An open-label comparison of the effects of simvastatin and niacin alone and combined on the lipid profile and lipoprotein (a) level in an Indian population with dyslipidemia

Abstract

Background:

Patients with dyslipidemia often require the use of >1 lipid-altering agent to achieve the target levels recommended by the National Cholesterol Education Program Adult Treatment Panel III.

Objective:

The aim of this study was to compare the effects of simvastatin and niacin alone and combined on the lipid profile and lipoprotein (a) (Lp[a]) level in an Indian population with dyslipidemia.

Methods:

This 12-week, open-label, nonrandomized study was conducted at the Departments of Pharmacology and Medicine, Government Medical College, Amritsar (Punjab), India. Patients aged 30 to 70 years with dyslipidemia were eligible. Patients were assigned to 1 of 3 treatment groups. Group 1 received simvastatin 20 mg/d for 12 weeks. Group 2 received niacin at doses of 375 mg/d for 1 week, 500 mg/d for 1 week, and 500 mg BID for 10 weeks. Group 3 received simvastatin 10 mg/d plus niacin (375 mg for 1 week and 500 mg for 11 weeks). The lipid profile (low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C], total cholesterol [TC], and triglycerides [TG]) and Lp(a) were measured before the start of therapy and at 6 and 12 weeks of treatment. Percentage changes from baseline were calculated. Adverse effects (AEs) were recorded at weeks 6 and 12 and through spontaneous reporting.

Results:

Ninety patients were enrolled (50 men, 40 women; 30 patients per treatment group). In group 1, the mean (SD) percentage decrease in LDL-C level at 12 weeks was 42.79% (16.29%) (P < 0.05), but no significant change was seen in group 2 or 3. The mean (SD) percentage increases in HDL-C level were 18.43% (13.28%) and 20.82% (17.57%) in groups 2 and 3, respectively (both, P < 0.05), but no significant change was seen in group 1. TC levels decreased by a mean (SD) of 32.97% (13.66%) in group 1 (P < 0.05), but no significant change was seen in group 2 or 3. TG and Lp(a) levels did not change significantly in any of the 3 treatment groups. Flushing, myalgia, and dyspepsia were the most common AEs in patients receiving niacin.

Conclusions:

In this study in Indian patients with dyslipidemia, simvastatin-niacin combination therapy was associated with greater changes in lipid profile compared with either agent used alone. Niacin was also associated with greater changes in Lp(a) levels. AEs were less prevalent with combination therapy than with niacin alone.Key words: dyslipidemia, simvastatin, niacin, combination therapy     

Anestesia em criança operada para lábio leporino associado à síndrome de Patau

Patients with Patau's syndrome (Trisomy 13) have multiple craniofacial, cardiac, neurological and renal anomalies with very less life expectancy. Among craniofacial anomalies cleft lip and palate are common. These craniofacial and cardiac anomalies present difficulties with anesthesia. We therefore describe the anesthetic management in the case of a Trisomy 13 child for operated for cleft lip at 10 months of age.     

Perinatal exposure of rats to Bisphenol A affects fertility of male offspring--an overview

Endocrine disruptors (ED) induce both functional and behavioral reproductive abnormalities. Bisphenol A (BPA) is a known ED that leaches from polycarbonate plastics, as such human exposure is common. Maternal BPA exposure has been shown to have negative effects on the fertility of male offspring. Pregnant rats exposed perinatally to environmentally relevant doses of BPA gave birth to offspring with significantly impaired spermatogenesis and fertility. Perinatal exposure had deleterious effects on the male germ line which manifested as impairments in the fertility of F(1) male offspring and subsequent F(2) and F(3) generations. This overview is an attempt to summarize the currently available data in the literature with regards to perinatal BPA exposure and male fertility.     

Major depression as a risk factor for chronic disease incidence: longitudinal analyses in a general population cohort

OBJECTIVE: Cross-sectional studies have consistently reported associations between major depression (MD) and chronic medical conditions. Such studies cannot clarify whether medical conditions increase the risk for MD or vice versa. The latter possibility has received relatively little attention in the literature. In this study, we evaluate the incidence of several important chronic medical conditions in people with and without MD. METHOD: The data source was the Canadian National Population Health Survey (NPHS). The NPHS included the Composite International Diagnostic Interview Short Form to assess past-year major depressive episodes. The NPHS also collected self-report data about professionally diagnosed long-term medical conditions. A longitudinal cohort was interviewed every 2 years between 1994 and 2002. Proportional hazards models were used to compare the incidence of chronic conditions in respondents with and without MD and to produce age-, sex- and covariate-adjusted estimates of the hazard ratios. RESULTS: The adjusted hazard ratios associated with MD at baseline interview were elevated for several long-term medical conditions: heart disease (1.7), arthritis (1.9), asthma (2.1), back pain (1.4), chronic bronchitis or emphysema (2.2), hypertension (1.7) and migraines (1.9). The incidences of cataracts and glaucoma, peptic ulcers and thyroid disease were not higher in respondents with MD. CONCLUSION: A set of conditions characterized particularly by pain, inflammation and/or autonomic reactivity has a higher incidence in people with MD.     

Relationship of Calcification of Atherosclerotic Plaque and Arterial Stiffness to Bone Mineral Density and Osteoprotegerin in Postmenopausal Women Referred for Osteoporosis Screening

Arterial calcification leading to increased arterial stiffness, a powerful risk factor for cardiovascular disease, may underlie the association of osteoporosis with cardiovascular disease in postmenopausal women. Osteoprotegerin (OPG), an indirect inhibitor of osteoclastogenesis, may be involved in arterial calcification. We examined relationships between calcification of subclinical atherosclerotic plaque and arterial stiffness with bone mineral density (BMD) and OPG in a group of 54 postmenopausal women referred for routine osteoporosis screening by dual-energy X-ray absorptiometric scanning of the lumbar spine and hip. Presence of calcified and noncalcified plaque in carotid and femoral arteries was examined using ultrasonography. Pulse wave velocity (PWV), a measure of arterial stiffness, was determined by sequential tonometry over the carotid and femoral region. Fifty-nine percent of osteoporotic women had calcified (echogenic) plaque at one or more sites compared with 42% and 20% for women with osteopenia and normal BMD, respectively (P = 0.04). There was a significant negative correlation between PWV and hip BMD (r = -0.35, P = 0.01), which remained significant when age, mean arterial pressure, and serum lipids were taken into account (P = 0.05). No significant relationships were observed between serum concentrations of OPG and lumbar spine or total hip BMD or with the number of arterial sites with calcified or noncalcified plaque. However, there was a strong correlation between OPG and PWV (r = 0.44, P = 0.001), which remained significant when adjusted for age (P = 0.01). These findings suggest that decreased BMD is associated with arterial calcification and stiffening and raise the possibility that OPG is a marker of arterial stiffening, independent of any association with BMD.