title: Safety and efficacy of simvastatin for the treatment of dyslipidemia in human immunodeficiency virus-infected patients receiving efavirenz-based highly active antiretroviral therapy.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of simvastatin for treatment of dyslipidemia in patients with the human immunodeficiency virus (HIV) who were receiving efavirenz-based highly active antiretroviral therapy (HAART), and to evaluate the effect of simvastatin when added to efavirenz on CD4(+) count, HIV viral load, and frequency of attainment of patient-specific National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III lipid goals.
  
  
  METHODS
  Retrospective medical record review.
  
  
  METHODS
  Veterans Affairs health care system in Dallas, Texas.
  
  
  METHODS
  Thirteen HIV-infected men who received a stable efavirenz-based HAART regimen concurrently with simvastatin 20 mg/day, and 19 HIV negative men who received simvastatin 20 mg/day (controls).
  
  
  RESULTS
  Demographic, clinical, and laboratory data were collected before and after starting simvastatin. Reductions in lipid profile values in the HIV-infected group versus HIV-negative group were as follows: total cholesterol -20% versus -28% (p=0.15), low-density lipoprotein cholesterol (LDL) -36% versus -41% (p=0.06), non-high-density lipoprotein cholesterol (non-HDL) -22% versus -33% (p=0.212), and total cholesterol:HDL ratio -33% versus -30% (p=0.26). These effects were seen without any documented adverse drug reactions or changes in viral and immunologic control. However, 28% fewer HIV-infected patients were able to achieve NCEP ATP III LDL goals compared with HIV-negative subjects.
  
  
  CONCLUSIONS
  These preliminary comparative data suggest that simvastatin can be safely and effectively used to treat dyslipidemia in HIV-infected patients receiving efavirenz-based HAART without compromising viral or immunologic control. However, our results are suggestive of slight lessening of the LDL-lowering effects, which might be explained by the known reduction in simvastatin levels with efavirenz. Furthermore, fewer HIV-infected patients were able to meet their NCEP ATP III goals compared with HIV-negative controls, highlighting the difficulty in treating this population to current standards of care.
authors.affiliation: School of Pharmacy, Texas Tech University Health Sciences Center, Dallas-Fort Worth Regional Campus, Dallas, Texas 75216, USA.
authors.forename: Anita P
authors.initials: AP
authors.lastname: Rahman
authors.forename: Susan A
authors.initials: SA
authors.lastname: Eaton
authors.forename: Sean T
authors.initials: ST
authors.lastname: Nguyen
authors.forename: Amy M
authors.initials: AM
authors.lastname: Bain
authors.forename: Kenna D
authors.initials: KD
authors.lastname: Payne
authors.forename: Roger
authors.initials: R
authors.lastname: Bedimo
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Busti
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000480:Alkynes; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D048588:Benzoxazines / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D003521:Cyclopropanes; D050171:Dyslipidemias / Q000150:complications / Q000188:drug therapy*; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D019821:Simvastatin / Q000009:adverse effects / Q000627:therapeutic use*; D019562:Viral Load
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D019821:Simvastatin; C098320:efavirenz