins on physical function among people with human immunodeficiency virus (PWH). Methods REPRIEVE was a double-blind randomized controlled trial evaluating pitavastatin for primary prevention of major adverse cardiovascular events in PWH. Time to complete 10 chair rises, 4-m gait speed, grip strength, and a modified short physical performance test were assessed annually for up to 5 years in the ancillary study PREPARE and analyzed using linear mixed models. Findings Of 602 PWH, 52% were randomized to pitavastatin and 48% to placebo. Median age was 51 years; 18% were female at birth; 2% transgender; and 40% Black, and 18% Hispanic. Median PREPARE follow-up was 4.7 (4.3–5.0) years. Muscle symptoms (grade ≥3 or treatment-limiting) occurred in 5% of both groups. There was no evidence of decline in chair rise rate in either treatment group and no difference in the pitavastatin group compared to placebo (estimated difference −0.10 [95% confidence interval, −.30 to 0.10] rises/min/year; P = .31). Small declines over time were observed in other physical function tests in both treatment groups, with no apparent differences between groups. Interpretation We observed minimal declines in physical function over 5 years of follow-up among middle-aged PWH, with no differences among PWH randomized to pitavastatin compared to placebo. This finding, combined with low prevalence of myalgias, supports the long-term safety of statin therapy on physical function, when used for primary prevention of major adverse cardiovascular events among PWH.

中文翻译:


匹伐他汀耐受性良好,对身体机能无不良影响



背景 关于他汀类药物对人类免疫缺陷病毒 (PWH) 患者身体机能的潜在益处或危害知之甚少。方法 REPRIEVE 是一项双盲随机对照试验,评估匹伐他汀对 PWH 主要不良心血管事件的一级预防作用。在辅助研究 PREPARE 中,每年评估完成 10 次椅子升起的时间、4 m 步态速度、握力和改进的短期身体机能测试,长达 5 年,并使用线性混合模型进行分析。结果在 602 名 PWH 中,52% 被随机分配到匹伐他汀组,48% 被随机分配到安慰剂组。中位年龄为 51 岁;18% 的出生时是女性;2% 跨性别者;40% 的黑人和 18% 的西班牙裔。中位 PREPARE 随访时间为 4.7 (4.3-5.0) 年。两组中 5% 的肌肉症状 (≥3 级或治疗限制性) 发生。没有证据表明两个治疗组的椅子上升率下降,与安慰剂相比,匹伐他汀组没有差异(估计差异 -0.10 [95% 置信区间,-.30 至 0.10] 上升/分钟/年;P = .31)。在两个治疗组的其他身体功能测试中观察到随着时间的推移而小幅下降,组间无明显差异。解释 我们在 5 年的随访中观察到中年 PWH 的身体机能下降最小,与安慰剂相比,随机分配至匹伐他汀组的 PWH 没有差异。这一发现,再加上肌痛的低患病率,支持他汀类药物治疗对身体机能的长期安全性,当用于 PWH 主要不良心血管事件的一级预防时。
更新日期:2024-08-16
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