Long-term use of aspirin and the risk of gastrointestinal bleeding.
Am J Med. 2011; 124(5):426-33 (ISSN: 1555-7162)
Huang ES; Strate LL; Ho WW; Lee SS; Chan AT
Gastrointestinal Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA.
BACKGROUND: In short-term trials, aspirin is associated with gastrointestinal bleeding. However, the effect of dose and duration of aspirin use on risk remains unclear.
METHODS: We conducted a prospective study of 87,680 women enrolled in the Nurses' Health Study in 1990 who provided biennial data on aspirin use. We examined the relative risk (RR) of major gastrointestinal bleeding requiring hospitalization or blood transfusion.
RESULTS: During a 24-year follow-up, 1537 women reported a major gastrointestinal bleeding. Among women who used aspirin regularly (≥2 standard [325 mg] tablets/week), the multivariate RR of gastrointestinal bleeding was 1.43 (95% confidence interval [CI], 1.29-1.59) when compared with nonregular users. Compared with women who denied any aspirin use, the multivariate RRs of gastrointestinal bleeding were 1.03 (95% CI, 0.85-1.24) for women who used 0.5 to 1.5 standard aspirin tablets/week, 1.30 (95% CI, 1.07-1.58) for women who used 2 to 5 tablets/week, 1.77 (95% CI, 1.44-2.18) for women who used 6 to 14 tablets/week, and 2.24 (95% CI, 1.66-3.03) for women who used more than 14 tablets/week (P(trend)<.001). Similar dose-response relationships were observed among short-term users (≤5 years; P(trend)<.001) and long-term users (>5 years; P(trend)<.001). In contrast, after adjustments were made for dose, increasing duration of use did not confer a greater risk of bleeding (P(trend) = .28).
CONCLUSION: Regular aspirin use is associated with gastrointestinal bleeding. Risk seems more strongly related to dose than duration of aspirin use. Efforts to minimize adverse effects of aspirin therapy should emphasize using the lowest effective dose among both short- and long-term users.
Thursday, June 23, 2011
FDA: 5-Alpha Reductase Inhibitors Associated with Increased Risk for High-Grade Prostate Cancer Diagnosis
The labels of 5-alpha reductase inhibitors (5-ARIs) are being changed to note an increased risk for being diagnosed with high-grade prostate cancer, the FDA announced on Thursday. The drugs (finasteride and dutasteride) are approved to treat benign prostatic hyperplasia and male pattern hair loss.
The announcement came after the FDA reviewed data from two prostate cancer prevention trials. In one, finasteride (given daily for 7 years) was associated with a higher frequency of prostate cancers with Gleason scores between 8 and 10, compared with placebo (1.8% vs. 1.1%). In the other, dutasteride (given daily for 4 years) was also associated with more high-grade cancers relative to placebo (1% vs. 0.5%).
The FDA recommends that physicians rule out prostate cancer before prescribing 5-ARIs for benign prostatic hyperplasia. Also, because these drugs lower prostate-specific antigen values, clinicians should be aware that if PSA increases while a patient is taking a 5-ARI — even if it is within the normal range — it may indicate the presence of prostate cancer
The announcement came after the FDA reviewed data from two prostate cancer prevention trials. In one, finasteride (given daily for 7 years) was associated with a higher frequency of prostate cancers with Gleason scores between 8 and 10, compared with placebo (1.8% vs. 1.1%). In the other, dutasteride (given daily for 4 years) was also associated with more high-grade cancers relative to placebo (1% vs. 0.5%).
The FDA recommends that physicians rule out prostate cancer before prescribing 5-ARIs for benign prostatic hyperplasia. Also, because these drugs lower prostate-specific antigen values, clinicians should be aware that if PSA increases while a patient is taking a 5-ARI — even if it is within the normal range — it may indicate the presence of prostate cancer
Friday, April 15, 2011
Phentermine plus Topiramate Leads to Significant Weight Loss at 1 Year
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.
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.
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
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