Glycemic Durability of Rosiglitazone, Metformin, or Glyburide Monotherapy. Article (PDF Available) in New England Journal of Medicine. The primary outcome was the time to monotherapy failure, which was defined as a Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. FPrime Recommended Article: Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy.
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The long-term goals for the management of type 2 diabetes mellitus T2DM center on the prevention of its chronic micro- and macrovascular complications, which requires normalization of glycemia and control of cardiovascular risk factors 1. Growing evidence from large clinical trials supporting earlier and more aggressive therapeutic strategies to manage hyperglycemia in diabetes has been reflected in current guidelines and mrtformin recommendations 2 metfromin 5.
Recent clinical trials on controlling hyperglycemia have supported more efficacious therapeutic approaches, most of which have clearly shown that double or triple combinations of available and emerging pharmaceutical agents are required to achieve that elusive, but well-recognized, near-normal hemoglobin A1c goal of less than 6.
The etiology of these defects is not fully understood. For the majority of patients, it is well-known that maximizing doses of single oral medications does not provide a sustained normalization of glycemia and can provoke unwanted side effects 9. Thus, successful current therapeutic approaches use early adoption of oral combination therapies, among the variety of medications that thankfully are currently available for use.
ADOPT provides an updated view of diabetes management for several reasons.
Considering the large number of subjects and the duration of blinded therapy in this landmark trial, however, ADOPT provides a superior level of confidence in its assessment of the monotherapy performance of these drugs compared with data from smaller previous studies of shorter duration.
Rosiglitazone effects on insulin sensitivity, however, continued to improve through 4—5 yr of follow-up. Interestingly, metformin exhibited reasonable insulin-sensitizing effects although not as robust as rosiglitazonean effect that has not been consistently shown in prior metformin trials. Although rosiglitazone provided superior glycemic durability, the ADOPT safety data were also consistent with the widely appreciated but unfortunate side effects of rosiglitazone to increase lower body adiposity and cause mild peripheral edema.
In contrast to the recent DREAM trial, which showed a dramatic efficacy of rosiglitazonr to delay glycemic progression in prediabetes that was accompanied by a surprising incidence of congestive heart failure 13there was no increase in nonadjudicated congestive heart failure CHF with rosiglitazone glybuuride with metformin in ADOPT. Curiously, the glyburide group had a significantly reduced incidence of CHF.
These data fit with the relatively low frequency of CHF with thiazolidinedione use, including when used in combination with sulfonylureas in elderly patients with a high incidence of baseline edema Metformin exhibited its anticipated incidence metfoormin unpleasant gastrointestinal side effects, and glyburide was associated monothefapy significant hypoglycemia, perhaps the worst performing sulfonylurea in this regard ADOPT also revealed a potential concern with increased bone fractures in women durabillty rosiglitazone.
Cross-sectional data have recently raised the possibility of osteopenia with thiazolidinedione use 16and until additional studies are completed, it may be prudent to monitor bone density in women taking rosiglitazone in clinical practice who have a high fracture risk. Rosiglitazone was more successful in achieving the lowest mean glucose control, and both metformin glycemkc rosiglitazone were superior to glyburide, factors that could make a difference in durability.
The mean dose of each monotherapy given to the patients in ADOPT was not reported, and it will be instructive to learn this parameter in the future. Nevertheless, as in clinical practice, we can only surmise that the fraction of patients achieving A1c levels to a goal of 6. When initiated several years ago, the ADOPT design to test individual monotherapies appropriately followed a common ,onotherapy in diabetes therapy at that time.
Nowadays, the growing demand for aggressive therapy as reflected in current clinical practice recommendations supports the earlier use of combinations of oral medications 35 The rationale for combination therapy in diabetes practice has become clear: Many current clinical trials with diabetes therapeutics are designed as add-on or initial coadministration of two drugs.
The multifactorial nature of T2DM pathogenesis, noted above, is also consistent with a superior metgormin response from medication combinations that address several underlying defects at once.
In addition, limiting the doses of the available drugs will help minimize their expected adverse effects, especially the gastrointestinal intolerance of metformin and the weight gain and fluid retention associated with thiazolidinediones. To these ends, ADOPT provides clinical trial evidence to support the early use of metformin and rosiglitazone.
Prior studies have shown that the combination of these two agents works well and minimizes the side effects of higher doses of each agent without hypoglycemia Sulfonylurea use, especially with aggressive glycemic targets, is not only a poor choice from a durability standpoint, but can be fraught with uncomfortable and potentially dangerous hypoglycemia glyceemic when used in early combinations Thus, translation of the ADOPT data supports a role for early use of metformin and rosiglitazone in combination, a well-tolerated, effective initial therapy that has been approved by the U.
Food and Drug Administration for this indication New agents that can further enhance glycemic control perhaps dyrability different mechanisms but also avoiding hypoglycemia, including the incretin agents, will be welcome additions to this therapeutic mix.
Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy.
The growing availability of fixed-drug-combination pills of this type will also significantly help to contain costs and simplify patient regimens. Oxford University Press is a department of the University of Oxford. It furthers the University’s objective of excellence in research, scholarship, and education by publishing worldwide. Sign In or Create an Account.
Close mobile search navigation Article navigation. Can J Diabetes 27 Suppl 2. Earlier intervention in type 2 diabetes: Management of hyperglycaemia in type 2 diabetes: Textbook of type 2 diabetes.
Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: Management of hyperglycemia in type 2 diabetes: Effects of rosiglitazone added to submaximal doses of metformin compared with dose escalation of metformin in type 2 diabetes: Email alerts New issue alert.
Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. – Semantic Scholar
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Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. – FPrime
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