scholarly journals Effect of Diacerein on Metabolic Control and Inflammatory Markers in Patients with Type 2 Diabetes Using Antidiabetic Agents: A Randomized Controlled Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Glaucia S. Tres ◽  
Sandra C. Fuchs ◽  
Fabiana Piovesan ◽  
Patricia Koehler-Santos ◽  
Fernanda dos S. Pereira ◽  
...  
Keyword(s):  
Metabolic Control ◽  
Hba1c Level ◽  
Controlled Trial ◽  
Term Treatment ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Glucose Lowering ◽  
Long Term Treatment ◽  
Inflammatory Profile

Introduction. Studies have shown that T2DM is an inflammatory disease. Thus, the present study was aimed at evaluating whether diacerein could improve the metabolic and inflammatory profile among patients with T2DM under long-term treatment with glucose-lowering agents. Methods. This is a double-blind, parallel, placebo-controlled trial with 72 participants randomly assigned to diacerein 50 mg or placebo for 12 weeks. The primary endpoint was the between-group difference in change in HbA1c. Secondary endpoints included the proportion of patients achieving metabolic control [HbA1c≤7.0% (53 mmol/mol)] and change in inflammatory mediators. Results. Participants in the diacerein group had greater reductions in mean HbA1c level in comparison to placebo (−0.98; 95% CI: −2.02 to 0.05, P=0.06), independently of confounding factors. The difference in HbA1c level was −1.3 (95% CI: −2.3 to −0.4) in favor of diacerein (P=0.007) in those with <14 years of diabetes duration versus 0.05 (−0.7 to 0.8; P=0.9) in those with longer duration. The diacerein group had a 50% increase in the number of participants at the lowest TNF-α level (≤1.46 pg/mL). Conclusions. In patients with long-established T2DM under long-term treatment with glucose-lowering agents, diacerein improves metabolic control as measured by HbA1c level and has a favorable impact on inflammatory profile. Clinical Trial Registry. This trial is registered with Brazilian Clinical Trials Registry (ReBEC) number RBR-29j956.

scholarly journals A randomized, double‐blind, placebo‐controlled trial to evaluate the efficacy, safety, and tolerability of long‐term treatment with prucalopride

2015 ◽  
Vol 27 (6) ◽  
pp. 805-815 ◽  
Author(s):  
H. Piessevaux ◽  
E. Corazziari ◽  
E. Rey ◽  
M. Simren ◽  
A. Wiechowska‐Kozlowska ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Term Treatment ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Long Term Treatment

Antiaggregatory Effects of Picotamide in Long-Term Treatment: A 2-Year, Double-Blind Placebo-Controlled Trial

1997 ◽  
Vol 2 (4) ◽  
pp. 292-295 ◽  
Author(s):  
Manlio Cocozza ◽  
Massimo Milani ◽  
Tommaso Picano ◽  
Ugo Oliviero ◽  
Nicola Russo ◽  
...  
Keyword(s):  
Platelet Aggregation ◽  
Ex Vivo ◽  
Controlled Trial ◽  
Term Treatment ◽  
Significant Inhibition ◽  
Diabetic Patients ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Long Term Treatment

The ex vivo antiaggregatory activity of picotamide, a dual antithromboxane agent, was assessed to find whether it was maintained in long-term treatment. In a double-blind, placebo-controlled 2-year study, 50 type 2 diabetic patients (35 men and 15 women; mean age 66 ± 5 years) were enrolled and randomly given picotamide, 300 mg t.i.d. or the corresponding placebo. Platelet aggregation studies were performed at baseline and after 1, 3, 6, 12, 18 and 24 months. Compliance to the treatment was assessed by pill count at each visit. Forty-nine patients concluded the study. Starting from month 1, compared with placebo, picotamide-treated patients showed a significant inhibition of agonist-induced (ADP, arachidonic acid and collagen) platelet aggregation (–41%). The antiaggregatory effect was maintained throughout the study. At month 24, in the picotamide group, platelet aggregation was significantly lower compared with placebo (–30%). After 24 months of treatment, 20 out of 23 (86%) picotamide-treated patients showed a significant inhibition of platelet aggregation, whereas the remaining three patients had a normal platelet response. During the study, 12 patients suffered from thrombotic events of death: nine in the placebo group and three in the picotamide group, respectively. It was concluded that picotamide maintains its antiaggregatory effect, in long-term treatment, in more than 85% of patients.

Unnecessary Use of Tranquillizers in Elderly Patients

1966 ◽  
Vol 112 (491) ◽  
pp. 989-990 ◽  
Author(s):  
Russell Barton ◽  
Lindsay Hurst
Keyword(s):  
Elderly Patients ◽  
Social Adjustment ◽  
Elderly Women ◽  
Controlled Trial ◽  
Psychiatric Hospitals ◽  
Term Treatment ◽  
Double Blind ◽  
Level Of Functioning ◽  
Long Term Treatment

The evidence that potent tranquillizers are useful in the long-term treatment of elderly patients with dementia in psychiatric hospitals is conflicting.Seager (1955), in a double-blind, controlled trial involving 48 elderly women, 29 of whom suffered from dementia, found a highly significant improvement of social adjustment associated with chlorpromazine therapy. Schulsinger (1961), Exton-Smith (1962) and Post (1963) claimed promazine to be of particular value for agitated elderly patients. Robinson (1959), on the other hand, compared the effects of prolonged administration of chlorpromazine, reserpine, leptazol and a placebo upon 84 senile female patients in a double-blind trial and found no statistically significant improvement associated with the active drugs. Indeed, in the case of chiorpromazine, he found a significant lowering of the level of functioning. Abse and Dahistrom (1960), in a double-blind controlled trial involving 8o patients over 60 years of age with various symptoms (including some with confusion), found that chlorpromazine did not give better results than placebo.

Long-term treatment with probiotics in primary care patients with irritable bowel syndrome – a randomised, double-blind, placebo controlled trial

2013 ◽  
Vol 48 (10) ◽  
pp. 1127-1135 ◽  
Author(s):  
Luise Mølenberg Begtrup ◽  
Ove B Schaffalitzky de Muckadell ◽  
Jens Kjeldsen ◽  
René dePont Christensen ◽  
Dorte Ejg Jarbøl
Keyword(s):  
Primary Care ◽  
Irritable Bowel Syndrome ◽  
Controlled Trial ◽  
Term Treatment ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Long Term Treatment ◽  
Primary Care Patients ◽  
Irritable Bowel

scholarly journals Long-term safety and effectiveness of lurasidone in schizophrenia: a 22-month, open-label extension study

CNS Spectrums ◽  
2016 ◽  
Vol 21 (5) ◽  
pp. 393-402 ◽  
Author(s):  
Christoph U. Correll ◽  
Josephine Cucchiaro ◽  
Robert Silva ◽  
Jay Hsu ◽  
Andrei Pikalov ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Term Treatment ◽  
Extension Study ◽  
Open Label ◽  
Double Blind ◽  
Syndrome Scale ◽  
Long Term Treatment ◽  
Open Label Extension ◽  
The Mean

ObjectiveTo evaluate the safety and effectiveness of lurasidone in the long-term treatment of patients with schizophrenia.MethodsPatients who completed a 6-week, double-blind (DB), placebo-controlled trial continued in a 22-month, open-label (OL) study during which they received once-daily, flexible-doses of lurasidone, 40–120 mg. Change in the Positive and Negative Syndrome Scale (PANSS) was analyzed using both observed case (OC) and last observation carried forward (LOCF) analyses.ResultsOf the 251 patients who entered the OL extension, 51.4% completed 6 months, 36.7% completed 12 months, and 26.7% completed 22 months of OL treatment. Treatment with lurasidone was associated with a mean change from DB baseline, in weight of +0.4 kg at Month 12 (n=99), and +0.8 kg at Month 24 (n=67; OC analyses). Median change from DB baseline to Month 12 and Month 24, respectively, was -1.0 and -9.0 mg/dL for total cholesterol; 0.0 and -1.0 mg/dL for LDL; +1.0 and -11.0 mg/dL for triglycerides; and 0.0 and +0.1/% for HbA1c (OC analyses). The mean PANSS total score was 96.5 at DB baseline and 69.5 at OL baseline. The mean change from DB baseline in the PANSS total score at Month 24 was -43.6 (OC) and -28.4 (LOCF). Thirty-seven patients (14.7%) discontinued due to an adverse event (AE) during OL treatment. Three AEs occurred in ≥10% of patients: schizophrenia (12.4%), akathisia (10.8%), and somnolence (10.8%); and 19.2% reported at least one movement disorder–related AE. Discontinuations due to AEs occurred in 14.8% of patients.ConclusionsIn this 22-month, open-label extension study, treatment with lurasidone was associated with minimal effects on weight, glucose, lipids, and prolactin. Patients demonstrated sustained improvement in the PANSS total score for up to 24 months of lurasidone treatment.

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