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From the ACP Diabetes Care Guide
This tool lists what to consider before providing patients with these medications.
From the ACP Diabetes Care Guide
Patients with diabetes have accelerated atherosclerosis and an increased incidence of premature cardiovascular events. Epidemiologic studies and major clinical trials have shown that cardiovascular risk factors-including hypercholesterolemia, hypertension, and cigarette smoking-have an increased impact on the incidence and progression of cardiovascular events. These risk factors often coexist as key components of the metabolic syndrome. In particular, patients with type 2 diabetes have an increased prevalence of lipid abnormalities (>80%, based on current goals) and hypertension (>60%). Moreover, patients with type 1 diabetes that is accompanied by renal disease and those with type 2 diabetes that is poorly controlled have additional lipid abnormalities, including high triglyceride levels and low HDL cholesterol levels.
Because of the markedly increased risk of cardiovascular disease in patients with diabetes and the established evidence for improved outcome with optimal management, various clinical practice guidelines (of the American College of Physicians [ACP], the American Diabetes Association [ADA], the American Heart Association [AHA], and others), advocate stricter goals for such patients than for those without diabetes. According to available recent national statistics, however, the control of glycemia, blood pressure, and LDL cholesterol is not being achieved in most patients with diabetes.
NOTE: You may order free copies of the complete ACP Diabetes Care Guide (book and CD-ROM).
From the ACP Diabetes Care Guide
Persons with diabetes are at increased risk for macrovascular disease; microvascular disease, including retinopathy and nephropathy; peripheral and autonomic neuropathies; and lower extremity disease.
- Diabetic retinopathy is the leading cause of noncongenital blindness among adults.
- Diabetes is the most common cause of endstage kidney disease in the United States, especially among Native American, Hispanic, and African American persons. One quarter to one third of patients with type 1 or type 2 diabetes develop some degree of nephropathy.
- Diabetes doubles the risk for cardiovascular disease in men and triples it in women (data from the Multiple Risk Factor Intervention Trial [MRFIT]).
- Patients with diabetes are several-fold more likely to have peripheral arterial disease than patients without diabetes.
- Peripheral arterial disease and foot ulcers in patients with diabetes account for two thirds of all nontraumatic amputations performed in the United States.
Screening for and prevention of these complications are fundamental to the care of patients with diabetes and are important components of quality of care initiatives for diabetes.
NOTE: You may order free copies of the complete ACP Diabetes Care Guide (book and CD-ROM).
ACP Summer Session was a two-day event that covered key topics and management strategies in the areas of cardiology, diabetes, pulmonary diseases, and neurological diseases. ACP Summer Session was held in Orlando, Florida on August 7-8, 2009 and in San Francisco, California on August 14-15, 2009. The following audio recordings with synchronized slides and course handouts are from the Orlando meeting and are available free to ACP members.
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ACP Summer Session was a two-day CME event that covered key topics and management strategies in the areas of cardiology, diabetes, pulmonary diseases, and neurological diseases. ACP Summer Session was held in Orlando, Florida on August 7-8, 2009 and in San Francisco, California on August 14-15, 2009. The following audio recordings with synchronized slides and course handouts are from the Orlando meeting and are available free to ACP members.
Login required (use ACP Online username/password)
- What level of creatinine elevation is "significant" as a cardiovascular risk factor?
- Should coronary artery disease and "traditional" cardiovascular risk factors be treated differently in patients with CKD compared with those without?
- Erythropoietin: Leave management to others?
- Does hypokalemia reduce cardiovascular benefit of hypertension care?
- What else do I do besides treating the blood pressure?
Diabetes imparts a 2- to 4-fold increased risk of major cardiovascular events. The presence of diabetes is now considered a cardiovascular risk equivalent, based on data indicating that patients with diabetes but no history of coronary artery disease are at a similar risk of myocardial infarction as a nondiabetic individual who has survived a previous infarction.
Because of this disproportionate suffering from cardiovascular disease, aggressive risk factor reduction strategies are imperative.
Note: Subscription to MKSAP 14 is required to view this material. For more information, visit www.acponline.org.
A new large study found that rosiglitazone was associated with a significantly higher risk of heart failure and death than pioglitazone in type 2 diabetics, leading researchers to question its ongoing use.
In the retrospective cohort study, researchers studied records of almost 40,000 outpatients age 66 years or older taking pioglitazone or rosiglitazone and followed them for six years. At follow-up, 5.3% of patients taking pioglitazone suffered death or hospital admission for either acute myocardial infarction (MI) or heart failure, compared with 6.9% of patients taking rosiglitazone. Secondary analyses, after adjustment for demographic and clinical factors and drug doses, revealed a lower risk of death and heart failure with pioglitazone but no significant difference in risk of acute MI. The results appear in the Aug. 18 BMJ.
Rosiglitazone and pioglitazone have been associated with cardiovascular risks in previous studies but it was unclear whether it was a class effect of thiazolidinediones, the authors noted. This study provides evidence that pioglitazone is associated with a lower risk of adverse cardiovascular events and death than rosiglitazone in comparable patients.
While the reasons for the difference are unclear, the authors continued, pioglitazone has more favorable effects on serum lipids than rosiglitazone and may have anti-inflammatory and anti-atherogenic effects. Rosiglitazone can promote excessive salt and water retention, which may underlie the increased risk of death in patients taking it, they added.
The authors acknowledged that their study was limited by the possibility that patients taking rosiglitazone had a higher baseline risk of heart failure and death than those prescribed pioglitazone. However, the two groups were highly similar and baseline risk would not likely explain why rosiglitazone was associated with a higher risk of death and heart failure but not of acute MI. Given the evidence against rosiglitazone and the lack of clinical advantage over pioglitazone, the authors suggested that physicians reevaluate the appropriateness of any patients starting or continuing treatment with rosiglitazone.
There is no difference in death or major cardiovascular event rates for diabetic patients who undergo medical therapy compared with prompt revascularization, or between those who undergo insulin sensitization vs. insulin provision, a new study found.
The study results indicate that, for many patients with heart disease and diabetes--especially those with less severe disease--optimal medical therapy is a good first-line strategy, an editorial accompanying the study said. When revascularization is indicated, however, the study supports previous research suggesting that CABG may be preferred over PCI, the editorial said.
A new study found that rosiglitazone doubled the risk of heart failure among type 2 diabetes patients but did not raise overall cardiovascular hospitalizations or deaths compared with standard therapy.
The manufacturer-sponsored Rosiglitozone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes, or RECORD, trial's results conflict with the findings of a 2007 study showing that rosiglitazone significantly increased the risk of myocardial infarction. The RECORD trial confirmed, however, earlier findings that rosaglitazone doubles the risk of distal fracture in older women. The study results were presented at the American Diabetes Association's annual scientific sessions and published online by the Lancet.
The authors concluded that the data are inconclusive about rosiglitazone's effects on myocardial infarction and that the drug does not increase the risk of overall cardiovascular morbidity or mortality compared with standard glucose lowering drugs. In an interview with Modern Medicine, a study author noted that rosiglitazone should not be used by patients who have heart failure or who are at increased risk of fracture but could be considered in other type 2 diabetics, particularly obese patients.
A large study of elderly patients hospitalized with heart failure found no significant association between elevated glucose levels at admission and mortality, whether or not patients had diabetes.
In the study, published in the April 14 Circulation, researchers evaluated more than 50,000 elderly patients hospitalized with heart failure between 1998-2001 and analyzed the association between admission glucose and all-cause mortality using multivariable Cox regression models. They found no significant relationship between glucose and 30-day or one-year mortality, even though the hyperglycemic heart failure patients had more severe heart failure on admission. Results did not differ between patients with or without diabetes.
The results demonstrate that the strong association between glucose and increased mortality risk seen in patients with acute myocardial infarction may not extend to patients with heart failure, the authors noted. They stressed that more disease-specific study on the relationship between glucose and patient outcomes may be needed before hospitals devote substantial resources to glycemic management strategies for all patients.
Screening for coronary artery disease does not improve outcomes in asymptomatic patients with type 2 diabetes, according to a new study.
The trial included 1,123 diabetic patients who were randomized to screening with adenosine-stress radionuclide myocardial perfusion imaging (MPI) or no screening. Follow-up ran from August 2000 to September 2007, with an average of 4.8 years. No significant differences were found in outcomes between the two groups: seven nonfatal myocardial infarctions (MI) and eight cardiac deaths occurred in the screened group, compared with 10 MIs and seven deaths in the unscreened group.
The study found that the discovery of significant MPI abnormalities in screening was associated with cardiac events, but the positive predictive value was low (12% for moderate or large defects). Overall, the cumulative cardiac event rate for the whole study population was only 2.9%. The research was published in the April 15 Journal of the American Medical Association.
Atrial fibrillation (AF) dramatically increases diabetic patients' risk of death, but that increase can be mitigated with blood-pressure medication, new data from the ADVANCE trial revealed.
The ADVANCE study included 11,140 patients with type 2 diabetes who were randomized to receive either a fixed combination of perindopril and indapamide or placebo. Measured outcomes included total mortality and cardiovascular disease outcomes over a four-year follow-up. Overall, patients with AF had a 61% increased risk of dying from any cause, 77% higher risk of death from cardiovascular causes, and a 68% higher risk of heart failure or other cerebrovascular problems.
Treatment with the blood-pressure medications reduced the risk of cardiovascular death by 18% and the all-cause risk of death by 14%. The reductions were similar in patients both with and without AF, but because the patients with AF had a higher baseline risk, a greater number were helped by the drugs, a press release explained. The researchers estimated that five years of active treatment would prevent one death for every 42 diabetic patients with AF and one for every 120 diabetics without.
The study authors noted that while rate and rhythm control is the usual therapeutic focus in patients with AF, this study indicates the importance of treating overall cardiovascular risk factors, such as blood pressure. Diabetic patients should be actively evaluated for the presence of AF, an author said. The study was published by the European Heart Journal on March 11.
Prescribing an ACE inhibitor together with a diuretic can reduce the risk of kidney disease in type 2 diabetics, even if they don't have high blood pressure, according to a new analysis from the ADVANCE study.
In the study of 11,140 diabetics, patients were randomly assigned to take either perindopril and indapamide or a placebo. Most of the patients were hypertensive, but 20% had normal blood pressure (under 130/80 mm Hg). At the follow-up of about four years, patients on the drugs had a 21% lower risk of renal events than controls. The active treatment group also had reduced risks of developing microalbuminuria and macroalbuminuria.
The findings held true even for patients who did not meet the criteria for high blood pressure. The lower the blood pressure level, the lower the risk of kidney disease found; the study could not identify a threshold below which the benefit was lost. Study authors called for more research on the topic, but also suggested that the new evidence may justify lowering the threshold at which type 2 diabetics are considered for antihypertensive treatment.
One limitation of the study was that it was not large enough to assess the impact of the drugs on kidney failure, a study author noted in a press release. It was also not possible to determine the impact of the specific drug combination used or to prove whether the renal effects were due entirely to the reduction in blood pressure. The study was published online by the Journal of the American Society of Nephrology
Two meta-analyses released last week add to the growing array of data on the cardiovascular effects of diabetes drugs rosiglitazone and pioglitazone.
The meta-analysis of rosiglitazone included four studies of 14,000 people and concluded that use of the drug for at least 12 months was associated with a significantly increased risk of myocardial infarction (MI) and heart failure, but the study did not find a significantly increased risk of cardiovascular mortality compared with controls.
The second meta-analysis used a database of 19 trials involving 16,000 patients provided by the manufacturer for independent analysis. Researchers found that pioglitazone was associated with a significantly lower risk of death, MI or stroke than controls. The drug did increase serious heart failure, although without an associated increase in mortality.
Authors of both analyses noted that it is unclear why the drugs--both thiazolidinediones--have such different effects on cardiovascular outcomes. The authors of the pioglitazone research concluded that the net clinical benefit of therapy with the drug is favorable. In their view, the reduction in irreversible ischemic events is not attenuated by the risk of more frequent heart failure complications.
The authors of the rosiglitazone analysis said that their research suggests a reversal of the benefit-to-harm balance that led the FDA to approve the drug. They propose that regulatory agencies reevaluate whether the drug belongs on the market. Physicians should not wait for a government decision, the authors advised, and should avoid prescribing the drug for patients who are at risk of cardiovascular events. Both meta-analyses were published in the Sept. 12 Journal of the American Medical Association.
Thiazolidinediones, primarily rosiglitazone (Avandia), increase the risk of congestive heart failure, acute myocardial infarction and death for older patients with diabetes, a new study found.
The retrospective cohort study used health care databases in Ontario to examine 159,026 diabetes patients age 66 years and older who had been treated with at least one hypoglycemic agent between 2002 and 2005. Follow up was for a median of 3.8 years. The study was published in the Dec. 12 Journal of the American Medical Association.
Patients treated with thiazolidinedione monotherapy had a 60% higher risk of congestive heart failure, a 40% higher risk of acute myocardial infarction and a 29% higher risk of death compared with people taking other hypoglycemic agent combination therapies. Patients treated with thiazolidinedione combination therapy had a 31% higher risk of congestive heart failure, and a 24% higher risk of death, but no higher risk of heart attack, compared with those taking other therapies. The association between thiazolidinedione treatment and cardiac events appears limited to rosiglitazone, the authors said.
Past research has indicated that rosiglitazone and pioglitazone may increase the risk of congestive heart failure, while two meta-analyses have suggested rosiglitazone may increase the risk of acute myocardial infarction. The FDA recently added boxed warnings to the drugs' labels to reflect these risks, but has stopped short of recommending that the drugs be pulled from the market.
"These findings provide evidence from a real-world setting and support data from clinical trials that the harms of thiazolidinediones may outweigh their benefits," though further studies are needed, the authors said. For now, clinicians need to weigh the potential benefits and harms of treatment on an individual basis, especially with high-risk elderly populations, they said.
A large government trial of diabetes treatments was halted last week after it was found that intensive efforts to lower patients? blood sugar were associated with higher mortality rates.
The ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial included more than 10,000 patients who had diabetes and at least two other risk factors for heart disease. The patients were randomized to either intensively low blood sugar goals (A1c of less than 6%) or standard goals and treatment (A1c between 7% and 7.9%). Over the almost four-year study period, 257 patients in the intensive group had died, compared with 203 patients in the standard group, NIH officials announced last week. Based on that survival difference (which works out to 3 deaths per 1,000 participants per year), officials decided to halt the intensive treatment arm of the trial.
The researchers have not uncovered an explanation for the difference in survival, although an investigation is ongoing. Overall, death rates in both groups were lower than in similar populations in other studies. Because of recent concerns, the researchers specifically looked at rosiglitazone for a link to the increased deaths, but they found no association. The standard treatment arm of the ACCORD study, as well as related trials of blood pressure and lipid treatment, will continue until the planned conclusion date of June 2009.
SAN FRANCISCO - Diabetes and testosterone studies topped the news at ENDO 08, the Endocrine Society's 90th annual meeting held last week. Among the research of interest to internists:
- Women with type 2 diabetes and heart disease get less intensive medical treatment for, and have poorer control of, these two conditions than men. In a study of nearly 45,000 diabetics, the comorbid women were 44% more likely than the comorbid men to have high LDL, but 15% less likely to get lipid-lowering medication. The women were also 19% more likely to have uncontrolled hypertension, and 15% more likely to have poor long-term control of their blood glucose levels. The findings may explain why death from heart disease has decreased among diabetic men in the past 25 years, but hasn't decreased for diabetic women, the study's lead author said.
- For obese and overweight men with type 2 diabetes, moderate fitness levels lowered the risk of all-cause death by 40%-50% during an average follow-up of seven years. By measuring peak metabolic rate during a standard treadmill exercise tolerance test, researchers classified fitness levels as low, moderate or high. Moderate fitness reduced death risk by 40% in healthy-weight and overweight men, and 52% in obese men, while high fitness level reduced death risk by 60% in healthy-weight men, and 65% in overweight men. The results suggest all diabetics, regardless of weight, should achieve and maintain at least a moderate fitness level, a study co-author said.
A recent large study found that poor glucose control was associated with a fourfold increase in mortality and major complications following cardiac surgery, regardless of whether patients had been diagnosed with diabetes.
Tight glucose control improves the cardiovascular risk of patients with type 2 diabetes years after intensive therapy is discontinued, a new study found.
Researchers looked at follow-up data from the United Kingdom Prospective Diabetes Study, in which 4,209 newly diagnosed patients were randomly assigned either conventional diabetes therapy (dietary restriction) or intensive therapy (either sulfonylurea or insulin or, in overweight patients, metformin). After the trial was concluded, 3,277 of the patients were followed over the next 10 years. The results were published in the Sept. 10 online New England Journal of Medicine.
One year after the study, differences between the groups in glycated hemoglobin levels had disappeared. However, after 10 years, the sulfonylurea-insulin group still had a 9% risk reduction in all diabetes-related end points, 24% lower rates of microvascular disease, and 15% and 13% reductions in myocardial infarction and death from any cause, respectively. The metformin group had even more dramatic differences, with 21% lower diabetes-related end points, 33% lower MI, and 27% less death from any cause.
The results of this study, which included more than 66,000 person-years of follow-up, indicate that the "legacy effect" of intensive glucose lowering is longer than has been previously reported, the authors concluded. The findings highlight the importance of glucose lowering (in addition to lipid-lowering and antihypertensive therapy) in reducing the risk of coronary events and death for patients with type 2 diabetes, they said.
In patients with type 2 diabetes, tight blood-pressure control reduces complications in the short-term but the benefits disappear after the intensive treatment stops, according to a new study.
In the United Kingdom Prospective Diabetes Study, 1,148 newly diagnosed patients (who also had hypertension) were randomly assigned to four years of tight or less-tight control of blood pressure. After the study, 884 of the patients were followed, through questionnaires and/or clinic visits, for 10 more years. The results were published in the Sept. 10 online New England Journal of Medicine.
During the trial, the two groups had significant differences in blood pressure, several diabetes-related endpoints (including diabetes-related death), and stroke. However, the differences in blood pressure disappeared within two years of the trial's termination. There was a continuing risk reduction in peripheral vascular disease in the tight-control group, but otherwise, the researchers found no sustained benefit for patients who had tight control of blood pressure. The two groups had no significant differences in myocardial infarction, death, or any of the additional endpoints.
The authors concluded that optimal blood-pressure control is important to reducing diabetic patients' risk of micro- and macrovascular disease, but that the treatment must be maintained in order for patients to sustain the benefits over the long term.
A recent trial concluded that aspirin and antioxidants offer no primary benefit in reducing cardiovascular events in diabetics, but researchers noted that diabetic patients should get aspirin anyway for the secondary benefit of preventing heart disease.
Researchers conducted a multicenter, randomized, double blind, 2x2 factorial, placebo-controlled trial to find whether aspirin and antioxidant therapy, combined or alone, reduced the cardiovascular events in type 1 and 2 diabetics with asymptomatic peripheral arterial disease. The study was funded by a government grant.
Researchers noted that they found no evidence to support the use of either aspirin or antioxidants in the primary prevention of cardiovascular events and mortality in diabetics. However, they said that aspirin should still be given to diabetics for secondary prevention of cardiovascular disease.
In an updated consensus statement on the management of type 2 diabetes, experts offered new guidance about thiazolidinediones, including advising against the use of rosiglitizone due to cardiovascular risks.
The update of the 2006 statement by the American Diabetes Association and the European Association for the Study of Diabetes notes that several analyses have suggested a 30%-40% increased risk for myocardial infarction with rosiglitazone, whereas pioglitazone has been shown to have no significant effects on cardiovascular disease. Given that there are other options, the committee recommended against using rosiglitazone but recommended use of pioglitazone or glucagons-like peptide-1 agonists (exenatide) in cases where hypoglycemia is particularly undesirable, such as in patients with hazardous jobs.
The groups continued to recommend a tiered approach to diabetes management:
- lifestyle interventions and metformin at diagnosis with a glycemic goal of less than 7% A1C;
- basal insulin or sulfonylurea if the target is not reached;
- Initiation of insulin if none of the above therapies work.
Use of newer, more expensive medications is increasing the average cost of treating diabetes, but metformin appears to be the most effective means of reducing cardiovascular complications, according to two new studies.
In the first study, researchers analyzed medications prescribed during all U.S. office visits for type 2 diabetes patients age 35 or older. In 1994, there were 25 million visits and the mean number of diabetes medications per treated patient was 1.14. In 2007, the number of visits had increased to 36 million and the meds to 1.63 per patient.
Over the same time period, insulin use declined from 38% of visits to 28%, and sulfonylurea use declined from 67% to 34%. In 2007, biguanides and glitazones were the leading therapeutic classes. Newer drugs were largely responsible for the increase in mean cost per prescription ($56 in 2001 to $76 in 2007) and aggregate drug expenditures ($6.7 billion in 2001 to $12.5 billion in 2007), researchers concluded. The study was published in the Oct. 27 Archives of Internal Medicine.
In a meta-analysis published in the same issue, data from 40 controlled trials tracked cardiovascular events in adults with type 2 diabetes. Metformin decreased the risk of cardiovascular mortality more than any other oral diabetes agent or placebo (odds ratio=0.74), and similar but not statistically significant trends were seen for cardiovascular morbidity and overall mortality. No other drug had a significant positive effect.
The Endocrine Society guideline focuses on the primary prevention of cardiovascular disease and type 2 diabetes in patients at metabolic risk. The presence of three or more risk factors, such as enlarged waist circumference, hypertension, and elevated plasma glucose levels, should alert a clinician to a patient at metabolic risk, the authors state. Among other recommendations, the guideline advises primary care physicians to incorporate regular screening procedures for metabolic risk factors into their practice and to have all patients at risk undergo a 10-year global risk assessment (i.e., calculate based on such factors as smoking, blood pressure, total cholesterol, diabetes) for cardiovascular disease to determine the targets for lipoprotein-lowering therapy. The guidelines appear in the November Journal of Clinical Endocrinology and Metabolism.
Questions
Conclusions
In patients with type 2 diabetes and coronary artery disease, adding prompt revascularization to medical therapy did not reduce mortality or major cardiovascular events; it did reduce major cardiovascular events in patients who were selected for bypass surgery for revascularization. Different types of insulin therapies had similar outcomes.
Question
In patients with type 2 diabetes, is rosiglitazone (RGZ) as add-on therapy to metformin (MFN) or sulfonylurea (SFU) noninferior to MFN plus SFU for cardiovascular (CV) outcomes?
Conclusion
In patients with type 2 diabetes, rosiglitazone added to metformin (MFN) or sulfonylurea (SFU) was noninferior to MFN plus SFU for overall cardiovascular safety but increased risk for heart failure and fractures.
Question
In adults without established cardiovascular disease (CVD) but with CVD risk factors, do statins reduce mortality?
Conclusion
In adults without established cardiovascular disease (CVD) but with CVD risk factors, statins reduce all-cause mortality and major coronary and cerebrovascular events.
Question
Does intensive glucose control reduce cardiovascular (CV) events and mortality in patients with type 2 diabetes mellitus?
Conclusion
In patients with type 2 diabetes mellitus, intensive glucose control reduced some cardiovascular events but did not change overall mortality.
Question
Do patients with diabetes and no history of myocardial infarction (MI) have similar risk for coronary artery disease (CAD) events as patients with previous MI and no diabetes?
Conclusion
Patients with diabetes and no history of myocardial infarction (MI) have a lower risk for coronary artery disease events than patients with previous MI and no diabetes.
Question
In patients with type 2 diabetes who are asymptomatic for coronary artery disease (CAD), does screening with myocardial perfusion imaging (MPI) reduce risk for cardiac events?
Conclusion
In patients with type 2 diabetes who were asymptomatic for coronary artery disease, screening with myocardial perfusion imaging did not reduce risk for cardiac events.
Question
In patients with screen-detected type 2 diabetes, does an intensive, multifactorial primary care treatment strategy reduce cardiovascular (CV) risk factors more than routine care?
Conclusion
In patients with screen-detected type 2 diabetes, an intensive, multifactorial, primary care treatment strategy reduced cardiovascular risk factors more than routine care.
Question
In patients with type 2 diabetes, how do various oral diabetes medications compare for long-term cardiovascular (CV) risk?
Conclusion
Metformin reduced risk for cardiovascular mortality compared with other oral diabetes drugs or placebo in type 2 diabetes.
Question
In patients with poorly controlled type 2 diabetes, how does intensive glucose control compare with standard control for reducing cardiovascular (CV) events?
Conclusion
Intensive glucose control and standard control did not differ for reducing cardiovascular events or death in patients with poorly controlled type 2 diabetes.
Question
Is telmisartan effective in patients with cardiovascular (CV) disease or diabetes with end-organ damage and intolerance to angiotensin-converting enzyme (ACE) inhibitors?
Conclusion
Telmisartan did not reduce a composite of cardiovascular death, myocardial infarction, stroke, or hospitalization for heart failure in patients with cardiovascular disease or diabetes with end-organ damage and intolerance to angiotensin-converting enzyme inhibitors.
Question
In patients with type 1 diabetes, how does intensive insulin therapy (IIT) compare with conventional therapy for development of hypertension?
Conclusions
Intensive insulin therapy reduced long-term risk for incident hypertension compared with conventional therapy in type 1 diabetes. The effect was observed when better glycemic control was obtained and to a lesser extent when albumin excretion rate was diminished but was uninfluenced by body mass index.
Question
In patients with diabetes and asymptomatic peripheral arterial disease, do aspirin or antioxidants reduce risk for cardiovascular (CV) events?
Conclusion
In patients with diabetes and asymptomatic peripheral arterial disease, aspirin and antioxidants (separately or combined) did not reduce risk for cardiovascular events.
Question
In patients with diabetes, do the benefits of early intensive glucose control in preventing diabetes-related complications continue after the intervention is stopped?
Conclusion
In patients with type 2 diabetes, the benefits of early intensive glucose control in preventing diabetes-related complications were sustained for up to 10 years after the intervention was stopped.
Question
In patients with type 2 diabetes, do the benefits of tight blood pressure (BP) control in preventing diabetes-related complications continue when differences in BP control are not sustained?
Conclusion
In patients with type 2 diabetes, the benefits of tight blood pressure control in preventing diabetes-related complications did not continue over 8 years after the tight-control intervention was stopped, except for a reduction in peripheral vascular disease.
Question
In type 2 diabetes, does intensive glucose control prevent adverse outcomes more than standard glucose control?
Conclusion
Compared with standard glucose control in type 2 diabetes, intensive glucose control with gliclazide and other drugs had no effect on macrovascular events, prevented new or worsening albuminuria, but led to greater hypoglycemia.
Question
In patients with type 2 diabetes and cardiovascular disease or risk factors, does intensive glucose control prevent cardiovascular events more than standard glucose control?
Conclusion
In patients with type 2 diabetes and cardiovascular disease or risk factors, intensive glucose control increased mortality and did not prevent cardiovascular events more than standard glucose control.
Question
In patients with type 2 diabetes and microalbuminuria, does an intensive, targeted multifactorial intervention reduce mortality in the long term?
Conclusion
Intensive therapy reduced mortality and morbidity in patients with type 2 diabetes and microalbuminuria at 5.5 years following a 7.8-year randomized trial.
Question
In older patients with type 2 diabetes, do thiazolidinediones (TZDs) increase risk for heart failure (HF), myocardial infarction (MI), and mortality more than other oral hypoglycemic agents?
Conclusion
In older patients with type 2 diabetes, thiazolidinediones (in particular, rosiglitazone) were associated with higher risks for heart failure, myocardial infarction, and mortality than other oral hypoglycemic agents.
Question
In patients with prediabetes or type 2 diabetes, do thiazolidinediones (TZDs) increase the risk for congestive heart failure (CHF) and cardiovascular death?
Conclusion
In patients with prediabetes or type 2 diabetes, thiazolidinediones increase the risk for congestive heart failure but not cardiovascular death.
Question
In patients with heart failure (HF) and diabetes, what is the relation between antidiabetic therapy and morbidity and mortality?
Conclusion
Metformin and thiazolidinediones are associated with reduced risk but insulin is associated with increased risk for all-cause mortality in patients with heart failure and diabetes.
Question
In patients with type 2 diabetes, what is the risk for heart failure (HF) associated with thiazolidinediones (TZDs)?
Conclusion
Thiazolidinediones increase risk for heart failure in patients with type 2 diabetes.
Question
In patients with type 2 diabetes, does pioglitazone reduce cardiovascular events, other adverse events, and mortality or improve health-related quality of life?
Conclusions
Based on 1 randomized trial, pioglitazone does not reduce risk for mortality or cardiovascular events in patients with type 2 diabetes. Some evidence exists that pioglitazone increases risk for such adverse events as weight gain, decrease in hemoglobin level, and edema.
Question
In patients with type 2 diabetes, is atorvastatin more effective than placebo for preventing cardiovascular (CV) events?
Conclusions
In low-risk patients with type 2 diabetes, atorvastatin did not prevent cardiovascular events.
Question
In patients with vascular disease, does lowering plasma homocysteine levels with folic acid and B vitamins reduce risk for major vascular events?
Conclusion
In patients with vascular disease, lowering plasma homocysteine levels with folic acid and B vitamins did not reduce risk for the composite endpoint of myocardial infarction, stroke, or death from cardiovascular causes more than placebo.
Question
In patients with type 1 diabetes, does long-term intensive insulin therapy (IIT) reduce cardiovascular disease (CVD) events?
Conclusion
In patients with type 1 diabetes, long-term intensive insulin therapy reduced cardiovascular disease events.
Question
In patients with type 2 diabetes mellitus, what is the effect of long-term fenofibrate therapy on coronary heart disease (CHD) events?
Conclusion
In patients with type 2 diabetes mellitus, long-term fenofibrate therapy did not reduce major coronary events but may reduce total cardiovascular disease events.
Question
In patients with type 2 diabetes and evidence of macrovascular disease, does pioglitazone reduce all-cause mortality and macrovascular complications?
Conclusions
In patients with type 2 diabetes and evidence of macrovascular disease, pioglitazone did not reduce the primary or preplanned secondary composite endpoints. Pioglitazone use reduced a “main secondary” composite endpoint of all-cause mortality, nonfatal MI, and stroke, but increased the incidence of heart failure.
Question
In patients with type 2 diabetes mellitus receiving hemodialysis, does atorvastatin reduce the composite risk for nonfatal myocardial infarction (MI), stroke, and death from cardiac causes?
Conclusion
In patients with type 2 diabetes receiving hemodialysis, atorvastatin did not reduce the composite risk for cardiovascular events or death from cardiac causes more than placebo.
Question
In black or nonblack patients with hypertension, is amlodipine or lisinopril better than chlorthalidone for reducing cardiovascular disease (CVD)?
Conclusions
In black or nonblack patients with hypertension, amlodipine or lisinopril was not better than chlorthalidone for reducing cardiovascular disease. Chlorthalidone was associated with a lower risk for heart failure than amlodipine or linisopril in either racial subgroup.
Question
In patients with vascular disease or diabetes mellitus, what is the cost-effectiveness of simvastatin compared with placebo for reducing major vascular events (MVEs)?
Conclusions
In patients with vascular disease or diabetes, simvastatin was cost-effective for reducing major vascular events and reduced hospitalization costs. Cost-effectiveness varied according to underlying risk for vascular events.
Question
In patients with type 2 diabetes and acute myocardial infarction (MI), does an insulin-glucose regimen followed by insulin-based therapy reduce mortality and morbidity (group 1) more than an insulin-glucose infusion followed by standard care (group 2) or standard care alone (group 3)?
Conclusion
In patients with type 2 diabetes and acute myocardial infarction, an insulin-glucose regimen with long-term insulin control was not better than an insulin regimen with standard glucose control for improving survival.
Question
In patients with type 2 diabetes mellitus and peripheral arterial disease (PAD), is picotamide better than aspirin for preventing all-cause mortality and major cardiovascular (CV) events?
Conclusions
In patients with type 2 diabetes mellitus and peripheral arterial disease, picotamide was more effective than aspirin for preventing all-cause mortality. Picotamide did not reduce nonfatal cardiovascular events.
Question
In older patients with isolated systolic hypertension (ISH) with or without diabetes, what is the long-term effectiveness of a diuretic-based, stepped-care antihypertensive therapy compared with placebo?
Conclusions
In older patients with isolated systolic hypertension, diuretic-based, stepped-care antihypertensive therapy reduced long-term cardiovascular mortality. Patients who had diabetes at baseline or who developed diabetes during follow-up and received stepped care had lower mortality rates than did those who received placebo.
Question
In patients with type 2 diabetes mellitus, is atorvastatin better than placebo for primary prevention of major cardiovascular disease (CVD) events?
Conclusion
In patients with type 2 diabetes mellitus, atorvastatin was more effective than placebo for reducing the rate of major cardiovascular disease events.
Question
In patients with type 2 diabetes mellitus, do lipid-lowering agents reduce cardiovascular disease (CVD) events?
Conclusion
In patients with type 2 diabetes mellitus (with or without coronary artery disease), lipid-lowering agents reduce cardiovascular disease events.
Question
In patients with abnormal fasting glucose (AFG) (diabetes and impaired fasting glucose [IFG]) and a history of myocardial infarction (MI) or unstable angina, is pravastatin better than placebo for reducing major coronary heart disease (CHD) events?
Conclusion
In patients with abnormal fasting glucose (diabetes and impaired fasting glucose) and a history of myocardial infarction or unstable angina, pravastatin reduced major coronary heart disease events.
Question
In patients with diabetes mellitus, does simvastatin reduce vascular events?
Conclusion
In adults with diabetes mellitus, simvastatin therapy at 40 mg daily reduced vascular events.
Background:
Results from clinical trials examining the effect of intensive glucose control on cardiovascular disease have been conflicting.
Purpose:
To summarize clinical benefits and harms of intensive versus conventional glucose control for adults with type 2 diabetes.
Data Sources:
Studies were retrieved by systematically searching the MEDLINE database (January 1950 to April 2009) with no language restrictions.
Study Selection:
Two independent reviewers screened abstracts or full-text articles to identify randomized trials that compared clinical outcomes in patients with type 2 diabetes receiving intensive glucose control and those receiving conventional glucose control.
Data Extraction:
Two investigators independently abstracted data on study variables and outcomes, including severe hypoglycemia, cardiovascular disease, and all-cause mortality.
Data Synthesis:
5 trials involving 27 802 adults were included. Intensive glucose targets were lower in the 3 most recent trials. Summary analyses showed that compared with conventional control, intensive glucose control reduced the risk for cardiovascular disease (relative risk [RR], 0.90 [95% CI, 0.83 to 0.98]; risk difference per 1000 patients per 5 years [RD], −15 [CI, −24 to −5]) but not cardiovascular death (RR, 0.97 [CI, 0.76 to 1.24]; RD, −3 [CI, −14 to 7]) or all-cause mortality (RR, 0.98 [CI, 0.84 to 1.15]; RD, −4 [CI, −17 to 10]). Intensive glucose control increased the risk for severe hypoglycemia (RR, 2.03 [CI, 1.46 to 2.81]; RD, 39 [CI, 7 to 71]). As was seen in the overall analyses, pooled findings from the early and more recent trials showed that intensive glucose control reduced the risk for cardiovascular disease and increased the risk for severe hypoglycemia.
Limitation:
Summary rather than individual data were pooled across trials.
Conclusion:
Intensive glucose control reduced the risk for some cardiovascular disease outcomes (such as nonfatal myocardial infarction), did not reduce the risk for cardiovascular death or all-cause mortality, and increased the risk for severe hypoglycemia.
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