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  #1   ^
Old Mon, Aug-05-02, 13:06
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Voyajer Voyajer is offline
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Plan: Protein Power LP Dilletan
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Default Niacin lowers cholesterol and raises HDL

Curr Atheroscler Rep 2001 Jan;3(1):74-82

The benefits of niacin in atherosclerosis.

Tavintharan S, Kashyap ML.

Cholesterol Research Center, Department of Veterans Affairs Healthcare System, University of California, Irvine, 5901 East Seventh Street (11/111-I) Long Beach, CA 90822, USA.

Niacin favorably alters all major lipid subfractions at pharmacologic doses. Alone or in combination, it promotes regression of coronary artery disease, decreases coronary events, stroke, and total mortality. Major recent progress in niacin is in four areas. Firstly, recent data indicate that it increases high-density lipoprotein (HDL) and lowers triglycerides and low-density lipoprotein (LDL) by mechanisms different from statins, fibrates, and bile-sequestrants, giving rationale for combination therapy to achieve synergistic effects for complete lipid goal achievement. Secondly, new data on an extended-release preparation of niacin given once nightly indicates that it is as effective and has greater tolerability than immediate-release niacin. Thirdly, preliminary data with a single tablet formulation extended-release niacin and an HMG CoA reductase inhibitor (lovastatin) shows it to be safe and very effective, especially for raising HDL. Finally, emerging evidence indicates that niacin can be used effectively and safely in patients with type 2 diabetes mellitus, who often have low HDL levels.



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Arch Intern Med 2002 Jul 22;162(14):1568-76

Efficacy, safety, and tolerability of once-daily niacin for the treatment of dyslipidemia associated with type 2 diabetes: results of the assessment of diabetes control and evaluation of the efficacy of niaspan trial.

Grundy SM, Vega GL, McGovern ME, Tulloch BR, Kendall DM, Fitz-Patrick D, Ganda OP, Rosenson RS, Buse JB, Robertson DD, Sheehan JP.

The University of Texas Southwestern Medical Center, Room Y3206, 5323 Harry Hines Blvd, Dallas, TX 75390-9052.

BACKGROUND: Diabetic dyslipidemia is characterized by high triglyceride levels; low high-density lipoprotein cholesterol levels; small, dense low-density lipoprotein particles; and high free fatty acid levels. Niacin reduces concentrations of triglyceride-rich and small low-density lipoprotein particles while increasing high-density lipoprotein cholesterol levels. It also lowers levels of free fatty acids and lipoprotein(a). However, the use of niacin in patients with diabetes has been discouraged because high doses can worsen glycemic control. We evaluated the efficacy and safety of once-daily extended-release (ER) niacin in patients with diabetic dyslipidemia. METHODS: During a 16-week, double-blind, placebo-controlled trial, 148 patients were randomized to placebo (n = 49) or 1000 (n = 45) or 1500 mg/d (n = 52) of ER niacin. Sixty-nine patients (47%) were also receiving concomitant therapy with statins. RESULTS: Dose-dependent increases in high-density lipoprotein cholesterol levels (+19% to +24% [P<.05] vs placebo for both niacin dosages) and reductions in triglyceride levels (-13% to -28% [P<.05] vs placebo for the 1500-mg ER niacin) were observed. Baseline and week 16 values for glycosylated hemoglobin levels were 7.13% and 7.11%, respectively, in the placebo group; 7.28% and 7.35%, respectively, in the 1000-mg ER niacin group (P=.16 vs placebo); and 7.2% and 7.5%, respectively, in the 1500-mg ER niacin group (P=.048 vs placebo). Four patients discontinued participation because of inadequate glucose control. Rates of adverse event rates other than flushing were similar for the niacin and placebo groups. Four patients discontinued participation owing to flushing (including 1 receiving placebo). No hepatotoxic effects or myopathy were observed. CONCLUSION: Low doses of ER niacin (1000 or 1500 mg/d) are a treatment option for dyslipidemia in patients with type 2 diabetes.

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Diabetes Obes Metab 2002 Jul;4(4):255-261

Niacin treatment of the atherogenic lipid profile and Lp(a) in diabetes.
Pan J, Lin M, Kesala R, Van J, Charles M.

Diabetes Research Center, Tustin, CA, and University of California, Irvine, USA.

OBJECTIVE: We tested the hypotheses that niacin is effective for the separate treatments of abnormalities of LDL particle size, HDL2 percentage and Lp(a) without potential negative effects on glycated haemoglobin. RESEARCH DESIGN AND METHODS: The atherogenic lipid profile lipids, such as triglycerides, small, dense LDL cholesterol (LDLc) particle mass, LDL particle size, total HDLc and HDL2 percentage as well as Lp(a), were measured in 42 diabetic patients with abnormalities of LDL particle size, HDL2 percentage and/or Lp(a) levels before and after niacin treatment. LDL particle size and HDL2 were measured using polyacrylamide gradient gel electrophoreses and Lp(a) was measured by enzyme-linked immunoabsorbance assay (ELISA). RESULTS: After niacin treatment, LDL peak particle diameter increased from 252 +/- 7 A to 263 +/- 7 (p < 0.0001), small, dense LDLc particle mass decreased from 27 +/- 11 mg/dL to 15 +/- 4 (p < 0.0001), total HDLc increased from 39 +/- 7 mg/dL to 51 +/- 11 (p < 0.0001), HDL2 as the percentage of total HDLc mass increased from 29 +/- 8% to 45 +/- 10 (p < 0.0001) and Lp(a) decreased from 43 +/- 17 mg/dL to 25 +/- 10 (p < 0.0001). Mean haemoglobin A1c level was improved during treatment from 7.6 +/- 1.8% to 6.5 +/- 1.0 (p < 0.0001) using increased oral agent and insulin treatment doses in more than 90% of the patients. A total of 21% of the patients were unable to tolerate niacin owing to reversible side-effects, and 14% were unable to adhere to the niacin dosing regimen of three times daily. CONCLUSIONS: These data indicate that in diabetic patients, niacin (i) is effective for treating diabetic dyslipidaemias associated with both the atherogenic lipid profile and Lp(a); (ii) must be used with modern and aggressive oral hypoglycaemic agents or insulin treatment; and (iii) is an important drug to treat diabetes dyslipidaemias because of its broad spectrum of effectiveness.

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Prev Cardiol 2000 Summer;3(3):131-135

The antilipidemic effects of plain and extended-release niacin.

White Robinson A, Sloan HL, Arnold G.

College of Nursing and Allied Health Professions University of Southwestern Louisiana, Lafayette, LA 70504.

The extensive antihyperlipidemic effects of niacin are well known. Cardiac doses of niacin are effective in lowering low density lipoprotein, triglyceride, and lipoprotein(a) levels and in elevating high density lipoprotein levels. Adverse reactions to niacin range from annoying cutaneous flushing to hepatic toxicity . A new extended-release form of niacin (Niaspan) has been found to have relatively mild hepatic effects. Nighttime dosing of Niaspan appears to attenuate cutaneous flushing. Regardless of the form of drug prescribed, patients advised to use niacin should be carefully screened and monitored. Adverse effects of niacin are emphasized because of their particular importance in the provision of primary care. The dosing schedules for both plain niacin and extended-release niacin are discussed. (c) 2000 by CHF, Inc.

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Am J Cardiol 2000 Dec 21;86(12A):51L-56L

Evaluating niacin in its various forms.

Knopp RH.

Division of Metabolism, Endocrinology and Nutrition, Northwest Lipid Research Clinic, University of Washington, Seattle, USA.

Niacin is available in a number of different formulations according to the speed of drug release. The nomenclature is not standardized, and many names are used interchangeably, creating confusion. Formulations that differ in time of release may have different lipid effects and vary in their adverse reaction profiles. Studies comparing immediate-release with various time-release formulations illustrate these variations. Studies have found immediate-release and the intermediate, or extended-release, once-a-day, prescription form of niacin (i.e., Niaspan), to be essentially equivalent with respect to their efficacy in reducing triglycerides and increasing high-density lipoprotein cholesterol (HDL-C). However, there are fewer side effects and better compliance associated with the latter form.

Am J Cardiol 2000 Dec 21;86(12A):46L-50L

Raising high-density lipoprotein cholesterol with niacin and fibrates: a comparative review.

Sprecher DL.

Department of Cardiology, The Cleveland Clinic Foundation, Ohio 44195, USA.

A growing number of trials that used fibrates and niacin alone or in combination with other lipid-altering agents have shown that both these drugs are effective for reducing total cholesterol, low-density lipoprotein cholesterol (LDL-C) and triglycerides, and for increasing high-density lipoprotein cholesterol (HDL-C) levels. These lipid changes are associated with a reduction in events such as fatal and nonfatal myocardial infarction, stroke, and transient ischemic attack. In angiographic trials, they are associated with disease regression, increased minimal luminal diameter, and protection from risk of new lesions. In a head-to-head comparison study, niacin 2,000 mg/day increased HDL-C more than gemfibrozil 1,200 mg/day, and decreased the total cholesterol-to-HDL-C ratio, lipoprotein (a) (Lp[a]), and fibrinogen levels significantly more. Combination therapies of niacin plus a resin or statin are effective, well tolerated, and safe.

---------------

Prog Cardiovasc Nurs 2001 Winter;16(1):14-20

Use of niacin in the prevention and management of hyperlipidemia.
Robinson AW, Sloan HL, Arnold G.

University of Louisana at Lafayette, College of Nursing and Allied Health Professions, PO Box 43810, Lafayette, LA 70504-3810, USA.

Niacin is an inexpensive drug useful in treating various forms of hyperlipidemia. Cardiac doses of niacin are effective in lowering serum triglyceride, low density lipoprotein, and lipoprotein-a levels and in elevating high density lipoprotein levels. Adverse reactions to niacin are varied and dose-dependent and range from annoying cutaneous flushing to hepatic toxicity. Patients advised to use the drug should be carefully screened and monitored. This paper reviews the pathologic and pharmacologic basis for niacin as an antilipemic agent. The biochemical and physiologic effects of the drug and its mechanisms of action are discussed. Emphasis is placed on the importance of aggressive management of serum lipids and the therapeutic uses of niacin. The use of niacin in primary and secondary prevention of heart disease is stressed. A patient education guide is included.
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  #2   ^
Old Thu, Aug-08-02, 16:30
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Voyajer Voyajer is offline
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Posts: 475
 
Plan: Protein Power LP Dilletan
Stats: 164/145/138 Female 5'7"
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This is an important study because it shows that after 15 years, those that used Niacin to lower cholesterol lived longer than those who took drugs.



J Am Coll Cardiol 1986 Dec;8(6):1245-55

Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin.

Canner PL, Berge KG, Wenger NK, Stamler J, Friedman L, Prineas RJ, Friedewald W.

The Coronary Drug Project was conducted between 1966 and 1975 to assess the long-term efficacy and safety of five lipid-influencing drugs in 8,341 men aged 30 to 64 years with electrocardiogram-documented previous myocardial infarction. The two estrogen regimens and dextrothyroxine were discontinued early because of adverse effects. No evidence of efficacy was found for the clofibrate treatment. Niacin treatment showed modest benefit in decreasing definite nonfatal recurrent myocardial infarction but did not decrease total mortality. With a mean follow-up of 15 years, nearly 9 years after termination of the trial, mortality from all causes in each of the drug groups, except for niacin, was similar to that in the placebo group. Mortality in the niacin group was 11% lower than in the placebo group (52.0 versus 58.2%; p = 0.0004). This late benefit of niacin, occurring after discontinuation of the drug, may be a result of a translation into a mortality benefit over subsequent years of the early favorable effect of niacin in decreasing nonfatal reinfarction or a result of the cholesterol-lowering effect of niacin, or both.
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  #3   ^
Old Sun, Aug-18-02, 15:17
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Voyajer Voyajer is offline
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Posts: 475
 
Plan: Protein Power LP Dilletan
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Am J Cardiol 1998 Dec 17;82(12A):74U-81U;

Efficacy and safety of an extended-release niacin (Niaspan): a long-term study.


Capuzzi DM, Guyton JR, Morgan JM, Goldberg AC, Kreisberg RA, Brusco OA, Brody J.

Department of Medicine, Cardiovascular Disease Prevention Center, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania 19107, USA.

Crystalline nicotinic acid (immediate-release niacin) is effective therapy for lipoprotein regulation and cardiovascular risk reduction. However, inconvenient regimens and unpleasant side effects decrease compliance. Sustained-release formulations designed to circumvent these difficulties increase hepatotoxicity. Niaspan, a new US Food and Drug Administration (FDA)-approved, once-daily, extended-release form, has been found effective and safe in short-term trials. The long-term efficacy and safety of Niaspan lipid monotherapy was studied in 517 patients (aged 21-75 years) for < or =96 weeks in dosages < or =3,000 mg/day. Primary efficacy endpoints were low-density lipoprotein (LDL) cholesterol and apolipoprotein B (apo B) changes from baseline; secondary efficacy endpoints were changes in total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, lipoprotein(a), and total cholesterol/HDL-cholesterol ratio; safety data included adverse events and laboratory values over the 2-year study period. LDL-cholesterol levels decreased significantly: 18% at week 48 and 20% at week 96; apo B reduction was similar (16% decrease at week 48 and 19% at week 96). Large elevations in HDL cholesterol (26%, week 48; 28%, week 96) allowed only modest decreases in total cholesterol (12% and 13%, respectively), whereas total cholesterol/HDL-cholesterol ratio decreased by almost one third. Triglyceride and lipoprotein(a) levels were decreased by 27% and 30%, respectively (week 48), and by 28% and 40%, respectively (week 96). All changes from baseline were significant (p <0.001). Niaspan was generally well tolerated, although flushing was common (75%); however, there was a progressive decrease in flushing with time from 3.3 episodes in the first month to < or = 1 episode by week 48. Aspirin was used by one third of patients before Niaspan dosing to minimize flushing episodes. Although serious adverse events occurred in about 10% of patients, none were considered probably or definitely related to Niaspan. Adverse events in general varied widely, but their true relation to the study drug is difficult to ascertain without a placebo (control) group. No deaths occurred. There were statistically significant changes in hepatic transaminases, alkaline phosphatase, direct bilirubin, phosphorus, glucose, amylase, and uric acid. However, these changes were mostly small and are not likely to be biologically or clinically significant (the decrease in phosphorus is a new finding in niacin therapy). No myopathy was observed. Thus, this long-term study confirms the earlier short-term findings that Niaspan is safe and effective as monotherapy in plasma lipoprotein regulation.

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Am J Cardiol 1998 Dec 17;82(12A):29U-34U;

A new extended-release niacin (Niaspan): efficacy, tolerability, and safety in hypercholesterolemic patients.

Morgan JM, Capuzzi DM, Guyton JR.

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania 19107, USA.

Immediate-release niacin manifests beneficial effects in cardiovascular disease with respect to dyslipidemic states. It lowers low-density lipoprotein (LDL) cholesterol, triglycerides, lipoprotein(a), and apoprotein B; at the same time, it increases high-density lipoprotein (HDL) cholesterol, HDL2, and apoprotein A-I. However, use of crystalline niacin has drawbacks: therapy requires multidose regimens, and side effects include flushing and pruritus. Slowing absorption with sustained-release formulations succeeds in decreasing flushing and increasing tolerance, but increases in hepatic enzyme levels have raised safety concerns. A new extended-release, once-daily formulation of niacin (Niaspan) shows promise in minimizing flushing while avoiding hepatotoxicity. A multicenter, randomized, double-blind clinical trial of Niaspan enrolled 122 patients with confirmed diagnosis of primary dyslipidemia (LDL cholesterol >4.14 mmol/L [160 mg/dL] and triglycerides <9 mmol/L [800 mg/dL]) into 3 treatment groups: (1) Niaspan 1,000 mg/day; (2) Niaspan 2,000 mg/day; and (3) placebo. The primary treatment endpoint was LDL-cholesterol level. This endpoint was not significantly affected by placebo (0.2% increase), but Niaspan decreased LDL cholesterol by 5.8% (1,000 mg/day) and 14.6% (2,000 mg/day) (p <0.001). Likewise, with placebo there were significant changes in total cholesterol, triglycerides, lipoprotein(a), and apoprotein B, whereas both Niaspan 1,000 and 2,000 mg/day significantly (p <0.001) decreased these parameters. In addition, both Niaspan groups showed significant (p <0.001) increases in HDL cholesterol (17% and 23%, respectively), including HDL subfractions. With respect to flushing, 20% of the placebo group reported at least 1 episode, whereas 88% and 83% of the Niaspon 1,000- and 2,000-mg/day groups, respectively, reported episodes. There was no hepatotoxicity as liver enzyme levels remained within clinically accepted limits in all treatment groups. However, Niaspan 2,000 mg/day showed a significant increase in aspartate aminotransferase compared with baseline and placebo. This trial demonstrated a cholesterol-modifying effect of Niaspan consistent with those reported for niacin, but demonstrated a better tolerance for flushing. Moreover, in contrast to sustained-release formulations, Niaspan showed relatively mild hepatic effects.

-------------------------------

Before 1995, sustained release Niacin bought over-the-counter damaged liver more than regular Niacin. However, as the above studies show the prescription form of Niacin called Niaspan which is time-released has been shown to cause less liver damage.

JAMA 1994 Mar 2;271(9):672-7

A comparison of the efficacy and toxic effects of sustained- vs immediate-release niacin in hypercholesterolemic patients.
McKenney JM, Proctor JD, Harris S, Chinchili VM.

School of Pharmacy, Medical College of Virginia, Virginia Commonwealth University, Richmond 23298.

OBJECTIVE--To compare escalating doses of immediate-release (IR) and sustained-release (SR) niacin for effectiveness in reducing levels of low-density lipoprotein cholesterol and triglycerides and increasing levels of high-density lipoprotein cholesterol, and for the occurrence of adverse reactions, especially hepatotoxicity. DESIGN--Randomized, double-blind, parallel comparison of IR and SR niacin administered sequentially at 500, 1000, 1500, 2000, and 3000 mg/d, each for 6 weeks. SETTING--Cholesterol research center. PATIENTS--Forty-six adults, 23 in each group, with low-density lipoprotein cholesterol levels greater than 4.14 mmol/L (160 mg/dL) after 1 month of a step 1 National Cholesterol Education Program diet. OUTCOME MEASURES--Fourteen-hour fasting lipid and lipoprotein cholesterol levels, results of clinical laboratory tests, a symptom questionnaire, and withdrawal rates. RESULTS--The SR niacin lowered low-density lipoprotein cholesterol levels significantly more than IR niacin did at the dosage of 1500 mg/d and above, while IR niacin increased high-density lipoprotein cholesterol levels significantly more than SR niacin did at all dosage levels. The reduction in triglyceride levels was similar with IR and SR niacin. Nine (39%) of the 23 patients assigned to the IR dosage form withdrew before completing the 3000-mg daily dose; the most common reasons for withdrawal were vasodilatory symptoms, fatigue, and acanthosis nigricans. Eighteen (78%) of the 23 patients assigned to the SR dosage form withdrew before completing the 3000-mg daily dose; the most common reasons for withdrawal were gastrointestinal tract symptoms, fatigue, and increases in levels of liver aminotransferases, often with symptoms of hepatic dysfunction. None of the patients taking IR niacin developed hepatotoxic effects, while 12 (52%) of the 23 patients taking SR niacin did. CONCLUSION--The SR form of niacin is hepatotoxic and should be restricted from use. The IR niacin is preferred for the management of hypercholesterolemia but can also cause significant adverse effects and should be given only to patients who can be carefully monitored by experienced health professionals.

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Heart Dis 2002 Mar-Apr;4(2):124-37

Lovastatin and extended-release niacin combination product: the first drug combination for the management of hyperlipidemia.
Gupta EK, Ito MK.

University of the Pacific Thomas J. Long School of Pharmacy and Health Sciences, Stockton, California, USA.

Advicor (lovastatin and extended-release niacin) is the first cholesterol-lowering combination product to become available for the management of hyperlipidemia. Lovastatin significantly lowers low-density lipoprotein cholesterol, whereas niacin significantly lowers triglycerides and lipoprotein (a) and markedly increases high-density lipoprotein cholesterol. These effects are ideal for managing a variety of lipid disorders, including metabolic syndrome. Lovastatin and niacin reduce coronary heart disease mortality in primary and secondary prevention patients, respectively. The extended-release niacin component uses a unique technology to minimize adverse effects (e.g., flushing and hepatotoxicity) while retaining the same lipid-altering effects as immediate-release niacin. The combination product appears to be well tolerated, with discontinuation due to adverse effects other than flushing occurring in a similar percent of patients as for lovastatin in clinical trials. Approximately 9% of patients discontinued the combination product due to flush. No confined cases of myopathy or hepatotoxicity have been reported with this product. Once-daily dosing provides ease of administration that should improve compliance and result in a greater proportion of patients meeting their low-density lipoprotein cholesterol goals. The nomenclature surrounding niacin products used to treat dyslipidemias is confusing. While only two types of niacin formulations exist (immediate-release formulations and formulations which dissolve more slowly than immediate-release formulations), government regulations allow for slowly dissolved niacin formulations to be divided into two types of niacin products; those that are available over-the-counter (OTC) and those that are available by prescription only. Over-the-counter slowly dissolved niacin preparations are not classified as OTC per se, but are considered "nutritional supplements". For this reason, they fall under the jurisdiction of the Federal Trade Commission and do not fall under the umbrella of the FDA branch that controls dyslipidemic products (Endocrine and Metabolic Division of the Center for Drug Evaluation and Research). The slowly dissolved niacin nutritional supplements have not been reviewed by the FDA for safety nor efficacy in the treatment of dyslipidemia nor are they required to meet generic drug rules (even though various brands are available). These brands are described on their labels as "sustained-release", "timed-release", and "slow-release" for example. Only two slowly absorbed niacin products have been approved by the FDA for the treatment of dyslipidemia; they are Niaspan (Kos Pharmaceuticals, Inc., Miami, FL) and Advicor (Kos Pharmaceuticals, Inc., Miami, FL) . The term "extended-release" has been given to these two products to simplify the terminology and differentiate the products from immediate-release niacin. In this review, we will use "extended-release" to refer to the FDA approved slowly dissolving niacin preparation and "sustained-release" to refer to the nutritional supplements (not FDA approved).

Last edited by Voyajer : Sun, Aug-18-02 at 15:25.
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  #4   ^
Old Sun, Aug-18-02, 15:53
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Voyajer Voyajer is offline
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Plan: Protein Power LP Dilletan
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No Flush Niacin in health food stores with Inositol has been shown to be safe in studies.

J Int Med Res 1979;7(6):473-83


An experimentally controlled evaluation of the effect of inositol nicotinate upon the digital blood flow in patients with Raynaud's phenomenon.

Holti G.

The vaso-active effects of inositol nicotinate (Hexopal) were investigated in thirty patients with primary and secondary Raynaud's phenomenon using several non-invasive experimental techniques under controlled conditions. The earlier formed impression that this drug requires a prolonged 'build-up' period was confirmed. Recording the time required to induce Raynaud's phenomenon as well as assessments of total and nutrient digital blood flow showed significant beneficial therapeutic effects upon the skin's microcirculation by inositol nicotinate. This study suggests that the therapeutic effect of this drug is not merely due to vasodilation but that other mechanisms such as enhanced fibrinolysis and lowering of serum lipids may play a significant part in its overall effect. Smokers responded slower than non-smokers, but even elderly patients with longstanding vasospastic disease showed measurably improved digital circulation. Unlike some other drugs in this field inositol nicotinate was found to be effective orally and to be devoid of unwanted side-effects. However, in the majority of patients it failed to abolish their increased vascular spasm although it diminished it significantly in most. It appears to be a safe and well tolerated drug, which, together with other symptomatic measures, merits to be used in the management of vasospastic disease of the extremities even in the presence of partial obliteration of the microcirculation.
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