Evaluation of Statin Therapy- Safety, Effect and Toxicity Mechanisms.

Conditions: MedDRA version: 8.1Level: LLTClassification code 10058108Term: Dyslipidaemia
Frequency of side effects in patients treated with HMG CoA reductase inhibitors.

Registration Number: EUCTR2006-004686-34-SE

Lead Sponsor: Karolinska University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Subjects should be :
1 > 18 years old
2 About to undergo Statins treatment or to change drug within the statingruop
3 The Investigator judge the patients ability to participate in the study according to protocol
4.Patients sign Informed Consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To prospectively assess of the frequency of Adverse Drug Reactions in (ADR) muscle in patients treated with HMG-CoA reductase inhibitors. ;Secondary Objective: 1. To prospectivily assess the frequency of other ADR´s in patients treated with HMG-CoA reductase<br>2. To identify genetic and other possible riskfactors for side -effects in patients treated with HMG-CoA reductase inhibitors. <br>3. To study the relationship betweenstatindose/concentration and ADR´s and effect and possible influence of drug-drug interactions. ;Primary end point(s): The ADR´s reports from doctors and patients<br>plasma/ serum levels of creatine kinases and myogloblin<br>

Secondary Outcome Measures