A web-based interactive lifestyle modification program improves lipid profile and serum adiponectin concentrations in patients with metabolic syndrome: the “Red Ruby” study

The effectiveness of internet-based programs in prevention and treatment of metabolic syndrome has not been fully explored. In the present study, we investigate the effect of a 6-month web-based interactive lifestyle modification program on anthropometric variables and biochemical risk factors of cardiovascular disease. The study had been carried out among 160 patients with metabolic syndrome (intervention, n?=?80; control, n?=?80). The primary outcomes were change in anthropometric variables, fasting serum glucose (FSG), lipid profile, insulin sensitivity, and serum adiponectin concentrations in intervention and control groups. Significant reductions in anthropometric variables and serum lipids were observed in both intervention and control groups; however, reduction in waist-to-hip ratio (WHR), total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C) was only significant in intervention group (P?<?0.05). Reduction in anthropometric variables and serum triglyceride, systolic and diastolic blood pressure, and liver enzymes were significant in intervention and control groups (P?<?0.05) but in women decrease in FSG, TC, and LDL-C were only significant in intervention group (P?<?0.05). The present study showed that a web-based intervention was effective in weight loss and improving cardio-metabolic factors in patients with metabolic syndrome after a 6-month intervention.     

Does sulphasalazine cause drug induced systemic lupus erythematosus? No effect evident in a prospective randomised trial of 200 rheumatoid patients treated with sulphasalazine or auranofin over five years

BACKGROUND: Sulphasalazine (SSZ) has been reported to cause drug induced systemic lupus erythematosus (SLE), but diagnosis of this complication in the context of rheumatoid arthritis (RA) is difficult. OBJECTIVE: To determine prospectively: (1) if patients become seropositive for antinuclear antibodies (ANA) during prolonged treatment with SSZ without clinical evidence of SLE; (2) if ANA positive patients develop more adverse reactions than ANA negative patients; (3) if drug induced SLE was identified in this cohort. METHODS: 200 patients enrolled in a randomised prospective trial of SSZ and auranofin (AUR) were followed up for five years. Baseline and annual ANA results were collected along with information on drug toxicity and reasons for discontinuation of treatment. RESULTS: Over five years 24 patients stopped taking SSZ and 49 AUR because of side effects. Of the features common to SLE, rash developed in nine SSZ patients and 11 AUR treated patients and mouth ulcers in three and four patients respectively. Six SSZ treated patients and three treated with AUR developed leucopenia, which promptly resolved with drug withdrawal. No adverse event was ascribed to drug induced SLE. Of the 72 SSZ treated patients who were ANA negative or weakly positive at outset, 14 (19%) became strongly ANA positive compared with 11 (14%) of 80 AUR patients. Patients ANA positive at baseline or who became ANA positive were not more likely to develop drug toxicity or to withdraw from treatment than those ANA negative throughout. CONCLUSION: ANA positivity is common in patients with RA, but the presence or development of ANA did not increase the likelihood of withdrawing from treatment. No case of drug induced SLE was seen over five years in this study.     

Safety/tolerability,efficacy and pharmacokinetics of 600-μg cotadutide in Japanese type 2 diabetes patients with a body mass index of 25 kg/m2 or higher: A phase I,randomized, double-blind,placebo-controlled study

Aim

To assess the safety/tolerability, efficacy and pharmacokinetics of once-daily, 600-μg cotadutide in Japanese type 2 diabetes patients with a body mass index of 25 kg/m² or higher.

Materials and Methods

This phase I, randomized, double-blind, placebo-controlled study (NCT04208620) enrolled patients to receive subcutaneous cotadutide at an escalating dose to determine the highest tolerated clinical dose (Cohort 1), then applied in Cohort 2. The primary endpoint was safety, including treatment-emergent adverse events (TEAEs); secondary endpoints included glycaemic control and body weight.

Results

Sixteen patients were randomly allocated to receive cotadutide or placebo in a 3:1 ratio. All patients were Asian, 62.5% were male, and the median age and body mass index were 60 years and 27.2 kg/m², respectively. Through the follow-up period of the study, 11/12 (91.7%) patients in the cotadutide group experienced a TEAE versus 1/4 (25.0%) patients in the placebo group. All TEAEs were mild, except for one moderate event. There were no deaths, serious TEAEs or TEAEs leading to study discontinuation. Gastrointestinal-related events were the most common TEAEs. Cotadutide-treated patients achieved significantly improved 7-day mean glucose measured by continuous glucose monitoring; the 7-day mean (standard deviation) at the end of treatment (day 70) was 112.23 (20.79) versus 206.85 (3.62) mg/dL for placebo. Mean respective changes in HbA1c were −1.13% (0.64%) and −0.17% (0.65%); and mean percentage changes in body weight were −6.93% (3.44%) and −1.23% (1.20%).

Conclusions

Cotadutide was well tolerated at doses up to 600 μg; efficacy versus placebo for weight loss and glycaemic control was shown.