In the treatment of type 2 diabetes not controlled by metformin and a sulfonylurea, no add-on drug has an obvious advantage over another, according to an Annals of Internal Medicine network meta-analysis.
Researchers examined 18 trials comprising 4500 participants with uncontrolled diabetes. (The add-on treatments were thiazolidinediones, glucagon-like peptide-1 agonists, dipeptidyl peptidase-4 inhibitors, insulins, and acarbose.) The following effects were noted:
No drug class had an advantage in controlling glycated hemoglobin levels.
Insulins and thiazolidinediones were associated with weight gain.
Glucagon-like peptide-1 agonists were associated with weight loss.
Insulins were associated with a doubled frequency of hypoglycemic episodes.
The authors acknowledge the limitations of network meta-analysis, in which some treatments are compared indirectly. They conclude that, in choosing a third drug, an individual patient's clinical features such as weight and hypoglycemia need to be considered.
Thursday, June 23, 2011
3-Month Treatment for Latent TB Infection as Effective as 9-Month Treatment
In patients with latent tuberculosis, a shorter treatment regimen may be as safe and effective as a longer course in preventing active disease, according to a CDC study presented on Monday at the American Thoracic Society conference.
Researchers studied some 8000 patients with latent TB who lived in countries with low to medium incidence of TB — mostly from the U.S. and Canada. Patients were randomized to either the standard treatment (9 months of self-administered daily isoniazid) or a shorter regimen (3 months of supervised weekly rifapentine and isoniazid). Over roughly 3 years' follow-up, seven patients on the shorter regimen developed TB disease, compared with 15 on standard treatment. The shortened-therapy group had a significantly higher rate of treatment completion (82% vs. 69%).
CDC Director Dr. Thomas Frieden called the findings "one of the biggest developments in TB treatment in decades." The CDC stresses that the results are only applicable to countries with low to moderate levels of latent infection
Researchers studied some 8000 patients with latent TB who lived in countries with low to medium incidence of TB — mostly from the U.S. and Canada. Patients were randomized to either the standard treatment (9 months of self-administered daily isoniazid) or a shorter regimen (3 months of supervised weekly rifapentine and isoniazid). Over roughly 3 years' follow-up, seven patients on the shorter regimen developed TB disease, compared with 15 on standard treatment. The shortened-therapy group had a significantly higher rate of treatment completion (82% vs. 69%).
CDC Director Dr. Thomas Frieden called the findings "one of the biggest developments in TB treatment in decades." The CDC stresses that the results are only applicable to countries with low to moderate levels of latent infection
lower dose asa appears to lower gi bleeds
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.
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.
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.
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