Charles Evguenia C, Olson Kari L, Sandhoff Brian G, McClure David L, Merenich John A
Clinical Pharmacy Cardiac Risk Service, Kaiser Permanente of Colorado, Denver, Colorado, USA.
Am J Med. 2005 Jun;118(6):618-24. doi: 10.1016/j.amjmed.2005.02.008.
To describe the rate, potential causes, symptoms, time to onset, and time to resolution of severe transaminitis associated with increased 3-hydroxy-3-methylglutaryl coenzyme reductase inhibitor ("statin") usage in a large group model health maintenance organization.
Health plan members 18 years of age and older, not receiving chemotherapy, who had received at least 1 statin prescription between January 1, 1997, and December 31, 2001 were eligible. All eligible patients with an alanine aminotransferase greater than 10 times the upper limit of normal at any time during the study period were identified using computerized laboratory records. Medical records were subsequently reviewed in order to determine whether the elevation was attributable to statin therapy.
Alanine aminotransferase had never been measured in 2334 of 25334 (9%) of eligible patients. In the remaining 23000 patients, 62 (0.3%) were identified with an alanine aminotransferase greater than 10 times the upper limit of normal during the 5-year study period. Of these, 17 (0.1% of 23000 patients) had severe transaminitis deemed directly attributable to statin use. All except 4 of these 17 cases were associated with drug interactions. In 16 cases, transaminitis resolved upon statin discontinuation.
In the observed study sample, statin-related severe transaminitis occurred infrequently. These findings support less frequent liver enzyme monitoring for most patients on statins. Continued monitoring remains warranted for patients on concomitant medications or those with comorbid conditions.
描述在一个大型团体模式健康维护组织中，与3-羟基-3-甲基戊二酰辅酶A还原酶抑制剂（“他汀类药物”）使用增加相关的严重转氨酶升高的发生率、潜在原因、症状、发病时间和缓解时间。
年龄在18岁及以上、未接受化疗且在1997年1月1日至2001年12月31日期间至少接受过1次他汀类药物处方的健康计划成员符合条件。利用计算机化实验室记录识别出在研究期间任何时间丙氨酸转氨酶大于正常上限10倍的所有符合条件的患者。随后对病历进行审查，以确定转氨酶升高是否归因于他汀类药物治疗。
在25334名符合条件的患者中，有2334名（9%）从未检测过丙氨酸转氨酶。在其余23000名患者中，有62名（0.3%）在5年研究期间被识别出丙氨酸转氨酶大于正常上限10倍。其中，17名（占23000名患者的0.1%）有被认为直接归因于他汀类药物使用的严重转氨酶升高。这17例中除4例外均与药物相互作用有关。在16例中，停用他汀类药物后转氨酶升高得到缓解。
在观察到的研究样本中，他汀类药物相关的严重转氨酶升高很少发生。这些发现支持对大多数服用他汀类药物的患者减少肝酶监测频率。对于同时服用其他药物或患有合并症的患者，仍有必要继续监测。
