OBJECTIVES: To assess patients' quality of life (HQL) post‐myocardial infarction and to identify related variables. METHODS: Patients admitted to the University of Michigan Medical Center with diagnosis of MI were identified consecutively and prospectively from October 1999 to May 2000. Clinical data were obtained retrospectively from medical records. Six months after discharge, patients were administered the Short Form‐12 (SF‐12), via telephone, to determine physical (PCS‐12) and mental (MCS‐12) functional status. RESULTS: Complete information was obtained from 148 patients. The mean age of patients was 64.7 years (±13.2) and 79.1% were male. The mean PCS‐12 scores were 35.4 (±9.12), and the mean MCS‐12 scores were 51.6 (±10.01). The median PCS‐12 scores were significantly lower in patients with an ejection fraction (EF) <40% (31.9 versus 38.4 for EF340%, p = 0.02), and prior MI (31.2 versus 38.5 without a history of MI, p = 0.01), congestive heart failure (CHF) (32.6 versus 37.4 without a history of CHF, p = 0.03), renal insufficiency (27.9 versus 37.7, p = 0.003), or peripheral vascular disease (29.4 versus 38.2 without a history of PVD, p = 0.004). The median MCS‐12 scores were significantly lower for patients under 65 years of age (49.6 versus 57.4 for patients 365 years of age, p = 0.001) and with a history of coronary artery bypass graft (CABG) (60.1 versus 54.7 without history of CABG, p = 0.01). There were no differences detected between gender, type of MI, diabetes, hypertension, angina, or smoking. CONCLUSIONS: HQL scores were lower for patients post‐MI with various comorbidities. Physical scores were significantly lower for patients with low EFs, prior MI, or CHF. Mental scores were significantly lower for patients <65 and those not having already undergone CABG surgery. Post‐MI, particular attention should be paid to these patients. Further work is needed to determine whether interventions aimed at these patients will result in improved quality of life.
OBJECTIVE: To perform an analysis of the cost of adverse events (AEs) associated with treatment by atorvastatin, fluvastatin, lovastatin, pravastatin, and simvastatin following NCEP low density lipoprotein‐cholesterol (LDL‐C) guidelines. METHODS: Data come from a 54‐week randomized, open‐label, double‐blind controlled trial conducted in 158 US centers between May 1997 and January 1999. Patients (n = 3916) with or without coronary heart disease and/or peripheral vascular disease were randomized to receive atorvastatin (n = 1958), fluvastatin (n = 497), lovastatin (n = 498), pravastatin (n = 481), and simvastatin (n = 482). Inclusion criteria included elevated LDL‐C for patients 18–80 years of age. Exclusion criteria included known hypersensitivity to HMG‐CoA reductase inhibitors, use of selected medications, and other patient characteristics. Data were collected on AEs. RESULTS: A total of 9707 AEs were reported during the trial. Of these AEs, 1327 (14%) were related to the use of study medications. Related AEs involved the digestive system (387, 29%), musculoskeletal system (356, 27%), central nervous system (269, 20%), skin (124, 9%), abnormal laboratory values (68, 5%), respiratory system (40, 3%), urogenital system (25, 2%), cardiovascular system (24, 2%), and miscellaneous (35, 3%). The 1327 medication related AEs were associated with the use of 1384 medical services. Many AEs were treated at scheduled study visits (239, 18%) and did not involve additional costs. Additional medical services typically consisted of physician office visits. There was one hospitalization (gastroenteritis). Costs of AEs were measured at Medicare payment rates—a third party perspective. The average cost of treating AEs were similar among study arms: atorvastatin $27.78, fluvastatin $31.78, lovastatin $26.58, pravastatin $25.17, and simvastatin $32.58 (no differences were significant at p < 0.1). CONCLUSIONS: Results suggest that the cost associated with adverse events related to study medications did not vary significantly among HMG‐CoA reductase inhibitors used to treat patients with elevated cholesterol levels.
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