Standard and intensive lipid-lowering therapy with statins for the primary prevention of vascular diseases: a population-based study.
OBJECTIVE
To describe the clinical profile of the patients that initiate statin therapy for the primary prevention of vascular diseases and to investigate the extent to which clinicians use intensive vs. standard regimens.


METHODS
A cross-sectional analysis of nationwide individual data regarding individuals ≥ 11 years with a first prescription of statin, recorded between 1 January 2007 and 31 December 2011. Subjects were defined as intensive therapy initiators if a statin dose superior to simvastatin 40 mg (or equivalent dose if different statin) was first prescribed. Multivariable logistic regression models were built for dependent summary variables to evaluate the strength of the association between them and the use of intensive therapy.


RESULTS
Overall, 69,737 patients receiving a first prescription of statin for the primary prevention of vascular diseases were identified. Predictors for intensive therapy initiation were male gender (adjusted OR: 1.28; 95%CI: 1.10-1.48), history of hypothyroidism (1.47; 1.17-1.85), current treatment of diabetes (1.18; 1.00-1.41), proteinuria (1.87; 1.12-3.12), age, and year of statin prescription. Modifiable risk factors associated with intensive therapy were elevated tryglicerides (1.63; 1.39-1.91), elevated LDL-C (1.96; 1.69-2.28), obesity (1.25; 1.07-1.47), smoking (1.32; 1.14-1.55), comedication with ezetimibe (3.76; 1.87-7.55), fibrates (1.96; 1.43-2.70) and calcium antagonists in women (1.42; 1.02-1.98).


CONCLUSIONS
The use of intensive therapy with statins in primary prevention was not very high in absolute terms, but is increasing considerably. The association between intensive therapy and previous hypothyroidism or its combination with fibrates may raise additional safety and tolerability concerns.
Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain, dmacias.sg@gmail.com.
D
D
Macías Saint-Gerons
C
C
de la Fuente Honrubia
D
D
Montero Corominas
M J
MJ
Gil
F
F
de Andrés-Trelles
F
F
Catalá-López
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000517:prevention & control*; D002648:Child; D003920:Diabetes Mellitus / Q000188:drug therapy / Q000453:epidemiology; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy / Q000453:epidemiology; D007037:Hypothyroidism / Q000188:drug therapy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy / Q000453:epidemiology; D011322:Primary Prevention; D012907:Smoking / Q000188:drug therapy / Q000453:epidemiology; D014280:Triglycerides / Q000097:blood; D055815:Young Adult
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D014280:Triglycerides