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Meta-analysis of nicotinamide treatment in patients with recent-onset IDDM. The Nicotinamide Trialists
P Pozzilli1, P D Browne, H Kolb
1Cattedra di Endocrinologia (I), University of Rome La Sapienza, Italy.
Objective:
Nicotinamide, a vitamin of the B group, has in vitro actions capable of interfering with the pathogenetic process leading to IDDM. Since 1987, several studies have evaluated nicotinamide as a means of protecting beta-cells from end-stage destruction in insulin-treated patients with newly diagnosed IDDM. The aim of the study was to determine whether nicotinamide protects residual beta-cell function when given at IDDM diagnosis.
Research Design And Methods:
We performed a meta-analysis of the integrated parameters of metabolic control (C-peptide, glycosylated hemoglobin, insulin dose) in 10 randomized (5 of which were placebo) controlled trials conducted in recent-onset IDDM patients for a total of 211 nicotinamide-treated patients. Data on the adverse effects of nicotinamide were also collected from an additional four trials to yield a grand total of 291 nicotinamide-receiving patients.
Results:
One year after diagnosis, baseline C-peptide was significantly higher in nicotinamide-treated patients, compared with control patients (0.73 +/- 0.65 vs. 0.32 +/- 0.56 ng/ml, P < 0.005). This statistical difference remained also when the five placebo-controlled trials only were considered (P < 0.05). No differences were observed in the insulin dose required or glycosylated hemoglobin values between nicotinamide and control patients. Adverse effects were reported in few patients (transient elevation of transaminase, n = 2; skin rash, n = 2; recurrent hypoglycemia, n = 2).
Conclusions:
This combined analysis demonstrates a therapeutic effect of nicotinamide in preserving residual beta-cell function when given at IDDM diagnosis in addition to insulin. Since adverse effects were negligible, we suggest that prolonged use of nicotinamide after IDDM diagnosis should be tested to see whether residual beta-cell function can be preserved for longer periods.
Insights
Nicotinamide supplementation at diagnosis helps preserve beta-cell function in patients with recent-onset insulin-dependent diabetes mellitus (IDDM). This vitamin B derivative showed a therapeutic effect with negligible adverse effects, warranting further investigation for long-term use.
Area of Science:
- Endocrinology
- Metabolic Diseases
- Nutritional Science
Background:
- Nicotinamide (vitamin B) exhibits in vitro properties that may counteract the pathological processes underlying insulin-dependent diabetes mellitus (IDDM).
- Previous studies explored nicotinamide's potential to protect pancreatic beta-cells from destruction in patients with newly diagnosed IDDM receiving insulin therapy.
Purpose of the Study:
- To evaluate the efficacy of nicotinamide in preserving residual beta-cell function in patients diagnosed with IDDM.
- To determine if nicotinamide administration at the time of IDDM diagnosis offers protective benefits to pancreatic beta-cells.
Main Methods:
- A meta-analysis was conducted on data from 10 randomized controlled trials, including 5 placebo-controlled studies.
- Integrated metabolic control parameters (C-peptide, glycosylated hemoglobin, insulin dose) were analyzed for 211 patients treated with nicotinamide.
- Adverse effects were collected from an additional four trials, encompassing 291 nicotinamide-receiving patients.
Main Results:
- One year post-diagnosis, nicotinamide-treated patients exhibited significantly higher baseline C-peptide levels compared to controls (0.73 vs. 0.32 ng/ml, P < 0.005).
- This significant difference in C-peptide was maintained even when considering only placebo-controlled trials (P < 0.05).
- No significant differences were found in insulin dosage requirements or glycosylated hemoglobin levels between the nicotinamide and control groups. Adverse effects were infrequent and mild.
Conclusions:
- The meta-analysis indicates a therapeutic benefit of nicotinamide in preserving residual beta-cell function when administered concurrently with insulin at IDDM diagnosis.
- Given the minimal adverse effects observed, further research is recommended to assess the long-term impact of nicotinamide on maintaining beta-cell function post-IDDM diagnosis.