Comparison and Assessment of Flixweed and Fig Effects on Irritable Bowel Syndrome with Predominant Constipation: A Single-Blind Randomized Clinical Trial.

BACKGROUND: Irritable bowel syndrome with predominant constipation (IBS-C) is a common digestive disorder. The current therapy is inadequate and evidence regarding the effect of herbal therapies on the relief of affected individuals is insufficient. The aim of this study was to investigate the beneficial effects of flixweed and fig consumption on IBS-C symptoms. METHODS: 150 patients with IBS-C were enrolled in this randomized, controlled trial. All patients were randomly assigned to three groups and received an intervention for four months. The IBS severity score system and quality-of-life questionnaires were used for evaluating IBS-C symptoms. C-reactive protein levels, frequency of defecation and hard stool were also assessed. RESULTS: Consumption of flixweed or fig, compared to a control group, caused a significant improvement in IBS symptoms including frequency of pain, distention, frequency of defecation and hard stool. Also, the findings showed a significant increase in quality of life, as well as satisfaction with overall bowel habits. However, flixweed and fig intake had no significant effects on abdominal pain severity and C-reactive protein levels. CONCLUSIONS: In conclusion, consumption of flixweed or fig for four months would be a useful therapy for alleviating IBS-C symptoms and can be a beneficial option for first-line treatment.

Biosimilar Infliximab in Inflammatory Bowel Disease: Outcomes of a Managed Switching Programme.

BACKGROUND AND AIMS: Biosimilar infliximab CT-P13 offers the potential for large drug acquisition cost savings. However, there are limited published data regarding its efficacy, safety, and immunogenicity in inflammatory bowel disease [IBD], particularly in switching IBD patients from originator to biosimilar infliximab. We present the outcomes of a service evaluation of switching IBD patients established on originator infliximab to biosimilar, using a managed switching programme funded via a gain share agreement in a UK teaching hospital. METHODS: Evaluation outcomes included drug persistence, changes in drug acquisition costs, patient-reported side effects, adverse events, patient outcomes assessed using the IBD-control Patient-Reported Outcome Measures [PROM] questionnaire, serum drug and antibody levels, and routinely collected biochemical markers. RESULTS: A total of 143 patients with IBD [118 Crohn's disease, 23 ulcerative colitis, 2 IBD unclassified] were switched from originator infliximab to CT-P13. Patients reported a similar incidence of side effects before and after switch. No clinically significant differences were observed in mean C-reactive protein [CRP], albumin, haemoglobin levels, or platelet and white cell counts after the switch to CT-P13, whereas mean IBD-control-8 score improved from 10.4 to 11.2 [p = 0.041]. There was no significant difference in drug persistence between biosimilar and originator infliximab [p = 0.94] and no increase in immunogenicity was found. Drug acquisition costs decreased by £40,000-60,000 per month. CONCLUSIONS: A managed switching programme from originator infliximab to biosimilar CT-P13 in IBD, using a gain-share agreement, delivers significant cost savings and investment in clinical services while maintaining similar patient-reported outcomes, biochemical response, drug persistence, and adverse event profile.

Assessment of the prophylactic role of aspirin and/or clopidogrel on experimentally induced acute myocardial infarction in hypercholesterolemic rats.

INTRODUCTION: Hyperlipidemia is a risk factor for cardiovascular diseases such as acute infarction. Inflammation and platelet activation are critical phenomena in acute myocardial infarction (AMI). AIM: The aim of the study was to assess potential protective effects of aspirin and/or clopidogrel on AMI in hypercholesterolemic rats. METHODS: Forty adult male Wistar rats were divided into five groups (eight rats in each). Group I included normal healthy rats. The other 32 rats were subjected to induction of hypercholesterolemia by high-fat diet for 3 weeks, followed by induction of AMI by subcutaneous injections of isoproterenol (85 mg/kg/day, for 2 days). Rats were divided into the following groups: group II, rats with induced hypercholesterolemia and AMI; group III, hypercholesterolemic rats that received aspirin 30 mg/kg/day orally for 7 days before induction of AMI; group IV, hypercholesterolemic rats that received clopidogrel 10 mg/kg/day orally for 7 days before induction of AMI; and group V, hypercholesterolemic rats treated with both aspirin and clopidogrel in the same doses for 7 days before induction of AMI. Serum levels of pentraxin 3 (PTX3), transforming growth factor-ß1 (TGF-ß1), creatine kinase (CK), lactate dehydrogenase (LDH), total cholesterol and triglycerides were estimated in all rats. RESULTS: Isoproterenol-induced AMI in hypercholesterolemic rats was associated with an increase in serum levels of PTX3, TGF-ß1, CK and LDH. Aspirin and/or clopidogrel pretreatment for 1 week led to a reduction of their levels as compared with non-treated rats. However, the reduction caused by combination of aspirin and clopidogrel was more than that caused by each drug separately. CONCLUSION: Combination of aspirin and clopidogrel could be a therapeutic option for hypercholesterolemic patients to attenuate the complex vascular inflammatory process which is a key step in the setting of AMI.

Role of C-reactive protein when prescribing a statin.

The clinical value of measuring C-reactive protein (CRP) to guide statin therapy is uncertain. It has no value in patients at high risk who would be treated regardless of CRP (eg, patients with coronary disease or of equivalent risk), in patients at low risk who do not warrant treatment, and those with other acute or chronic inflammatory conditions that amplify CRP. Drawbacks to the widespread clinical use of CRP include its small impact on risk prediction beyond other risk factors, and evidence from JUPITER and other trials that baseline CRP is unable to identify patients who obtain greater absolute benefits from statin therapy. Furthermore, the within-person variability of CRP is about the same as the reduction in CRP from intensive statin therapy, and this leads to many patients registering an increase in CRP with treatment. For these reasons, CRP has no clear role in determining who should receive statin therapy or for monitoring the success of treatment.

Assessment of the efficacy of pamidronate in ankylosing spondylitis: an open prospective trial.

INTRODUCTION: Bisphosphonates have anti-inflammatory properties in arthritic conditions. This study was conducted to assess the therapeutic potential of intravenous pamidronate in nonsteroidal anti-inflammatory drug (NSAID) refractory/intolerant cases of ankylosing spondylitis (AS). METHODS: A total of 35 NSAID refractory/intolerant AS patients with Bath AS Disease Activity Index (BASDAI) score 4 or above were recruited for the study. Monthly pamidronate infusions (60 mg) were administered to the patients for six months. Treatment outcomes were assessed by comparing baseline values with the values after six infusions using BASDAI, Bath AS Functional Index (BASFI), Metrology Index (BASMI) and Global Score (BAS-G), C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). An improvement was defined according to the Assessments in Ankylosing Spondylitis (ASAS)-20 and BASDAI-50. RESULTS: 26 patients received all the six infusions. Of these, 22 (85 percent) achieved ASAS-20 and 20 (77 percent) achieved BASDAI-50 responses. Decrements were noted in the mean BASDAI (56.4 percent), BASFI (52.66 percent), BASMI (55.72 percent), BAS-G (66.71 percent), ESR (52.12 percent) and CRP (72.84 percent) after six months. The tender and swollen joint counts of 14 (54 percent) patients with peripheral arthritis were respectively reduced to a mean value of 0.85 and nil, from the baseline of 2.57 and 1.2. Early feel good response was noted in 16 (62 percent) patients within 48 hours of the first infusion. Fever, arthralgia and myalgia were observed in six cases after the first infusion, and in one case, after the second infusion. These symptoms resolved spontaneously within 24 hours. CONCLUSION: Intravenous pamidronate has good efficacy for the treatment of AS.

Fiber's impact on high-sensitivity C-reactive protein levels in cardiovascular disease.

PURPOSE: To determine if increased dietary or supplemental intake of fiber slows or prevents inflammation as evidenced by high-sensitivity C-reactive protein (hs-CRP) values. DATA SOURCES: CINAHL, Medline, Health Source, Nursing/Academic Edition, and the Cochrane Library. CONCLUSIONS: Evidence from this review suggested significant associations between fiber consumption and decreased risk for cardiovascular (CV) disease as evidenced by a decrease in hs-CRP levels. Six of the seven articles reviewed showed statistically significant decreases in hs-CRP levels as dietary fiber was increased. IMPLICATIONS FOR PRACTICE: Fiber in the diet may play a strong role in CV health as evidenced by six clinical trials completed using amount of fiber intake in relation to inflammation, particularly hs-CRP levels. Patients need to be educated to adhere to a high fiber diet, either by dietary or supplemental means, using the recommended 25-30 g of fiber per day.

Cost-effectiveness of rosuvastatin for primary prevention of cardiovascular events according to Framingham Risk Score in patients with elevated C-reactive protein.

CONTEXT: The Food and Drug Administration (FDA) recently approved rosuvastatin calcium for prevention of cardiovascular events in patients who have elevated levels of high-sensitivity C-reactive protein (hs-CRP) but not overt hyperlipidemia. The FDA's decision was based primarily on research reported by the JUPITER (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin) Study Group. The cost-effectiveness of such treatment is unknown. OBJECTIVE: To compare the cost-effectiveness of treatment with rosuvastatin vs standard management, according to Framingham Risk Score (FRS), for the primary prevention of cardiovascular events in patients who have hs-CRP levels of 2.0 mg/L or higher and low-density lipoprotein cholesterol (LDL-C) levels of less than 130 mg/dL. METHODS: A Markov-type model was used to calculate the incremental cost-effectiveness ratio of rosuvastatin (20 mg daily) vs standard management for the primary prevention of cardiovascular events in patients over a 10-year period. Cost data were obtained from the Centers for Medicare & Medicaid Services and the Red Book drug reference. Health utility measures were obtained from the literature. Cardiovascular event data were obtained directly from the JUPITER Study Group. One-way sensitivity analysis and probabilistic sensitivity analysis were conducted. RESULTS: Treating patients with rosuvastatin to prevent cardiovascular events based on a hs-CRP level greater than 2.0 mg/L and an LDL-C level of 130 mg/dL or lower would result in estimated incremental cost-effectiveness ratios of $35,455 per quality-adjusted life year (QALY) in patients with an FRS greater than 10% and $90,714 per QALY in patients with an FRS less than or equal to 10%. Results of probabilistic sensitivity analysis suggested that in patients with an FRS greater than 10%, the probability that rosuvastatin is considered cost-effective at $50,000 per QALY is approximately 98%. In patients with an FRS less than or equal to 10%, the probability that rosuvastatin is considered cost-effective at $50,000 per QALY is 0%. CONCLUSIONS: Compared with standard management, treatment with rosuvastatin is a cost-effective strategy over a 10-year period for preventing cardiovascular events in patients with FRS greater than 10%, elevated hs-CRP levels, and normal LDL-C levels.

The comparison of the effects of standard 20 mg atorvastatin daily and 20 mg atorvastatin every other day on serum LDL-cholesterol and high sensitive C-reactive protein levels.

OBJECTIVE: In this study, we aimed at comparing the effects of standard once daily 20 mg atorvastatin treatment with that of atorvastatin 20 mg administered every other day on serum lipids and high sensitive C-reactive protein (hs-CRP) levels. METHODS: Sixty-one patients with serum total cholesterol levels of above 200 mg/dl and low density lipoprotein (LDL)--cholesterol levels of above 130 mg/dl were included in this prospective, randomized study. The patients were randomized into daily treatment of 20 mg atorvastatin (standard treatment) and 20 mg atorvastatin every other day (every other day treatment) groups. Before the treatment and at each visit, serum lipids and hs-CRP levels of all the patients were measured. Statistical analyses were performed Chi-square, unpaired t and two-way repeated measurements ANOVA tests. RESULTS: In the every other day treatment group, there was a 36.1% reduction in LDL-cholesterol levels by the end of first month (p<0.01). At the end of three months there was further decrease of 10.2% in LDL-cholesterol levels when compared to 1 month levels (p>0.05). The LDL cholesterol levels of the group receiving 20 mg atorvastatin every day was reduced by %41 by the end of 1 month (p<0.01). At the end of three months, the difference between the changes in the all lipid parameters of the two groups was not found to be of statistical significance. In the group receiving the medication every other day, there was a 21% decrease in hs-CRP levels compared to the basal measurements at the end of first month (p<0.05). In the group, receiving the medication every day the decrease in hs-CRP levels at the end of one month was more striking (37%, p<0.05). However, the effects of both treatment arms on hs-CRP levels, did not differ significantly (p>0.05). CONCLUSIONS: Alternate-day dosing of atorvastatin causes a significant lipid-lowering and antiinflammatory effects similar to that of daily administration and yet may provide some cost savings.

An assessment of the joint associations of aspirin and statin use with C-reactive protein concentration.

BACKGROUND: The use of aspirin alone and statins alone has been shown to reduce markers of inflammation, including C-reactive protein (CRP); however, their combination has been poorly studied. METHODS: In a cross-sectional analysis of black and white adults > or =45 years old from the REGARDS cohort, the associations of aspirin and statin use with CRP were examined. Individuals requiring nonsteroidal anti-inflammatory drug therapy or those taking aspirin for reasons other than cardioprotection were excluded from analysis. Participants were classified into 1 of 4 groups: aspirin only (n = 3,673), statin only (n = 1,898), both agents (n = 3,008), or neither agent (n = 7,718). RESULTS: Estimated mean CRP was 2.78 mg/L for subjects taking neither drug, 2.73 mg/L with aspirin only, 2.29 mg/L with statins only, and 2.03 mg/L for subjects taking both agents. The combined use of both agents was associated with an apparent synergistically lower CRP; the mean CRP level among these combined users was 0.21 mg/L lower than that anticipated from additive association related to aspirin and statins alone (P for interaction = .01). Associations were larger among participants reporting a history of cardiovascular disease. In addition, among statin users, the use of aspirin for >5 years compared with < or =5 years was associated with apparent significantly lower CRP concentrations (P = .01). CONCLUSIONS: The combined use of aspirin and statins was associated with a synergistically lower CRP concentration, especially among participants taking aspirin for >5 years. Given the limitations of this study and the modest associations, randomized controlled trial evidence is needed to confirm the findings.

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.

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.