Abstract
Introduction: In 2009, several epidemiological studies suggested a higher frequency of malignancy in insulin glargine-treated patients. A number of follow-up epidemiological population studies as well as two randomized, controlled clinical studies, one a 5000-patient retinopathy study and the other a 12,000-patient cardiovascular outcomes trial (ORIGIN), found no higher frequency of malignancy in glargine-treated patients. Areas covered: We reviewed the existing literature as well as U.S. FDA records to investigate the association of cancer, diabetes, and insulin. There is a 20-40% higher incidence of malignancy in type 2 diabetes patients. Certain cancers are more common, including hepatocellular and pancreatic carcinoma, colorectal cancer, renal cancer, and breast and endometrial cancer, and non-Hodgkin's lymphoma. There are numerous inter-related factors which may promote both diabetes and malignancy, including dietary patterns, obesity, insulin resistance, and alcoholism. Patients who receive insulin treatment are typically older and "sicker" than those who receive oral agents. Expert opinion: It is very difficult to prove causal associations between diabetes and cancer due to the host of confounding factors. The hypothesis that hyperinsulinemia and IGF-1 receptor activation promote cancer is strong, but confounded by the association of hyperinsulinemia with obesity, which separately promotes malignancy. Although statistical techniques to adjust for confounding variables can improve epidemiological comparisons, the lesson of the glargine cancer controversy is that controlled clinical trials are the only means to definitely prove hypotheses.
| Original language | English |
|---|---|
| Pages (from-to) | 247-263 |
| Number of pages | 17 |
| Journal | Expert Opinion on Drug Safety |
| Volume | 12 |
| Issue number | 2 |
| DOIs | |
| State | Published - Mar 2013 |
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All Science Journal Classification (ASJC) codes
- Pharmacology (medical)
Cite this
Glargine safety, diabetes and cancer. / Rendell, Marc; Akturk, Halis Kaan; Tella, Sri Harsha.
In: Expert Opinion on Drug Safety, Vol. 12, No. 2, 03.2013, p. 247-263.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Glargine safety, diabetes and cancer
AU - Rendell, Marc
AU - Akturk, Halis Kaan
AU - Tella, Sri Harsha
PY - 2013/3
Y1 - 2013/3
N2 - Introduction: In 2009, several epidemiological studies suggested a higher frequency of malignancy in insulin glargine-treated patients. A number of follow-up epidemiological population studies as well as two randomized, controlled clinical studies, one a 5000-patient retinopathy study and the other a 12,000-patient cardiovascular outcomes trial (ORIGIN), found no higher frequency of malignancy in glargine-treated patients. Areas covered: We reviewed the existing literature as well as U.S. FDA records to investigate the association of cancer, diabetes, and insulin. There is a 20-40% higher incidence of malignancy in type 2 diabetes patients. Certain cancers are more common, including hepatocellular and pancreatic carcinoma, colorectal cancer, renal cancer, and breast and endometrial cancer, and non-Hodgkin's lymphoma. There are numerous inter-related factors which may promote both diabetes and malignancy, including dietary patterns, obesity, insulin resistance, and alcoholism. Patients who receive insulin treatment are typically older and "sicker" than those who receive oral agents. Expert opinion: It is very difficult to prove causal associations between diabetes and cancer due to the host of confounding factors. The hypothesis that hyperinsulinemia and IGF-1 receptor activation promote cancer is strong, but confounded by the association of hyperinsulinemia with obesity, which separately promotes malignancy. Although statistical techniques to adjust for confounding variables can improve epidemiological comparisons, the lesson of the glargine cancer controversy is that controlled clinical trials are the only means to definitely prove hypotheses.
AB - Introduction: In 2009, several epidemiological studies suggested a higher frequency of malignancy in insulin glargine-treated patients. A number of follow-up epidemiological population studies as well as two randomized, controlled clinical studies, one a 5000-patient retinopathy study and the other a 12,000-patient cardiovascular outcomes trial (ORIGIN), found no higher frequency of malignancy in glargine-treated patients. Areas covered: We reviewed the existing literature as well as U.S. FDA records to investigate the association of cancer, diabetes, and insulin. There is a 20-40% higher incidence of malignancy in type 2 diabetes patients. Certain cancers are more common, including hepatocellular and pancreatic carcinoma, colorectal cancer, renal cancer, and breast and endometrial cancer, and non-Hodgkin's lymphoma. There are numerous inter-related factors which may promote both diabetes and malignancy, including dietary patterns, obesity, insulin resistance, and alcoholism. Patients who receive insulin treatment are typically older and "sicker" than those who receive oral agents. Expert opinion: It is very difficult to prove causal associations between diabetes and cancer due to the host of confounding factors. The hypothesis that hyperinsulinemia and IGF-1 receptor activation promote cancer is strong, but confounded by the association of hyperinsulinemia with obesity, which separately promotes malignancy. Although statistical techniques to adjust for confounding variables can improve epidemiological comparisons, the lesson of the glargine cancer controversy is that controlled clinical trials are the only means to definitely prove hypotheses.
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U2 - 10.1517/14740338.2013.770469
DO - 10.1517/14740338.2013.770469
M3 - Article
VL - 12
SP - 247
EP - 263
JO - Expert Opinion on Drug Safety
JF - Expert Opinion on Drug Safety
SN - 1474-0338
IS - 2
ER -