PMID- 15366322
OWN - NLM
STAT- MEDLINE
DCOM- 20041109
LR  - 20190607
IS  - 0946-1965 (Print)
IS  - 0946-1965 (Linking)
VI  - 42
IP  - 8
DP  - 2004 Aug
TI  - The use of atorvastatin treatment in usual care environments: pooled analysis of 
      six prospective, observational studies in 90,535 patients.
PG  - 423-33
AB  - OBJECTIVE: We investigated the pattern of use as well as the efficacy and safety 
      of atorvastatin in unselected inpatients and outpatients in routine clinical 
      practice in Germany. DESIGN: Six prospective, observational studies with a 
      similar design were pooled. The studies lasted for up to 12 weeks and data from 
      90,535 patients (7,287 inpatients, 83,248 outpatients) were collected. The 
      studies were performed in Germany in 2000 and 2001. Hospital or office-based 
      physicians selected hyperlipemic patients with or without coronary heart disease 
      (CHD) for once daily treatment with atorvastatin. Information on demographics, 
      atorvastatin dosage, concomitant medication, concomitant diseases, cardiovascular 
      risk factors, lipid profile as well as adverse events (AEs) and serious adverse 
      events (SAEs) were obtained at 2-3 visits and descriptively analyzed. MAIN 
      OUTCOME MEASURES: Absolute and relative changes in lipid parameters, percentage 
      of patients with low-density lipoprotein cholesterol (LDL-C) values within target 
      ranges according to the National Cholesterol Education Program (NCEP) criteria, 
      and frequencies of AEs. RESULTS: On average, patients were treated for 22.4 days 
      (inpatients) and 106.0 days (outpatients), respectively. The overall mean 
      atorvastatin dose of 14.4 mg/day was well tolerated by a heterogeneous patient 
      population with a variety of concomitant diseases and medications. Overall, 0.8% 
      of patients suffered from one or more AEs, 0.6% were considered as 
      treatment-related. The corresponding figures for SAEs and treatment-related SAEs 
      were 0.1% (131 patients) and 0.01% (13 patients), respectively. Subgroup analyses 
      did not reveal a particular safety concern in any subgroup. In total, 99% of 
      patients judged the tolerability of atorvastatin as very good or good. The mean 
      percentages of reduction in LDL-C at the final visit ranged between 24.8% and 
      28.5%. Overall, 26.3% of patients reached the NCEP LDL-C goal compared to 4.9% at 
      baseline. Inpatients achieved the target range for LDL-C more frequently than 
      outpatients (35.3% vs 25.6%). An underuse of atorvastatin titration in clinical 
      practice in Germany was apparent, particularly in outpatients. CONCLUSIONS: The 
      use of atorvastatin in usual care environments is effective and safe. There is a 
      gap between treatment guidelines and clinical practice in Germany as reflected by 
      the number of patients outside the target range for LDL-C. A major opportunity 
      exists to increase the number of patients who achieve LDL-C target ranges by 
      appropriate dose titration and/or giving patients a higher initial dose. 
      Available guidelines need to be implemented more stringently.
FAU - Vetter, S
AU  - Vetter S
AD  - Pfizer Ltd., Karlsruhe, Germany. Silke.Vetter@Pfizer.com
FAU - Ruf, G
AU  - Ruf G
FAU - Regourd, E
AU  - Regourd E
FAU - Marz, W
AU  - Marz W
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PL  - Germany
TA  - Int J Clin Pharmacol Ther
JT  - International journal of clinical pharmacology and therapeutics
JID - 9423309
RN  - 0 (Anticholesteremic Agents)
RN  - 0 (Heptanoic Acids)
RN  - 0 (Lipids)
RN  - 0 (Pyrroles)
RN  - A0JWA85V8F (Atorvastatin)
SB  - IM
MH  - *Anticholesteremic Agents/administration & dosage/adverse effects/therapeutic use
MH  - Atorvastatin
MH  - Cardiovascular Diseases/*prevention & control
MH  - Drug Administration Schedule
MH  - *Drug Utilization Review
MH  - Germany
MH  - *Heptanoic Acids/administration & dosage/adverse effects/therapeutic use
MH  - Humans
MH  - Lipids/blood
MH  - Prospective Studies
MH  - *Pyrroles/administration & dosage/adverse effects/therapeutic use
EDAT- 2004/09/16 05:00
MHDA- 2004/11/13 09:00
CRDT- 2004/09/16 05:00
PHST- 2004/09/16 05:00 [pubmed]
PHST- 2004/11/13 09:00 [medline]
PHST- 2004/09/16 05:00 [entrez]
AID - 10.5414/cpp42423 [doi]
PST - ppublish
SO  - Int J Clin Pharmacol Ther. 2004 Aug;42(8):423-33. doi: 10.5414/cpp42423.