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Medical News You May Have Missed - Week of March 18th


Antidepressants and pre-term delivery; annual BP check?; stroke before age 50; niacin questioned; incretins and pancreatic disease

Meta-Analysis: Antidepressant Use During Pregnancy Increased Pre-Term Delivery

Women who continued use of antidepressant medications during their pregnancies had an increased risk for preterm delivery and low birth weight, according to a meta-analysis titled Selected Pregnancy and Delivery Outcomes After Exposure to Antidepressant Medication and published online in JAMA: Psychiatry. However, the researchers emphasized that the increased risk was small and that physicians and patients “must weigh the effect of untreated maternal depression against the potential adverse effects of antidepressant exposure.”

The researchers included 23 studies that reported outcomes associated with pharmacologic treatment during pregnancy.

Analysis of data from 13 studies that looked at the association between antidepressant use and preterm delivery, an increased pooled odds ratio of 1.55 (P<.001) for preterm delivery was found for women who used antidepressants compared with those who did not. A similar association was found for antidepressant use and risk for young gestational age, with women on antidepressants having a mean difference of -0.45 weeks (P<.001).

Finally, antidepressant use was associated with a mean difference of -74 grams birth weight compared to women who were not on antidepressants. However, when women on antidepressants were compared with women with depression no association with decreased birth weight was found.

“In contrast, the results for gestational age, preterm delivery, and Apgar scores (at 1 and 5 minutes) were similar whether the control group was all mothers or only depressed mothers, although the sample size was reduced for the latter comparison,” the researchers wrote. “This similarity suggests that exposure to antidepressants may be the determining factor for these detrimental pregnancy and delivery outcomes.”

The study abstract can be read here.

Click here for the next article.


Study Suggests Utility of Annual BP Check

Measuring a patient's blood pressure once a year instead of at every visit would reduce the rate of false-positive results in patients who do not have hypertension and eliminate the need for further workup in many patients, according to a recent study.

Researchers at the Mayo Clinic conducted a retrospective case control study of 68 patients who had hypertension and 372 patients who did not. During a 5-year period, 4287 blood pressure measurements were recorded; 29.6% of patients who did not have hypertension were found to have had at least 1 blood pressure reading higher than 140/90 mmHg.

“Prompt antiviral therapy in newborns that begins within days of exposure may help infants clear the virus and achieve long-term remission without lifelong treatment by preventing such viral hideouts from forming in the first place,” said Deborah Persaud, MD, Johns Hopkins Children's Center virologist and lead author on the report.

Almost 40% of the blood pressure readings would be retained with an annual screening strategy. In addition, when screened once a year, only 18% of patients who did not have hypertension had a measured blood pressure higher than 140/90 mmHg. However, the annual screening method would not have identified 7.4% of patients with hypertension on or before their diagnosis.

Specificity was 82% for annual reading compared with 70.4% for usual practice. There was no difference in sensitivity between the methods.

The researchers noted that there is a difference “between obtaining a blood pressure reading for hypertension screening purposes and obtaining a blood pressure reading because it is clinically relevant.”

The study, Screening For Hypertension Annually Compared With Current Practice, was published in Annals of Family Medicine.

Click here for the next article.


Stroke at Young Age Ups Risk for Death

Patients who experience stroke at age 50 years or younger had a significantly increased risk for mortality compared with the expected mortality in the general population, according to data from the Follow -Up of Transient Ischemic Attack and Stroke Patients and Unelucidated Risk Factor Evaluation (FUTURE) study, published in the Journal of the American Medical Association. In fact, depending on the type of event, stroke at an earlier age increased mortality at least threefold.

The study, conducted in the Netherlands, looked at 959 adults aged 18 to 50 years who experienced transient ischemic attack (TIA; n=262), ischemic stroke (n=606), or hemorrhagic stroke (n=91). During the mean 11-year follow-up period, 20% of patients died.

The researchers calculated the 20-year risk for death among stroke patients who survived 30 days or more. For TIA, the 20-year mortality risk was 24.9%; 29 patients had died, while only 11.2 deaths were expected, translating into a standardized mortality ratio (SMR) of 2.6 (P<.001).

These numbers only increased for ischemic and hemorrhagic stroke. Nine patients died from hemorrhagic stroke compared with 2.3 expected deaths (SMR=3.9; P<.001) and 111 died from ischemic stroke compared with 28.6 expected deaths (SMR=3.9; P<.001).

“To minimize the higher-than-expected mortality, the underlying cause of the stroke (eg, atherosclerosis, atrial fibrillation, valvular heart disease) and cause of the symptomatic cardiovascular disease (eg, hypertension, smoking, alcohol abuse) need to be diagnosed accurately at presentation, treated appropriately, and, if possible, eliminated,” wrote editorialists commenting on the study. “If elimination of the cause is not possible, long-term follow-up and control of the disease and its risk factors need to be maintained vigilantly.”

Read the study abstract.
Read a preview of an accompanying editorial.

Click here for the next article.


Reconsider Use of Niacin in Patients with Heart Disease

Patients taking niacin/laropiprant (Tredaptive) may have reason to stop treatment. The combination of niacin with the anti-flushing agent laropiprant was found to provide no benefit to patients with vascular disease, and may even have some harmful adverse effects, according to data from the HPS2-THRIVE study presented last weekend at ACC.2013 in San Francisco.

The study, which included more than 25,000 patients, indicated that patients receiving the combination drug had a similar number of major vascular events as patients receiving placebo (13.2% vs. 13.7%; P=0.29).

In addition, patients taking niacin/laropiprant experienced an increased rate of several adverse events:

• Excess bleeding: 2.5% vs. 1.9%

• Infections: 8% vs. 6.6%

• New onset diabetes: 9.1% vs. 7.3%

• Diabetic complications: 11.1% vs. 7.5%

• Gastrointestinal problems: 4.8% vs. 3.8%

• Skin issues: 0.7% vs. 0.4%

Merck, the manufacturer of the drug, suspended worldwide availability in January after preliminary results of the HPS2-THRIVE study were announced in December.

The study identified 190 unique diagnostic errors, defined as missed, delayed, or wrong diagnoses at a large Veterans Affairs facility and a large private health care system. Of the 190 cases, 68 unique diagnoses were missed including pneumonia (6.7%), decompensated congestive heart failure (5.7%), acute renal failure (5.3%), cancer (5.3%) and urinary tract infection (4.8%).

The abstract presented at ACC is available here.

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FDA Investigating Pancreatic Risk Associated with Type 2 Diabetes Drugs

On March 14, the FDA announced that it is evaluating research that suggests an increased risk for pancreatitis and pancreatic duct metaplasia in patients with type 2 diabetes treated with incretin mimetics such as:

• Exenatide (Byetta, Bydureon)
• Liraglutide (Victoza)
• Sitagliptin (Januvia, Janumet, Janumet ZR, Jivisync)
• Saxagliptin (Onglyza, Kombiglyze XR).
• Alogliptin (Nesina, Kazano, Oseni)
• Linagliptin (Tradjenta, Jentadueto)

The investigation is based on unpublished research from a study of a small number of pancreatic tissue specimens taken from patients after death from unspecified causes.

Currently, no new conclusions about the safety of these drugs have been reached. The FDA has requested methodology used to collect and study these specimens, and the tissue samples used, so it can further investigate.

The FDA said that health care professionals should continue to follow the prescribing recommendations in the drug labels, but they are also encouraged to report adverse events or side effects to the FDA.

To report issues:
• Complete and submit the report online: www.fda.gov/MedWatch/report.htm
• Download form (link below) or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm

Read the FDA Safety Alert.

Click here to return to the first article.


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