Title
Effectiveness cost and safety of lipid lowering therapy by comparing LDL C goal attainment as per LAI and ACC guidelines in patients newly initiated on lipid lowering therapy

Type of study
Prospective longitudinal study

Aim
To evaluate the effectiveness cost and safety of lipid lowering therapy by comparing the proportion of patients achieving LDL C target goals as per Lipid Association of India and American College of Cardiology guidelines at 1 month and 6 months

Objectives
To compare the proportion of patients achieving LDL C targets as per Lipid Association of India and American College of Cardiology guidelines at 1 month and 6 months
To evaluate the cost of lipid lowering therapy over 6 months
To assess the incidence and nature of adverse events during follow up

Justification
Dyslipidaemia is a major modifiable risk factor for atherosclerotic cardiovascular disease and contributes significantly to morbidity and mortality in India. There are differences in LDL C target recommendations between Lipid Association of India and American College of Cardiology guidelines and limited Indian data comparing goal attainment as per these recommendations. Cost of therapy and adverse effects influence adherence and outcomes. This study aims to generate real world data on effectiveness cost and safety of lipid lowering therapy in the Indian population.

Study setting
Department of Cardiology Kasturba Hospital KMC Manipal

Study period
Two years

Sample size
400 patients

Inclusion criteria
Adults aged 18 years and above
Newly initiated on lipid lowering therapy
Available baseline lipid profile prior to initiation

Exclusion criteria
Already on lipid lowering therapy
Incomplete baseline lipid profile data
Pregnant or lactating women
Patients with hepatic or renal dysfunction

Methods
Eligible patients will be enrolled after written informed consent. Baseline fasting lipid profile will be recorded before starting therapy. Details of lipid lowering drugs and approximate monthly cost will be documented. Patients will be followed up at 1 month and 6 months. Fasting lipid profile will be recorded at each visit as part of routine care. Adverse drug reactions and intolerance will be assessed during in person visits or telephonic follow up. Patients lost to follow up will be contacted telephonically for data collection. LDL C goal attainment will be assessed as per Lipid Association of India and American College of Cardiology guidelines. Treatment modifications and associated costs will be documented.

Statistical analysis
Data will be entered in Microsoft Excel and analysed using IBM SPSS version 25. Categorical variables will be expressed as frequencies and percentages and analysed using Chi square test or Fishers exact test. Continuous variables will be expressed as mean and standard deviation and compared using Students t test. Odds ratios with 95 percent confidence intervals will be calculated. Logistic regression analysis will be performed. A p value less than 0.05 will be considered statistically significant.

Outcome measures
Proportion of patients achieving LDL C targets as per Lipid Association of India and American College of Cardiology guidelines at 1 month and 6 months
Cost of lipid lowering therapy over 6 months
Incidence and nature of adverse drug reactions

Risks and benefits
Possible adverse effects such as myalgia elevated liver enzymes or gastrointestinal intolerance will be monitored and managed as per standard protocols. Patients may benefit from optimization of therapy and improved lipid control.

Ethical considerations
Institutional Ethics Committee approval will be obtained and patient confidentiality will be maintained.

Budget
No external funding required