Sunday, August 12, 2007

Support for Antibiotics + Vitamin C + Niacin: Abstracts from Recent Scientific Publications

The following abstracts are examples of recent scientific studies supporting the blog entry using vitamin C, niacin, and drugs together to optimize the recovery of good health.

(1) The effect of 24 months of combination statin and extended-release niacin on carotid intima-media thickness: ARBITER 3. Taylor, Allen J.; Lee, Hyun J.; Sullenberger, Lance E. Cardiology Service, Walter Reed Army Medical Center, Washington, DC, USA. Current Medical Research and Opinion (2006), 22(11), 2243-2250. Publisher: LibraPharm Ltd.

The ARBITER 2 trial showed that extended-release niacin (ERN) when added to statin monotherapy slowed the progression of carotid atherosclerosis over 12 mo. Whether longer treatment with ERN would have a greater effect on carotid intima-media thickness (CIMT) is unknown. The long-term effects of ERN on high-d. lipoprotein (HDL-C) cholesterol and CIMT were examd. during 12-24 mo treatment with ERN in ARBITER 2 participants who either continued or were crossed over (from placebo) to ERN 1000 mg daily. Among 149 subjects completing ARBITER 2, 130 (88%) enrolled in ARBITER 3. The prespecified primary endpoints were the within-group change in CIMT and HDL-C in patients receiving placebo for 12 mo (n = 71), ERN for 12 mo (comprised of subjects from ERN treatment during ARBITER 2 (n = 78) and those crossed over to ERN from placebo after ARBITER 2 (n = 47)), and ERN for 24 mo spanning ARBITER 2 and 3 (n = 57). Five subjects discontinued the study due to flushing side effects. The study was completed by 104 subjects (47 crossed over from placebo; 57 with ERN continued from ARBITER 2). HDL-C increased in the ERN group from 39.5  6.7 to 48.6  13.3 mg/dL (p < 0.001) along with modest redns. in LDL-C and TG. Among 125 participants treated with ERN for 12 mo, there was a net regression of CIMT of -0.027  0.011 mm (p < 0.001 vs. placebo). Among 57 participants treated with ERN for 24 mo, there was addnl. significant regression of CIMT of -0.041  0.021 mm (p = 0.001 vs. placebo). Controlling for changes in LDL and triglycerides, only changes in HDL-C were independently assocd. with regression of CIMT (P = -0.25; p = 0.001). When added to statin therapy, ERN significantly increases HDL-C and induces atherosclerosis regression measured by CIMT over 24 mo. Limitations to this study include its open-label design and the inability to relate CIMT effects to clin. outcomes.

(2) Evaluation of efficacy and safety of fixed dose lovastatin and niacin ER combination in Asian Indian dyslipidemic patients: a multicentric study. Sharma, Manoj; Sharma, Deepika R.; Singh, Vikram; Panwar, R. B.; Hira, H. S.; Mohan, Bishav; Kumar, Naveen; Sharma, S. K.; Gupta, Rajeev. Clinical Research Division, Panacea-Biotec Ltd., New Delhi, India. Vascular Health and Risk Management (2006), 2(1), 87-93. Publisher: Dove Medical Press (NZ) Ltd.


Asian Indian dyslipidemia is characterized by: borderline high low-d. lipoprotein (LDL) cholesterol and apolipoprotein (apo) B; high triglycerides, low high-d. 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-wk 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 clin. and biochem. 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 wk and in 11 patients increased to lovastatin (20 mg) and niacinER (1000 mg). An intention-to-treat anal. 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 dermatol. adverse effects: flushing, pruritus, and rash. The mean values of various lipid parameters (mg/dL) at baseline, and at weeks 4, 12, and 24 resp. 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23mg/dL; triglycerides 171.172, 159.575, 149.245, and 135.240mg/dL; HDL cholesterol 45.67, 48.97, 51.69, and 53.910mg/dL; lp(a) 48.526, 40.121, 35.421, and 26.919mg/dL; and apoA1/apoB ratio 0.960.7, 1.040.4, 1.170.5, and 1.450.5 (p<0.01). The percentage of decline in various lipids at 4, 12, and 24 wk was: total cholesterol 11.8%, 18.8%, and 25.2%; LDL cholesterol 17.0%, 28.8%, and 38.0%;
triglyceride 6.8%, 12.8%, and 21.0%; lp(a) 17.5%, 26.9%, and 44.5% resp. (p<0.01). HDL cholesterol and apoA1/apoB increased by 7.2%, 13.1%, and 18.2%; and 7.9%, 21.9%, and 51.6% resp. (p<0.01). Target LDL levels (<100mg/dL in subjects with manifest coronary heart disease or diabetes; <130 mg/dL in subjects with >2 risk factors) were achieved in 92 (80.7%) patients. No significant changes were obsd. in systolic or diastolic blood pressure, blood creatinine, transaminases, or creatine kinase. A fixed dose combination of lovastatin and niacinER significantly improved cholesterol lipoprotein lipids as well as lp(a) and apoA1/apoB levels in Asian Indian dyslipidemic patients. Satisfactory safety and tolerability profile in this population was also demonstrated.

(3) Evaluation of ascorbic acid treatment in clinical and subclinical mastitis of Indian dairy cows. Naresh, Ram; Dwivedi, S. K.; Swarup, D.; Patra, R. C. Division of Medicine, Indian Veterinary Research Institute, Izatnagar, India. Asian-Australasian Journal of Animal Sciences (2002), 15(6), 905-911. Publisher: Asian-Australasian Journal of Animal Sciences.

A study was carried out to assess the therapeutic effect of ascorbic acid in mastitis of dairy cows. The herd with a population of 250-275 lactating cows was screened for clin. and subclin. mastitis for 5 mo. Based on inclusion and exclusion criteria, 18 animals each with clin. and subclin. mastitis in one quarter only were selected as study population. Twelve cows (group A) with normal udder and health were also selected as a healthy control. Clin. mastitis cows were grouped as B (n=12) and C (n=6). Cows of group B were treated with ascorbic acid at 25 mg/kg, s.c. for 5 consecutive days and intramammary infusion (Ampicillin sodium 75 mg and Cloxacillin sodium 200 mg/infusion) based on antibiotic sensitivity test, till complete recovery. Group C cows received only intramammary infusion till the complete recovery. Eighteen subclin. mastitis cows were divided in group D (n=12) and E (n=6). Cows of group D were treated with ascorbic acid at 25 mg/kg s.c. for 5 consecutive days while group E did not receive any treatment. California mastitis test (CMT), somatic cell count (SCC), phys. changes of udder, and milk were used to diagnose and classify the mastitis. Evaluation of the therapy was based on CMT score and phys. changes of udder and milk. Sample size calcn. was also performed but was not followed for control groups due to the scarcity of cases. Adequate blinding was done when and where required to avoid the biases. Confounding variables like herd, age of the cow; stage of the lactation, season, and geog. region were duly considered and adequate blocking was followed. Ascorbic acid was administered in clin. and subclin. cases even after cure considering its immunostimulatory and healing inducing effects. The recovery rate was faster in the cases of clin. mastitis treated with ascorbic acid along with an intramammary infusion (group B) than the quarters of group C cows. Quarter wise the av. duration/no.
(3.160.11 days) of antimicrobial intramammary infusion was significantly (p<0.01) less in group B than that of av. duration/no. (5.330.20 days) of group C. Subclin. mastitis cows treated with ascorbic acid showed 83.33% recovery while 16.77% did not respond to treatment till the last day of the study. Cows of group E (untreated) did not recover from the mastitis. Subjective parameters viz. swelling, pain reflex of udder, and phys. changes in milk from quarter of ascorbic acid-treated cows (group B) disappeared earlier than that of group C cows. Thus, the ascorbic acid might be useful as an adjunct in the case of clin. mastitis to get quick recovery with a less no. of intramammary infusions. High recovery rate in subclin. mastitis quarters of group D cows is appreciable and opens a new avenue to conduct further trials in a larger population in various field conditions. However, the pharmacol. of ascorbic acid with particular ref. to the health of mammary gland needs to be investigated.


At 4:46 PM, Anonymous Anonymous said...

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