A combination of phentermine and topiramate appears to be an effective obesity treatment, according to a phase III, industry-conducted trial published in the Lancet.
Some 2500 patients who were overweight or obese and had at least two comorbidities were randomized to placebo or low- or high-doses of phentermine plus topiramate. All patients received diet and lifestyle counseling. At 56 weeks, patients in the treatment groups lost more weight than controls (high-dose, 10.2 kg; low-dose, 8.1 kg; placebo, 1.4 kg). A higher proportion of patients in the treatment groups also achieved 10% weight loss (high-dose, 48%; low-dose, 37%; placebo, 7%).
Patients in the treatment groups reported higher rates of dry mouth, constipation, and paresthesia. In addition, a dose-related increase was observed in depression- and anxiety-related adverse events.
Friday, April 15, 2011
Sunday, March 13, 2011
BMI, Other Adiposity Measures Don't Add Much to Cardiovascular Risk Prediction
Measures of adiposity do not greatly improve cardiovascular risk prediction beyond that provided by blood pressure, diabetes history, and lipid profile, according to a study in the Lancet.
Researchers assessed data on 220,000 patients free of cardiovascular disease in 58 prospective cohorts. Over a mean 5.7 years' follow-up, some 14,000 cardiovascular events occurred.
After adjustment for age, sex, smoking status, systolic blood pressure, diabetes history, and total and HDL cholesterol, increasing increments of BMI, waist-to-hip ratio, and waist circumference were individually associated with roughly similar increases in cardiovascular risk (with hazard ratios ranging from 1.07 to 1.12). In addition, adding these adiposity measures to a cardiovascular risk prediction model that included traditional risk factors did not improve the model's risk discrimination.
Commentators note: "The study dispelled previous hope that assessment of body size could replace the cost, time, and inconvenience of blood lipids assay."
Researchers assessed data on 220,000 patients free of cardiovascular disease in 58 prospective cohorts. Over a mean 5.7 years' follow-up, some 14,000 cardiovascular events occurred.
After adjustment for age, sex, smoking status, systolic blood pressure, diabetes history, and total and HDL cholesterol, increasing increments of BMI, waist-to-hip ratio, and waist circumference were individually associated with roughly similar increases in cardiovascular risk (with hazard ratios ranging from 1.07 to 1.12). In addition, adding these adiposity measures to a cardiovascular risk prediction model that included traditional risk factors did not improve the model's risk discrimination.
Commentators note: "The study dispelled previous hope that assessment of body size could replace the cost, time, and inconvenience of blood lipids assay."
Thursday, March 3, 2011
Long-Term Use of Proton-Pump Inhibitors May Lower Magnesium Levels
Using a proton-pump inhibitor for extended periods may cause low serum magnesium levels, the FDA cautioned yesterday. The agency issued the alert after reviewing more than 50 cases of hypomagnesemia in patients taking PPIs over long periods, usually a year or more.
Possible adverse effects of hypomagnesemia include tetany, arrhythmias, and seizures. The alert primarily applies to prescription PPIs, which are indicated for long-term use. The FDA says there is little risk from over-the-counter PPIs when taken as directed for 14 days.
Before prescribing a PPI for a long period, clinicians should consider baseline magnesium testing as well as occasional testing throughout treatment. Periodic magnesium testing is also advised in patients concurrently taking digoxin, because low magnesium in these patients carries a greater risk for serious side effects.
The FDA said that long-term PPI use may affect intestinal absorption of magnesium, although the mechanism is unknown.
Possible adverse effects of hypomagnesemia include tetany, arrhythmias, and seizures. The alert primarily applies to prescription PPIs, which are indicated for long-term use. The FDA says there is little risk from over-the-counter PPIs when taken as directed for 14 days.
Before prescribing a PPI for a long period, clinicians should consider baseline magnesium testing as well as occasional testing throughout treatment. Periodic magnesium testing is also advised in patients concurrently taking digoxin, because low magnesium in these patients carries a greater risk for serious side effects.
The FDA said that long-term PPI use may affect intestinal absorption of magnesium, although the mechanism is unknown.
Thursday, February 24, 2011
stroke sides affects mood
Right brain strokes also spawn cheerful survivors while left brain strokes leave the survivor with depression (Rosenfeld, 1997).
Prescription Drug Prices in Canada
The high cost of prescription drugs, combined with the lack of prescription drug coverage for many older Americans, has resulted in substantial interest in how countries such as Canada attempt to restrain prescription drug prices. Many older Americans have discovered first-hand the potential savings from buying their prescription drugs from Canadian pharmacies. However, while Canada does tend to have lower drug prices than the U.S. for many prescription drug products, attention to prices is only part of the story of Canadian efforts to reduce overall drug costs.
One reason that drug prices tend to be lower in Canada is that prices for drugs that are still under patent—and therefore have no generic substitutes—are regulated by the federal Patented Medicine Prices Review Board (PMPRB). This Board establishes the maximum prices that can be charged in Canada for patented drugs. The PMPRB has been credited with keeping average annual price increases for patented drugs at or below zero since 1992. In addition, Canadian drug price levels fell from 123 percent of the median drug price level for seven industrialized countries (France, Germany, Italy, Sweden, Switzerland, the United Kingdom, and the United States) in 1987 to 101 percent of the comparator median in 2002. During that same period, the average U.S. prices for patented drugs rose from 36 percent above to 67 percent above average Canadian prices.
A second reason for lower Canadian prices is price negotiations by health insurers that are based on evaluations of clinical effectiveness of prescription drugs. Insurers, particularly the provincial drug benefit plans that provide coverage for most elderly, disabled, and low-income Canadians, have adopted cost management approaches that apply clinical evaluations to identify therapeutically similar drugs and negotiate with manufacturers in order to get the best price among similar products. These prices become available to other insurers (who tend to provide coverage to most other Canadians) because the provincial health plans publish the prices in their formulary, the list of drugs which they will cover.
Canada's success in restraining drug prices, however, has not fully restrained the growth of prescription drug spending. Prescription drug spending in Canada rose by about 9 percent per year between 1990 and 2001 (compared to 12 percent annual growth in the United States), due not only to drug prices but also to higher use per person and the changing mix toward more costly medications. Expenditures on prescription drugs account for an increasing share of national health care spending, and these costs threaten the ability of provincial and private benefit plans to continue providing benefits at current levels. As a result of financial pressures, public policy discussions in Canada have moved beyond the issue of drug prices to suggestions that provinces establish structures to ensure that a drug's price reflects its relative therapeutic value and that patients and physicians have both the information and incentives to balance benefits and actual costs. There also has been debate in Canada about whether the federal government should take a more prominent role in helping to restrain prescription drug costs beyond price alone, such as whether to adopt a national drug formulary.
What lessons does the Canadian experience offer the United States as it contends with rising drug costs? The most important lesson from the Canadian experience may come not from price regulation but from Canada's increasing use of clinical and economic evaluation to make drug payment decisions. The establishment of conditions for a more competitive pharmaceutical marketplace based on evaluations of quality and price may fit the American political context better than price controls. Indeed, to some extent, these policies are already being adopted in the United States within the Department of Veterans' Affairs and several state Medicaid programs.
Whatever programs the United States may turn to in reducing prescription drug spending, it will be important to evaluate their impact both on patient access to existing drugs and on pharmaceutical research and development-in effect, access to future drugs. Whether these management systems could successfully restrain pharmaceutical spending in the United States without adversely affecting access or pharmaceutical research and development is yet to be seen. They certainly warrant further assessment as Americans and their health insurers seek greater value for their pharmaceutical dollar.
By:David Gross, Senior Policy Advisor, AARP Public Policy Institute
Publish Date:July 1, 2003
One reason that drug prices tend to be lower in Canada is that prices for drugs that are still under patent—and therefore have no generic substitutes—are regulated by the federal Patented Medicine Prices Review Board (PMPRB). This Board establishes the maximum prices that can be charged in Canada for patented drugs. The PMPRB has been credited with keeping average annual price increases for patented drugs at or below zero since 1992. In addition, Canadian drug price levels fell from 123 percent of the median drug price level for seven industrialized countries (France, Germany, Italy, Sweden, Switzerland, the United Kingdom, and the United States) in 1987 to 101 percent of the comparator median in 2002. During that same period, the average U.S. prices for patented drugs rose from 36 percent above to 67 percent above average Canadian prices.
A second reason for lower Canadian prices is price negotiations by health insurers that are based on evaluations of clinical effectiveness of prescription drugs. Insurers, particularly the provincial drug benefit plans that provide coverage for most elderly, disabled, and low-income Canadians, have adopted cost management approaches that apply clinical evaluations to identify therapeutically similar drugs and negotiate with manufacturers in order to get the best price among similar products. These prices become available to other insurers (who tend to provide coverage to most other Canadians) because the provincial health plans publish the prices in their formulary, the list of drugs which they will cover.
Canada's success in restraining drug prices, however, has not fully restrained the growth of prescription drug spending. Prescription drug spending in Canada rose by about 9 percent per year between 1990 and 2001 (compared to 12 percent annual growth in the United States), due not only to drug prices but also to higher use per person and the changing mix toward more costly medications. Expenditures on prescription drugs account for an increasing share of national health care spending, and these costs threaten the ability of provincial and private benefit plans to continue providing benefits at current levels. As a result of financial pressures, public policy discussions in Canada have moved beyond the issue of drug prices to suggestions that provinces establish structures to ensure that a drug's price reflects its relative therapeutic value and that patients and physicians have both the information and incentives to balance benefits and actual costs. There also has been debate in Canada about whether the federal government should take a more prominent role in helping to restrain prescription drug costs beyond price alone, such as whether to adopt a national drug formulary.
What lessons does the Canadian experience offer the United States as it contends with rising drug costs? The most important lesson from the Canadian experience may come not from price regulation but from Canada's increasing use of clinical and economic evaluation to make drug payment decisions. The establishment of conditions for a more competitive pharmaceutical marketplace based on evaluations of quality and price may fit the American political context better than price controls. Indeed, to some extent, these policies are already being adopted in the United States within the Department of Veterans' Affairs and several state Medicaid programs.
Whatever programs the United States may turn to in reducing prescription drug spending, it will be important to evaluate their impact both on patient access to existing drugs and on pharmaceutical research and development-in effect, access to future drugs. Whether these management systems could successfully restrain pharmaceutical spending in the United States without adversely affecting access or pharmaceutical research and development is yet to be seen. They certainly warrant further assessment as Americans and their health insurers seek greater value for their pharmaceutical dollar.
By:David Gross, Senior Policy Advisor, AARP Public Policy Institute
Publish Date:July 1, 2003
Wednesday, January 26, 2011
Statins for the primary prevention of cardiovascular disease
Summary
Statins for the primary prevention of cardiovascular disease
Cardiovascular disease (CVD) is ranked as the number one cause of mortality and is a major cause of morbidity world wide. Reducing high blood cholesterol which is a risk factor for CVD events is an important goal of medical treatment. Statins are the first-choice agents. Since the early statin trials were reported, several reviews of the effects of statins have been published highlighting their benefits particularly in people with a past history of CVD. However for people without a past history of CVD (primary prevention), the evidence is less clear. The aim of this systematic review is to assess the effects, both in terms of benefits and harms of statins for the primary prevention of CVD. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE until 2007. We found 14 randomised control trials with 16 trial arms (34,272 patients) dating from 1994 to 2006. All were randomised control trials comparing statins with usual care or placebo. Duration of treatment was minimum one year and with follow up of a minimum of six months. All cause mortality. coronary heart disease and stroke events were reduced with the use of statins as was the need for revascularisations. Statin treatment reduced blood cholesterol. Taking statins did not increase the risk of adverse effects such as cancer. and few trials reported on costs or quality of life. This current systematic review highlights the shortcomings in the published trials and we recommend that caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.
This is a Cochrane review abstract and plain language summary, prepared and maintained by The Cochrane Collaboration, currently published in The Cochrane Database of Systematic Reviews 2011 Issue 1, Copyright © 2011 The Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).
This record should be cited as: Taylor F, Ward K, Moore THM, Burke M, Davey Smith G, Casas J-P, Ebrahim S. Statins for the primary prevention of cardiovascular disease. Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.: CD004816. DOI: 10.1002/14651858.CD004816.pub4
Editorial Group: Heart Group
This version first published online: January 19. 2011
Last assessed as up-to-date: September 8. 2007
Abstract
Background
Reducing high blood cholesterol, a risk factor for cardiovascular disease (CVD) events in people with and without a past history of coronary heart disease (CHD) is an important goal of pharmacotherapy. Statins are the first-choice agents. Previous reviews of the effects of statins have highlighted their benefits in people with coronary artery disease. The case for primary prevention, however, is less clear.
Objectives
To assess the effects, both harms and benefits, of statins in people with no history of CVD.
Search strategy
To avoid duplication of effort, we checked reference lists of previous systematic reviews. We searched the Cochrane Central Register of Controlled Trials (Issue 1, 2007), MEDLINE (2001 to March 2007) and EMBASE (2003 to March 2007). There were no language restrictions.
Selection criteria
Randomised controlled trials of statins with minimum duration of one year and follow-up of six months, in adults with no restrictions on their total low density lipoprotein (LDL) or high density lipoprotein (HDL) cholesterol levels, and where 10% or less had a history of CVD, were included.
Data collection and analysis
Two authors independently selected studies for inclusion and extracted data. Outcomes included all cause mortality, fatal and non-fatal CHD, CVD and stroke events, combined endpoints (fatal and non-fatal CHD, CVD and stroke events), change in blood total cholesterol concentration, revascularisation, adverse events, quality of life and costs. Relative risk (RR) was calculated for dichotomous data, and for continuous data pooled weighted mean differences (with 95% confidence intervals) were calculated.
Main results
Fourteen randomised control trials (16 trial arms; 34,272 participants) were included. Eleven trials recruited patients with specific conditions (raised lipids, diabetes, hypertension, microalbuminuria). All-cause mortality was reduced by statins (RR 0.83, 95% CI 0.73 to 0.95) as was combined fatal and non-fatal CVD endpoints (RR 0.70, 95% CI 0.61 to 0.79). Benefits were also seen in the reduction of revascularisation rates (RR 0.66, 95% CI 0.53 to 0.83). Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects. There was no clear evidence of any significant harm caused by statin prescription or of effects on patient quality of life.
Authors' conclusions
Although reductions in all-cause mortality, composite endpoints and revascularisations were found with no excess of adverse events, there was evidence of selective reporting of outcomes, failure to report adverse events and inclusion of people with cardiovascular disease. Only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life. Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.
Statins for the primary prevention of cardiovascular disease
Cardiovascular disease (CVD) is ranked as the number one cause of mortality and is a major cause of morbidity world wide. Reducing high blood cholesterol which is a risk factor for CVD events is an important goal of medical treatment. Statins are the first-choice agents. Since the early statin trials were reported, several reviews of the effects of statins have been published highlighting their benefits particularly in people with a past history of CVD. However for people without a past history of CVD (primary prevention), the evidence is less clear. The aim of this systematic review is to assess the effects, both in terms of benefits and harms of statins for the primary prevention of CVD. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE until 2007. We found 14 randomised control trials with 16 trial arms (34,272 patients) dating from 1994 to 2006. All were randomised control trials comparing statins with usual care or placebo. Duration of treatment was minimum one year and with follow up of a minimum of six months. All cause mortality. coronary heart disease and stroke events were reduced with the use of statins as was the need for revascularisations. Statin treatment reduced blood cholesterol. Taking statins did not increase the risk of adverse effects such as cancer. and few trials reported on costs or quality of life. This current systematic review highlights the shortcomings in the published trials and we recommend that caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.
This is a Cochrane review abstract and plain language summary, prepared and maintained by The Cochrane Collaboration, currently published in The Cochrane Database of Systematic Reviews 2011 Issue 1, Copyright © 2011 The Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).
This record should be cited as: Taylor F, Ward K, Moore THM, Burke M, Davey Smith G, Casas J-P, Ebrahim S. Statins for the primary prevention of cardiovascular disease. Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.: CD004816. DOI: 10.1002/14651858.CD004816.pub4
Editorial Group: Heart Group
This version first published online: January 19. 2011
Last assessed as up-to-date: September 8. 2007
Abstract
Background
Reducing high blood cholesterol, a risk factor for cardiovascular disease (CVD) events in people with and without a past history of coronary heart disease (CHD) is an important goal of pharmacotherapy. Statins are the first-choice agents. Previous reviews of the effects of statins have highlighted their benefits in people with coronary artery disease. The case for primary prevention, however, is less clear.
Objectives
To assess the effects, both harms and benefits, of statins in people with no history of CVD.
Search strategy
To avoid duplication of effort, we checked reference lists of previous systematic reviews. We searched the Cochrane Central Register of Controlled Trials (Issue 1, 2007), MEDLINE (2001 to March 2007) and EMBASE (2003 to March 2007). There were no language restrictions.
Selection criteria
Randomised controlled trials of statins with minimum duration of one year and follow-up of six months, in adults with no restrictions on their total low density lipoprotein (LDL) or high density lipoprotein (HDL) cholesterol levels, and where 10% or less had a history of CVD, were included.
Data collection and analysis
Two authors independently selected studies for inclusion and extracted data. Outcomes included all cause mortality, fatal and non-fatal CHD, CVD and stroke events, combined endpoints (fatal and non-fatal CHD, CVD and stroke events), change in blood total cholesterol concentration, revascularisation, adverse events, quality of life and costs. Relative risk (RR) was calculated for dichotomous data, and for continuous data pooled weighted mean differences (with 95% confidence intervals) were calculated.
Main results
Fourteen randomised control trials (16 trial arms; 34,272 participants) were included. Eleven trials recruited patients with specific conditions (raised lipids, diabetes, hypertension, microalbuminuria). All-cause mortality was reduced by statins (RR 0.83, 95% CI 0.73 to 0.95) as was combined fatal and non-fatal CVD endpoints (RR 0.70, 95% CI 0.61 to 0.79). Benefits were also seen in the reduction of revascularisation rates (RR 0.66, 95% CI 0.53 to 0.83). Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects. There was no clear evidence of any significant harm caused by statin prescription or of effects on patient quality of life.
Authors' conclusions
Although reductions in all-cause mortality, composite endpoints and revascularisations were found with no excess of adverse events, there was evidence of selective reporting of outcomes, failure to report adverse events and inclusion of people with cardiovascular disease. Only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life. Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.
Aspirin for Primary Prevention in Diabetes
Previous guidelines recommended low-dose aspirin therapy for the primary prevention of stroke in patients with type 1 or type 2 diabetes mellitus who were at increased cardiovascular (CV) risk. Risk factors included patient age older than 40 years, a family history of CV disease, hypertension, smoking, dyslipidemia, or albuminuria. Aspirin therapy was not recommended for patients younger than 30 years of age because no benefit had been demonstrated, and aspirin was contraindicated in patients under 21 years of age because of associated risk for Reye syndrome.[1]
Since the Antithrombotic Trialists' Collaboration (ATT-C) published their first meta-analysis results in May 2009, questioning the value of low-dose aspirin for primary prevention, confusion has been expressed about when to recommend aspirin for patients with diabetes. The ATT-C performed a meta-analysis of 6 primary prevention trials, including 95,000 individuals with low-average CV risk and 16 secondary prevention trials with 17,000 individuals who had high CV risk. This analysis showed that primary prevention of vascular events with aspirin is of uncertain value, whereas the risk for major episodes of hemorrhage may increase.[2]
The ATT-C updated their recommendations for aspirin in primary prevention after considering the results from the POPADAD (Prevention of Progression of Arterial Disease and Diabetes),[3] JPAD (Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes),[4] and AAA (Aspirin for Asymptomatic Atherosclerosis)[5] trials. They concluded that the benefit of aspirin appeared to outweigh its risks when used for secondary, but not primary, prevention.[6]
De Berardis and colleagues conducted a second meta-analysis of 6 studies with 10,117 participants, which suggested that the benefit of aspirin in the primary prevention of major CV events or death in people with diabetes may be lower than in other high-risk populations.[7] Evidence demonstrating that low-dose aspirin is beneficial was lacking in this analysis, and the benefits were not found to exceed the risk for major bleeding, particularly in patients at low CV risk (< 20% over 10 years) and in older patients (> 70 years of age) at high risk of bleeding.[7]
These recent findings have prompted an evaluation of the current guidelines for aspirin use in primary prevention. The American Diabetes Association (ADA) Standard of Medical Care in Diabetes--2010 guidelines have backed off slightly on recommending aspirin use. The guidelines now recommend the consideration of aspirin therapy 75-162 mg daily as a primary prevention strategy for patients with type 1 or type 2 diabetes mellitus who are at increased CV risk (10-year risk > 10%).
Aspirin should not be recommended for patients at low CV risk, including women younger than 60 years of age, men younger than 50 years of age with no major risk factors, and patients with 10-year CV risk < 5%, because the low benefit is offset by the risk for significant bleeding.
Clinical judgment should be used for patients at intermediate risk or older patients with no risk factors. This generally includes most men older than 50 years of age or women older than 60 years of age who have at least 1 additional major risk factor, such as family history of CV disease, hypertension, smoking, dyslipidemia, or albuminuria.[8] To determine risk factors, 2 assessment tools may be used: the Atherosclerosis Risk in Communities (ARIC) Risk Calculator or the ADA's Risk Assessment Tool, Diabetes Personal Health Decisions.
In summary, it remains questionable how much benefit or risk aspirin confers for primary prevention in patients with diabetes. Currently, 2 trials are under way to answer key questions about the risk/benefit ratio: ASCEND (A Study of Cardiovascular Events iN Diabetes) and ACCEPT-D (Aspirin and Simvastatin Combination for Cardiovascular Events Prevention Trial in Diabetes). These are large, ongoing studies that will enroll up to 15,000 participants with anticipated completion dates of 2011 and 2013, respectively.
Until results from these studies are in, providers should use clinical judgment, including known approaches, to minimize CV risk, such as smoking cessation, statins, angiotensin-converting enzyme inhibitors, and the achievement of good glucose control before considering aspirin for primary prevention.
Since the Antithrombotic Trialists' Collaboration (ATT-C) published their first meta-analysis results in May 2009, questioning the value of low-dose aspirin for primary prevention, confusion has been expressed about when to recommend aspirin for patients with diabetes. The ATT-C performed a meta-analysis of 6 primary prevention trials, including 95,000 individuals with low-average CV risk and 16 secondary prevention trials with 17,000 individuals who had high CV risk. This analysis showed that primary prevention of vascular events with aspirin is of uncertain value, whereas the risk for major episodes of hemorrhage may increase.[2]
The ATT-C updated their recommendations for aspirin in primary prevention after considering the results from the POPADAD (Prevention of Progression of Arterial Disease and Diabetes),[3] JPAD (Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes),[4] and AAA (Aspirin for Asymptomatic Atherosclerosis)[5] trials. They concluded that the benefit of aspirin appeared to outweigh its risks when used for secondary, but not primary, prevention.[6]
De Berardis and colleagues conducted a second meta-analysis of 6 studies with 10,117 participants, which suggested that the benefit of aspirin in the primary prevention of major CV events or death in people with diabetes may be lower than in other high-risk populations.[7] Evidence demonstrating that low-dose aspirin is beneficial was lacking in this analysis, and the benefits were not found to exceed the risk for major bleeding, particularly in patients at low CV risk (< 20% over 10 years) and in older patients (> 70 years of age) at high risk of bleeding.[7]
These recent findings have prompted an evaluation of the current guidelines for aspirin use in primary prevention. The American Diabetes Association (ADA) Standard of Medical Care in Diabetes--2010 guidelines have backed off slightly on recommending aspirin use. The guidelines now recommend the consideration of aspirin therapy 75-162 mg daily as a primary prevention strategy for patients with type 1 or type 2 diabetes mellitus who are at increased CV risk (10-year risk > 10%).
Aspirin should not be recommended for patients at low CV risk, including women younger than 60 years of age, men younger than 50 years of age with no major risk factors, and patients with 10-year CV risk < 5%, because the low benefit is offset by the risk for significant bleeding.
Clinical judgment should be used for patients at intermediate risk or older patients with no risk factors. This generally includes most men older than 50 years of age or women older than 60 years of age who have at least 1 additional major risk factor, such as family history of CV disease, hypertension, smoking, dyslipidemia, or albuminuria.[8] To determine risk factors, 2 assessment tools may be used: the Atherosclerosis Risk in Communities (ARIC) Risk Calculator or the ADA's Risk Assessment Tool, Diabetes Personal Health Decisions.
In summary, it remains questionable how much benefit or risk aspirin confers for primary prevention in patients with diabetes. Currently, 2 trials are under way to answer key questions about the risk/benefit ratio: ASCEND (A Study of Cardiovascular Events iN Diabetes) and ACCEPT-D (Aspirin and Simvastatin Combination for Cardiovascular Events Prevention Trial in Diabetes). These are large, ongoing studies that will enroll up to 15,000 participants with anticipated completion dates of 2011 and 2013, respectively.
Until results from these studies are in, providers should use clinical judgment, including known approaches, to minimize CV risk, such as smoking cessation, statins, angiotensin-converting enzyme inhibitors, and the achievement of good glucose control before considering aspirin for primary prevention.
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