From January 1994 through May 1995, Prudential HealthCare-North Texas prospectively studied 299 member patients diagnosed with hypercholesterolemia for whom pharmacotherapy with one of four 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, also known as statins, was prescribed. The purpose of this study was to measure the relative cost-effectiveness (CE) of these drugs in a real-world setting. This study provides information to assist decision makers in managed-care organizations (MCO) in making formulary selections. The study used a prospective, randomized, balanced cohort design, examining patients who had been prescribed initial therapy with a statin drug as monotherapy. Costs (direct medical and indirect costs) and effectiveness (percent reduction in low-density lipoprotein cholesterol levels) were based on approximately the first 6 months of initial therapy. Both the MCO and patient perspectives were considered. In the base case, mean CE ratios were significantly lower for fluvastatin compared with lovastatin, pravastatin, and simvastatin from both the managed-care perspective and the patient perspective. Sensitivity analysis did not alter the CE conclusions, even under conditions of varying cost structures. Although differences were found in the effectiveness of lovastatin, pravastatin, and simvastatin measured in this study versus efficacy measured for these drugs in controlled clinical trials, sensitivity analysis suggests that these differences alone do not determine the superior CE of fluvastatin. Finally, this study supports the idea that well-designed formularies should consider drug CE (based on safety, effectiveness, and cost) and that integration of the pharmacy benefit management with other medical management is essential. These results provide evidence that fluvastatin may represent a more cost-effective formulary choice among statin products used for initial monotherapy of hypercholesterolemia.

译文

从1994年1月到1995年5月,Prudential HealthCare-North Texas前瞻性研究了299名被诊断为高胆固醇血症的成员患者,为他们开了四种3-羟基-3-甲基戊二酰辅酶a还原酶抑制剂之一 (也称为他汀类药物) 的药物治疗。这项研究的目的是在现实环境中测量这些药物的相对成本效益 (CE)。这项研究提供了信息,以帮助管理式护理组织 (MCO) 的决策者进行处方选择。该研究使用了前瞻性,随机,平衡的队列设计,检查了使用他汀类药物作为单一疗法的初始疗法的患者。费用 (直接医疗和间接费用) 和有效性 (低密度脂蛋白胆固醇水平降低的百分比) 大约基于初始治疗的前6个月。考虑了MCO和患者的观点。在基本情况下,从管理护理的角度和患者的角度来看,氟伐他汀与洛伐他汀,普伐他汀和辛伐他汀的平均CE比显着降低。即使在成本结构不同的情况下,敏感性分析也不会改变CE的结论。尽管在本研究中发现洛伐他汀,普伐他汀和辛伐他汀的有效性与对照临床试验中这些药物的有效性存在差异,但敏感性分析表明,仅这些差异并不能确定氟伐他汀的优越CE。最后,本研究支持以下观点: 精心设计的处方应考虑药物CE (基于安全性,有效性和成本),并且将药房效益管理与其他医疗管理相结合至关重要。这些结果提供了证据,表明氟伐他汀可能代表了用于高胆固醇血症的初始单一疗法的他汀类药物中更具成本效益的配方选择。

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