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Long-Term Outcomes from the Utilization of a Novel Web-Based Lipid Management Software in a Single Specialty Cardiology Practice

      Synopsis: The cardiovascular disease (CVD) evaluator is a web-based expert system written in Visual Basic 6 and DotNet and patented by USPO. The system basically comes up with specific diagnostic and therapeutic recommendations for the individual patient from clinical information, lipid profile, emerging risk factors (if available), and advanced lipid profile, including genetic risk factors. It uses published CV disease risk-scoring systems such as Framingham and published guidelines such as NCEP, ITF, ADA, and NKF. The diagnostic and therapeutic recommendations are determined on the basis of clinical trials, which are cited in the reference section of the output and the relevant journal articles can instantly be linked to through an HTML web page.
      Purpose: The long-term clinical outcomes comparison of two groups of high-risk patients managed by physicians versus physician or midlevel aided by novel lipid management software with a patented algorithm.
      Methods: We randomly retrieved the current records of 200 patients (100 with coronary heart disease) whose initial lipid management decisions were aided by the system within 6 months of its implementation in August 2005 and compared their outcomes with a 200 clinical-profile-matched control group managed by clinical cardiologists. The primary end point was the achievement of target low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol at any point. The safety end point included discontinuation of any medication for persistently elevated CPK with symptoms or elevated LFTs. The secondary end point was combined events of CV death, nonfatal myocardial infarction, or any revascularization. Fisher's exact test was used for statistical analysis.
      Results: A total of 69 of the 97 patients with CAD in the study group reached the primary end point, whereas only 39 of 95 patients in the control group did (P = .0001). As for the patients without CAD, 78 of the 100 in the study group versus 52 in the control group achieved the primary point (P = .001). Seven patients in the study arm and four in the control arm discontinued their medicines as the result of elevated LFTs or myopathy. There were 23 combined events in the CAD arm of the control group over 4 years versus 14 in the CAD arm of the study group.
      Conclusions: The use of a novel patented expert system in a lipid clinic significantly improves the clinical outcomes of wide variety of high-risk patients with lipid disorders.
      Table 1Study population
      Study group, n = 200Control group, n = 200P value
      CASHD100100ns
      PVD1313ns
      CVD129ns
      Type 2 DM5246ns
      DSM without DM6668ns
      FRS 10-Yr Risk >%205248ns
      Age, Average6159ns
      Male6659ns
      Table 2The impact of the system on clinical decision-making and compliance
      Study, n = 197Control, n = 195P value
      Combination therapy at the onset8212.001
      Combination therapy at follow-up144102.001
      Use of advanced lipid profiling3628.5
      Use of preventive imaging202.001
      Use of additional risk markers426.001
      Maintenance at 1 year162112.01
      Discontinuation rate2252.01
      Table 3Outcomes
      Study group, n = 197Control group, n = 195P value
      Target LDL–C achieved163132.05
      Target non-HDL-C achieved14791.01
      HDL-C > 4012288.01
      Composite events2037.01