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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
August 20, 2016

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Calcium Supplements Linked to Dementia Risk in Women with Cerebrovascular Disease
Eating Oily Fish Twice Weekly Might Help Prevent Diabetic Retinopathy
Revascularization Associated with Better Function in Intermittent Leg Claudication
Cholesterol-Lowering PCSK9 Inhibitors Way Too Expensive
Eleven-Year Outcomes in the Early Treatment of MS
Long-Term History of Treated MS at a Single Academic Center
Prenatal Acetaminophen Use Linked to Behavioral Problems in Offspring, Study Suggests
FDA Catches China's Zhejiang Medicine hiding Active Pharmaceutical Ingredient Test Data
European Medicines Agency Nails Artemis India Plant Over Simvastatin Active
  Pharmaceutical Ingredient Manufacturing Issues
Diagnoses of Early-Stage Prostate Cancer fell after USPSTF Recommendation

Calcium Supplements Linked to Dementia Risk in Women with
Cerebrovascular Disease

By Amy Orciari Herman, Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
Calcium supplementation is associated with increased risk for dementia in women with cerebrovascular disease, according to a small, observational study in Neurology.
Using Swedish registries, researchers followed 700 women aged 70 to 92 without dementia at baseline. Roughly 14% were using calcium supplements at baseline, and about half were still doing so at follow-up 5 years later.
Some 59 women developed dementia during the study. Calcium use at baseline was associated with increased risk for dementia -- but only among women with a history of stroke (odds ratio, 6.8) and those with white matter lesions on CT scans (odds ratio, 3.0).
Among the potential mechanisms, the authors note: "The steep increase in serum calcium levels after calcium supplementation might lead to increased coagulability, lipohyalinosis, or altered vascular flow." They also point out that calcium has a major role in the processes underlying cell necrosis.
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Eating Oily Fish Twice Weekly Might Help Prevent Diabetic Retinopathy
By Amy Orciari Herman, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
Consumption of 500 mg/day of long-chain omega-3 polyunsaturated fatty acids — the equivalent of 2 servings/week of oily fish — might confer lower risk for diabetic retinopathy in middle-age and older adults, according to a subanalysis from a randomized trial in JAMA Ophthalmology.
Researchers in Spain studied nearly 3500 adults (average age, 68) with type 2 diabetes who were assigned to follow a Mediterranean diet or a low-fat control diet. At baseline, 75% were consuming at least 500 mg/day of omega-3 fatty acids.
During 6 years’ follow-up, 69 participants developed diabetic retinopathy. After adjustment for confounders (including randomized dietary intervention), those consuming 500 mg/day of omega-3s at baseline had a 48% lower risk for developing sight-threatening diabetic retinopathy than those consuming less.
The authors note that long-chain omega-3s are a substrate for oxylipins, which have anti-inflammatory and antiangiogenic properties. The retina is rich in omega-3s, but the amount depends on one’s intake.
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Revascularization Associated with Better Function in Intermittent Leg Claudication
By Kelly Young, Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
In patients with intermittent leg claudication, revascularization may lead to greater gains in function, symptoms, and quality of life than medical therapy. The findings appear in JAMA Surgery.
Researchers enrolled roughly 325 patients with moderate-to-severe intermittent claudication. Nearly 90% received a medical intervention, which included a walking program, smoking cessation counseling, and medication. The rest received revascularization.
At 12 months’ follow-up, both groups reported improvements in function, symptoms, and quality of life, but the revascularization group saw bigger gains. For instance, the revascularization group scored 20 points better on 100-point scales in both distance and pain.
The authors conclude: “Although our findings suggest that revascularization interventions may be a superior alternative to more conservative approaches, caution is warranted. These procedures are expensive, frequently require reintervention, and in the long run carry a substantial risk of worse outcomes in the patient.
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Cholesterol-Lowering PCSK9 Inhibitors Way Too Expensive
By Joe Elia, Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
Drugs known as PCSK9 inhibitors, although effective at lowering LDL cholesterol, are too expensive to be cost-effective, a JAMA analysis finds.
Researchers used 2015 drug prices and national health data to construct models of cost effectiveness in two groups approved for using PCSK9 inhibitors: people with heterozygous familial hypercholesterolemia and those with atherosclerotic cardiovascular disease. PCSK9 inhibitors cost roughly $15,000 per year wholesale.
Compared with adding ezetimibe to statin therapy over the patients' lifetimes, adding PCSK9 inhibition in familial hypercholesterolemia would prevent over 300,000 additional cardiovascular deaths, nonfatal heart attacks, and strokes — but at cost of over $500,000 per quality-adjusted life-year (QALY). Similarly, in atherosclerotic disease, over 4 million serious events would be averted, but would cost over $400,000 per QALY.
The authors point out that achieving a QALY of $100,000 would necessitate lowering PCSK9 costs by about two thirds — to about $4500 annually.
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Neurology 2016 Aug 10
Eleven-Year Outcomes in the Early Treatment of MS
Early treatment reduced long-term relapse rates.
The BENEFIT trial was a 2-year, randomized, placebo-controlled, multicenter, manufacturer-funded study to evaluate interferon β-1b (IFN) for the prevention of a second clinical relapse in patients with an initial demyelinating event and abnormal brain magentic resonance imaging indicating possible multiple sclerosis (MS). Placebo recipients (delayed-treatment group) were provided the option to receive IFN open-label upon having a second clinical event or after completion of 2 years of follow-up. Of the original 468 randomized patients, 278 (59%) underwent regular assessments available for analyses. Of these, 167 had received early treatment and 111 had delayed treatment.
With early versus delayed treatment, a second clinical event occurred an average of 2.7 years later. Relapse rates were 19% lower in the early-treatment group, an effect that was sustained even after the delayed-treatment group started therapy. Only 25 patients converted to secondary progressive MS (SPMS) by 11 years, with a nonsignificant trend favoring early treatment (4.5% vs. 8.3%; P=0.5). Disability scores remained low and comparable between the groups, as were patient self-report and quality-of-life scores. An early, small (1 point out of 60) improvement in paced auditory serial addition test scores within the early treatment group was sustained throughout the 11 years (P=0.007).
COMMENT: Early use of IFN was associated with improved relapse rates compared with delayed treatment in this follow-up of the BENEFIT trial. Even after the delayed-treatment group started, the difference persisted for 7 of the 9 years of follow-up. Other trials of clinically isolated syndrome showed a similar effect with early treatment, which may be due to early reduction and alteration of inflammatory parameters. Caveats include the open-label design and incomplete ascertainment in this study. However, the progression of MS in this millenium, when treated early, appears to be considerably more favorable than suggested by historic epidemiologic studies. Rates of conversion to SPMS were low among both groups, and <10% required a cane to ambulate by 11 years.
CITATION(S): Kappos L et al. The 11-year long-term follow-up study from the randomized BENEFIT CIS trial.Neurology 2016 Aug 10; [e-pub]. (http://www.neurology.org/content/early/2016/08/10/WNL.0000000000003078.full.pdf+html)
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Ann Neurol 2016 Jul 27
Long-Term History of Treated MS at a Single Academic Center
Factors commonly cited as early predictors of disease progression failed to predict long-term disease worsening.
To document long-term progression of multiple sclerosis (MS) in the modern treatment era, researchers recruited 471 patients between 2004 and 2005 from one center, who had annual assessments for the first 5 years and at least 10 years' total follow-up (median 17 years since disease onset). Disability progression was defined by worsening on the expanded disability status scale (EDSS) that was sustained during the study. Medications were classified as platform therapy (injectable therapies and oral immunosuppressants) or high potency therapy (natalizumab, rituximab, mitoxantrone, and cyclophosphamide).
During the 10-year follow-up, 55% of participants experienced worsening on the EDSS (75% of those with progressive MS) and 5% of relapsing MS patients needed a cane to ambulate. Risk for worsening EDSS was increased with higher baseline relapse rates and EDSS scores. Risk for converting to secondary progressive (SP) MS was increased with male gender and later age of onset. Risk for transitioning to SPMS was 6% at 10 years from onset and 24% at 20 years. No evidence of disease activity (NEDA) at year 2 was achieved in only 18% and was not associated with improved EDSS outcomes at year 10. Clinical worsening was not more common with development of new or enlarging T2 during the first 2 years; nor was it less common with than without treatment escalation (from no treatment to platform therapy, or from platform to high-potency therapy).
COMMENT: These findings suggest low correlation between baseline characteristics and long-term MS outcomes. The findings also do not confirm a long-term benefit for treatment escalation during disease monitoring. Because treatments were open label, how the patients would have done without treatment escalation is difficult to know. At baseline, <2% of patients used high-efficacy agents, and natalizumab was just re-released from voluntary withdrawal. Therefore, whether this study reflects current standard of practice of earlier use of high-potency therapy and treating to a NEDA target is unclear.
Fortunately, conversion to progressive MS in the treatment era is less than in pretreatment natural history studies (40%–60%). Yet, 24% still progressed to SPMS after 2 decades. The lingering question is whether we should be more aggressive with our treatments, and whether greater use of high-efficacy therapy will affect disability and disease progression.
CITATION(S): Cree B et al. Long-term evolution of multiple sclerosis disability in the treatment era. Ann Neurol 2016Jul 27; [e-pub].
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Prenatal Acetaminophen Use Linked to Behavioral Problems in Offspring,
Study Suggests

By Amy Orciari Herman, Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
Children exposed prenatally to acetaminophen in the second and third trimesters are at increased risk for behavioral problems, suggests an observational study in JAMA Pediatrics.
Roughly 7800 women who expected to give birth in 1991–1992 answered questions about their use of acetaminophen during pregnancy and about 5 years' afterward. The women also completed behavioral assessments of their children when they were 7 years old.
About half of mothers reported acetaminophen use at 18 weeks’ pregnancy, 40% at 32 weeks, and nearly 90% postnatally. Five percent of children were found to have behavioral problems. After adjustment for confounders, acetaminophen use at both 18 and 32 weeks' gestation was associated with significantly increased risks for conduct problems and hyperactivity; use at 32 weeks was also associated with emotional symptoms. Postnatal use was not significantly associated with behavioral outcomes.
As a potential mechanism, the authors point to the "endocrine-disrupting properties of acetaminophen."
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FDA Catches China's Zhejiang Medicine hiding Active Pharmaceutical
Ingredient Test Data

The FDA has warned another Chinese drugmaker after finding it had been hiding batch test results that showed high peaks of out-of-spec readings. The FDA found that the employees routinely performed "unofficial analyses" that they kept out of the official quality-control records for its APIs. Some of the hidden records "displayed large unknown peaks that were not reported in the official records for the same samples," the FDA reported. And that, the agency said, could mean "the presence of unknown and uncharacterized impurities (including potential contaminants) in your drugs." 
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European Medicines Agency Nails Artemis India Plant Over Simvastatin Active Pharmaceutical Ingredient Manufacturing Issues
Another API maker in India is in trouble over manufacturing issues; the Artemis Biotech plant in Hyderabad. The German drug authority did the legwork, leading to the recommendation that EU countries not accept the company's simvastatin APIs, plus the possibility its plant certification will be revoked. Among other issues, the authority reported a "demonstrated lack of QA oversight" including keeping important GMP data outside of the quality-management system, problems with data integrity, and conducting the plant's repackaging operations without any documentation and QA approval. 
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Diagnoses of Early-Stage Prostate Cancer fell after USPSTF Recommendation
By Kelly Young, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
Diagnoses of early-stage prostate cancer continued their downward trend in 2013, according to a research letter in JAMA Oncology. In 2008, the U.S. Preventive Services Task Force recommended against routine prostate-specific antigen (PSA) testing in men aged 75 and older, and in 2012, they expanded this recommendation to all men.
From 2012 to 2013, the incidence of localized or regional-stage prostate cancer fell 6% from 357 to 335 per 100,000 men in those aged 50 to 74 years, and it dropped 7% from 379 to 354 in older men. These reductions were smaller than the 19% drop observed between 2011 and 2012. The decrease in cancer diagnoses coincided with a drop in PSA testing.
The authors conclude: "Whether this pattern will lead to a future increase in the diagnosis of distant-stage disease and prostate cancer mortality requires long-term monitoring because of the slow-growing nature of this malignant neoplasm."

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