***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background Niacin is widely available over the counter ( OTC ) . We sought to determine the safety of 500 mg immediate release niacin , when healthy individuals use them as directed . Methods 51 female and 17 male healthy volunteers ( mean age 27 years SD 4.4 ) participated in a r and omized placebo-controlled blinded trial of a single dose of an OTC , immediate-release niacin 500 mg ( n = 33 ) , or a single dose of placebo ( n = 35 ) on an empty stomach . The outcomes measured were self-reported incidence of flushing and other adverse effects . Results 33 volunteers on niacin ( 100 % ) and 1 volunteer on placebo ( 3 % ) flushed ( relative risk 35 , 95 % confidence interval ( CI ) 6.8–194.7 ) . Mean time to flushing on niacin was 18.2 min ( 95 % CI : 12.7–23.6 ) ; mean duration of flushing was 75.4 min ( 95 % CI : 62.5–88.2 ) . Other adverse effects occurred commonly in the niacin group : chills ( 51.5 % vs. 0 % , P < .0001 ) , generalized pruritus ( 75 % vs. 0 % , P = < .001 ) , gastrointestinal upset ( 30 % vs. 3 % , P = .005 ) , and cutaneous tingling ( 30 % vs. 0 % , P = < .001 ) . Six participants did not tolerate the adverse effects of niacin and 3 required medical attention . Conclusion Clinicians counseling patients about niacin should alert patients not only about flushing but also about gastrointestinal symptoms , the most severe in this study . They should not trust that patients would receive information about these side effects or their prevention ( with aspirin ) from the OTC packet insert Niacin extended-release/lovastatin is a new combination product approved for treatment of primary hypercholesterolemia and mixed dyslipidemia . This open-labeled , multicenter study evaluated the safety of bedtime niacin extended-release/lovastatin when dosed as initial therapy and patient compliance to treatment in various clinical practice setting s. A total of 4,499 patients with dyslipidemia requiring drug intervention was enrolled at 1,081 sites . Patients were treated with 1 tablet ( 500 mg of niacin extended-release/20 mg of lovastatin ) once nightly for 4 weeks and then 2 tablets for 8 weeks . Patients also received dietary counseling , educational material s , and reminders to call a toll-free number that provided further education about dyslipidemia and niacin extended-release/lovastatin . Primary end points were study compliance , increases in liver transaminases to > 3 times the upper limit of normal , and clinical myopathy . Final study status was available for 4,217 patients ( 94 % ) .  Compliance to niacin extended-release/lovastatin  was 77 % , with 3,245 patients completing the study . Patients in the southeast and those enrolled by endocrinologists had the lowest compliance and highest adverse event rates . Flushing was the most common adverse event , reported by 18 % of patients and leading to discontinuation by 6 % . Incidence of increased aspartate aminotransferase and /or alanine aminotransferase > 3 times the upper limit of normal was < 0.3 % . An increase of creatine phosphokinase to > 5 times the upper limit of normal occurred in 0.24 % of patients , and no cases of drug-induced myopathy were observed . Niacin extended-release/lovastatin 1,000/40 mg , dosed as initial therapy , was associated with good compliance and safety and had very low incidences of increased liver and muscle enzymes Patients with combined hyperlipidemia and low high-density lipoprotein ( HDL ) cholesterol levels may benefit from combination therapy with a statin and niacin ; therefore , we assessed the efficacy and safety of rosuvastatin and extended-release ( ER ) niacin alone and in combination in 270 patients with this atherogenic dyslipidemia . Men and women > or = 18 years with fasting total cholesterol levels > or = 200 mg/dl , triglycerides 200 to 800 mg/dl , apolipoprotein B > or cf=110 mg/dl , and HDL cholesterol < 45 mg/dl were r and omized to 1 of 4 treatments in this 24-week , open-label , multicenter trial : rosuvastatin 10 to 40 mg ; ER niacin 0.5 to 2 g ; rosuvastatin 40 mg/ER niacin 0.5 to 1 g ; or rosuvastatin 10 mg/ER niacin 0.5 to 2 g. Percent changes from baseline in low-density lipoprotein ( LDL ) cholesterol , non-HDL cholesterol , and other lipid measurements at week 24 were determined by analysis of variance , with statistical testing performed separately between the rosuvastatin monotherapy group and each remaining treatment group . Daily doses of rosuvastatin 40 mg reduced LDL and non-HDL cholesterol significantly more than either ER niacin 2 g or rosuvastatin 10 mg/ER niacin 2 g ( -48 % vs -0.1 % and -36 % for LDL cholesterol and -49 % vs -11 % and -38 % for non-HDL cholesterol , respectively ; p < 0.01 for all comparisons ) ; no additional reduction in LDL or non-HDL cholesterol was observed with the combination of rosuvastatin 40 mg/ER niacin 1.0 g ( -42 % and -47 % ; p = NS ) . Triglyceride reductions ranged from -21 % ( ER niacin monotherapy ) to -39 % ( rosuvastatin 40 mg/ER niacin 1 g ) , but no observed differences were statistically significant . Compared with rosuvastatin alone , rosuvastatin 10 mg/ER niacin 2 g produced significantly greater increases in HDL cholesterol ( 11 % vs 24 % , p < 0.001 ) and apolipoprotein A-I ( 5 % vs 11 % , p < 0.017 ) . Similar increases in HDL cholesterol and apolipoprotein A-I were noted between the monotherapy groups . Over 24 weeks , rosuvastatin alone was better tolerated than either ER niacin alone or the combinations of rosuvastatin and ER niacin BACKGROUND AND OBJECTIVES Adverse effects complicate the use of drugs that are prescribed for phosphate control in dialysis patients . Alternative treatment options are needed . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS Nicotinic acid inhibits intestinal phosphate reabsorption and increases HDL cholesterol . This study tested the phosphate-lowering and HDL-increasing effect of Niaspan ( prolonged-release nicotinic acid ) in patients who were undergoing dialysis .  Efficacy , safety , and tolerability of Niaspan were prospect ively studied . Twenty dialysis patients , who were receiving a stable dosage of a calcium salt-containing drug for phosphate control , received after a 2-wk washout period Niaspan for 12 wk . Patients were started on 375 mg/d , and the dosage was increased every 2 wk to achieve 500 , 1000 , 1500 , and 2000 mg/d , respectively . Clinical and laboratory parameters were prospect ively recorded in patients who tolerated a target dosage of > or = 1000 mg/d . RESULTS Seventeen patients tolerated > or = 1000 mg/d Niaspan ( mean dosage 1470 + /- 110 mg/d ) . Niaspan treatment for 12 wk decreased serum phosphate values from 7.2 + /- 0.5 to 5.9 + /- 0.6 mg/dl ( P < 0.015 ) . In contrast , Niaspan did not affect serum calcium levels . A significant increase in HDL cholesterol from 40 + /- 3.2 to 59 + /- 5.5 mg/dl ( 34 % ) was also observed with Niaspan ( P = 0.0005 ) . CONCLUSIONS Niaspan effectively lowered serum phosphate levels and significantly increased HDL cholesterol .  Niaspan may provide an alternative or adjunctive treatment option in dialysis patients METHODS A total of 102 patients were r and omized to either mono-therapy with simvastatin ( 40 mg daily ) or triple-therapy with simvastatin ( 40 mg daily ) , extended-release niacin ( 1500 mg daily ) , and ezetimibe ( 10 mg daily ) . MRI was performed at baseline and 6 , 12 , and 24 months . SFA wall , lumen , and total vessel volumes were quantified . MRI-derived SFA parameters and lipids were analyzed with multilevel models and nonparametric tests , respectively . RESULTS Baseline characteristics did not differ between mono and triple-therapy groups , except for ethnicity ( p = 0.02 ) . SFA wall , lumen , and total vessel volumes increased non-significantly for both groups between baseline and 24-months . Non-high-density lipoprotein cholesterol was significantly reduced at 12 months with triple-therapy compared with mono-therapy ( p = 0.01 ) . CONCLUSION No significant differences were observed between mono-therapy using simvastatin and triple-therapy with simvastatin , extended-release niacin , and ezetimibe for 24-month changes in SFA wall , lumen , and total vessel volumes . CLINICAL TRIAL REGISTRATION INFORMATION NCT00687076 ; Link : http:// clinical trials.gov/ct2/show/NCT00687076 Patients with schizophrenia have in different studies shown reduced niacin sensitivity and lower electrodermal activity ( EDA ) after auditory stimulation . Peripheral mediation of prostagl and ins may have a physiological role in both responses . This motivates study of both niacin response and electrodermal responding in the same patients with schizophrenia . Thirty patients with schizophrenia and 17 controls were investigated with EDA and thereafter given 200 mg niacin orally with continuous assessment of skin temperature . The patients showed a delayed temperature increase after niacin ingestion ( P=0.002 ) and a higher frequency of electrodermal non-responding ( P<0.05 ) . Response/non-response for niacin  correlated with EDA response/non-response in the patient group ( P=0.009 ) . The niacin test revealed a slower vasodilation reaction in the patients . The association between response patterns for the niacin test and EDA suggests that a common aberration in skin physiology may be of importance for both reactions in schizophrenia Asian Indian dyslipidemia is characterized by : borderline high low-density lipoprotein ( LDL ) cholesterol and apolipoprotein ( apo ) B ; high triglycerides , low high-density lipoprotein ( HDL ) cholesterol and apoA1 ; and high lipoprotein(a ) ( lp[a ] ) . We performed a controlled multicentric trial in India to evaluate the efficacy and safety of a fixed dose combination of lovastatin and niacin extended release ( niacinER ) formulation in patients with moderate to severe dyslipidemia . Consecutive subjects that satisfied the selection criteria , agreed to an informed consent , and with no baseline presence of liver/renal disease or heart failure were enrolled in the study . After a 4-week run-in period there were 142 patients with LDL levels ≥130 mg/dL. Eleven patients were excluded because of uncontrolled hyperglycemia and 131 patients were recruited . After baseline evaluation of clinical and biochemical parameters all subjects were administered lovastatin ( 20 mg ) and niacinER ( 500 mg ) combination once daily . Dose escalation was done on basis of lipid parameters at 8 weeks and in 11 patients increased to lovastatin ( 20 mg ) and niacinER ( 1000 mg ) . An intention-to-treat analysis was performed and data was analyzed using nonparametric Wilcoxon signed rank test . Thirteen patients ( 10 % ) were lost to follow-up and 4 ( 3 % ) withdrew because of dermatological adverse effects : flushing , pruritus , and rash . The mean values of various lipid parameters ( mg/dL ) at baseline , and at weeks 4 , 12 , and 24 respectively were : total cholesterol 233.9 ± 27 , 206.3 ± 27 , 189.8 ± 31 , and 174.9 ± 27 mg/dL ; LDL cholesterol 153.4 ± 22 , 127.3 ± 21 , 109.2 ± 27 , and 95.1 ± 23 mg/dL ; triglycerides 171.1 ± 72 , 159.5 ± 75 , 149.2 ± 45 
    Output:
    
In individuals with dyslipidemia or cardiovascular disease  , nicotinic acid monotherapy seems to be protective against any adverse effects considered , as adverse events occurred at doses above those used with other treatments .