Genetically Guided Statin Therapy to Improve Medication Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 4
- 主要终点
- Morisky Medication Adherence Scale (MMAS) Score
研究概览
简要总结
The purpose of this study is to examine if using genetics can improve statin adherence in patients who should be taking statins but are not because of prior side effects. This study will assist physicians/providers in making a personalized health care plan for prevention of cardiovascular disease.
详细描述
Hydroxy-methylglutaryl-coenzyme A (HMG Co-A) reductase inhibitors ("statins") are commonly prescribed to lower low density lipoprotein cholesterol (LDLc) and to prevent cardiovascular disease (CVD), a leading cause of morbidity and mortality. Long-term adherence to statins in the primary care environment is challenging; consequences of statin non-adherence include higher LDLc levels, hospitalizations, costs, and death due to CVD.
Medication non-adherence is complex and multifactorial and can be associated with a number of factors including medication cost, complexity of medication regimen, poor provider-patient relationship / communication, and adverse side effects. For statins, side effects such as muscle aches, cramping, and pain (referred to broadly as statin-related myopathy) are a frequent cause of non-adherence. These symptoms are non-specific and are frequent reasons for stopping statin therapy, due to patient or provider concern about the possibility of statin-related myopathy. Many patients may be needlessly deprived of the cardiovascular benefits of long-term statin use.
A genetic risk factor for statin myopathy and subsequent non-adherence has recently been identified. In a genome-wide association study, a genetic variant (named SLCO1B1*5) was a main contributor of statin myopathy. It was demonstrated that the SLCO1B1*5 variant is not only a predictor of myopathy, but also of premature statin discontinuation. The risk with the *5 allele is statin specific: greatest with simvastatin and atorvastatin use, the least with pravastatin or rosuvastatin. Therefore, the SLCO1B1*5 variant is common, can predict myopathy, subsequent non-adherence, and due to its statin-specific effects creates a novel research paradigm for personalizing statins to an individual's genetic profile. Carriers of the SLCO1B1*5 variant may do best on rosuvastatin, pravastatin, or fluvastatin whereas non-carriers may be treated with any statin.
The objective of this study is to conduct a randomized trial comparing two strategies:
- genetically guided statin therapy vs.
- usual care (i.e., a strategy without genetics) on the effects of statin adherence and LDLc lowering.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current patient (defined as seen in the last year) of the Duke Primary Care at Pickett Road, Pickens Family Medicine Center or Travis Air Force Base
- •Age greater than or equal to 18 years
- •Current non-utilization of statin therapy for either of the following reasons: (a) Prior side effects thought to be attributed by the patient to statin use AND/OR (b) Physician removal of statin due to presumed associated side effects
- •No statin use for the past 6 weeks
- •Active email account
- •Computer access available in order to complete on-line surveys
- •Ability to provide informed consent
排除标准
- •Prior rhabdomyolysis, or Creatine Kinase (CK) elevation > 10 times the upper limit of normal with any statin therapy
- •Prior unexplained elevation in hepatic enzymes [Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 3 times upper limit of normal] with any statin therapy
- •Current daily grapefruit juice usage (on average >1quart/day)
- •Expected long term use (longer than 3 months) of the following medications known to interfere with statin metabolism or disposition at time of enrollment until the randomization is complete. However, short-term (<14 days) is allowed for the duration of the study
- •Participation in a drug research study in the past 30 days
- •Previous use of 4 or more statins
结局指标
主要结局
Morisky Medication Adherence Scale (MMAS) Score
时间窗: 3 months and 8 months
The Morisky Medication Adherence Scale (MMAS) is a self-reported measure of adherence, collected at baseline for general medication and at 3 and 8 months of followup for statin specific adherence. The eight-item MMAS survey will be used. This is a modified version of the original four-item MMAS capturing further aspects of adherence behavior. The survey includes 8 yes/no items that are summed to create an overall adherence score ranging from of 0 to 8, with higher scores indicating better adherence. The primary hypothesis is that the genetically guided statin therapy leads to greater adherence of statin therapy, corresponding to a higher MMAS score.
次要结局
- Low Density Lipoprotein Cholesterol (LDLc) at Baseline, Month 3 and Month 8(Baseline, Month 3, Month 8)
- Change in Short Form -12 Item (SF-12) Health Survey - Physical Component (PC)(Baseline, Month 3, Month 8)
- Change in Short Form -12 Item (SF-12) Health Survey - Mental Component (MC)(Baseline, Month 3, Month 8)
- Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8(Baseline, Month 3, Month 8)
- Medication Possession Ratio (MPR) From Baseline to Last Patient Follow-up(Baseline to Last patient follow-up in study (3 months or 8 months))
- Number of Participants Reporting New Statin Prescriptions(Baseline, Month 3, Month 8)
- Brief Pain Inventory (BPI) Score - Pain Interference at Month 3 and Month 8(Month 3 and Month 8)
- Brief Pain Inventory (BPI) Score - Pain Severity at Month 3 and Month 8(Month 3 and Month 8)
- Physical Activity Scale Score(Baseline and Month 8)