Day: 04/01/2013

Ondansetron in pregnancy and risk of adverse fetal outcomes.

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Ondansetron is frequently used to treat nausea and vomiting during pregnancy, but the safety of this drug for the fetus has not been well studied.

METHODS: We investigated the risk of adverse fetal outcomes associated with ondansetron administered during pregnancy. From a historical cohort of 608,385 pregnancies in Denmark, women who were exposed to ondansetron and those who were not exposed were included, in a 1:4 ratio, in propensity-score-matched analyses of spontaneous abortion (1849 exposed women vs. 7396 unexposed women), stillbirth (1915 vs. 7660), any major birth defect (1233 vs. 4932), preterm delivery (1792 vs. 7168), and birth of infants at low birth weight and small for gestational age (1784 vs. 7136). In addition, estimates were adjusted for hospitalization for nausea and vomiting during pregnancy (as a proxy for severity) and the use of other antiemetics.
RESULTS: Receipt of ondansetron was not associated with a significantly increased risk of spontaneous abortion, which occurred in 1.1% of exposed women and 3.7% of unexposed women during gestational weeks 7 to 12 (hazard ratio, 0.49; 95% confidence interval [CI], 0.27 to 0.91) and in 1.0% and 2.1%, respectively, during weeks 13 to 22 (hazard ratio, 0.60; 95% CI, 0.29 to 1.21). Ondansetron also conferred no significantly increased risk of stillbirth (0.3% for exposed women and 0.4% for unexposed women; hazard ratio, 0.42; 95% CI, 0.10 to 1.73), any major birth defect (2.9% and 2.9%, respectively; prevalence odds ratio, 1.12; 95% CI, 0.69 to 1.82), preterm delivery (6.2% and 5.2%; prevalence odds ratio, 0.90; 95% CI, 0.66 to 1.25), delivery of a low-birth-weight infant (4.1% and 3.7%; prevalence odds ratio, 0.76; 95% CI, 0.51 to 1.13), or delivery of a small-for-gestational-age infant (10.4% and 9.2%; prevalence odds ratio, 1.13; 95% CI, 0.89 to 1.44).
CONCLUSIONS: Ondansetron taken during pregnancy was not associated with a significantly increased risk of adverse fetal outcomes.

Source: NEJM

Intensive Glycemic Control and End-Stage Renal Disease in Type 2 Diabetes.

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One case of ESRD was prevented for every 430 intensively treated patients.

In recent randomized trials, intensive glycemic control did not prevent macrovascular events in patients with longstanding type 2 diabetes. In one of those trials (ADVANCE, with 11,000 patients overall; JW Gen Med Jun 6 2008), intensive control prevented macroalbuminuria, a surrogate endpoint for microvascular disease, from developing in some patients. Now, the researchers present information on the most important renal endpoint — progression to end-stage renal disease (ESRD).

After 5 years, mean glycosylated hemoglobin (HbA1c) levels were 7.3% and 6.5% in the standard- and intensive-treatment groups, respectively. ESRD occurred in 20 standard-treatment patients and in 7 intensive-treatment patients. The difference is statistically significant, but about 430 patients underwent intensive glycemic control to prevent 1 case of ESRD. Researchers found no significant differences between groups in incidences of “renal death” or doubling of serum creatinine level.

Comment: The authors believe that their results show “intensive glucose lowering using ADVANCE-like regimens may be beneficial for many people with diabetes.” However, the word “many” here is in the eye of the beholder: Editorialists express concern about the large number needed to treat and note that intensive control can confer both benefits and harms. They conclude that “an A1c target <6.5% for type 2 diabetes should be used cautiously, if at all — perhaps only in well-informed patients who are younger, at lower risk for hypoglycemia, and free of symptomatic cardiovascular disease.”

Source: Journal Watch General Medicine

Clopidogrel Is Safe Before Hip Fracture Surgery.

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In an observational study, clopidogrel did not confer risk for serious perioperative bleeding.

In general, surgery should be done promptly after hip fracture. However, when the patient has been taking clopidogrel (Plavix), the surgeon might be concerned about excessive perioperative bleeding. In fact, the following statement appears in the official prescribing information for clopidogrel: “If a patient is to undergo surgery and an antiplatelet effect is not desired, discontinue Plavix five days prior to surgery.”

In this retrospective cohort study from Mayo Clinic, investigators identified 40 hip-fracture patients who were taking clopidogrel at admission and who underwent surgery within 36 hours. Cases were compared with 80 controls (matched for age, sex, and several other clinical variables) who also underwent prompt surgery for hip fractures and who had not been taking clopidogrel. Two major bleeding events occurred in the clopidogrel group, and three occurred among controls (a nonsignificant difference). The incidence of a broader combined bleeding outcome (encompassing major bleeding events, need for transfusions, and fall in hemoglobin level) also was similar in the two groups.

Comment: This study suggests that clopidogrel is not associated with substantial excess risk for serious bleeding in patients who undergo hip fracture surgery. Whether surgeons had more technical difficulty in controlling intraoperative bleeding in clopidogrel recipients than in controls was not addressed in this report.

 

Source: Journal Watch General Medicine

 

 

High-potency statins may increase risk for kidney injury.

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Recent data demonstrate that use of high-potency statins increased the risk for acute kidney injury in patients by 34% compared with low-potency statin use.

Researchers in Canada conducted a retrospective, observational analysis of 2 million patients, aged 40 years or older, who were newly prescribed high-potency statinsin seven Canadian provinces, the United States and the United Kingdom between 1997 and 2008 (mean age, 68 years; 50% women).

High-potency statins were defined as those that produced a ≤45% reduction in LDL. Rosuvastatin(Crestor, AstraZeneca) at 10 mg or more, atorvastatin(Lipitor, Pfizer) at 20 mg or more and simvastatin at 40 mg or more were defined as high-potency statins.

Overall, 2,067,639 patients were newly exposed to statins. The researchers recorded 59,636 patients with chronic kidney injury using statins within 3 years before cohort entry. Within 120 days of treatment, 4,691 patients with non-chronic kidney disease were hospitalized for acute kidney injury and 1,896 were hospitalized with chronic kidney injury. Researchers found that high-potency statin users were 34% more likely to be hospitalized with acute kidney injury within 120 days compared with low-potency statin users. This risk remained elevated for 2 years after initiation (fixed-effect rate ratio=1.34; 95% CI, 1.25-1.43). Those who took high-potency statins with chronic kidney disease did not have as large an increase in admission rate (1.1).

“We estimate that 1,700 patients with non-chronic kidney disease need to be treated with a high-potency statin instead of a low-potency statin for 120 days to cause one additional hospitalization for acute kidney injury,” Colin R. Dormuth, MD, of the department of anesthesiology, pharmacology and therapeutics at the University of British Columbia, Canada, and colleagues wrote in the study.

Source: Endocrine Today

New drug application for SGLT2, empagliflozin, submitted to FDA.

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A new drug application for the novel investigational sodium glucose co-transporter-2 inhibitor, empagliflozin, has been submitted to the FDA, according to a press release.

Empagliflozin (Boehringer Ingelheim and Eli Lilly and Company) is similar to another SGLT2 inhibitor, canagliflozin (Invokana, Janssen), which was recommended for approval by the Endocrinologic and Metabolic Drugs Advisory Committee in January.

According to the press release, empagliflozin is being investigated in a phase 3 clinical trial program that plans to enroll more than 14,500 patients. Moreover, the program includes 12 multinational clinical trials, including a large cardiovascular outcomes trial. Presentation of the data is expected at scientific medical meetings and in publications this year and in 2014.

During the EASD annual meeting in October 2012, the pharmaceutical companies released results from a pooled analysis of phase 2b data for empagliflozin. Researchers collected data from two randomized, double blind, placebo-controlled trials that evaluated the safety and efficacy of empagliflozin alone (n=408) or as add-on therapy to metformin (n=495) in adults with type 2 diabetes.

According to data, 152 patients were assigned to empagliflozin 10 mg, 152 were assigned empagliflozin 25 mg and 153 were assigned placebo. After the 12-week study, mean systolic BP decreased by 3.8 mm Hg in the empagliflozin 10-mg group and by 4.5 mm Hg in the 25-mg group vs. 1.2 mm Hg in the placebo group.

Furthermore, empagliflozin was well tolerated, the researchers said. Adverse event rates were similar among treatment and placebo groups (34.2% and 31.6% in empagliflozin 10-mg and 25-mg groups, and 34.6% in the placebo group).

The most common adverse events associated with empagliflozin include urinary tract and genital infections.

Source: Endocrine Today

 

Routine Propofol Sedation Increases Risk During Colonoscopy.

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In a large database study, anesthesia assistance was associated with an elevated risk for perforation, splenic injury, or aspiration pneumonia.

 

The use of anesthesiologist-administered propofol sedation for colonoscopy is increasing in the U.S. (JW Gastroenterol April 13 2012 and JW Gastroenterol Feb 17 2012). Propofol use during colonoscopy is associated with shorter recovery time and higher patient satisfaction but also an estimated 20% increase in health care costs. Whereas most studies on the use of propofol sedation during colonoscopy have focused on its economic cost, researchers now explore another possible disadvantage — increased risk for complications.

Using a database of linked U.S. Medicare and cancer registry data, investigators identified patients without cancer who underwent diagnostic colonoscopy between 2000 and 2009, assessed whether they received anesthesiology services, and determined whether they were hospitalized during the 30 days following colonoscopy for perforation, splenic injury, or aspiration pneumonia. Data on the type of anesthetic agent used were unavailable, but investigators assumed that anesthesiologist-administered propofol was used most often.

Of 165,527 colonoscopy examinations in 100,359 patients, 35,128 procedures (21.2%) were performed with anesthesia assistance. Complications of aspiration, perforation, or splenic injury occurred more frequently in patients who received anesthesia assistance than in those who did not (0.22% vs. 0.16%, P<0.001; odds ratio, 1.46; 95% confidence interval, 1.09–1.94). This difference was mostly attributable to the difference in risk for aspiration (0.14% vs. 0.10%; P=0.02). The risks for perforation and splenic injury were similar between groups. Other independent risk factors for these complications were older age, male sex, increased comorbidity, and undergoing the procedure in a hospital.

Comment: Although the overall rate of complications was very low, the use of anesthesia services for diagnostic colonoscopy resulted in a higher risk for complications. These findings might result in part from confounding if patients who received anesthesia assistance were sicker or more prone to complications and were chosen to receive anesthesia for those reasons. Also, the data were from a period when propofol was sometimes administered by trained nurses rather than anesthesiologists, and the relative safety of this approach compared to anesthesia-administered services cannot be determined. Finally, these findings might be more pronounced in the types of patients included in this trial (65 years old), and whether the observed increased risk is present in younger or more healthy patients remains to be determined.

Source: Journal Watch Gastroenterology

 

Routine Propofol Sedation Increases Risk During Colonoscopy In a large database study, anesthesia assistance was associated with an elevated risk for perforation, splenic injury, or aspiration pneumonia. The use of anesthesiologist-administered propofol sedation for colonoscopy is increasing in the U.S. (JW Gastroenterol April 13 2012 and JW Gastroenterol Feb 17 2012). Propofol use during colonoscopy is associated with shorter recovery time and higher patient satisfaction but also an estimated 20% increase in health care costs. Whereas most studies on the use of propofol sedation during colonoscopy have focused on its economic cost, researchers now explore another possible disadvantage — increased risk for complications. Using a database of linked U.S. Medicare and cancer registry data, investigators identified patients without cancer who underwent diagnostic colonoscopy between 2000 and 2009, assessed whether they received anesthesiology services, and determined whether they were hospitalized during the 30 days following colonoscopy for perforation, splenic injury, or aspiration pneumonia. Data on the type of anesthetic agent used were unavailable, but investigators assumed that anesthesiologist-administered propofol was used most often. Of 165,527 colonoscopy examinations in 100,359 patients, 35,128 procedures (21.2%) were performed with anesthesia assistance. Complications of aspiration, perforation, or splenic injury occurred more frequently in patients who received anesthesia assistance than in those who did not (0.22% vs. 0.16%, P<0.001; odds ratio, 1.46; 95% confidence interval, 1.09–1.94). This difference was mostly attributable to the difference in risk for aspiration (0.14% vs. 0.10%; P=0.02). The risks for perforation and splenic injury were similar between groups. Other independent risk factors for these complications were older age, male sex, increased comorbidity, and undergoing the procedure in a hospital. Comment: Although the overall rate of complications was very low, the use of anesthesia services for diagnostic colonoscopy resulted in a higher risk for complications. These findings might result in part from confounding if patients who received anesthesia assistance were sicker or more prone to complications and were chosen to receive anesthesia for those reasons. Also, the data were from a period when propofol was sometimes administered by trained nurses rather than anesthesiologists, and the relative safety of this approach compared to anesthesia-administered services cannot be determined. Finally, these findings might be more pronounced in the types of patients included in this trial ( 65 years old), and whether the observed increased risk is present in younger or more healthy patients remains to be determined.

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In a simulation study, percent adequate chest compressions performed by in-hospital providers fell below 70% within 120 seconds in child and adult manikins.

 

The American Heart Association defines effective chest compression during cardiopulmonary resuscitation (CPR) as >100 compressions per minute at a depth >38 mm. In a prospective randomized crossover study, investigators compared quality of compressions and the work required to perform them on a 5-year old manikin and an adult manikin. Forty-five in-hospital healthcare providers performed single-rescuer continuous compressions for up to 10 minutes on both the child and adult manikins. A HeartStart MRx Monitor/Defibrillator was used to quantify compression rate and compression depth at 30-second intervals.

Mean chest compression rate remained above 100 per minute for both manikins. Mean compression depth decreased over the 10-minute period for both the child (41 to 34 mm) and adult (42 to 36 mm) manikins. Measured energy expended during CPR was comparable to that expended during running or swimming, and was about 15% greater for the adult than the child manikin. Over the 10-minute period, the percentage of adequate compressions fell from 85% to less than 40% for both manikins. Fewer than 70% of compressions were adequate by 90 seconds in the child and 120 seconds in the adult. Self-reported fatigue during the first 2 minutes was low in comparison to the decrease in compression quality.

Comment: Whether due to fatigue, declining vigilance, or other causes, providers perform high-quality CPR for only a brief period of time. These data support switching the person providing chest compressions every 2 minutes during resuscitation in adults and children.

 

Source: Journal Watch Emergency Medicine

 

Coccidioidomycosis on the Rise in the U.S.

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The incidence of coccidioidomycosis, or “valley fever,” increased eightfold in the endemic area of the U.S. from 1998 through 2011, according to MMWR. The endemic area comprises Arizona, California, Nevada, New Mexico, and Utah.

Analyzing data from the National Notifiable Diseases Surveillance System, CDC researchers found that the incidence in this region rose from 5.3 to 42.6 cases per 100,000 population over the study period. The increase was seen among all age groups, but those aged 60 and older were most affected.

Speculating on the reasons for the increase, MMWR‘s editors note thatCoccidioides spores, which live in the soil, might have spread readily because of drought, rainfall, temperatures, or construction activity. They also acknowledge that changes in disease surveillance might have affected the numbers. Nonetheless, they conclude that clinicians “should be aware of this increasingly common infection when treating persons with influenza-like illness or pneumonia who live in or have traveled to endemic areas.”

Source: MMWR

 

Study Finds Concerns Around Current Infection Control Practices.

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Multidrug-resistant Mycobacterium abscessus is frequently transmitted between patients with cystic fibrosis, suggesting that current infection control is not adequate, according to a Lancet study.

Researchers analyzed 168 isolates from 31 patients with pulmonary M. abscessus infection at a U.K cystic fibrosis center. Within clusters ofM. abscessus subspecies massiliense, isolates from different patients were often more closely related to each other than were isolates from within a single individual, suggesting transmission of the bacteria between patients. In addition, some isolates were resistant to macrolides and aminoglycosides in patients previously unexposed to those antibiotics, supporting the notion of cross-infection. The authors say transmission is likely occurring indirectly, such as through fomite contamination or lung function testing.

The authors conclude that their findings raise “several important questions about current infection control measures used in treatment centers, the potential for cross-infection in other patient groups and with other … species, and whether mandatory notification of infections with M. abscessus complex and routine whole genome sequencing might be required to identify and control the spread.”

Source: Lancet 

 

Does Acupuncture Improve Symptoms of Allergic Rhinitis?.

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Acupuncture is associated with some improvements for patients with seasonal allergic rhinitis, but these improvements are not clinically relevant, according to a study in the Annals of Internal Medicine.

Some 420 patients were randomized to 8 weeks of acupuncture, sham acupuncture, or no acupuncture. Actual acupuncture was associated with a statistically significant improvement in the primary outcome measure, mean change from baseline in the 6-point Rhinitis Quality of Life Questionnaire score. However, there were no clinically significant differences across the groups.

Source: Journal Watch General Medicine