• Shingles Risk Factors
• Zoster Raises Risk for Stroke
• Adolescent BMI Linked to All-Cause Mortality by Age 50
• FDA: Oral Viscous Lidocaine Should Not Be Used for Kids' Teething Pain
• High Opioid Prescribing Rates - and How Florida Could Be a Model
• FDA Approves First Motorized Exoskeleton to Help Paraplegics Walk
• Vitamin C Supplementation Improves Lung Function in Infants of Pregnant Smokers
• Effects of Smoking During Pregnancy Are Long-Lasting
• Novel Inhaled Insulin Approved for Diabetes
• Obstructive Sleep Apnea, Obesity, and Cardiovascular Risk Factors
MM: Here we see that the Shingles vaccine is likely contraindicated in many of the most susceptible Shingles or Herpes patients. Unfortunately there is no way to avoid the various herpes viruses in the world around us. That being said, the most appropriate and easiest approach to treatment, with the lowest risk of side effects is the use of a topical anti-viral cream or ointment such as Acyclovir. This is a prescription product that should be applied directly to the affected area as soon as there is the slightest notion of an outbreak. The rapid use of this product has been demonstrated in many studies to actually prevent an outbreak. If a lesion has already appeared then the ointment can reduce the severity and duration of the outbreak. It is important that the product be applied 3-5 times daily at the first sign of an outbreak or when a lesion has appeared and then twice daily application is appropriate. This approach appears much better than the oral medication and does not carry the same risks of a vaccine. Mark Drugs has compounded prescription acyclovir ointment and cream in a variety of strengths and sizes that are appropriate for different types and sites of herpes or shingles lesions. Please contact us or have your physician or health care provider contact us for information or a prescription order.
BMJ 2014 May 13
Shingles Risk Factors
Several diseases both increase the risk for clinical zoster and contraindicate use of the currently available vaccine.
Herpes zoster (shingles) is caused by the reactivation of latent varicella zoster virus. The lifetime risk for this condition is 30%, rising to 50% in individuals surviving to age 85. The most dreaded sequella — postherpetic neuralgia — develops in ≤12% of zoster patients aged ≥50. A live-virus vaccine (Zostavax) is effective in preventing or lessening the severity of zoster and postherpetic neuralgia and is approved for patients aged ≥50.
In a recent case-control study of risk factors for zoster, researchers used U.K. Clinical Practice Research Datalink records to compare 144,959 adults with zoster between 2000 and 2011 with 549,336 age-, sex-, and practice-matched controls who had no history of zoster or postherpetic neuralgia at the index date of their corresponding case-patient (but could go on to develop zoster and therefore also be considered a case-patient).
The median age at zoster diagnosis was 62 for both groups, but about 45% of cases occurred in individuals aged ≤60. Major immunosuppressive conditions such as HIV infection, myeloma, and lymphoma strongly increased risk. Other factors related to increased risk included rheumatoid arthritis, inflammatory bowel disease, chronic obstructive pulmonary disease, asthma, chronic kidney disease, diabetes (type 1 only), and depression. Although systemic lupus erythematosus carried one of the strongest relative risks, it was rare enough to have little overall effect. The effects of many risk factors were larger in younger patients.
Comment: Although the increased risk associated with the above conditions comes as no surprise, this study has quantified risk factors in a large number of patients. The authors emphasize that many of the conditions that increase zoster risk contraindicate use of live-virus preparations such as the zoster vaccine, highlighting the need for new preventive strategies.
Citation(s): Forbes HJ et al. Quantification of risk factors for herpes zoster: Population based case-control study. BMJ 2014 May 13; [e-pub ahead of print].
(http://dx.doi.org/10.1136/bmj.g2911)
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MM: Early treatment of the viral infection seems to reduce risk of secondary problems such as CVA. Although the risk for CVA may disappear after a year, the viral infection does not. Unlike a bacterial infection, herpes viral infections appear to be lifelong and are brought out at times of stress. this stress may be emotional, psychological or physical such as infection or surgery. Additionally, these viral infections may be contagious even if they are not active lesions due to a phenomena called "viral shedding" . The bottom line is that most Americans have been exposed to these viruses and either have active lesions or are carriers. Reducing stressors may reduce the frequency of outbreaks but the individual outbreak severity is best managed by direct application of an anti-herpes/shingles ointment directly to the outbreak site. Please contact Mark Drugs for more information.
Clin Infect Dis 2014 Jun 1; 58:1497
Zoster Raises Risk for Stroke
Excess risk for cerebrovascular accident in zoster patients persists for 6 months then disappears.
Case reports have suggested that herpes zoster acutely raises risk for cerebrovascular accident (CVA); postulated mechanisms include generalized endothelial dysfunction associated with acute infections and specific destructive effects of zoster on vascular walls. Researchers probed a clinical database of >5 million patients to characterize the association between zoster and CVA.
Among adults with new diagnoses of zoster, overall risk for both ischemic and hemorrhagic stroke rose significantly in the first month after diagnosis, slowly diminished during the following 6 months, and vanished by 1 year. The effect was mitigated by antiviral treatment: Among treated patients, risk for stroke in the first month was not significantly different from baseline and was about half that of untreated patients; stroke risk exceeded baseline only in the second and third months after diagnosis.
Both herpes zoster ophthalmicus and zoster in other trigeminal nerve branches raised stroke risk almost three times higher than zoster in other dermatomes. This risk peaked in the second and third month after diagnosis; it was somewhat attenuated by treatment but still remained significantly elevated over baseline.
Comment: Previous cohort studies have suggested similar excess risk for CVA immediately following diagnosis of zoster (and other studies hint at elevated risks for transient ischemic attack and myocardial infarction). These data provide additional evidence of the benefits of antiviral treatment during episodes of zoster and imply that the benefits of vaccination might exceed its much-advertised effects on preventing postherpetic neuralgia.
Citation(s): Langan SM et al. Risk of stroke following herpes zoster: A self-controlled case-series study. Clin Infect Dis 2014 Jun 1; 58:1497.
(http://dx.doi.org/10.1093/cid/ciu098)
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MM: Overall lifestyle seems to be the most important combination. Apparently it's never too early to consider an optimal body weight when it comes to longevity. We must also remember that physical activity in conjunction with total body weight management is important. The premise that a person can be thin on the outside and fat on the inside emphasizes this lifestyle combination modification/practice. Couple this with a comprehensive supplement program and a person has the best chances to obtain and maintain an optimal formula for a long and healthier life.
J Clin Endocrinol Metab 2014 Jun; 99:2095
Adolescent BMI Linked to All-Cause Mortality by Age 50
Adults who were overweight or obese as adolescents did not experience the gains in life expectancy that those with normal adolescent weight achieved during the past 4 decades.
Obesity prior to adulthood is linked with increased risk for death in middle-aged and elderly individuals, but whether this association holds true for those younger than age 50 is not known. Investigators analyzed body-mass index (BMI) and socioeconomic information collected from more than 2 million Israeli adolescents (aged 16–20; born 1950–1993; 59% male) during evaluations for compulsory military service and compared it with subsequent data on all-cause mortality prior to age 50. Individuals with preexisting medical conditions and those who died from military trauma were excluded.
Approximately 15,000 men and 3000 women died during follow-up (mean ages at death, 36 and 35, respectively). Among both sexes, higher and lower BMIs (especially >97th percentile and <3rd percentile) were associated with increased mortality before age 50. Among men, multivariate analyses accounting for birth year, age, education, and socioeconomic status revealed that BMI was significantly associated with all-cause mortality beginning at 50th percentile BMI (hazard ratio at 50th–75th percentile, 1.05) and peaking at ≥97th percentile BMI (HR, 1.90). Parallel analyses for women revealed a similar trend, but beginning at ≥85th percentile BMI (HR for 85th–90th percentile, 1.33) and peaking at ≥97th percentile BMI (HR, 2.16). Adults of normal weight during adolescence experienced a decrease in mortality HR in each successive 10-year birth cohort from 1950 to 1980; this trend was not observed for adults who were overweight or obese as adolescents.
Comment: If these data can be applied to the U.S. population, we won't need to wait 40 or 50 years to see a spike in deaths attributable to increases in adolescent obesity rates. Whether becoming normal weight in the third decade of life can ameliorate this risk is unknown. That the increased risk for death before age 50 is observed even among men whose BMI during adolescence was in the 50th to 75th percentile range is particularly troubling and merits further study.
Citation(s): Twig G et al. Adolescence BMI and trends in adult mortality: A study of 2.16 million adolescents. J Clin Endocrinol Metab 2014 Jun; 99:2095.
(http://dx.doi.org/10.1210/jc.2014-1213)
http://www.ncbi.nlm.nih.gov/pubmed/24601695?access_num=24601695&link_
type=MED&dopt=Abstract
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MM: Over the years we have seen all kinds of remedies for teething pain. I remember my grandmother saying that placing some whiskey on the fingertip and rubbing it on a baby's gums was the ultimate teething treatment. It was probably as effective as giving a gunshot victim a shot of whiskey during the civil war in preparation to remove the bullet or amputate a limb. Sure, it was used but how valid a treatment and how safe a treatment was it? Clove oil on the gums is another treatment that has been used for ages. Unfortunately these patients are unable to express whether something is truly effective or just knocks them out and makes the parent or caregiver's job a little easier.
FDA: Oral Viscous Lidocaine Should Not Be Used for Kids' Teething Pain
By Amy Orciari Herman, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
Prescription oral viscous lidocaine 2% should not be applied topically to treat teething pain in infants and children, as it may cause serious injury including seizures and death, the FDA warned on Thursday. A black-box warning will be added to the drug's label to emphasize this risk.
An FDA review of adverse events through 2013 identified 22 cases of harm from oral viscous lidocaine 2% in children aged 5 months to 3.5 years: six cases were fatal, three were considered life-threatening, eleven required hospitalization, and two required medical intervention without hospitalization.
The FDA reminds healthcare providers that the drug is not approved to treat teething pain and thus should not be prescribed for this indication. Clinicians should advise parents to follow the American Academy of Pediatrics' recommendations for managing teething pain. These include using a teething ring chilled in the refrigerator (not freezer) and gently massaging the child's gum with one's finger
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuman
MedicalProducts/ucm402790.htm
http://www2.aap.org/oralhealth/pact/ch2_sect5.cfm
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MM: It seems rare that Florida is ever lauded as a model for administrative or governmental excellence or success but apparently the state has achieved significant success in a very short time when it comes to stemming prescription narcotic abuse and diversion. The number of narcotic prescriptions that are written for and dispensed nationwide is of great concern to healthcare practitioners, parents, law enforcement agents and the DEA. If this much narcotic pain medication is truly required then we are failing in treating this condition and alternative approaches must be investigated in greater depth. Unfortunately, many patients with chronic pain are treated with the wrong meds. Herbal remedies are useful for many as is taking a completely different approach such as Low Dose Naltrexone (LDN), or Neuropathic Pain Creams and Gels. Mark Drugs has these and other options available for those in pain. Please contact us for more information and guidance.
High Opioid Prescribing Rates - and How Florida Could Be a Model
By Kelly Young
Edited by David G. Fairchild, MD, MPH, and Richard Saitz, MD, MPH, FACP, FASAM
For every 100 people in the U.S. in 2012, there were 82.5 prescriptions written for opioid pain relievers and 37.6 prescriptions for benzodiazepines, according to new CDC data in MMWR. Prescription rates varied widely and were highest in the South.
CDC officials point to Florida as a model for combating prescription opioid abuse. The state enacted legislation regulating pain clinics in 2010 and banned physicians from dispensing schedule II and III drugs from their offices the following year. As a result, drug diversion (i.e., channeling of drugs to illegal markets) declined, and the oxycodone overdose death rate was halved.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm63e0701a1.htm
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MM: This is very exciting news for the 200,000+ Americans with spinal cord injuries. It may be the first step in achieving true independence for many people with different degrees of disability.
FDA Approves First Motorized Exoskeleton to Help Paraplegics Walk
By Amy Orciari Herman
Edited by Susan Sadoughi, MD, and Jaye Elizabeth Hefner, MD
The FDA has approved the first motorized wearable exoskeleton device to allow patients with paraplegia due to spinal cord injury to sit, stand, and walk with help from a caregiver.
The ReWalk device consists of the following:
- a metal brace that supports the legs and part of the upper body;
- motors that allow movement at the hips, knees, and ankles;
- a tilt sensor;
- a backpack that holds a computer and power supply.
The patient wears a wireless remote control on the wrist, which is used to command "ReWalk" to stand, sit, or walk. Crutches are also used for extra support.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm402970.htm
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MM: I will not encourage pregnant moms to keep smoking if they have the option to quit but this study demonstrates that a very inexpensive, safe and accessible option exists that could possibly change the life of their newborn.
JAMA 2014 May 28
Vitamin C Supplementation Improves Lung Function in Infants of Pregnant Smokers
Vitamin C supplementation was associated with improved lung function at birth and reduced risk for wheezing at 1 year.
Smoking during pregnancy adversely affects lung development in infants. In a U.S. multicenter, placebo-controlled, double-blind trial, investigators examined whether vitamin C supplementation (500 mg/day) in pregnant smokers (≥1 cigarette/day) improves lung function and reduces risk for wheezing in infants. Researchers randomized 179 pregnant smokers who declined smoking cessation to receive vitamin C supplementation or placebo beginning at 22 weeks' gestation.
Infant pulmonary function tests (PFTs; ratio of time to peak tidal expiratory flow to expiratory time and passive respiratory system compliance per kg) measured within 72 hours of birth were significantly improved in the vitamin C group. Pulmonary function in newborns of mothers who received vitamin C supplementation was similar to that of infants of nonsmoking mothers. Average newborn respiratory rates were similar in the vitamin C and placebo groups. During the first year of life, infants of mothers who received vitamin C supplementation had significantly less wheezing than infants of mothers who received placebo (21% vs. 40%; relative risk, 0.56), but no significant difference in PFTs. Among a small subgroup of genotyped mothers, one risk allele was associated with the biggest decrease in lung function and the best response to vitamin C. Vitamin C supplementation was not associated with any serious adverse events.
Comment: All efforts should be made to induce pregnant women to cease smoking. Vitamin C supplementation is an inexpensive and safe way to protect newborn lungs from the damage of nicotine in pregnant women who continue smoking.
Citation(s): McEvoy CT et al. Vitamin C supplementation for pregnant smoking women and pulmonary function in their newborn infants: A randomized clinical trial. JAMA 2014 May 28; [e-pub ahead of print].
(http://dx.doi.org/10.1001/jama.2014.5217)
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MM: There are so many reasons to quit smoking when you are pregnant. Below are some examples of the negative effects that the child bears from the mother's habit. I do not know if taking 500mg daily of Vitamin C will benefit these conditions, but if a mom insists on continuing to smoke throughout pregnancy, then she has the responsibility to at least try to minimize the health risks to the unborn child.
JAMA Psychiatry 2014 May 14
Effects of Smoking During Pregnancy Are Long-Lasting
Young adults who were exposed prenatally to smoking show poorer response inhibition.
Smoking during pregnancy has been linked to higher rates of externalizing disorders in offspring. These disorders, such as attention-deficit/hyperactivity disorder (ADHD) and conduct disorder are associated with decreased inhibitory control. Researchers examined the relationship of prenatal smoking to activity and structure of brain regions involved in response inhibition.
Participants were 178 young adults (73 men) who had been followed prospectively since birth, including four ADHD assessments between ages 2 and 11. In the group, 13.5% had mothers who smoked >5 cigarettes per day during pregnancy. Prenatal exposure to smoking was associated with higher rates of parental postnatal smoking and higher rates of offspring's nicotine dependence, psychosocial adversity, and lifetime ADHD symptoms.
At age 25, participants underwent functional magnetic resonance imaging during a response inhibition (“NoGo”) task. Study results were controlled for sex, psychosocial and obstetric adversity, lifetime nicotine dependence, parental postnatal smoking and prenatal stress, ADHD symptoms, and novelty seeking, which was measured at age 19. Prenatal smoking was associated with lower activity during the task in the anterior cingulate cortex, inferior frontal gyrus (IFG), and supramarginal gyrus, and with smaller volume of the right IFG.
Comment: This study did not control for parental diagnoses like ADHD or alcohol use disorder. However, the findings of lower activity in brain regions related to response inhibition in adults exposed prenatally to smoking are consistent with previous associations between prenatal smoking and externalizing disorders. This study reinforces the importance of strongly discouraging smoking in pregnant women and aggressively encouraging them to quit
Citation(s): Holz NE et al. Effect of prenatal exposure to tobacco smoke on inhibitory control: Neuroimaging results from a 25-year prospective study. JAMA Psychiatry 2014 May 14; [e-pub ahead of print].
(http://dx.doi.org/10.1001/jamapsychiatry.2014.343)
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MM: Although this is a wonderful idea since it eliminates the need for needles and the consequent local deterioration of the tissue at injection sites, the jury is still out as to the long term effectiveness of this dosage form for managing diabetic needs. Another use for this approach may be the treatment of Alzheimer's Disease (AD). Clinical studies have demonstrated the usefulness of inhaled insulin for patients with AD. This is an easy to administer dosage form and the bio-availability of the dose may not be as important for the AD patient when compared to the diabetic patient.
Novel Inhaled Insulin Approved for Diabetes
By Kristin J. Kelley
Edited by Susan Sadoughi, MD, and Jaye Elizabeth Hefner, MD
The FDA on Friday approved a rapid-acting inhaled insulin powder (marketed as Afrezza) for treating types 1 and 2 diabetes. The drug — taken at mealtime — must be used in conjunction with long-acting insulin in those with type 1 diabetes.
In clinical trials, Afrezza was shown to be noninferior to standard mealtime injectable insulin for reducing hemoglobin A1c levels.
Patients with chronic lung disease (e.g., asthma, COPD) shouldn't use Afrezza due to an increased risk for bronchospasm; the drug's label carries a boxed warning to advise of this risk. It is also not recommended for smokers or for treating diabetic ketoacidosis. The most common side effects include cough, hypoglycemia, and throat pain.
The FDA previously rejected Afrezza twice, the New York Times reports, but an advisory panel finally voted to approve it this past April. Postmarketing studies will examine whether the inhaled insulin impairs lung function or increases the risk for lung cancer, and whether it's safe for children.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm403122.htm
http://www.nytimes.com/2014/06/28/business/afrezza-a-new-inhaled-insulin-is-approved-by-fda.html?_r=0
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MM: Weight loss appears to generally be a means of reducing systemic inflammation as represented by C-reactive protein (CRP). The benefits of this may seem obvious in that decreased inflammation leads to less discomfort, greater ability to move about and overall improved Quality of Life. In spite of this, it can't be denied that weight gain and obesity are perils that have reached epidemic proportions in western cultures. The advice to simply avoid fattening foods is insufficient as many people follow what are considered by most as "healthy diets" yet they continue to be plagued by weight gain and obesity. A general lack of understanding and a greater lack of legitimate and valid direction for patients seems to be prevalent. The bottom line is that aggressive actions to lose weight irrespective of how obese a person has become must take place. The HCG metabolic Syndrome and Weight Loss Protocol seems to be about the best approach to dramatic weight loss and improved health that is available. Please contact Mark Drugs for more information.
N Engl J Med 2014 Jun 12; 370:2265
Obstructive Sleep Apnea, Obesity, and Cardiovascular Risk Factors
Researchers tease out the relative effects of weight reduction and continuous positive airway pressure in obese patients with OSA.
Obstructive sleep apnea (OSA) and obesity are related to each other, and both conditions are associated with atherosclerotic risk factors. In this study, researchers sought to determine the relative contributions of weight loss and continuous positive airway pressure (CPAP) to improvement in risk factors in 181 patients with obesity (body-mass index, >30 kg/m2), moderate-to-severe OSA, and serum C-reactive protein level >1.0 mg/L (median, ≈4.5 mg/L).
Patients were randomized to an intensive weight-loss program, CPAP, or both. At 24 weeks, mean decrease in weight was 7 kg in the weight-loss and combined-intervention groups, and none in the CPAP-only group. In an intent-to-treat analysis at 24 weeks, average CRP levels (the primary endpoint) declined significantly (by about 30%) from baseline in the weight-loss and combined-intervention groups, but not in the CPAP group. Findings were similar in a “per-protocol” analysis that included only those CPAP recipients who were reasonably adherent to CPAP. Improvement in systolic blood pressure was greater with the combined interventions than with either intervention alone — but only in the per-protocol analysis. Changes in LDL and HDL cholesterol levels did not differ significantly among the groups.
Comment: In obese patients with OSA, CPAP was less effective than weight loss in lowering C-reactive protein levels, and CPAP added to weight loss did not lower CRP levels beyond weight loss alone. Because CRP is a surrogate endpoint, the clinical importance of these findings is unclear. Blood pressure lowering was the one potentially important outcome for which CPAP and weight reduction were synergistic — but only among those who were highly adherent to CPAP.
Citation(s): Chirnos JA et al. CPAP, weight loss, or both for obstructive sleep apnea. N Engl J Med 2014 Jun 12; 370:2265.
(http://dx.doi.org/10.1056/NEJMoa1306187)
http://www.ncbi.nlm.nih.gov/pubmed/24918371?access_num=24918371&link_
type=MED&dopt=Abstract
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