Home  |  Patients  |  Physicians  |  In the News  |  Hours/Location  |  Contact
        Bio-Identical Hormones
             Hormones for Women
             Hormones for Men
             Hormone Drug Info
      • Erectile Dysfunction
      • HCG Weight Loss
      • NasoNeb & Sinus Meds
      • Pain Management
      • LDN, MS & Autoimmune
      • Sterile Clean Room
      • Veterinary Compounding

             Drug Shortages
             AMA Recognition
             Legal Information
             Insurance Services
        Nutritional Products
             Product Review Process
             Synergy Blends
        Veterinary Products
             Drug Shortages
        What is the Rose Garden
        Compression Hosiery
        Bras & Camisoles
        Swim Suits
        Hats & Turbans
        Lymphedema Garments

     • Rental, Repair, Sales
     • NasoNeb & Sinus Meds
     Breast Pumps & Nursing
     • Product List

        Product List
        Product Review Process
        Synergy Blends
        Veterinary Products
        •  Compounds
        •  Supplements

        PCAB Accreditation
        Legal Information
      • Staff Members
        History of Mark Drugs

Content 7


The Doctor and the Pharmacist

Radio Show Articles:
April 5, 2014

Back to Specialties button

Should We Put Statins in the Water? A Possible Therapy to Speed Healing of Venous Ulcers
New ACC/AHA Guidelines make 12.8 Million More Adults Eligible for Statins
Statin Associated with Slower Brain Atrophy in Progressive Multiple Sclerosis
Sex Differences in Diabetes-Associated Risk for Stroke
Elevated Blood Biomarker Potentially Useful in Concussion Diagnosis
Anxiolytics and Hypnotics Associated with Long-Term Mortality Hazard
High-Frequency Hearing Loss Cochlear Implant Approved
A Triple Therapy with Doxycycline Is Ineffective for Multidrug-Resistant H. pylori
Does Helicobacter pylori Eradication Improve Functional Dyspepsia?
Mometasone Moment
Certain Genetic Profiles Can Amplify the Fattening Effect of Fried Foods
Hepatitis C's Drug Price Draws Legislative Attention, Stock Analysts Sanguine

MM In my opinion statins, in general, are over-used. There are cases, however, when statins may be useful on a limited basis. Statins tend to decrease inflammation and its possible, that when used locally in a wound or limited to a specific body region, they may be of added benefit in the wound healing process. One of the challenges to wound healing is that the body tries to shut off resources to a severely injured area in order to preserve the rest of the organism (body). Statins may be able to partially override this protective function and may improve the healing process to these ulcerated areas. Using a statin in a transdermal cream or gel may be another viable approach to assisting this healing process that keeps the treatment relatively local and decreases any potential adverse drug side effects or limit systemic presence.
Br J Dermatol 2014 Feb 7
Should We Put Statins in the Water? A Possible Therapy to Speed Healing of Venous Ulcers
Results in smaller ulcers were impressive.
Venous insufficiency is a major cause of leg ulcers, and treatment of these ulcers is often difficult. Compression is the primary therapy. Previous reports have suggested benefits from adjuvant treatment with low-dose aspirin (Lancet 1994; 344:164), pentoxifylline (Cochrane Database Syst Rev 2012; 12:CD001733), and most recently, topical beta-blockers (J Am Acad Dermatol 2013; 69:e204). Simvastatin has been shown to have potential benefit for wound healing in animal studies.
These authors performed a double-blind, placebo-controlled trial of simvastatin 40 mg in 66 patients with uninfected ulcers smaller than 10 cm in diameter. Simvastatin was given for 10 weeks with compression; patients were seen every 2 weeks. Results were analyzed for ulcers ≤5 cm and >5 cm. Five patients dropped out. Overall, 72% of simvastatin-treated ulcers healed versus 32% in the control group. Ulcers ≤5 cm had better responses (100% with simvastatin and 46% with control) than larger ulcers. There were no differences in toxicity between the two groups.
Comment: Simvastatin is a relatively nontoxic agent. The results reported in this small but seemingly well-designed study are impressive and warrant consideration of larger studies. Simvastatin may prove to be a promising additional therapy for the management of venous leg ulcers.
Citation(s): Evangelista MT et al. Simvastatin as a novel therapeutic agent for venous ulcers: A randomized, double-blind, placebo-controlled trial. Br J Dermatol 2014 Feb 7; [e-pub ahead of print].
Top of Page


New ACC/AHA Guidelines make 12.8 Million More Adults Eligible for Statins
By Larry Husten
Millions more people are now eligible for statin therapy under the 2013 guidelines from the American College of Cardiology and American Heart Association, a New England Journal of Medicine study finds.
Extrapolating data from a representative sample of the U.S. population, researchers calculated the number of adults aged 40 to 75 who would be eligible for statin therapy under the old guideline and the new one. Among the findings:

Harlan Krumholz, a cardiologist with NEJM Journal Watch, commented: "The guideline recommendation is intended to be just that — a recommendation about a threshold that might make sense to use in a treatment decision. The guidelines are clear that the patient's preference is what matters most. So it is really impossible to know if more people will be taking statins."
Adapted from CardioExchange
Top of Page


MM: Unfortunately this same dose of simvastatin is associated with a much greater incidence of drug adverse side effects. Therefore, caution must be taken, even if these patients are at advanced stages of their MS. Other medications, such as Low Dose naltrexone (LDN) may show as good if not superior responses in these patients. I find it upsetting that the medical community could embrace a high, confirmed dangerous dose of an allopathic drug, such as Simvastatin but will reject the use of a confirmed, low risk product such as LDN when being used for a debilitating condition such as MS.
Statin Associated with Slower Brain Atrophy in Progressive Multiple Sclerosis
By Joe Elia
A phase 2 study shows a slowing of brain atrophy with a high-dose statin in patients with secondary progressive multiple sclerosis.
According to a Lancet study, 140 patients were randomized to 80 mg of simvastatin or placebo daily for 24 months. The main outcome was MRI-detected change in brain volume. Measurements were taken at baseline, 12 months, and 25 months.
Atrophy was slower in the statin versus placebo group (roughly 0.3% vs. 0.6% per year — after adjustment, a 40% relative reduction).
The investigators note that because statins "have cell protective properties and improve cerebrovascular haemodynamics, they could be used in patients with later stage multiple sclerosis in whom vascular and brain parenchymal cell dysfunction take place." However, they and commentators caution against overinterpreting the current results and call for phase 3 studies.
Top of Page


MM: The reasons for women being at higher risk for stroke if they are in a diabetic or pre-diabetic state may be unclear but what is very clear is that women must be more cognizant, careful and pro-active about placing themselves in a healthier lifestyle and preventing themselves from entering these at risk states in the first place. Appropriate dietary regimens, exercise, supplements and when necessary, medications can no longer be ignored if a person is at a risk of stroke.
Lancet 2014 Mar 7
Sex Differences in Diabetes-Associated Risk for Stroke
Excess risk for stroke was higher in diabetic women than in diabetic men.
Compared with men, women have higher relative risk for fatal coronary heart disease associated with diabetes, even after adjustment for differences in other cardiovascular risk factors. Is the same true for stroke? To find out, researchers analyzed data from 64 cohort studies (>775,000 adults with and without diabetes), conducted in various countries, in which sex-specific relative risks were reported for fatal and nonfatal strokes; follow-up ranged from 5 to 32 years.
After adjustment for multiple other risk factors, relative risk for fatal or nonfatal stroke associated with diabetes was 2.28 in women and 1.83 in men — a significant difference. These risks were not affected significantly by study duration, year of study enrollment, region, age, smoking status, or stroke subtype.
Comment: Citing evidence that the liver and skeletal muscle tend to be more sensitive to insulin in women than in men and that prediabetic women have greater endothelial dysfunction and more severe hypertension than prediabetic men, the authors propose that women might accumulate more cardiovascular risk before progressing to overt diabetes. Reasons for these sex differences remain unclear, but this study calls attention to the particular importance of optimizing management of known cardiovascular risk factors in prediabetic and diabetic women.
Citation(s): Peters SAE et al. Diabetes as a risk factor for stroke in women compared with men: A systematic review and meta-analysis of 64 cohorts, including 775 385 individuals and 12 539 strokes. Lancet 2014 Mar 7; [e-pub ahead of print]"
Top of Page


MM: Early detection before conditions can worsen are a key to prevention of long lasting brain injury. This is an example of when additional testing is appropriate because a simple observation may be insufficient to assess an underlying or hidden problem.
Elevated Blood Biomarker Potentially Useful in Concussion Diagnosis
By Kelly Young
The plasma biomarker total tau (T-tau) appears to increase after a sports-related concussion, according to a JAMA Neurology study.
Researchers collected blood samples from nearly 300 professional hockey players in Sweden before their season and after a friendly game. Of these, 28 also had their blood analyzed after a concussion.
The biomarker with the greatest diagnostic accuracy was T-tau, which is a marker of axonal damage. T-tau levels increased immediately after the injury, and the 1-hour T-tau concentrations predicted the time to symptom resolution. S-100 calcium-binding protein B (S-100B), a marker for astroglial injury, reached peak levels during the hour after concussion, but S-100B levels were also increased after a friendly game with no head injury.
Editorialists conclude: "It is likely that biomarker panels measuring tau as well as other proteins that reflect astrocytic, endothelial, and microglial pathobiology will ultimately be required for blood biomarkers to fulfill their promise in the clinical management of [traumatic brain injury]."
Top of Page


MM: Sleeping and anti-anxiety medications tend to be readily accepted by much of the population. They are typically considered safe and for only temporary use. This entire medication class has been demonstrated time and again to develop dependencies with patients. Now we see that there may be a long term increased risk of death.
Anxiolytics and Hypnotics Associated with Long-Term Mortality Hazard
By Joe Elia
Use of anxiolytic and hypnotic drugs carries an increased mortality risk even after usage stops, according to a retrospective cohort study in BMJ.
Using the U.K.'s General Practice Research Database, researchers followed mortality in roughly 35,000 adults who'd received benzodiazepines; "Z" drugs such as Ambien and Sonata; other anxiolytics and hypnotics; or combinations of the three categories. Users were matched with some 70,000 other patients without such prescriptions.
During roughly 8 years of follow-up, there was an overall doubling of mortality risk among the users relative to controls (adjusted hazard ratio, 2.1). The risk remained significant after restricting the analysis to those who only received the drugs in the first year.
After excluding deaths in the first year of follow-up, the authors calculate that there were 4 excess deaths linked to drug use per 100 people followed over the 8-year period.
Top of Page


MM: My wife has been telling me for years that I am losing my hearing and I tend to agree with her. Unfortunately, the range that I am losing that hearing in would not be helped with a hearing aid. I have been to multiple otolaryngologists and audiology testing and those results have been confirmed. This is not an unusual problem for men and women in their 50's and 60's. perhaps some permutation of this research will assist this growing portion of our population. If the population needing these products grows large enough then undoubtedly there will be sufficient financial incentive to develop and approve this technology.
High-Frequency Hearing Loss Cochlear Implant Approved
By the Editors
The FDA has approved a device that allows people who can only hear low-frequency sounds — with or without a hearing aid — to also hear high-frequency sounds.
In its announcement, the agency says the device, the Nucleus Hybrid L24 Cochlear Implant System, combines the features of a cochlear implant with a hearing aid. The hearing-aid portion isn't implanted.
Top of Page


MM: Once again we see that the overuse of antibiotics for a particular condition (in this case, gastric or duodenal ulcers) has led to super-bugs that are antibiotic resistance. There are other options for treating GI ulcers other that triple or quadruple antibiotic therapy. Additionally, it is now being questioned whether H. pylori is responsible for all upper GI ulcers as has been widely theorized. The use of chewable probiotics and digestive enzymes such as our Heart Burn Away Chewable Tablets is frequently successful for GERD, gas, bloating and a variety of mild to moderate GI complaints. Please contact us at Mark Drugs for more information about the potential use of this product.
Helicobacter 2014 Apr; 19:90
A Triple Therapy with Doxycycline Is Ineffective for Multidrug-Resistant H. pylori
In a proof-of-concept study in Portugal, none of the 15 patients completing a 10-week course of pantoprazole, amoxicillin, and doxycycline was cured.
Standard therapies for Helicobacter pylori infection have decreasing effectiveness because of increasing drug resistance. Tetracycline is a common component of different H. pylori treatment regimens, but doxycycline may have potential therapeutic advantages of better tissue penetration and less frequent dosing. In an effort to identify a potential therapy for patients with multidrug-resistant H. pylori infection, investigators in Portugal prospectively studied the efficacy of a proton-pump inhibitor (PPI), amoxicillin, and doxycycline regimen.
The study comprised 16 patients (13 women, 3 men) with known resistance to clarithromycin, metronidazole, and levofloxacin but susceptibility to amoxicillin and tetracycline based on cultures of endoscopic biopsies. Patients received pantoprazole (80 mg) twice daily for 3 days followed by a 10-day course of pantoprazole (80 mg), amoxicillin (1 g), and doxycycline (100 mg), all twice daily. Fifteen patients completed the therapy. Eradication success was determined by a breath test at 6 to 10 weeks after treatment.
All patients showed persistent H. pylori infection after therapy. The authors conclude that triple therapy with a proton-pump inhibitor, amoxicillin, and doxycycline is useless in patients with multidrug-resistant H. pylori infection.
Comment: The optimal approach to treating multidrug-resistant H. pylori infection has not been established and may vary geographically with drug resistance patterns. Findings of this small study suggest that PPI-based triple therapy using doxycycline is unlikely to be successful in this setting.
Citation(s): Almeida N et al. Triple therapy with high-dose proton-pump inhibitor, amoxicillin, and doxycycline is useless for Helicobacter pylori eradication: A proof-of-concept study. Helicobacter 2014 Apr; 19:90.

Top of Page


MM: Just as important a question should be, "Is eradication of H pylori appropriate for functional dyspepsia?" Or, are there other, as beneficial, safe or safer and as effective alternative treatments available? The answer to these questions is No, it's not always necessary to eradicate H. pylori and yes, there are other options. Heart Burn Away Chewable Tablets is frequently successful for GERD, gas, bloating and a variety of mild to moderate GI complaints. Please contact us at Mark Drugs for more information about the potential use of this product.
J Clin Gastroenterol 2014 Mar; 48:241
Does Helicobacter pylori Eradication Improve Functional Dyspepsia?
Amidst conflicting results of previous studies, a recent meta-analysis shows positive findings.
Functional dyspepsia is a common disorder with heterogeneous etiologies. Multiple studies have evaluated the effect of Helicobacter pylori eradication on functional dyspepsia symptoms with variable results. Now, investigators in China have conducted a meta-analysis of the issue using data from randomized, controlled trials.
The meta-analysis included high-quality studies (Jadad score >3) that assessed the effect of H. pylori eradication therapy on the severity of functional dyspepsia symptoms, included at least 12 months of follow-up, and were published in English.
Fourteen studies met inclusion criteria and comprised 2993 patients. Although only four studies suggested a benefit of H. pylori treatment, a pooled analysis of all study data showed a benefit of therapy on symptom severity (odds ratio, 1.38, 95% confidence interval, 1.18–1.62, P<0.0001). When analyzed by geographic region, the treatment benefit was observed in studies from Asia, Europe, and America.
Comment: Although the preponderance of studies was negative, the pooled analysis was positive, which suggests that many of the studies were underpowered. Moreover, the positive finding is not just attributable to larger numbers of patients in the positive studies. In three of the five largest studies, no statistically significant benefit was shown. Several limitations must be considered. Eradication success rates were not available. Most importantly, the definition of functional dyspepsia was heterogeneous, including any symptoms of nausea, reflux, or ulcer pain, which may have different pathophysiologies. In addition, the study endpoint was defined as any improvement in symptoms, not symptom resolution; therefore, many patients may have experienced persistent symptoms after treatment. There is no question that H. pylori infection should be treated. However, the cost-effectiveness of H. pylori testing for all patients with functional dyspepsia requires further study in areas with varying prevalences of H. pylori infection.
Citation(s): Zhao B et al. Efficacy of Helicobacter pylori eradication therapy on functional dyspepsia: A meta-analysis of randomized controlled studies with 12-month follow-up. J Clin Gastroenterol 2014 Mar; 48:241.

Top of Page


MM: Lichen Sclerosis (LS) is one of those life tormenting conditions that is typically inadequately treated and rarely if ever cured. Chronic use of a potent steroid such as clobetasol can lead to adrenal suppression and potentially death. Mometasone is a much gentler steroid and carries less risk potential when compared to clobetasol. Fortunately. it appears to be comparable effective.
Br J Dermatol 2014
Mometasone Moment
As a first-line treatment for vulvar lichen sclerosus, mometasone furoate appears to be as safe and effective as clobetasol propionate.
Vulvar lichen sclerosus (VLS) causes itching, burning, pain, painful intercourse, sexual dysfunction, bleeding, and other genital miseries, including scarring. Topical applications of the ultrapotent steroid clobetasol propionate 0.05% (CP) for 3 months provides effective, safe, and reliable first-line therapy (British Association of Dermatologists' guidelines: strength of recommendation B; quality of evidence 2++). CP has some theoretical medical-legal risks, as prescribing guides and package inserts limit treatment to only 2 weeks and do not specifically address treating VLS. Mometasone furoate 0.1% (MMF) is a potent topical steroid recently suggested to work just as well as CP, with perhaps greater safety. Studies suggest twice-weekly applications of MMF can maintain remissions and prevent relapse.
Investigators compared efficacy, tolerability, and patient satisfaction with CP 0.05% ointment and MMF 0.1% ointment for active VLS in 54 patients. Itching and burning were assessed using a visual analog scale. An objective scoring system measured erythema, leukoderma (pallor), hyperkeratosis, and purpura/excoriations, and the scores were summed to arrive at a global objective score.
Topical corticosteroid was applied once daily for 5 days each week for 4 weeks, then every other day for 4 weeks, and then twice weekly for 4 weeks. At 3 months, there was no between-group difference in response rates; 89% of patients experienced protocol-defined response in each group. Percentages achieving at least 75% improvement in subjective and objective scores were not significantly different between groups. Signs and especially symptoms were markedly reduced from baseline with both treatments. No noteworthy adverse effects were observed, and most subjects were satisfied with treatments.
Comment: Without treatment, vulvar lichen sclerosus can make life miserable, and scarring can cause disfigurement. Patients with VLS have an increased risk for squamous cell carcinomas. It's not clear that either clobetasol propionate or mometasone furoate reduces cancer risk, but this and other studies show that treatment can improve signs and symptoms in many patients. Early treatment may limit progression and make symptomatic relief easier. This small study used unvalidated symptom and severity scales, but it is a rare randomized trial comparing corticosteroids. Long-term safety was not addressed, but MMF ointment is probably at least as safe as CP ointment, based on potency.
Citation(s): Virgili A et al. First randomized trial on clobetasol propionate and mometasone furoate in the treatment of vulvar lichen sclerosus: Results of efficacy and tolerability. Br J Dermatol 2014; [e-pub ahead of print].
Top of Page


MM: Not all people and not all foods are created the same. Some of us can tolerate substantial carbs and fats and suffer no great weight gain. Others are virtually intolerant of these food groups. Unfortunately, this study only shows that people who are already fat have a greater tendency to get fatter when they eat foods that got them that way in the first place.
Certain Genetic Profiles Can Amplify the Fattening Effect of Fried Foods
By Joe Elia
Genetic profiles associated with increased body mass index can worsen the effects of fried food on weight gain, a BMJ study suggests. Editorialists point out, however, that the findings' impact is tempered by "poor" predictive power at the individual level.
Researchers used questionnaires to measure fried food consumption in two cohorts comprising more than 15,000 adults. They also created a risk score based on the presence of genetic polymorphisms associated with BMI.
Those with the highest genetic risk scores showed a worse effect on BMI when comparing high versus low consumption — the difference amounting to roughly 1 BMI unit between consumption categories. Those with the lowest genetic risk scores did not show a similar BMI difference — only about 0.5 BMI unit between consumption categories.
The findings were confirmed in a separate cohort of more than 20,000 women.
Top of Page


MM: It's rather amazing that Gilead received a fast track priority review to get this drug to market that saved them years of sitting in the pipeline and tens of millions if not more in testing and then they come forward to literally rape the public coffers through price gouging for this product. To add insult to injury, the arrogance of analysts that the objections are taken merely as "a little noise" throws salt into a wound. The way I see it is either this treatment is ineffectual and the company plans to steal as much as it can until a better product hits the market or they simply figure that after the initial noise, Medicaid and other public insurance will merely bite the bullet, pay the bills and send American taypayers further in debt with our abominable healthcare payment systems.
Hepatitis C's Drug Price Draws Legislative Attention, Stock Analysts Sanguine
By Joe Elia
Sovaldi (sofosbuvir), which received FDA approval last December to treat hepatitis C, costs an even $1000 per pill — or $84,000 for a 12-week course of treatment. That has legislators calling for the manufacturer to explain the price.
In a March 20 letter to Gilead Science's CEO, three members of the House Committee on Energy and Commerce write that, because hepatitis C is prevalent in low-income patients, "the affordability problems are likely to be particularly acute for state Medicaid programs and those patients served by these programs."
They request that Gilead explain how it arrived at the price, reminding the company of the value afforded by the FDA's priority review.
The New York Times reports that the letter sent Gilead's stock price down almost 5% on Friday. However, it quoted a Deutsche Bank analyst: "We just look at this letter as a little bit of noise."

Top of Page

Home | Contact | Roselle (630) 529-3400 | Deerfield (877) 419-9898 | Careers | Sitemap