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In patients of type 2 diabetes mellitus when initial management with a single agent does not yield desired blood sugar levels. Drugs sometimes cause serious injuries to the livers of patients, with loss of hepatic function leading to illness, disability, hospitalization, and even life threatening liver failure and death or need for liver transplantation. Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
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Similar to the nontransplant settings, the use of fasting plasma glucose (FPG) versus oral glucose tolerance test (OGTT) to define diabetes mellitus also changes the prevalence of NODAT. As the number of patients with type 2 diabetes reaches epidemic proportions worldwide a€“ and is expected to double during the next 20 years a€“ researchers are working to gain a basic understanding of the molecular relationships between diabetes and heart disease to identify new drug targets. Using cutting-edge physiological, molecular and proteomic approaches, the team closely examined a key signaling pathway called mammalian target of rapamycin (mTOR). In 2006, in a study published in the Journal of Molecular and Cellular Cardiology, the team reported a protective role of rapamycin against heart disease in a non-diabetic animal model.
According to Das and Kukreja, further research is needed to understand the molecular mechanisms underlying metabolic and heart function benefits of rapamycin in patients with diabetes. Scientists at Dana-Farber Cancer Institute have discovered why diabetic-like symptoms develop in some patients given rapamycin, an immune-suppressant drug that also has shown anti-cancer activity and may even slow ageing. Having diabetes doubles a person's risk of dying after a heart attack, but the reason for the increased risk is not clear. Elderly mice suffering from age-related heart disease saw a significant improvement in cardiac function after being treated with the FDA-approved drug rapamycin for just three months.
Too much sugar can set people down a pathway to heart failure, according to a study led by researchers at The University of Texas Health Science Center at Houston (UTHealth). In their mission to design new biomaterials that promote tissue regeneration, Drexel University researchers have identified how inflammation, when precisely controlled, is crucial to bone repair. New research by University of Iowa scientists helps explain how a hormone system often targeted to treat cardiovascular disease can also lower metabolism and promote obesity.
A low-intensity type of laser treatment may offer a non-invasive, drug-free treatment for thrombocytopenia - a potentially life-threatening shortage of the blood cells called platelets that are essential to blood clotting.
Researchers at Johns Hopkins Medicine report they have identified a biochemical pathway linking oxidative stress and the amino acid cysteine in Huntington's disease. An infusion of stem cells could help restore proper drainage for fluid-clogged eyes at risk for glaucoma.
This study was done to assess the types of ADRs presenting to the Accident and Emergency department (A&E) of the University Hospital of the West Indies.
Detection and management of diabetes mellitus in recipients of solid organ transplants 12.1. Sugested guidelines for pre-transplant baseline evaluation and post-transplant screening for NODAT12.3.
In a prospective study designed to evaluate the use of OGTT for risk-stratifying patients for NODAT, Sharif et al.
ObesitySimilar to the general population, obesity has been shown to be associated with the development of NODAT in most studies (Setoguchi et al., 2005). This finding has not yet been validated in either transplant recipients or prospective trials in the general population (Bosch et al., 2006).
Rapamycin inhibits mTOR signaling and subsequently prevents endothelial dysfunction, obesity, hyperglycemia, insulin resistance, inflammation and oxidative stresses.
Diabetes is associated with heart attack, and patients with elevated fasting glucose are at a three-fold increased risk of mortality following a heart attack. 14in the Journal of Biological Chemistry, researchers report that rapamycin, an antibiotic used to boost organ survival in transplant patients, may protect the heart against complications associated with type 2 diabetes in an animal model.
It is a signaling pathway responsible for the regulation of cell growth and metabolism, and has been implicated in a number of human diseases, including diabetes. The team has plans for new studies in translational animal models of type 2 diabetes to show that rapamycin can minimize damage to the heart after an acute heart attack. Admissions to the A&E associated with drugs were followed on a weekly basis for 19 weeks from October 2007 to February 2008 using the patient logbook.
There has been scant literature on the incidence of diabetes mellitus after a successful pancreas transplant.
Of interest, ADPKD patients with normal native kidney function have been shown to have insulin resistance and compensatory hyperinsulinemia (Vareesangthip et al., 1997). Medical records of patients with suspected ADRs were collected and evaluated by an Emergency Medicine Consultant of A&E to confirm the occurrence of ADRs and the suspected drug. Although not a risk factor per se, increased insulin clearance after a successful kidney transplant can unmask pre-transplant impaired glucose tolerance or pre-existing diabetes mellitus that manifests clinically as NODAT.
Although some studies failed to demonstrate an association between obesity and the development of NODAT, obesity and its associated peripheral insulin resistance state is a known risk factor for type 2 diabetes. The variation in the reported incidence may be due in part to the lack of a standard definition of the condition, the duration of follow-up, the presence of both modifiable and non-modifiable risks factors, and the type of organ transplants among others. Risk factors for NODATRisk factors for the development of NODAT are categorized as non-modifiable and modifiable or potentially modifiable, the former category to facilitate the identification of high risk individuals, and the latter two categories to optimize the management of NODAT. Pharmacological managementWhen lifestyle modification fails to achieve adequate glycemic control, medical intervention is recommended.
Drug induced hypoglycaemia accounted for 28 (56.3%) cases of ADRs and included mainly patients on insulin, with or without a sulphonylurea therapy. Nonetheless, the pattern of body fat distribution has been suggested to play a contributory role. Orally administered agents can be used either alone or in combination with other oral agents or insulin. Most of these diabetic patients also had co-morbidities and were on multi-drug therapy (18). Pham5[1] Department of Medicine, Nephrology Division, Kidney Transplant Program, David Geffen School of Medicine at UCLA, United States of America[2] Department of Medicine, Greater Los Angeles VA Medical Center and David Geffen School of Medicine at UCLA, United States of America[3] Department of Medicine, Cardiology Division, Bay Pines VA Medical Center, Bay Pines, Florida, United States of America[4] Department of Medicine, Division of Cardiovascular Diseases, VA Medical Center, University of Tennessee Health Science Center, Memphis, TN, United States of America[5] Department of Medicine, Nephrology Division, UCLA-Olive View Medical Center and David Geffen School of Medicine, United States of America1. Corticosteroid-associated NODATThe now well-established contributory role of corticosteroid on NODAT was first described by Starlz in 1964 in renal transplant recipients.
Studies in healthy women showed that upper body or male-type obesity has a much greater association with insulin resistance and impaired glucose tolerance than lower body or female-type obesity (Kissebah et al., 1982). The choice of pharmacologic therapy is based on the potential advantages and disadvantages associated with the different classes of oral agents. Introduction New onset diabetes mellitus after transplantation (NODAT) is a serious and common complication following solid organ transplantation.
In one single-center study consisting of 126 lung and heart-lung transplant recipients, diabetes has a reported prevalence of 6% at 1 year and 7% at 5 years.
Table 3 summarizes the mechanisms of action and potential advantages and disadvantages of different classes of oral agents. The lower prevalence of diabetes in this study was thought to be due in part to a lower frequency of cystic fibrosis patients (8.7% vs. It is speculated that intra-abdominal fat or waist-to-hip ratio may be more important risk factors for NODAT than total body weight or BMI (Davidson et al., 2003). Kidney transplant recipients who develop NODAT have variably been reported to be at increased risk of fatal and nonfatal cardiovascular events and other adverse outcomes including infection, reduced patient survival, graft rejection, and accelerated graft loss compared with those who do not develop diabetes.
In contrast to the DOPPS study results, in an analysis of the national cohort study consisting of more than 5,000 dialysis patients with type 2 diabetes Brunelli et al. Limited clinical studies in liver, heart and lung transplants similarly suggested that NODAT has an adverse impact on patient and graft outcomes. Ischemic heart disease was also found to be associated with an increased incidence of NODAT (Ye et al., 2010b). The following chapter presents an overview of the literature on the current diagnostic criteria for NODAT, its incidence after solid organ transplantation, suggested risk factors and potential pathogenic mechanisms. In a single-center study consisting of 97 consecutive adult heart transplant recipients, a family history of diabetes and the need for insulin beyond the first 24 hours after transplantation were shown to be risk factors for the development NODAT (Depczynski et al., 2000).
Whether complete withdrawal of chronic low dose corticosteroid therapy (prednisolone 5 mg daily) improves glucose metabolism remains to be studied.
In a recent retrospective analysis consisting of 640 nondiabetic renal transplant recipients Bayer et al. The impact of NODAT on patient and allograft outcomes and suggested guidelines for early identification and management of NODAT will also be discussed.
Nonetheless, in recent years several studies have suggested a potential beneficial effect of steroid-free immunosuppression on NODAT risk reduction (Luan et al., 2011). Multivariate analysis incorporating the individual metabolic syndrome components as covariates demonstrated that of all the pre-transplant metabolic syndrome components, only low-density lipoprotein was independently associated with the development of NODAT.The precise role of the metabolic syndrome or metabolic syndrome component(s) in the development of NODAT remains to be defined. Nonetheless, great caution should be exercised when rosiglitazone is used in the setting of kidney transplantation because all kidney transplant recipients should be regarded as having at least stage II-IV chronic kidney disease.
Los ingresos al DAE asociados con medicamentos, fueron seguidos de forma hebdomadaria por un período de 19 semanas, desde octubre de 2007 hasta febrero de 2008, usando el libro de registro de pacientes. Nonetheless, the overlapping metabolic risk factors for type 2 diabetes and cardiovascular disease (e.g. Las historias clínicas de los pacientes sospechosos de RAMs fueron recogidas y evaluadas por un Consultante de Medicina de Emergencia del DAE con el fin de confirmar que se trataba en efecto de un caso de RAM y verificar el medicamento de sospecha. Figure 1.Risk Factors for NODATSimilar to type 2 diabetes in the general population, both genetic and environmental factors have been suggested to play a role in the development of NODAT. The cumulative incidence of NODAT within three years post-transplant were 12.3% in steroid-free vs. There is strong evidence suggesting that individuals with a family history of diabetes among first-degree relatives have an increased risk of developing NODAT with one study reporting a seven fold increase in the condition (Davidson et al., 2003).
ProteinuriaEarly report from single-center study suggested an association between proteinuria on day 5 after transplantation and the development of NODAT (Kuypers et al., 2008).
A randomized, placebo-controlled, double-blind, prospective trial to evaluate the safety and efficacy of vildagliptin in patients with NODAT is currently underway (Haidinger et al., 2010).
The current WHO and American Diabetes Association (ADA) guidelines for the diagnosis of prediabetic states (IFG and IGT) and diabetes mellitus are provided in Table 1 (modified from Davidson et al., 2003).
The increased prevalence of NODAT associated with a family history of diabetes has been documented across all types of solid organ transplantation.


Overall, steroid-containing regimens at the time of hospital discharge were associated with a 42% increased risk for NODAT. However, these findings have been challenged because proteinuria on day 5 may just reflect the highly concentrated urine associated with hyperglycemia-induced osmotic diuresis from the early posttransplant use of high dose corticosteroid or residual native kidney proteinuria. Caution should be exercised when these agents are used in the transplant setting, particularly with regards to drug to drug interactions. Notably, patients from programs that frequently adopted steroid-free regimens had reduced odds of NODAT compared with those from programs that commonly used steroid-contatining regimens.
Furthermore, it has been shown that immediate posttransplant proteinuria generally resolves several weeks after transplantation (Myslak et al., 2006). Vildagliptin should be avoided in patients with hepatic impairment and stage IV-V chronic kidney disease and the dose of sitagliptin should be adjusted for renal insufficiency. Other non-modifiable risk factors include recipient male gender, the presence of certain HLA antigens such as HLA A 30, B27, B42, increasing HLA mismatches, DR mismatch, deceased donor kidneys, male donor, and acute rejection history (Depczynski et al., 2000). The dose dependent diabetogenic effect of corticosteroid was also observed in recipients of nonrenal organ transplants. Nonetheless, in a subsequent single-center retrospective study designed to evaluate the impact of early proteinuria (3 and 6 months after transplantation) and urinary albumin excretion (UAE) on NODAT, Roland et al. Adult polycystic kidney disease (ADPKD) has been suggested to confer an increased risk of developing NODAT in some studies but not in others (P.T. Se concluye que la hipoglicemia inducida por medicamento es la RAM mayor que se presenta al DAE del Hospital Universitario de West Indies. SummaryNODAT is a common complication after solid organ transplantation and has variably been reported to have an adverse impact on patient and allograft outcomes. Se trata de una RAM prevenible, y por ende las investigaciones ulteriores deben evaluar los posibles factores responsables de estas ocurrencias. NODAT-free survival was greater in patients with normoalbuminuria than in those with microalbuminuria, and greater in those with microalbuminuria than in those with macroalbuminuria (p=0.0326). Risk stratification and intervention to minimize risk should be an integral part in the management of the transplant recipients. The authors also demonstrated that pulse pressure was an independent risk factor for NODAT, suggesting that early low-grade proteinuria and pulse pressure may be markers of the metabolic syndrome or vascular damage or both. Clinicians must be familiar with the patients’ immune history prior to manipulating their immunosuppressive therapy.in an attempt to ameliorate NODAT risk. When lifestyle modification fails to achieve adequate glycemic control, medical intervention is often necessary. An adverse drug reaction (ADR), as defined by the World Health Organization (1), is the response to a drug which is noxious and unintended and which occurs at doses normally used for the prophylaxis, diagnosis or therapy of a disease or for the modification of physiological functions. HypomagnesemiaIn the general population, not only has hypomagnesemia been shown to be associated with type 2 diabetes, but numerous studies have also reported an inverse relationship between glycemic control and serum Mg levels (P.C.
The routine care of patients with NODAT should include an evaluation of hemoglobin A1C level every three months and regular screening for diabetic complications.
It should be noted that hemoglobin A1C cannot be accurately interpreted within the first three months post transplantation due to various factors including possible blood transfusions in the early posttransplant period and the presence of anemia or impaired allograft function. Similar to the nontransplant settings, hypomagenesemia has also been shown to be an independent predictor of NODAT in recipients of renal and liver transplants. Blood transfusions may render the test invalid until new hemoglobin is formed and the presence of anemia and kidney impairment can directly interfere with the A1C assay.
They are a frequent cause of mortality and morbidity of patients worldwide (2-4), accounting for 2-7% of hospital admissions and being the fourth to sixth leading cause of death (2, 5). In a single-center retrospective analysis consisting of 254 renal transplant recipients Van Laecke et al.
An artifactual reduction in A1C level has been reported in islet cell transplant recipients taking dapsone for pneumocystis carinii (P. Additionally, worldwide trends suggest that the majority are related to the pharmacological action of the drug (TypeA) and preventable, rather than being associated with some action not explained by the pharmacology of the drug (Type B) such as an allergic response and irritation of organs. Therefore, monitoring of ADRs is vital to the assessment of risk versus benefits of drugs, especially since pre-market clinical trials have limited assessment of drugs used in children, the elderly, as well as the impact of long term use, comorbidities and drug interactions. While the association between the use of CNIs was strongly related to hypomagnesemia, NODAT disappeared after adjustment for Mg levels suggesting that the diabetogenic effect of CNIs is at least in part related to hypomagnesemia. While some assessment has been made of the cases of drug-related angio-edema presenting to the University Hospital of the West Indies in Jamaica (6), there is little available data on other types of ADRs. Furthermore, a lower proportion of CsA-ME patients with NODAT required hypoglycemic medication or dual therapy with insulin and oral hypoglycemic agents compared with their tacrolimus-treated counterparts. Conversely, the use of mTOR inhibitors appeared to be a risk factor for NODAT after adjustment for Mg levels. In transplant recipients with multiple CVD risk factors, more frequent monitoring of lipid profile should be performed at the discretion of the clinicians. The present study aimed to examine the prevalence and trends of ADRs presenting to the Accident and Emergency department of the University Hospital of the West Indies.
The greater diabetogenic effect of tacrolimus compared to CSA has been reported to occur across renal and nonrenal transplant groups. The same group of authors subsequently demonstrated that both pretransplant hypomagenesemia and hypomagnesemia in the first-month posttransplantation were independent predictors of NODAT in recipients of liver transplants (Van Laecke et al., 2010).
Statins or the HMG-CoA reductase inhibitors are the most widely used lipid lowering agents in both the nontransplant and transplant settings. In a meta-analysis to evaluate the reported incidence of NODAT after solid organ transplantation, Heisel and colleagues found a higher incidence of insulin-dependent diabetes mellitus (IDDM) in Tac- vs. It was a prospective, observational study conducted on patients seen at the Accident and Emergency department (A&E) of the University Hospital of the West Indies from October 2007 to February 2008 for 19 weeks. Whether Mg supplementation and correction of Mg deficiency reduce the incidence of insulin resistance or NODAT remains to be studied.
An assessment of whether the ADR was type A, that is, associated with the pharmacological action of the drug or type B, that is, not related to pharmacological action (eg allergic) (7) was also done. Impaired glucose tolerance before transplantationAbnormal glucose metabolism has been reported to be a risk factor for the development of NODAT in some but not all studies. Information taken from patient medical records included details of drugs implicated (daily dose and route), length of ADR event, description of the ADR, abnormal laboratory test results, age and gender. Nonetheless, not all studies showed that Tac is more diabetogenic than cyclosporine (Meiser et al., 1998).
Other relevant history, such as coadministered drugs and other pre-existing medical conditions were also collected. The frequency and distribution of the most common ADRs and drugs associated with ADRs were analyzed. ADRs were classified using the scale of "certain, probable, possible, unlikely, unclassified and unclassifiable" as standardized by the World Health Organization (8).
In a single-center study consisting of 45 OLT recipients treated with either CSA (n=9) or high- (n=15) vs. Among patients with IFG pretransplant, 70% had hyperglycemia at one year (IFG 43% and NODAT 27%).
There was a greater representation of females (29, 60% of the total ADRs) than males (19, 40% of ADRs, odds ratio = 1.5).
Interaction between tacrolimus and concomitant hepatitis C infection (HCV)In a retrospective study of more than 400 kidney transplant recipients with no known pre-transplant diabetes, Bloom and colleagues have shown that among the HCV(+) cohort, NODAT occurred more often in the Tac- compared with the CSA-treated groups (57.8% vs. HCV-associated NODATThe association between HCV infection and impaired fasting glucose or the development of overt type 2 diabetes mellitus in the general population has long been suggested.
In contrast, among the HCV (-) cohort, the rates of NODAT were similar between the two calcineurin inhibitor (CNI) groups (Tac vs.
Potential mechanisms of the diabetogenic effect of HCV infection include insulin resistance, decreased hepatic glucose uptake and glycogenesis, and direct cytopathic effect of the virus on pancreatic ? cells (Bloom & Lake, 2006). Similar to the non-transplant settings, the link between hepatitis C and the development of NODAT has also been recognized in solid organ transplant recipients. Twenty-five of the cases were classified as probable, 19 as possible and 4 were unclassifiable (Table 2).
Whether concomitant exposure to tacrolimus and HCV plays a synergistic role in the development of NODAT remains speculative. Clinical studies in recipients of orthotopic liver transplant (OLT) recipients have implicated insulin resistance associated with active HCV infection as a predominant pathogenic mechanism.
Twelve ADRs (25%) were type B reactions, involving 2 cases of gastrointestinal irritation, 10 cases of allergic responses, most being skin related allergies and one anaphylaxis, resulting in death. Effects of sirolimus on glucose metabolismEarly large randomized clinical trials suggested that sirolimus is devoid of diabetogenic effects either used alone or in combination therapy with CNI. It was suggested that the virus had a direct effect on insulin resistance as no difference in ? cell function or hepatic insulin extraction between the HCV (+) and (-) groups was observed. The hypoglycaemia was mainly associated with insulin only therapy (12 cases), followed by oral hypoglycaemic drugs (OHA, 12 cases) and 4 related to insulin plus OHA combination. The presenting complaints of all diabetic patients were the result of the induced hypoglycaemic state and records of 13 patients documented them as being compliant with their drug regimen (2 reported non-compliance, 7 had no notes on compliance). In one single-center study, tacrolimus and sirolimus combination therapy was found to be associated with a higher incidence of NODAT than tacrolimus alone immunosuppression (Sulanc et al., 2005).
The doses of the drugs involved in each case were determined to be in the therapeutic dose range.
Subsequent large registry study also demonstrated an association between sirolimus and the development of NODAT.
Cytomegalovirus-associated NODATThe link between cytomegalovirus (CMV) infection and the development of NODAT was first reported in 1985 in a renal transplant recipient (Lehr et al., 1985). The majority of diabetic patients also had other complications ranging from cardiovascular diseases (with and without renal failure 16) to myasthenia gravis (1) and parkinsonism (1) but specific details related to these co-morbidities, including information on drug therapy were not completely documented in patients' case notes (Table 3). In an analysis of the USRDS database consisting of more than 20,000 primary kidney transplant recipients receiving sirolimus (Sir) or CNI (CsA or Tac) or both in various combination therapy with an antimetabolite (MMF or AZA), Johnston et al.
Limited studies suggested that both asymptomatic CMV infection and CMV disease are independent risk factors for the development of NODAT.
Patients with active CMV infection had a significantly lower median insulin release compared to their CMV negative counterparts, suggesting that impaired pancreatic ? cell insulin release may be involved in the pathogenic mechanism of CMV-associated NODAT. Drugs with action on the central nervous poor compliance was determined for one and compliance information was missing for 2 cases.
It is speculated that CMV-induced release of proinflammatory cytokines may lead to apoptosis and functional disturbances of pancreatic ?-cells (Hjelmasaeth et al., 2005). Anti-CD25 monoclonal antibodies In a single-center study consisting of 74 stable kidney transplant recipients with 3 month-follow-up, Bayes et al.


The report showed that 6 out of every 1000 patients presenting to A&E were likely to be experiencing complications to normal drug therapeutic doses. Kidney transplantsClinical studies evaluating the impact of NODAT on patient and allograft outcomes after solid organ transplantation have yielded variable results. The development of NODAT has also been shown to be associated with an adverse impact on patient survival and an increased risk of graft rejection and graft loss, as well as an increased incidence of infectious complications (Ojo, 2006). Of the 20 patients comprising these other groups, good compliance with therapy was confirmed for 16 cases, that is consistent with advance age being an established risk factor for the occurrence of ADRs (9-11). Calcineurin inhibitorsImpaired insulin secretion has been suggested to contribute to the development of CNI-associated NODAT (Crutchlow & Bloom, 2007).
The study consisted of >37,000 renal transplant recipients with a functioning transplant for at least 1 year.
None of the patients' casefiles indicated use of herbal preparations which is known to be a highly prevalent practice in Jamaican culture and patients do not willingly discuss this practice with their physicians (12-13).
Risk stratification according to diabetes status (pre-transplant diabetes, NODAT) and acute rejection (AR) at 1 year demonstrated that pre-transplant diabetes is the major predictor of all-cause and cardiovascular mortality whereas acute rejection during the first year is the major predictor of death-censored transplant failure. Herbal preparations are also associated with ADRs (14) and therefore use with prescribed medications could change classification from "probable" to "possible". In recipients of pancreas transplants, both calcineurin inhibitors CSA and Tac have been shown to cause reversible toxicity to islet cells.
In contrast, NODAT alone was not associated significantly with any study outcomes (Kuo et al., 2010). This therefore limits confidence in causality assessment, as patients may not have provided this information. In a study of 26 pancreas allograft biopsies from 20 simultaneous kidney-pancreas transplant recipients, a significant correlation was seen between the presence of islet cell damage and serum levels of Tac and CSA, as well as with the Tac peak level (Drachenberg et al., 1999).
Nonetheless, the study results were regarded as inconclusive due to the wide confidence intervals and the relatively short duration of follow-up. Cytoplasmic swelling and vacuolization, and marked decrease or absence of dense-core secretory granules in ?-cells were demonstrated on electron microscopy.
It is noteworthy that in a large registry study consisting of more than 27,000 primary kidney transplant recipients with graft survival of at least 1 year and with longer-term follow-up, Cole et al.
In Italy and Spain, drug induced hypoglycaemia is ranked as the fourth leading cause of ADRs presenting to emergency rooms, accounting for less than 10% of the cases (15-16). Serial biopsies from two patients with hyperglycemia and evidence of islet cell damage receiving Tac immunosuppression demonstrated reversibility of the damage upon discontinuation of tacrolimus. This difference in proportions could be due to differences in patient admission procedures between hospitals.
Sirolimus (mTOR inhibitors)Suggested pathogenic mechanisms of sirolimus-induced hyperglycemia include sirolimus-associated impaired insulin-mediated suppression of hepatic glucose production, ectopic triglyceride deposition leading to insulin resistance, and direct ? cell toxicity (Crutchlow & Bloom, 2007).
However, studies on the effects of sirolimus on insulin action and secretion have yielded variable and conflicting results. Currently existing literature suggests that the effects of sirolimus on glucose metabolism appear to be cell-species- and dose-dependent (Subramanian & Trence, 2007). This is consistent with other studies out of the United States of America and Hong Kong, showing a higher risk of hypoglycaemia in insulin users (17-20). Drug induced hypoglycaemia is characterized as a type A adverse drug reaction and therefore is preventable. Anti-CD25 monoclonal antibodiesThe pathogenic mechanisms of anti-CD25-induced NODAT have not been established. It is well established that along with advancing age, co-morbidities and multi-drug use increase the risk of hypoglycaemia. However, suppression of regulatory T-cells has been suggested to play a contributory role (Aasebo et al., 2010).
However, there was no difference in patient survival between the two groups at 1-, 2- and 5-years follow-up.
For example, concomitant administration of non-selective beta blockers or angiotensin converting enzyme inhibitors can increase the risk of hypoglycaemia in patients with diabetes mellitus and coadministration of anti-diabetic drugs may require dose adjustments (21). Studies in diabetes-prone mice have shown that anti-IL2-antibody treatment trigger insulinitis and early onset diabetes through inhibition of Foxp3-expressing CD25+ CD4+ regulatory T-cells (Setoguchi et al., 2005).
Therefore, assessment of preventability becomes important in order to determine what adjustments could be made to obviate re-occurrence. Suggested pathogenic mechanisms of immunosuppressive drug-induced NODAT are summarized in table 2. It also requires evaluating whether there is need for therapeutic dose monitoring, information of previous problems with drug exposure and possible involvement of medication error. Some of these factors, such as blood concentration of drugs, patient history of previous ADRs and severity of co-morbid states could not be determined from patient case-notes and therefore no assessment was made of the preventability of the ADRs.
Pre-transplant baseline evaluationSuggested guidelines for pre-transplant baseline evaluation of potential transplant candidates is shown in Figure 2. There may be a need to design specific protocols for the collection and management of ADRs. Patients with evidence of IGT or abnormal OGTT before transplantation should be counseled on lifestyle modifications including weight control, diet, and exercise. The A&E department should be most concerned about the implications of the number of cases of drug induced hypoglycaemia. The goals for the life-style modification involved achieving and maintaining a weight reduction of at least 7 percent of initial body weight through a healthy low-calorie, low-fat diet and at least 150 minutes of physical activity per week. Consideration should be given to the design of specific protocols to accommodate adequate data collection that will facilitate causality assessment and reduce the risk of occurrences. Selection of an immunosuppressive regimen should be tailored to each individual patient, weighing the risk of developing diabetes after transplantation against the risk of acute rejection.
Early detection of NODAT after transplantation Studies investigating the best predictive tool for identifying patients at risk for developing NODAT early after transplantation are currently lacking.
While fasting plasma glucose (FPG) is readily available in clinical practice it may be normal in kidney transplant recipients with abnormal glucose homeostasis.
It has been suggested that transplant patients have an atypical form of insulin resistance and their plasma glucose often peeks before lunch. However, it is noteworthy that while acute rejection has been suggested to increase the risk for NODAT, it usually does not occur before day 5. Obtaining OGTT and FPG at day 5, therefore, may preclude the subset of patients with higher risk of developing NODAT. Hence, it has been suggested that performing OGTT at 10-12 weeks post-transplantation might be useful as an alternative or supplementary test to day 5 OGTT (P.T. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies.
The routine recommendation of performing an OGTT early after transplantation awaits further studies. Suggested pre-transplant baseline evaluation and post-transplant screening for NODAT is shown in Figure 2. Management of established NODATThe management of NODAT should follow the conventional approach for patients with type 2 diabetes mellitus as recommended by many clinical guidelines established by well-recognized organizations including the American Diabetes Association (ADA).
Nonetheless, it should be noted that the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial was discontinued prematurely because of a satistically significant increase in all-cause mortality in the intensive- compared with the standard- glycemic treatment groups (Gerstein et al., 2008).
Trends in hospital admissions for adverse drug reactions in England: analysis of national hospital episode statistics 1998-2005. Study similar to that of the ACCORD study in recipients of solid organ transplantation is lacking. Nonetheless, the determination of hemoglobin A1C target levels for solid organ transplant recipients should be individualized based on hypoglycemia risks.
Dietary modification and physical activityThe Diabetes Prevention Program has demonstrated that a structured diet and physical activity program that achieves and maintains modest weight loss for overweight adults with IGT can significantly reduce the development of diabetes.
Defining realistic goals such as a target weight loss of 5-10% of total body weight and patient- centered approach to education may be invaluable in achieving success. Modification of immunosuppressionModification of immunosuppression should be considered in high-risk patients. Corticosteroid dose reduction has been shown to significantly improve glucose tolerance during the first year after transplantation (Kasiske et al., 2003). Steroid-sparing regimen or steroid avoidance protocol should be tailored to each individual patient.
Tac to CSA conversion therapy in patients who fail to achieve target glycemic control or in those with difficult to control diabetes has yielded variable results.
Belatacept -- a selective T cell costimulation blocker, is a promising new immunosuppressant that has been suggested to have better cardiovascular and metabolic risk profiles compared with cyclosporine (lower blood pressure, better lipid profiles and lower NODAT incidence) (Vanrenterghem et al., 2011).
Adverse drug reactions causing hospitalization can be monitored from computerized medical records and thereby indicate the quality of drug utilization.
The practice of polypharmacy involving herbal and prescription medicines in the treatment of diabetes mellitus, hypertension, and gastrointestinal disorders, in Jamaica. Clinical evidence of herb-drug interactions: a systematic review by the natural standard research collaboration. Adverse drug reactions as cause of visit to the emergency department: incidence, features and outcomes.
Hospitalization and discharge education of emergency department patients with hypoglycemia. Incidence and risk factors for serious hypoglycemia in older persons using insulin or sulfonylureas.
Estimates on the incidence of antidiabetic drug-induced severe hypoglycaemia in Hong Kong. Frequency of severe hypoglycemia requiring emergency treatment in type 1 and type 2 diabetes: a population-based study of health service resource use. Hypoglycaemia in elderly patients with diabetes mellitus: causes and strategies for prevention. Identifying clinically significant preventable adverse drug events through a hospital's database of adverse drug reaction reports.



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