Benefit-Risk Assessment of Statins (Lipid Lowering Agents): A Multi-Criteria Decision Analysis

BACKGROUND: Benefit-risk assessment (BRA) concept has been increasingly used in drug evaluation, and multi-criteria decision analysis (MCDA) is one of the recommended BRA tools. The objective of this study was to assess benefits and risks of statins (lipid lowering agents) by MCDA, based on patient's, clinical expert's and policymaker's perspectives. METHODS: Benefit and risk criteria and levels of statins were identified from literatures and interviews of stakeholders. SWING weight technique, which asked stakeholders to choose the most preferred criterion if they change its level from minimum to maximum, was used to measure the weight of each criterion. There were six patients, six clinical experts and 10 policymaker groups. Each group had four members and was asked to discuss and make consensus for giving their importance scores to four benefit and risk criteria (stroke event reduction, myocardial infarction event reduction, myalgia and hepatotoxicity). The collected scores were used to calculate the criteria weights. The criterion weights were multiplied by each statin's criterion scores to calculate the total weighted score of each statin. Total weighted scores were used to rank the order of statins, which reflected the preference order of statins in each perspective. RESULTS: From four perspectives (patients, experts, policymakers and overall), the most and least important criteria were myocardial infarction reduction and myalgia, respectively. Patients and experts agreed on the order of importance for stroke reduction and hepatotoxicity, but policymakers had a different order. From expert, policymaker and overall perspectives, atorvastatin had the highest total weighted score, followed by simvastatin, fluvastatin, lovastatin, pravastatin and rosuvastatin. However, patient group agreed only with the orders of atorvastatin, fluvastatin, pravastatin and rosuvastatin. CONCLUSIONS: Atorvastatin was the most preferred statin across all perspectives. This study presented the feasibility of applying MCDA in drug evaluation process and encouraged the engagement of multi-stakeholders in decision-making process.