Early Administration of Azithromycin and Prevention of Severe Lower Respiratory Tract Illnesses in Preschool Children With a History of Such Illnesses

The goal of this study was to determine if early administration of azithromycin in preschool children suffering from recurrent lower respiratory tract infections would effective at preventing the progression of the infection.

The study was a randomized, double-blind, placebo controlled parallel study taking place across 9 centers in the US. There were 607 patients, ranging in age from 12-71 months old, with past history of recurrent respiratory infections. Patients either received 12mg/kg daily of azithromycin or a placebo at the onset of infection sympthoms, with the clinical endpoint being the number of infections not progressing to a severe level.

The study concluded that the azithromycin treatment significantly reduced the risk of progression of the infection, with a hazard ratio of 0.64, and a risk difference of developing the first infection between the azithromycin group and the placebo group of 0.03. The patients treated with azithromycin infrequently experienced any adverse side effects from the treatment.

This study is interesting to me because it seems that many respiratory infections can be prevented early on if treated with azithromycin, reducing the suffering of the child and saving the patient and the healthcare system money, which is desirable for all parties. It is also useful to know for a fact that this particular antibiotic is successful in treating these types of infections so that an appropriate drug therapy can be chosen from the start instead of having to try multiple different antibiotics.

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PPI–clopidogrel interaction a concern after stent placement

The goal of this study was to determine if there was an increased risk of adverse cardiac events in patients with DM2 who were using clopidogrel and a PPI concomitantly following drug-eluting stent placement(DES).

There were roughly 10,000 patients in this study, with the clinical endpoints of the study being whether patients with DES who were either using clopidogrel alone or in combination with a PPI experienced acute coronary syndrome and readmission to the hospital due to revascularization after 3,6, or 12 months.

The researchers found that patients using the combination of drugs had a 6 month hazard ratio of 1.63 and a 12 month hazard ratio of 1.37. Patients who had previous history of acute coronary syndrome who received the drug combination were at a higher risk of ACS following stent placement(1.55 times more likely) than those who received clopidogrel alone.

I think this study is very interesting because many patients will be using a PPI while also using an anti-platelet drug such as clopidogrel. What is also concerning is that if patients are not counseled on the increased risk of ACS when combining these two drugs, patients can elect to purchase an OTC PPI on their own, and may unknowingly subject themselves to this risk. I think that this drug interaction may be an important point for pharmacsists to counsel on when first dispensing clopidogrel to patients.

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Study confirms phenylephrine ineffective for nasal congestion

The goal of this study was to determine if phenylephrine, a widely used nasal decongestant, is effective at the 10mg dose in adults with seasonal allergic rhinitis(SAR).

The study was a multicenter, parallel, open label trial with randomized conditions and 540 participants, all of whom were adults with SAR but were in otherwise good health. The patients were subjected to 7 days of treatment with either 1omg tablets of PE(daily dose ranging from 10-40mg) or with a placebo. The clinical endpoint was the mean change from baseline in reflective nasal congestion score.

The results of the study were that none of the different groups(10mg, 20mg, 30mg, or 40mg daily) had a statistically significant change from baseline congestion. The study also found that PE was tolerated in daily doses up to 30mg, with 18.4% of patients experiencing an adverse reaction to treatment, the most common being headache(3.0%).

This study is interesting to me as many people commonly use OTC decongestants that contain phenylephrine, however this study seems to suggest that they will not be seeing any real effect from its use. As pharmacists, we can use the information from this study to suggest patients use a different OTC decongestant that is more likely to produce an actual effect.

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Specific SSRIs and birth defects: bayesian analysis to interpret new data in the context of previous reports

The focus of this study was to reanalyze previous studies using Bayesian analysis to determine which SSRIs, if any, were associated with different types of birth defects.

The study took place across 10 centers in the U.S., with almost 18,000 mothers of infants who did not experience birth defects and almost 10,000 mothers of infants who did experience birth defects. The study then looked to see if these mothers had used citalopram, escitalopram, fluoxetine, paroxetine, or sertraline in the month before pregnancy through the third month of pregnancy. The study was adjusted to take into accound race/ethnicity, education level, smoking, and obesity of the mother.

The study concluded that the most commonly used SSRI was sertraline, but no birth defects could be correlated to the use of this drug. There were also no defects strongly correlated with citalopram or escitalopram. The researchers concluded that some birth defects did occur 2-3.5 times more frequently in the infants of women using paroxetine or fluoxetine early in pregnancy.

This study is interesting to me, as it gives us a better guideline of which SSRIs are safer to use in pregnant women. If the switch from one type of SSRI can dramatically reduce the risk of birth defect, I think most mothers would be happy to know this and would be very likely to switch medications.

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Primary prevention with lipid lowering drugs and long term risk of vascular events in older people: population based cohort study

The objective of this study was to determine if the use of statins or fibrates in an older population with no history of cardiovascular events affected the risk of coronary heart disease and stroke. The study used a random sample of 7484 individuals(63% female) aged 65 or older from three french cities.

The study found that those using either drug were at a decreased risk of stroke compared to those not using a lipid lowering drug, however no association was found between those using either drug and a decreased risk of coronary heart disease. The researchers analyzed the data based on age, sex, body mass index, and hypertension amongst other variables, and found that overall there was a 30% decrease in risk of stroke for those using a lipid lowering drug.

I think this study is important for understanding the use of statins and fibrates. With the data from this study, there appears to be a clear indication for the use of statins or fibrates for stroke prevention, however there doesn’t seem to be an indication for the use of either drug in prevention of coronary artery disease. With this knowledge, we can help prevent drug therapy problems and recommend that different drugs should be used to prevent coronary heart disease.

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New Option for Gout

As of December 22, 2015, the FDA has approved the use of Zurampic (lesinurad) to treat hyperuricemia (high uric acid levels in the blood), when it is used concomitantly with a xanthine oxidase inhibitor.

The drug helps the kidneys excrete excess uric acid by inhibiting transporters in the kidney that aid in uric acid reabsorption.  The drug was tested in 3 randomized, placebo controlled studies over the course of 12 months. The trial involved over 1500 patients. Patients received the drug in combination with a xanthine oxidase inhibitor for the duration of the study. The study showed that those treated with the new drug, in combination with an XOI, had reduced serum uric acid levels.

The most common side effects of the new drug include headache, influenza, and acid reflux, however the new drug comes with a black box warning about the possibility of acute renal failure while using the drug.

I think the announcement of a new antigout medication is exciting, as there are over 3 million new cases of the disease per year in the U.S.(per Mayo Clinic Website). I think it will be interesting to see how the new drug fairs against competitors such as colchicine, both in sales and in efficacy, and what information will be obtained for the postmarketing study of the drug.

Link to press release


Link to package insert

Melatonin Supplementation for Children With Atopic Dermatitis and Sleep Disturbance

Difficulty sleeping is commonplace for children with atopic dermatitis, a condition similar to eczema that causes itchy inflammation of the skin. It has been found that children suffering from AD have decreased levels of nighttime melatonin. Because melatonin has both sleep-inducing and anti-inflammatory properties, the researchers in this study hypothesized that melatonin may be an effective treatment for pediatric patients suffering from AD.

The researchers used a randomized, double blind, placebo-controlled study involving patients aged 1-18 who had AD affecting at least 5% of their total body surface area. patients received either 3mg daily of melatonin or placebo for four weeks. The primary outcome of AD severity was measured using the SCORAD index, and the secondary outcome of sleep impact was measured using actigraphy and polysomnography, as well as urinalysis of sulfatoxymelatonin, the byproduct of melatonin metabolism.

After treatment, the SCORAD mean score dropped by 9.1, and the sleep-onset time dropped by 21.4 minutes on average. Importantly, no adverse effects were reported during the trial.

This study is interesting for patients looking for an OTC solution to both atopic dermatitis as well as sleep issues. The fact that no adverse events occured helps to support the conclusion that melatonin is not only an effective and cheaper solution to two issues as once, but it is also a safe solution in the pediatric population. This knowledge will be useful for us to know in the future, as over 3 million cases of AD are diagnosed annually(Source: Mayo Clinic)


Association between use of warfarin with common sulfonylureas and serious hypoglycemic events: retrospective cohort analysis

This study aimed to answer the question of whether or not concurrent use of warfarin with a sulfonylurea such as glipizide or glimepiride led to an increased risk of hypoglycemia among a geriatric population. The study took a sample from medicare patients aged 65 or older who used the two medications simultaneously, and the outcome measurement was emergency room or hospital visit with a primary diagnosis of hypoglycemia. The rate of admission of patients using sulfonylurea/warfarin concurrently was then compared to the rate of hospitalization in patients only using sulfonylureas. The study found that persons using the two medications concurrently were 1.22 times more likely to be hospitalized with hypoglycemia(95% confidence interval) and were 1.47 times more likely to be hospitalized with a fall related fracture(95% confidence interval).

Because these medications are so commonly used together in older adults, with over 70,000 patients filling a script for both medications between 2006-2011, it will be important as pharmacists/pharmacy technicians to make a point to our patients that there is an increased risk of hypoglycemia and fall related fracture when taking these two medications concurrently. By providing this information to our patients, we can help prevent hospitalizations that cost the healthcare system large amounts of money each year.

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