Key result
Tolbutamide therapy maintained its hypoglycaemic effect over 69 months, demonstrating that the delayed reappearance of hyperglycaemia was not primarily a drug-related phenomenon.
Why the study?
Does tolbutamide maintain its hypoglycaemic effect over time compared to placebo and insulin in newly diagnosed ketosis resistant diabetics?
RCT (n=50)
randomized
Does tolbutamide maintain its hypoglycaemic effect over time compared to placebo and insulin in newly diagnosed ketosis resistant diabetics?
The secondary failure of tolbutamide to maintain normoglycemia over long-term follow-up is likely due to natural disease progression rather than a specific loss of drug efficacy.
Answers are grounded in this paper and cite their sources.
Tolbutamide sustains hypoglycaemic efficacy for 69 months in new ketosis-resistant diabetes; confirms secondary failure reflects disease progression, not drug tolerance.
Summary: An evaluation of the hypoglycaemic effect of tolbutamide was performed over 69 months in 50 newly diagnosed ketosis resistant diabetics who were predominantly obese, female, and Negro in origin. All were participants in the University Group Diabetes Programme, and were randomly assigned to four treatment groups (placebo, tolbutamide, constant insulin, and variable insulin), which were indistinguishable by baseline characteristics. The hypoglycaemic effect of intravenously administered tolbutamide showed no evidence of change with time and was not significantly different in tolbutamide treated patients. The hypoglycaemic effect of orally administered tolbutamide in the fasting state was also maintained throughout. After a glucose load a specific impairment of the hypoglycaemic effect of tolbutamide was noted during the course of the study. However, a progressive rise in blood sugar levels occurred in all treatment groups after the first twelve months of therapy both in the fasting state and after a glucose load, and this was greater than any changes in treatment response. The changes in blood sugar levels were not related to changes in body weight. The results show that the delayed reappearance of hyperglycaemia associated with tolbutamide therapy is not primarily and drug related phenomenon.
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Jerums et al. (1974) conducted an RCT in ketosis resistant diabetes (n=50). Tolbutamide vs. placebo, constant insulin, and variable insulin was evaluated on hypoglycaemic effect and blood sugar levels. Tolbutamide therapy maintained its hypoglycaemic effect over 69 months, demonstrating that the delayed reappearance of hyperglycaemia was not primarily a drug-related phenomenon.
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