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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
June 18, 2016

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More Evidence for Checking Vitamin D Levels in Inflammatory Bowel Disease
The Newest Antibiotics on the Block
The Benefits and Detriments of Salt: It's Complicated
WHO Agency: Very Hot Beverages Probably Are Carcinogenic
High Prevalence of Iron Deficiency Without Anemia in Girls with Heavy Menses
FDA Strengthens Warnings on Two Diabetes Drugs
I'll Have That on Whole Wheat: More Evidence for Whole Grains' Health Benefits
C. difficile Infection Is Associated with Poor Outcomes in Ulcerative Colitis
Abortion Around the World
Small Febrile Seizure Risk Seen After Several Co-administered Vaccines
A Potassium-Competitive Acid Blocker in Helicobacter pylori Therapy

Am J Gastroenterol 2016 May; 111:712
More Evidence for Checking Vitamin D Levels in Inflammatory Bowel Disease
In IBD patients with low vitamin D levels, vitamin D supplementation reduced healthcare utilization.
Low vitamin D levels have been implicated as a risk factor for worse disease course in inflammatory bowel disease (IBD). To further examine this issue, investigators conducted a 5-year longitudinal study involving 965 IBD patients (62% with Crohn disease, 38% with ulcerative colitis).
Vitamin D deficiency was present in 8.9% of patients at study entry and was highest in young males. During the 5-year follow-up, patients with low vitamin D levels required significantly more steroids, biologic initiation, narcotics for pain control, computed tomography scans, emergency department visits, hospitalizations, and surgery than did those with normal vitamin D levels. Patients with low vitamin D levels had no evidence of higher inflammatory markers, such as C-reactive protein or erythrocyte sedimentation rate, and no poorer treatment compliance or fewer clinic visits.
To control for the effect of disease severity on vitamin D levels, the investigators conducted a subgroup analysis of patients in clinical remission at study entry. In this group, more patients with low versus normal vitamin D levels required steroids (51% vs. 37%) and IBD-related surgery (34% vs. 22%). Moreover, patients with low vitamin D levels who had vitamin D supplementation progressively reduced their healthcare utilization during the 5 years of follow-up, whereas those with low vitamin D levels who did not receive supplementation increased their healthcare utilization.
COMMENT: The importance of the study lies in the longitudinal 5-year follow-up. Given that vitamin D supplementation is both benign and inexpensive, and despite the persistent possibility of confounders in studies of this type, it seems reasonable to systematically check vitamin D levels in IBD patients and supplement as appropriate.
CITATION(S): Kabbani TA et al. Association of vitamin D level with clinical status in inflammatory bowel disease: A 5-year longitudinal study. Am J Gastroenterol 2016 May; 111:712.

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Ann Intern Med 2016 May 31
The Newest Antibiotics on the Block
A critical study finds that most are high priced “me-too” drugs.
The explosion of multidrug-resistant bacteria has challenged the ingenuity not only of clinicians but also of policy makers. One proposed policy solution was a “10 by 20” initiative sponsored in 2010 by the Infectious Disease Society of America, calling for the release of 10 new antibiotics by 2020. We are well on our way toward that goal, with 8 new antibiotics approved by the FDA since 2010. Researchers have now compiled a group portrait of these new agents.
Four new agents have been approved for skin infections (ceftaroline, dalbavancin, tedizolid, and oritavancin), two for complicated intra-abdominal or urinary tract infections (ceftolozane-tazobactam and ceftazidime-avibactam), one for C. difficile infection (fidaxomicin) and one for drug-resistant tuberculosis (bedaquiline); ceftaroline was also approved for community-acquired pneumonia. All the new agents but bedaquiline are members of established drug classes. Clinical trials took from 5 to 9 years (median, 6.2) and fast-track FDA approval for all eight drugs took about 8 months. Almost all the drug approvals were based on noninferiority trials in fewer than 1000 patients. Prices for seven of the new agents are considerably higher than for their comparator drugs, ranging from twice as high to almost 6000 times higher. The one exception is tedizolid, which costs about the same as its comparator linezolid.
COMMENT: The authors' conclusion is brief and telling: “recently approved antibiotics have generally been lacking in biological innovation or public health importance.” They fault the “me-too” pattern of drug development, the vague clinical outcomes selected as endpoints in most of the premarketing trials, and the premium pricing despite unclear evidence of improved clinical benefit.
CITATION(S): Deak D et al. Progress in the fight against multidrug-resistant bacteria? A review of U.S. Food and Drug Administration–approved antibiotics, 2010–2015. Ann Intern Med 2016 May 31; [e-pub].
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Lancet 2016 May 20
The Benefits and Detriments of Salt: It's Complicated
The effects differ between those with and without hypertension.
Controversy surrounds recommendations about sodium consumption. In a pooled analysis of four partially manufacturer-supported studies involving 133,118 individuals from 49 countries (roughly half hypertensive and half normotensive), investigators sought to define the relationship between sodium intake and cardiovascular events. The study group comprised participants in four prospective studies for whom measures of 24-hour urinary sodium excretion were available. These measures were used to infer intake. The median follow-up was 4.2 years.
The results varied by hypertension status: higher sodium intake was most strongly associated with higher systolic blood pressure in those with hypertension, although the association was positive in both groups. Higher sodium intake (sodium excretion, ≥7 g/day) was associated with higher risk for all-cause death and major cardiovascular events only in those with hypertension. Lower sodium intake (excretion, <3 g/day) was associated with increased risk for death and major cardiovascular events in both those with hypertension and those without.
COMMENT: This large, international study shows interesting complexity in the relationship of sodium intake to risk. Lower intake was a consistent risk-raising factor, whereas higher intake was a risk factor only for those with hypertension. In an era of precision medicine, these findings raise questions regarding our ability to determine why risk is associated with sodium intake in some and, ultimately, our ability to determine individual risk. A one-size-fits-all approach may not serve everyone, and for now, these results suggest that people with hypertension have the most to gain by avoiding high-sodium diets.
CITATION(S): Mente A et al. Associations of urinary sodium excretion with cardiovascular events in individuals with and without hypertension: A pooled analysis of data from four studies. Lancet 2016 May 20; [e-pub].
O'Brien E.Salt — too much or too little? Lancet 2016 May 20; [e-pub]. (http://dx.doi.org/10.1016/S0140-6736(16)30510-4)
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WHO Agency: Very Hot Beverages Probably Are Carcinogenic
By Amy Orciari Herman, Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
Drinking very hot beverages — above 65 degrees Celsius (149 degrees Fahrenheit) — probably causes esophageal cancer, according to the latest findings from a working group for the World Health Organization's International Agency for Research on Cancer (IARC).
The conclusion, the group notes, was based on limited epidemiologic evidence in humans, with most studies conducted in places where tea or maté tends to be drunk particularly hot (e.g., China, South America). Writing in the Lancet Oncology, the IARC researchers say that "biological plausibility exists for an association between very hot beverages and cell injury and the sequelae that might lead to cancer."
The good news: the researchers have downgraded coffee as a carcinogen. On the basis of more than 1000 studies, the group concluded that coffee is "unclassifiable as to its carcinogenicity to humans" — a substantial shift from 1991, when the IARC said that coffee was "possibly carcinogenic."
Iced coffee, anyone?
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J Pediatr Adolesc Gynecol 2016 Jun 1
High Prevalence of Iron Deficiency Without Anemia in Girls with Heavy Menses
Half of girls evaluated for heavy menstrual bleeding had iron deficiency, and >50% of these had normal hemoglobin and mean corpuscular volume levels.
The CDC recommends that adolescents with extensive menstrual blood loss be screened annually for anemia. How often do such women have iron deficiency without anemia? To find out, investigators from a hematology clinic for young women retrospectively reviewed data from 114 consecutive patients aged 9–19 years who were referred for evaluation of heavy menstrual bleeding. All patients had complete blood counts (CBCs) and serum ferritin levels taken. Results were as follows:

COMMENT: Because these data are from a referral population with a high prevalence of underlying hematologic abnormalities, it's unclear how generalizable they are to general pediatric practice. Furthermore, there is no uniform agreement as to the ferritin level that defines iron deficiency (the CDC uses 15), and the study does not include data about the red blood cell definition width, a standard part of automated blood counts. Nonetheless, I think these data are provocative, and I would be inclined to check a ferritin level even if the CBC is normal in women who have many months of heavy bleeding, other symptoms such as fatigue, or other risk factors for iron deficiency (being obese/overweight or vegetarian).
Note to readers: At the time NEJM Journal Watch reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.
CITATION(S): Johnson S et al. Iron deficiency without anemia: A common yet under-recognized diagnosis in young women with heavy menstrual bleeding. J Pediatr Adolesc Gynecol 2016 Jun 1; [e-pub].
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FDA Strengthens Warnings on Two Diabetes Drugs
By Kristin J. Kelley, Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
Two drugs used to treat type 2 diabetes — canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)
—  are associated with an increased risk for acute kidney injury, cautions the FDA. The language on the existing labels for both sodium-glucose cotransporter-2 (SGLT2) inhibitors will be revised to include more information on this risk and ways to minimize it.
There have been 101 "confirmable" cases of acute kidney injury reported to the FDA from March 2013 to October 2015. Hospitalization was required in 96 cases; 4 patients died. Additionally, 15 required dialysis.
Patients taking canagliflozin and dapagliflozin should be advised to seek medical attention if they notice symptoms of acute kidney injury (e.g., decreased urine, swelling in the legs or feet). The FDA also advises clinicians to evaluate renal function before treatment starts, and then continue to monitor it periodically.
In recent weeks, the agency announced it is investigating a possibly increased amputation risk for patients on canagliflozin. Additionally, late last year, all SGLT2-inhibitor labels were updated to warn of risks for ketoacidosis and serious urinary tract infections.

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I'll Have That on Whole Wheat: More Evidence for Whole Grains'
Health Benefits

By Amy Orciari Herman, Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
A large meta-analysis in The BMJ strengthens the evidence supporting the connection between whole grain intake and better health outcomes.
Researchers examined data from 45 prospective cohort studies evaluating grain intake and numerous disease and mortality outcomes. Overall, an increase in whole grain intake of three servings per day was associated with a significant, 16% reduction in risk for coronary heart disease (CHD), a 13% reduction in cardiovascular disease, and a 15% reduction in total cancer. Whole grain intake was also associated with significant reductions in all-cause mortality and mortality from CHD, stroke, cardiovascular disease, and cancer.
The authors point to several possible mechanisms underlying whole grains' protective effects — for example, the high fiber content can lead to better glycemic control. They conclude that their findings "support dietary recommendations to increase intake of whole grains and as much as possible to choose whole grains rather than refined grains."
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Am J Gastroenterol 2016 May; 111:691.
C. difficile Infection Is Associated with Poor Outcomes in Ulcerative Colitis
Risks for colectomy, mortality, and postoperative complications after colectomy were elevated in patients with UC who developed C. diff infection.
In the current population-based study from Alberta, Canada, researchers examined risk for Clostridium difficile infection and its effect on outcomes in ulcerative colitis (UC), following 1754 patients with a new diagnosis of UC. Patients with a prior diagnosis of C. difficile infection were excluded.
The 5-year cumulative risk for developing C. diff infection in the cohort was 3.4%. The remaining results, adjusted for disease severity, were as follows:

COMMENT: As the authors suggest, special efforts should be made to eradicate C. difficile infections in patients with ulcerative colitis, including fecal microbiota transplantation in patients with multiple recurrences.
CITATION(S): Negrón ME et al. Ulcerative colitis patients with Clostridium difficile are at increased risk of death, colectomy, and postoperative complications: A population-based inception cohort study. Am J Gastroenterol 2016 May; 111:691.
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Lancet 2016 May 11
Abortion Around the World
Legal restrictions do little to reduce abortion rates.
In the U.S., induced abortion poses minimal risks to women's health; however, in countries where abortion is illegal, complications are common. In 2012, 6.9 million women worldwide received treatment for complications of unsafe abortion. To examine changes in global rates of abortion over the last 20 years, as well as the effects of legal restrictions on abortion, investigators compiled data from multiple international sources for 1069 country-years.
Among women of reproductive age (range, 15–44), an estimated 35 abortions per 1000 women worldwide occurred annually in 2010–2014, compared with 40 per 1000 women in 1990–1994. However, because of population growth, the absolute annual number of abortions rose from 50 million to 56 million. From 2010 to 2014, the abortion rate was lowest in North America (17 per 1000 women), while in developing countries the rate was 37 per 1000 women and in the Caribbean the rate was 65 per 1000 women. In the 58 countries that prohibit abortion or allow the procedure only to save a woman's life, the abortion rate was 37 per 1000 women; for the 63 countries in which abortion is legal on request, the rate was 34 abortions per 1000 women.
COMMENT: These data provide a stark reminder that legal restrictions on abortion do little to reduce abortion rates, but dramatically raise risk for abortion complications. Although increasing access to highly effective contraception has been clearly shown to reduce rates of abortion, few of the 24 U.S. states with targeted restrictions on abortion provision have made access to contraception a priority.
CITATION(S): Sedgh G et al. Abortion incidence between 1990 and 2014: Global, regional, and subregional levels and trends. Lancet 2016 May 11; [e-pub].
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10-Small Febrile Seizure Risk Seen After Several Co-administered Vaccines
By Kelly Young
Trivalent inactivated influenza vaccine — when coadministered with either a diphtheria-tetanus-acellular-pertussis (DTaP)-containing vaccine or pneumococcal conjugate vaccine (PCV) — carries a small but significantly increased risk for febrile seizure in young children, suggests a Pediatrics study.
Using a vaccine safety database, researchers studied over 300 confirmed febrile seizure cases following vaccination from 2006 to 2011 among children aged 6 to 23 months. Children whose seizure occurred 14 to 20 days after the vaccine made up the control group, and those whose seizures occurred within 24 hours of vaccination served as the risk group.
When the flu vaccine was administered with DTaP, the seizure risk was 24 per 100,000 vaccinated people; when given with PCV, the risk was 16 per 100,000. When all three were given together, the risk reached 30 per 100,000. Editorialists write that the average pediatrician could expect to see one febrile seizure every 5 to 10 years following vaccine coadministration.
Dr. Deborah Lehman of NEJM Journal Watch Pediatrics and Adolescent Medicine comments: "The benefits of vaccines clearly outweigh the small increased risk of febrile seizure following vaccination, and delayed administration of vaccines increases the risk of preventable infections."
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Am J Gastroenterol 2016 May 17
A Potassium-Competitive Acid Blocker inHelicobacter pylori Therapy
Eradication was greater with a triple therapy based on a potassium-competitive acid blocker than with a PPI-based triple therapy.
Standard proton-pump inhibitor (PPI)–based triple therapy for Helicobacter pylori eradication has demonstrated decreasing efficacy as antibiotic resistance increases. Investigators retrospectively compared the eradication of H. pylori in 175 propensity-score–matched pairs of patients treated in a single Japanese hospital during a 34-month period. All patients received amoxicillin 750 mg and clarithromycin 200 mg twice daily for 7 days. In addition, one group received a PPI (lansoprazole 20 mg or rabeprazole 30 mg), and another received a potassium-competitive acid blocker (P-CAB; vonoprazan 20 mg), each twice daily for 7 days. H. pylori eradication was evaluated by a breath test or stool antigen test.
The eradication rate was significantly higher in the P-CAB group compared with the PPI group in both the intention-to-treat analysis (89% vs. 71%) and the per-protocol analysis (91% vs. 72%). More skin rashes occurred in the P-CAB group, but no severe adverse effects occurred.
COMMENT: Although promising, the results of this small, single-center study need to be replicated in other settings to determine if a P-CAB is more effective than a PPI in H. pylori treatment. Of note, the recent Toronto consensus conference recommended that all first-line therapy should last for 14 days and that clarithromycin should only be used in areas with very low resistance (NEJM JW Gastroenterol Jul 2016 and Gastroenterology 2016 Apr 18; [e-pub]). If P-CABs are to have a place in H. pylori therapy, additional trials will be needed in which they are combined with other antibiotic regimens for longer durations.
CITATION(S):Suzuki S et al. The efficacy and tolerability of a triple therapy containing a potassium-competitive acid blocker compared with a 7-day PPI-based low-dose clarithromycin triple therapy. Am J Gastroenterol2016 May 17; [e-pub].

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