Background Systematic data on discontinuation of statins in routine practice of medicine are limited. Objective To investigate the reasons for statin discontinuation and the role of statin-related events (clinical events or symptoms believed to have been caused by statins) in routine care settings. Design A retrospective cohort study. Setting Practices affiliated with Brigham and Women's Hospital and Massachusetts General Hospital in Boston. Patients Adults who received a statin prescription between 1 January 2000 and 31 December 2008. Measurements Information on reasons for statin discontinuations was obtained from a combination of structured electronic medical record entries and analysis of electronic provider notes by validated software. Results Statins were discontinued at least temporarily for 57 292 of 107 835 patients. Statin-related events were documented for 18 778 (17.4%) patients. Of these, 11 124 had statins discontinued at least temporarily; 6579 were rechallenged with a statin over the subsequent 12 months. Most patients who were rechallenged (92.2%) were still taking a statin 12 months after the statin-related event. Among the 2721 patients who were rechallenged with the same statin to which they had a statin-related event, 1295 were receiving the same statin 12 months later, and 996 of them were receiving the same or a higher dose. Limitations Statin discontinuations and statin-related events were assessed in practices affiliated with 2 academic medical centers. Utilization of secondary data could have led to missing or misinterpreted data. Natural-language-processing tools used to compensate for the low (30%) proportion of reasons for statin discontinuation documented in structured electronic medical record fields are not perfectly accurate. Conclusion Statin-related events are commonly reported and often lead to statin discontinuation. However, most patients who are rechallenged can tolerate statins long-term. This suggests that many of the statin-related events may have other causes, are tolerable, or may be specific to individual statins rather than the entire drug class. Primary funding source National Library of Medicine, Diabetes Action Research and Education Foundation, and Chinese National Key Program of Clinical Science.

/pdf/discontinuation-of-statins-in-routine-care-settings-a-cohort-1bcmnkc3vg.pdf

Discontinuation of statins in routine care settings: a cohort study.

Insulin and hyperandrogenism in women with polycystic ovary syndrome.

Polycystic ovary syndrome (PCOS) has multiple etiologies including ovarian and adrenal hyperandrogenism, neuro-endocrine and hypothalamic-pituitary dysfunction, and disorders of peripheral insulin resistance. Obesity is neither necessary nor sufficient for the PCOS phenotype, and the association of PCOS with obesity is not universal, with national, cultural, and ethnic differences. Obesity, particularly visceral adiposity which is common in obese and non-obese women with PCOS, amplifies and worsens all metabolic and reproductive outcomes in PCOS. Obesity increases insulin resistance and compensatory hyperinsulinemia, which in turn increases adipogenesis and decreases lipolysis. Obesity sensitizes thecal cells to LH stimulation and amplifies functional ovarian hyperandrogenism by upregulating ovarian androgen production. Obesity increases inflammatory adipokines which, in turn, increase insulin resistance and adipogenesis. Lifestyle interventions focused on diet-weight loss and concurrent exercise are central to therapy which also commonly subsequently needs to include pharmacologic therapy. PCOS symptoms commonly improve with 5% to 10% weight loss, but 25% to 50% weight loss, usually achievable only through bariatric surgery, may be required for morbid obesity unresponsive to lifestyle-medical treatment. Bariatric surgery is a valuable approach to weight loss in PCOS where BMI is ≥40 kg/m2 when non-surgical treatment and/or induction of pregnancy have failed, and can be an initial treatment when BMI is ≥50 kg/m2. Further research in PCOS is needed to better understand the fundamental basis of the disorder, to ameliorate obesity, to correct hyperandrogenism, ovulation, hyperinsulinemia, and to optimize metabolic homeostasis.

Characteristics of obesity in polycystic ovary syndrome: Etiology, treatment, and genetics.

Introduction: Statin-induced myopathy is an important cause of statin intolerance and the most common cause of statin discontinuation Observational studies estimate that 10 – 15% of statin users develop statin-related muscle side effects ranging from mild myalgia to more severe muscle symptoms with significant CPK elevations Areas covered: This article reviews the epidemiology, clinical features, risk factors and mechanisms of statin-induced myopathy and provides an evidence-based algorithm for managing patients with statin myopathy Expert opinion: There are multiple risk factors for statin-induced myopathy that are both patient-related (age, genetics, co-morbidities) and drug-related (statin metabolism via the CYP system, drug–drug interactions and statin drug transport) Management options for statin-intolerant patients include statin switching, especially to low-dose, non-daily doses of long-acting statins, such as rosuvastatin and atorvastatin, and other non-statin lipid-lowering agents, such as ez

Statin-induced myopathy: a review and update

Background: Red yeast rice is an herbal supplement that decreases low-density lipoprotein (LDL) cholesterol level. Objective: To evaluate the effectiveness and tolerability of red yeast rice and therapeutic lifestyle change to treat dyslipidemia in patients who cannot tolerate statin therapy. Design: Randomized, controlled trial. Setting: Community-based cardiology practice. Patients: 62 patients with dyslipidemia and history of discontinuation of statin therapy due to myalgias. Intervention: Patients were assigned by random allocation software to receive red yeast rice, 1800 mg (31 patients), or placebo (31 patients) twice daily for 24 weeks. All patients were concomitantly enrolled in a 12-week therapeutic lifestyle change program. Measurements: Primary outcome was LDL cholesterol level, measured at baseline, week 12, and week 24. Secondary outcomes included total cholesterol, high-density lipoprotein (HDL) cholesterol, triglyceride, liver enzyme, and creatinine phosphokinase (CPK) levels; weight; and Brief Pain Inventory score. Results: In the red yeast rice group, LDL cholesterol decreased by 1.11 mmol/L (43 mg/dL) from baseline at week 12 and by 0.90 mmol/L (35 mg/dL) at week 24. In the placebo group, LDL cholesterol decreased by 0.28 mmol/L (11 mg/dL) at week 12 and by 0.39 mmol/L (15 mg/dL) at week 24. Low-density lipoprotein cholesterol level was significantly lower in the red yeast rice group than in the placebo group at both weeks 12 (P < 0.001) and 24 (P = 0.011). Significant treatment effects were also observed for total cholesterol level at weeks 12 (P < 0.001) and 24 (P = 0.016). Levels of HDL cholesterol, triglyceride, liver enzyme, or CPK; weight loss; and pain severity scores did not significantly differ between groups at either week 12 or week 24. Limitation: The study was small, was single-site, was of short duration, and focused on laboratory measures. Conclusion: Red yeast rice and therapeutic lifestyle change decrease LDL cholesterol level without increasing CPK or pain levels and may be a treatment option for dyslipidemic patients who cannot tolerate statin therapy.

Red Yeast Rice for Dyslipidemia in Statin-Intolerant Patients: A Randomized Trial

Rosuvastatin 5 and 10 mg/d: a pilot study of the effects in hypercholesterolemic adults unable to tolerate other statins and reach LDL cholesterol goals with nonstatin lipid-lowering therapies

In 74 women with polycystic ovary syndrome, treated for 4 years with metformin (MET) and diet, we prospectively assessed whether, and to what degree, weight loss, reduction of insulin resistance, and amelioration of coronary heart disease risk factors could be sustained. We hypothesized that response to MET-diet would not differ by pretreatment body mass index (BMI) classes or =25 to or =30 to or =40 (extremely obese). [table: see text] Metformin-diet was successful in producing stable approximately 8% weight reduction for all 4 years (trend P or =40, > or =30 to or =25 to .1) in the 4 BMI categories. By stepwise regression, weight loss was a significant (P < or = .01) positive explanatory variable for reduction in HOMA-IR for all 4 follow-up years. Metformin-diet in women with polycystic ovary syndrome effectively and safely reduces weight and LDL-C while raising HDL-C, and maintains these outcomes stable over 4 years.

Sustainability of 8% weight loss, reduction of insulin resistance, and amelioration of atherogenic-metabolic risk factors over 4 years by metformin-diet in women with polycystic ovary syndrome.

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Rosuvastatin 5 and 10 mg/d: a pilot study of the effects in hypercholesterolemic adults unable to tolerate other statins and reach LDL cholesterol goals with nonstatin lipid-lowering therapies

Sustainability of 8% weight loss, reduction of insulin resistance, and amelioration of atherogenic-metabolic risk factors over 4 years by metformin-diet in women with polycystic ovary syndrome.