Frequency of side effects in patients treated with HMG CoA reductase inhibitors. MedDRA version: 8.1 Level: LLT Classification code 10058108 Term: Dyslipidaemia
Conditions
Interventions
Trade Name: Several different products HMG-CoA reductase inhibitors
Pharmaceutical Form: Tablet
INN or Proposed INN: SIMVASTATIN
CAS Number: 79902639
Concentration unit: mg milligram(s)
Concentration
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: No
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 2. To identify genetic and other possible riskfactors for side -effects in patients treated with HMG-CoA reductase inhibitors. 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 plasma/ serum levels of creatine kinases and myogloblin | — |
Countries
Sweden
Outcome results
None listed