Pioglitazone had a mixed risk profile, and rosiglitazone increased risk for ischemic heart disease, but neither increased mortality.
Results from small clinical trials and early pooled analyses have raised concerns about cardiovascular risks associated with rosiglitazone, one of two thiazolidinediones used to treat patients with type 2 diabetes mellitus. Two new meta-analyses further clarify the risks associated with pioglitazone and rosiglitazone.
Independent researchers analyzed data provided by the manufacturer from 19 randomized trials (16,390 patients) that compared pioglitazone with placebo or an active comparator. Most treatment protocols were 12 to 24 months. The hazard ratios for myocardial infarction, stroke, or death each were reduced after about 1 year of treatment with pioglitazone, although only the 18% reduction in the combined endpoint was significant. Risk for serious heart failure was significantly increased by 41%.
In a review of 140 randomized trials, researchers found 4 trials (14,291 patients) that compared rosiglitazone with placebo or an active comparator and had at least 12 months of follow-up. The risk for myocardial infarction in patients who received rosiglitazone was increased by about 40%, and the risk for heart failure was more than doubled; however, the risk for death from cardiovascular disease was not increased.
Comment: Both thiazolidinediones are associated with increased risk for heart failure in patients with type 2 diabetes mellitus, but only rosiglitazone appears to increase risk for ischemic heart disease. Prescribing information for both drugs now includes a "black box" warning about heart failure; in addition, an FDA advisory committee has suggested that warnings about ischemic heart disease be included for rosiglitazone. Editorialists note how unlikely it would have been for either drug to have been approved initially had these risks been known. They call for tighter postmarketing surveillance, especially for new classes of drugs and in higher-risk patients.
— Thomas L. Schwenk, MD
Friday, December 21, 2007
Raloxifene Approved for Reducing Invasive Breast Cancer Risk
The osteoporosis drug raloxifene (Evista) has been approved for the prevention of invasive breast cancer in postmenopausal women with osteoporosis or postmenopausal women at high risk for invasive breast cancer, the FDA announced Friday.
The agency warned that raloxifene, a selective estrogen receptor modulator, should not be taken with cholestyramine or estrogens. Premenopausal women, especially if they are pregnant or considering pregnancy, also should not take this drug.
Raloxifene can cause serious side effects, including deep venous thrombosis, pulmonary embolism, and death due to stroke. Accordingly, the director of the FDA's Center for Drug Evaluation and Research cautioned that "the benefits and risks of taking [raloxifene] should be carefully evaluated for each individual woman."
The agency warned that raloxifene, a selective estrogen receptor modulator, should not be taken with cholestyramine or estrogens. Premenopausal women, especially if they are pregnant or considering pregnancy, also should not take this drug.
Raloxifene can cause serious side effects, including deep venous thrombosis, pulmonary embolism, and death due to stroke. Accordingly, the director of the FDA's Center for Drug Evaluation and Research cautioned that "the benefits and risks of taking [raloxifene] should be carefully evaluated for each individual woman."
Monday, December 3, 2007
Hypertonic Saline for Bronchiolitis
Nebulized hypertonic saline reduced hospital length of stay in young children with bronchiolitis.
Viral bronchiolitis is a common cause of hospitalization for infants and young children during the winter months, but evidence does not support therapeutic interventions other than supportive care (Journal Watch Pediatrics and Adolescent Medicine Jan 10 2007). Nebulized hypertonic saline (HS) has shown promise in the treatment of small airway obstruction in patients with cystic fibrosis. To evaluate the efficacy of this treatment for viral bronchiolitis, investigators in Canada and the United Arab Emirates randomized 96 children younger than 18 months (mean age, 4.7 months) who were hospitalized with moderately severe bronc hiolitis to receive frequent (every 2–6 hours) doses of either nebulized 3.0% HS or 0.9% normal saline (NS).
Hospital length of stay, the primary outcome, was significantly shorter in the HS group than in the NS group (2.6 vs. 3.5 days). Discharge decisions were based on clinical judgment or protocol-based criteria at the treating clinician’s discretion. The frequency of add-on nonprotocol treatments, given at the attending physician’s discretion, was similar in the two groups; about 60% of nebulizations in both groups included albuterol or racemic epinephrine. No adverse respiratory effects were noted, although two children in the HS group and three in the NS group were withdrawn from the study by parents because of crying or agitation during nebulization.
Comment: Most of the hospitalized infants in this study tested positive for respiratory syncytial virus. Thus, these findings are applicable to typical moderately ill infants with bronchiolitis in the U.S. The nebulization treatments in this study were frequent, every 2 hours at first, but a previous inpatient study that administered nebulizations three times daily reported a similar 1-day reduction in hospital stay. Because most patients in the current study received additional nebulized medications rather than hypertonic saline alone, editorialists propose a future study to explore the possible synergy between HS and bronchodilators.
— Cornelius W. Van Niel, MD
Published in Journal Watch Pediatrics and Adolescent Medicine November 7, 2007
Citation(s):
Kuzik BA et al. Nebulized hypertonic saline in the treatment of viral bronchiolitis in infants. J Pediatr 2007 Sep; 151:266.
Medline abstract (Free)
Calogero C and Sly PD. Acute viral bronchiolitis: To treat or not to treat — That is the question. J Pediatr 2007 Sep; 151:235.
Viral bronchiolitis is a common cause of hospitalization for infants and young children during the winter months, but evidence does not support therapeutic interventions other than supportive care (Journal Watch Pediatrics and Adolescent Medicine Jan 10 2007). Nebulized hypertonic saline (HS) has shown promise in the treatment of small airway obstruction in patients with cystic fibrosis. To evaluate the efficacy of this treatment for viral bronchiolitis, investigators in Canada and the United Arab Emirates randomized 96 children younger than 18 months (mean age, 4.7 months) who were hospitalized with moderately severe bronc hiolitis to receive frequent (every 2–6 hours) doses of either nebulized 3.0% HS or 0.9% normal saline (NS).
Hospital length of stay, the primary outcome, was significantly shorter in the HS group than in the NS group (2.6 vs. 3.5 days). Discharge decisions were based on clinical judgment or protocol-based criteria at the treating clinician’s discretion. The frequency of add-on nonprotocol treatments, given at the attending physician’s discretion, was similar in the two groups; about 60% of nebulizations in both groups included albuterol or racemic epinephrine. No adverse respiratory effects were noted, although two children in the HS group and three in the NS group were withdrawn from the study by parents because of crying or agitation during nebulization.
Comment: Most of the hospitalized infants in this study tested positive for respiratory syncytial virus. Thus, these findings are applicable to typical moderately ill infants with bronchiolitis in the U.S. The nebulization treatments in this study were frequent, every 2 hours at first, but a previous inpatient study that administered nebulizations three times daily reported a similar 1-day reduction in hospital stay. Because most patients in the current study received additional nebulized medications rather than hypertonic saline alone, editorialists propose a future study to explore the possible synergy between HS and bronchodilators.
— Cornelius W. Van Niel, MD
Published in Journal Watch Pediatrics and Adolescent Medicine November 7, 2007
Citation(s):
Kuzik BA et al. Nebulized hypertonic saline in the treatment of viral bronchiolitis in infants. J Pediatr 2007 Sep; 151:266.
Medline abstract (Free)
Calogero C and Sly PD. Acute viral bronchiolitis: To treat or not to treat — That is the question. J Pediatr 2007 Sep; 151:235.
Saturday, November 24, 2007
Tuesday, November 13, 2007
Relation Between Oral Contraceptive Use and Cervical Cancer
Use of oral contraceptives for 5 or more years doubles the risk for invasive cervical cancer, but the risk decreases progressively after stopping use, according to a Lancet study.
Researchers examined data on oral contraceptive use from 24 studies comprising some 11,200 women with invasive cervical cancer and 35,500 controls. The risk for cancer increased with duration of use, was highest in current users, and declined with time since last use. Among those who'd stopped using oral contraceptives for 10 years or more, the risk was similar to that of never users.
To give a sense of the additional risk, the authors estimate that 10 years' use starting at age 20 would raise the cumulative cancer incidence at age 50 from 3.8 to 4.5 per 1000 women.
An editorialist points out a potential confounding factor: "Women using oral contraceptives are more likely to be exposed to HPV than are those using barrier methods or not having sexual intercourse."
Lancet article (Free abstract; full text requires subscription)
Researchers examined data on oral contraceptive use from 24 studies comprising some 11,200 women with invasive cervical cancer and 35,500 controls. The risk for cancer increased with duration of use, was highest in current users, and declined with time since last use. Among those who'd stopped using oral contraceptives for 10 years or more, the risk was similar to that of never users.
To give a sense of the additional risk, the authors estimate that 10 years' use starting at age 20 would raise the cumulative cancer incidence at age 50 from 3.8 to 4.5 per 1000 women.
An editorialist points out a potential confounding factor: "Women using oral contraceptives are more likely to be exposed to HPV than are those using barrier methods or not having sexual intercourse."
Lancet article (Free abstract; full text requires subscription)
Monday, November 5, 2007
Sunday, November 4, 2007
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