Anticholesteremic Agents ; adverse effects ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; adverse effects

Animals ; Chronic Disease ; Heart Failure ; drug therapy ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; adverse effects ; therapeutic use

Anticholesteremic Agents ; adverse effects ; Dose-Response Relationship, Drug ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; adverse effects ; Liver ; drug effects

Statins are a kind of prescription drug that is widely used to treat hyperlipidemia, coronary artery disease, and other atherosclerotic diseases. A common side effect of statin use is a mild rise in liver aminotransferases, which occurs in less than 3% of patients. Statin-related liver injury is most commonly caused by atorvastatin and simvastatin, but severe liver injury is uncommon. Therefore, understanding and evaluating hepatotoxicity and weighing the benefits and risks is of great significance to better realize the protective effect of statins.
Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects* ; Atorvastatin/adverse effects* ; Simvastatin/adverse effects* ; Chemical and Drug Induced Liver Injury/drug therapy* ; Drug-Related Side Effects and Adverse Reactions/drug therapy*

Gynecomastia is a common benign disease characterized by the progressive enlargement of the glandular tissue of the male breast due to an imbalance between the levels of estrogen and androgen in the blood. The etiology may vary and may be physiological, pharmacological, pathological, or even idiopathic. Among men, drug-induced gynecomastia may account for 10% to 20% of cases. The literature contains six case reports of rosuvastatin-induced gynecomastia. Withdrawal of statin or switching to a less potent statin can lead to symptom improvement and avoidance of unnecessary tests and patient anxiety. A 62-year-old male patient developed unilateral gynecomastia after 13 months of rosuvastatin therapy. After switching to a different statin (pravastatin), his symptoms improved within 2 months. Thus, clinicians should be aware of the possibility of occurrence of gynecomastia when statins are prescribed.
Anxiety ; Breast ; Drug-Related Side Effects and Adverse Reactions ; Estrogens ; Gynecomastia ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Male ; Middle Aged ; Rosuvastatin Calcium

OBJECTIVE: To identify mitochondrial gene variants associated with statin-induced myalgia in Chinese patients with coronary artery disease (CHD). METHODS: This study was conducted in a cohort of 403 patients with CHD receiving rosuvastatin therapy, among whom 341 patients had complete follow-up data concerning myalgia and 389 patients had documented measurements of plasma creatine kinase (CK) level. All these patients underwent genetic analysis using GSA chip for detecting mitochondria gene variants associated with myalgia. A logistic regression model was used to assess the association between 69 mitochondrial single-nucleotide polymorphisms (SNPs) and myopathy in 341 patients. The impact of these mutation sites on CK levels in 389 patients was evaluated by linear regression analysis. RESULTS: G12630A variant was identified to correlate with an increased risk of myalgia in CHD patients (OR: 8.689, 95% CONCLUSIONS Mitochondrial G12630A variation is associated with statin-induced myalgia in patients with CHD, indicating the necessity of different treatment strategies for patients who carry this risk allele.
China ; Coronary Artery Disease/genetics* ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects* ; Mitochondria ; Myalgia ; Polymorphism, Single Nucleotide

Humans ; Cardiovascular Diseases/chemically induced* ; East Asian People ; Risk Factors ; Heart Disease Risk Factors ; Lipids ; Anticholesteremic Agents/adverse effects* ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Treatment Outcome

A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs, especially marketed traditional Chinese medicine (TCM) products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed, and recommendations are given for improving the validity of postmarketing studies in TCM products.
Anaphylaxis ; chemically induced ; Drug-Related Side Effects and Adverse Reactions ; Drugs, Chinese Herbal ; adverse effects ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; adverse effects ; Neural Networks (Computer) ; Product Surveillance, Postmarketing ; Research Design ; Rhabdomyolysis ; chemically induced

OBJECTIVETo investigate the clinical features and prognosis of rhabdomyolysis related to seizure attacks and use of statin.

METHODSThe medical records of 3 patients with established diagnosis of rhabdomyolysis were analyzed and the related literatures were reviewed.

RESULTSAll the 3 patients had seizure attacks and/or used statin before the onset of rhabdomyolysis. Two of the patients complained of back pain, and all the 3 patients had dark-colored urine. Serum levels of creatine kinase (CK) were markedly increased by over 50 times above the normal upper limit. CK level kept increasing even after proper interventions, till reaching the peak level about 3 days later. The patients improved rapidly with full recovery thereafter, and CK became normal in 2 weeks. None of the patients had renal failure.

CONCLUSIONSeizure attacks and use of statin are common risk factors for non-traumatic rhabdomyolysis. Caution needs to be taken when prescribing statin to patients with recent seizure attacks. Special attention should be given to such early symptoms as muscle pain, weakness and dark-colored urine, and CK level monitoring is advisable in such cases.

Cerebral Infarction ; drug therapy ; Creatine Kinase ; blood ; Epilepsy ; complications ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; adverse effects ; therapeutic use ; Lovastatin ; adverse effects ; therapeutic use ; Male ; Middle Aged ; Rhabdomyolysis ; chemically induced ; enzymology ; etiology ; Simvastatin ; adverse effects ; therapeutic use

BACKGROUNDRosuvastatin has been claimed to be more potent than other statins in its ability to lower the low-density lipoprotein (LDL) cholesterol levels. This study aimed to investigate the clinical efficacy of rosuvastatin in LDL cholesterol lowering therapy for new or switched hyperlipidaemic Chinese patients.

METHODSThis study was a retrospective one in patients who took rosuvastatin in the outpatient clinics of Prince of Wales Hospital during the period of July 1, 2004 to June 30, 2005. The prescribing pattern, the utilization pattern and the side effect profile were recorded. Attainment of lipid goals for each patient was assessed according to the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III guidelines.

RESULTSA total of 261 Chinese patients (mean age (64.8 +/- 12) years; 55.6% male) were recruited into the study. The mean LDL-cholesterol level was (3.50 +/- 1.29) mmol/L prior to Rosuvastatin and (2.30 +/- 1.73) mmol/L after Rosuvastatin treatment (P < 0.0001). Rosuvastatin raised the LDL-cholesterol goal achievement rate from 28.0% to 74.3% in all patients combined (P < 0.0001) and from 11.0% to 79.0% for statin naive patients (P < 0.0001). Approximately 4% of patients developed side effects including myalgia, elevated liver enzymes, and dizziness.

CONCLUSIONRosuvastatin was effective in improving LDL-cholesterol goal attainment and lowering LDL-cholesterol and triglyceride (TG) levels in either newly started or switched patients.

Adult ; Aged ; Cholesterol, LDL ; blood ; Female ; Fluorobenzenes ; adverse effects ; therapeutic use ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; therapeutic use ; Male ; Middle Aged ; Pyrimidines ; adverse effects ; therapeutic use ; Retrospective Studies ; Rosuvastatin Calcium ; Sulfonamides ; adverse effects ; therapeutic use