Carallo Claudio, Capozza Alessandro, Gnasso Agostino
Metabolic Diseases Unit, Department of Clinical and Experimental Medicine, "Magna Graecia" University, Catanzaro, Italy.
Metab Syndr Relat Disord. 2022 Dec;20(10):567-575. doi: 10.1089/met.2021.0127. Epub 2022 Nov 7.
Statin therapy is a cornerstone of cardiovascular disease treatment and prevention. Unfortunately, 7%-29% of statin-treated patients complain of muscular fatigue, cramps, and/or pain (statin-associated muscle symptoms [SAMS]). In recent years, the important role of vitamin D in muscle health maintenance has been highlighted. In addition, hypovitaminosis D is very prevalent, and might be a reversible risk factor for SAMS occurrence. In our controlled intervention study, patients suffering from both SAMS and hypovitaminosis D underwent vitamin D replacement for 6 months. SAMS intensity and its impact on the quality of life were evaluated with a questionnaire during follow-up. A subgroup of patients who were not at the low-density lipoprotein cholesterol (LDL-C) target attempted a statin rechallenge after 3 months. Control subjects, with SAMS only, were not treated. Blood vitamin D levels reached 261% of baseline values. Pain intensity was reduced by 63%, and all life quality indicators improved. At follow-up, percentage variations in SAMS intensity and in vitamin D levels were inversely related ( = 0.57, = 0.002). In a multiple regression analysis, this association was found to be independent. Among the rechallenge subgroup, 75% successfully tolerated high-intensity statins during the follow-up. The parameters of interest were unchanged in control subjects. In our findings, the amount of increase in vitamin D concentrations is directly related to SAMS improvement. Although randomized studies are needed, 25(OH)D levels can be measured, and eventually supplemented, in all patients suffering from SAMS, and this can be done together with a statin rechallenge after 3 months for patients who are not at the LDL-C target. The study protocol was registered with the EudraCT clinical trial register [ID: 2019-003250-83] in date April 8, 2020.
他汀类药物治疗是心血管疾病治疗和预防的基石。不幸的是，7% - 29%接受他汀类药物治疗的患者抱怨有肌肉疲劳、痉挛和/或疼痛（他汀类药物相关肌肉症状[SAMS]）。近年来，维生素D在维持肌肉健康方面的重要作用得到了强调。此外，维生素D缺乏症非常普遍，可能是SAMS发生的一个可逆风险因素。在我们的对照干预研究中，患有SAMS和维生素D缺乏症的患者接受了6个月的维生素D补充治疗。在随访期间，通过问卷调查评估SAMS强度及其对生活质量的影响。未达到低密度脂蛋白胆固醇（LDL-C）目标的患者亚组在3个月后尝试重新使用他汀类药物。仅患有SAMS的对照受试者未接受治疗。血液维生素D水平达到基线值的261%。疼痛强度降低了63%，所有生活质量指标均有所改善。在随访时，SAMS强度和维生素D水平的百分比变化呈负相关（r = 0.57，P = 0.002）。在多元回归分析中，发现这种关联是独立的。在重新使用他汀类药物的亚组中，75%的患者在随访期间成功耐受了高强度他汀类药物。对照受试者的相关参数未发生变化。在我们的研究结果中，维生素D浓度的增加量与SAMS的改善直接相关。尽管需要进行随机研究，但对于所有患有SAMS的患者都可以检测25(OH)D水平，并最终进行补充，对于未达到LDL-C目标的患者，可以在3个月后与重新使用他汀类药物一起进行。该研究方案于2020年4月8日在欧洲临床试验注册数据库[ID：2019 - 003250 - 83]中注册。
