PMID- 16860175
OWN - NLM
STAT- MEDLINE
DCOM- 20061114
LR  - 20151119
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 28
IP  - 6
DP  - 2006 Jun
TI  - Rosuvastatin 5 and 10 mg/d: a pilot study of the effects in hypercholesterolemic 
      adults unable to tolerate other statins and reach LDL cholesterol goals with 
      nonstatin lipid-lowering therapies.
PG  - 933-42
AB  - BACKGROUND: Patients with high levels of low-density lipoprotein cholesterol 
      (LDL-C) might not tolerate 3-hydroxy-3-methylglutaryl coenzyme A reductase 
      inhibitors ("statins") because of adverse effects (AEs) and might not respond 
      well enough to nonstatin lipid-lowering therapies (LLTs) to meet LDL-C goals. 
      OBJECTIVE: The purpose of this study was to assess the acceptability, 
      effectiveness, and safety profile of rosuvastatin 5 and 10 mg/d in consecutively 
      referred patients with primary high LDL-C who were unable to tolerate other 
      statins because of myalgia and, subsequently in some cases, unable to reach LDL-C 
      goals with nonstatin LLT. METHODS: This prospective, open-label pilot study was 
      conducted in consecutively referred male and female patients aged 38 to 80 years 
      with primary high LDL-C (mean, 177 mg/dL) at The Cholesterol Center, Jewish 
      Hospital, Cincinnati, Ohio. Patients were instructed in the National Cholesterol 
      Education Program Adult Treatment Panel III (NCEP ATP III) therapeutic lifestyle 
      changes diet. Rosuvastatin 5 mg/d was administered to patients categorized by 
      NCEP ATP III risk stratification as moderately high risk, and rosuvastatin 10 
      mg/d was administered to patients categorized as high or very high risk. End 
      points included acceptability (assessed using patient-initiated discontinuation 
      of rosuvastatin), effectiveness (absolute and percentage reductions in LDL-C and 
      triglycerides), and safety profile (aspartate and alanine aminotransferases [AST 
      and ALT, respectively] >3 times the laboratory upper limit of normal [xULN] or 
      elevations in creatine kinase [CK]>10xULN). RESULTS: A total of 61 patients were 
      enrolled (41 women, 20 men; mean [SD] age, 60 [10] years; 5-mg/d dose, 25 
      patients; 10-mg/d dose, 36 patients). Myalgia, a predominant AE, had caused 50 
      patients to previously discontinue treatment with atorvastatin; 30, simvastatin; 
      19, pravastatin; 5, fluvastatin; 2, ezetimibe/simvastatin; and 1, lovastatin. 
      Eighteen patients subsequently failed to reach LDL-C goals with nonstatin LLT(s) 
      alone (colesevelam, 10 patients; ezetimibe, 8; niacin extended release, 2; and 
      fenofibrate, 1). After a median treatment duration of 16 weeks, rosuvastatin 5 
      mg/d+diet was associated with a mean (SD) decrease from baseline in LDL-C of 75 
      (34) mg/dL (mean [SD] %Delta, -42% [18%]) (P<0.001 vs baseline). After a median 
      treatment duration of 44 weeks, rosuvastatin 10 mg/d+diet was associated with a 
      mean (SD) decrease from baseline in LDL-C of 79 (49) mg/dL (mean [SD] %Delta, 
      -42% [24%]) (P<0.001 vs baseline). Of the 61 patients, 1 receiving the 10-mg/d 
      dose discontinued rosuvastatin treatment because of unilateral muscular pain 
      after 4 weeks; no AST or ALT levels were >3xULN, and no CK levels were >10xULN. 
      CONCLUSION: In these 61 hypercholesterolemic patients unable to tolerate other 
      statins and, subsequently in some cases, unable to meet LDL-C goals while 
      receiving nonstatin LIT monotherapy, these preliminary observations suggest that 
      rosuvastatin at doses of 5 and 10 mg/d+diet was well tolerated, effective, and 
      had a good safety profile.
FAU - Glueck, Charles J
AU  - Glueck CJ
AD  - The Cholesterol Center, Jewish Hospital, Cincinnati, OH 45229, USA. 
      glueckch@healthall.com
FAU - Aregawi, Dawit
AU  - Aregawi D
FAU - Agloria, Mahlia
AU  - Agloria M
FAU - Khalil, Qasim
AU  - Khalil Q
FAU - Winiarska, Magdalena
AU  - Winiarska M
FAU - Munjal, Jitender
AU  - Munjal J
FAU - Gogineni, Srikanth
AU  - Gogineni S
FAU - Wang, Ping
AU  - Wang P
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Cholesterol, LDL)
RN  - 0 (Cholinergic Antagonists)
RN  - 0 (Fluorobenzenes)
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 0 (Pyrimidines)
RN  - 0 (Sulfonamides)
RN  - 0 (Triglycerides)
RN  - 83MVU38M7Q (Rosuvastatin Calcium)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Cholesterol, LDL/*blood
MH  - Cholinergic Antagonists/administration & dosage/adverse effects/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Fluorobenzenes/administration & dosage/adverse effects/*therapeutic use
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Hypercholesterolemia/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Pyrimidines/administration & dosage/adverse effects/*therapeutic use
MH  - Rosuvastatin Calcium
MH  - Sulfonamides/administration & dosage/adverse effects/*therapeutic use
MH  - Triglycerides/blood
EDAT- 2006/07/25 09:00
MHDA- 2006/11/15 09:00
CRDT- 2006/07/25 09:00
PHST- 2006/03/31 00:00 [accepted]
PHST- 2006/07/25 09:00 [pubmed]
PHST- 2006/11/15 09:00 [medline]
PHST- 2006/07/25 09:00 [entrez]
AID - S0149-2918(06)00140-8 [pii]
AID - 10.1016/j.clinthera.2006.06.004 [doi]
PST - ppublish
SO  - Clin Ther. 2006 Jun;28(6):933-42. doi: 10.1016/j.clinthera.2006.06.004.