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

OBJECTIVETo analyze the clinical features of statin-induced myopathy.

METHODThe statin-induced myopathy case reported as adverse drug reaction (ADR) to the Beijing Center for ADR Monitoring during January 2007 to December 2012 was summarized, patients were divided to myopathy group and rhabdomyolysis group, according to the absence or presence of rhabdomylysis. The clinical characteristics, medication history and outcome were compared between the two groups.

RESULTSA total of 160 statin-induced myopathy cases (54 in rhabdomyolysis group (33.8%) and 106 cases in myopathy group (66.3%)) were collected from the database (mean age: (64.22 ± 13.55) years old, 51.2% male, n = 82). The ADR occurred immediately after the first medication and up to 4 years after medication. Observed clinical features were myalgia, myositis, asymptommatic creatine kinase (CK) elevation or rhabdomyolysis. The average age were (68.54 ± 15.41) years old in rhabdomylysis group and (62.02 ± 12.41) years old in myopathy group (P = 0.004). There was no gender difference between the rhabdomylysis group and myopathy group (P = 0.406) . Twenty-four cases (44.4%) in rhabdomyolysis group and 26 cases (16.5%) in myopathy group were treated with high dose statin (P < 0.001). Percent of simvastatin treatment was significantly higher in rhabdomyolysis group (70.4% (38/54) ) than in myopathy group (32.1% (34/106), P < 0.001). Spearman correlation analysis showed that age, high-dose statin treatment and simvastatin use were all positively correlated with rhabdomylysis (P < 0.001), and the correlation coefficients (r value) were 0.305, 0.290 and 0.364, respectively. Four patients (aged from 71 to 85 years) died because of ADR and all 4 cases received high-dose statin treatment, 3 of them suffered from complex combined diseases, acute disease progression and complex multiple drug use history.

CONCLUSIONSSevere statin-induced myopathy, like rhabdomyolysis, is more likely to occur in old patients, in patients taking high-dose statin, especially simvastatin.

Aged ; Female ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; adverse effects ; Male ; Middle Aged ; Muscular Diseases ; chemically induced ; Myositis ; chemically induced ; Rhabdomyolysis ; chemically induced ; Simvastatin ; adverse effects

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

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

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