Two meta-analyses including some of these observational studies reported a highly significant reduction in cancer incidence or mortality associated with metformin use (risk reductions ranged between 31 and 34%) (The majority of studies published to date have reported the role of metformin in preventing the occurrence of cancer in general and of some cancers in particular. Thus, by forming the nonuser group, the authors artificially induced a cohort that was immortal and cancer free before the index date but had more deaths and cancers after entry into the cohort. Actually – it is just the opposite!

The 3,340 subjects who entered the cohort while using sulfonylureas and remained on these throughout the entire follow-up and the 1,229 who used only metformin from day 1 throughout follow-up pose no problem to the definition of exposure. There are more sophisticated ways to estimate the rate ratio while properly accounting for such time-varying exposures, such as Cox proportional hazards models with time-dependent factors. Even a relatively benign drug, like metformin, can cause digestive issues and rare, but severe, complications such as lactic acidosis (excessive acidity in the body). Moreover, this person-time should be classified as unexposed until the second metformin prescription, at which point the remaining person-time should be classified as metformin-exposed. Indeed, if the potential matched nonuser had a diagnosis of cancer or had died prior to the index date, it was discarded.

In choosing among potential nonusers for a given user, a variation of bias from time lags was introduced.

In the case of the association between metformin and cancer, we believe that methodologically inaccurate studies, even if their results are replicated in different settings, should not be the driving force behind long and expensive trials.

Find support, ask questions and share your experiences with 315,007 members of the diabetes community.Delicious diabetes recipes, updated every Monday. How does metformin work?

Moreover, new observational studies using more rigorous designs and analyses that avoid these biases should urgently be undertaken before more randomized trials are initiated in vain.S.S. Metformin has modest effects on blood glucose levels but helps to reduce the amount of insulin produced by the body and therefore has wider benefits including reducing Cancer occurs when new cells grow in an uncontrolled fashio, resulting in a tumour. An alternative approach simply is to use an intent-to-treat approach (as is done in RCTs) that classifies exposure according to the first OHA prescription type, irrespective of switching to or adding the other agent, with, of course, the limitations of interpretation inherent to this approach.In a subsequent publication reanalyzing the same data, the authors recognized the presence of immortal time bias, claiming “we extended our analyses by classifying time-varying exposure of metformin, sulfonylureas and insulin therapy” (Immortal time bias also was evident in a study using Taiwanese National Health Insurance data in 2000 (Immortal time bias is introduced in this study from the definition of metformin exposure. Time-related biases include immortal time bias, a bias introduced with time-fixed cohort analyses that misclassify unexposed time as exposed; time-window bias, a bias introduced because of differential exposure opportunity time windows between subjects; and time-lag bias, a bias introduced by comparing treatments given at different stages of the disease (Metformin is a drug of choice for the management of type 2 diabetes mellitus (In parallel, a series of observational studies conducted in various databases generally reported similar beneficial results with metformin, thus “confirming” the findings of the 2005 study.

However, these biases have not been described in detail in the field of diabetes.

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The reported rates of cancer death for metformin (245/39,026 = 6.3 per 1,000 person-years) and for sulfonylureas (162/16,700 = 9.7 per 1,000 person-years), which were based on misclassified denominators, produced a crude rate ratio of 0.65.

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