Pilot Study: Statin Therapy to Improve Medication Adherence
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 4
- 主要终点
- Change in Medication adherence
研究概览
简要总结
The purpose of this pilot 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 with statins. This study will assist physicians in making a personalized health care plan for prevention of cardiovascular disease.
详细描述
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.
Specific Aims:
Aim 1: To measure the effect of genotype-guided statin prescription on patients' concerns regarding the risks of statin therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 or Center for Living
- •Age greater than or equal to 18 years
- •Provider interested in prescribing statins for cardiovascular disease prevention
- •Ability to provide informed consent
排除标准
- •Prior rhabdomyolysis, defined as CK elevation > 10 times the upper limit of normal with any statin therapy
- •Prior unexplained elevation in hepatic enzymes (AST or ALT > 3 times upper limit of normal) with any statin therapy
- •Use of medications known to interfere with statin metabolism or disposition
- •Participation in a drug research study in the past 30 days
结局指标
主要结局
Change in Medication adherence
时间窗: baseline and four month post genotyping
Medication adherence is assessed by the 8-item Morisky medication adherence scale (MMAS). The first 7 questions of the MMAS are scored one point for 'yes' and zero points for a 'no' response; the last question is assessed using a 5-point Likert-type responses ranging from "usually" to "all the time" (usually = 1; all the time = 5). Non-adherence is defined as a score higher than zero. For the purposes of this pilot study, the MMAS is adapted to focus on cholesterol lowering therapies.
Change in Beliefs about Medicines
时间窗: Baseline and four months post genetic testing
The Beliefs about Medicines Questionnaire (BMQ) is a validated tool and assesses patients' beliefs about their medications. Specifically, the BMQ assesses patients' perceived necessity for the prescribed medication to treat their disease as well as their concerns about adverse effects of the medication. The BMQ-specific survey will be employed as applied to 1) cholesterol lowering therapy and 2) medication therapy in general. Each question is answered with a 5-point Likert scale, ranging from 1 = strongly disagree to 5 = strongly agree. Scores obtained for individual items within the Concerns or Necessities scales are summed and total scores range from 5 to 25 (higher scores indicate stronger beliefs). Perceived concerns associated with drugs have been found to be significant predictors of poorer medication adherence.
次要结局
- Number of new statin prescriptions written(Four months)
- Patient reported medication utilization, as a surrogate for medication adherence(Four months)
- Percentage of patients who meets their National Cholesterol Education Program (NCEP) low-density lipoprotein cholesterol (LDLc)goals(Four months)