Statin Related Muscle Pain and Coenzyme Q 10

Statins are used to lower cholesterol levels in an effort to reduce the risk of developing cardiovascular disease. They are used after a patient has exhausted lifestyle changes such as changing their diet to a low cholesterol diet, exercising regularly and losing weight without their cholesterol dropping to levels that are considered acceptable to reduce your risk of vascular events.

Patients starting on statins often complain of muscles aches, pains and slow recovery of muscle pain after exercising. In a few individuals the muscle pain, inflammation and damage becomes severe. One of the known, but little understood, negative side effects of statin medications are the lowering of your Coenzyme Q 10 level. CoQ10 works at the subcellular level in energy producing factories called mitochondria. Statin drugs, which inhibit the enzyme HMG-CoA Reductase lower cholesterol while also lowering CoQ10 levels by 16-54 % based on the study reporting these changes.

The November 16, 2018 edition of the Journal of the American Medical Association published a review article by David Rakel, MD and associates that suggested that supplementing your diet with CoQ 10 would reduce muscle aches and pains while on statin therapy. Twelve studies were reviewed and the use of CoQ10 was associated with less muscle pain, weakness, tiredness and cramps compared to placebo. The studies used daily doses of 100 to 600 mg with 200 mg being the most effective dosage. Finding the correct dosage is important because the product is expensive with forty 200 mg tablets selling for about $25.

Since CoQ10 is fat soluble, you are best purchasing formulations that are combined with fat in a gel to promote absorption. As with all supplements, which are considered foods not drugs , it is best if they are UPS Labs certified to insure the dosage in the product is the same as listed on the label and that it contains no unexpected impurities.

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Patient Safety and the Joint Commission

Two of my local hospitals just invested $3 – $4 million dollars in preparation for an inspection of the facilities by the Joint Commission on Accreditation of Hospitals (JCAHO). The cost of the inspection runs in the $10 million dollar range after the preparation costs. The inspection is a high stress situation for the administration because if you fail, or lose your accreditation, the private insurers will void their contract with you and you won’t get paid for the work done.

Medicare through the Center for Medicare Services (CMS) is preferential to JCAHO so much so that they perform 80% of the inspections of hospitals in America. When JCAHO was initially formed it was in response to poor care in small private hospitals in non-urban nonacademic centers. They cleaned that up.

The current version uses up a great deal of money, creating a legion of hospital administrators running around with clipboards and computer tablets without making any meaningful dent in mistakes and outcome results. In a recent study published in the British Medical Journal the outcomes and re-admissions rate for the same problem within 30 days of discharge were compared at hospitals which rely on state surveys of quality and safety as opposed to the JCAHO ten million dollar survey. They found that there was no statistically significant difference.

In a related report hosted by the journal Health Affairs, a review of the 1999 report of the National Academies of Sciences, Engineering and Medicine entitled, “To Err is Human, Building a Safer Health System” was discussed. That controversial report claimed that 44,000 to 98,000 deaths per year occur due to medical errors. They discussed the work of Linda Aiken, PhD, RN, professor and director of the Center for Health Outcomes and Policy Research at the University of Pennsylvania. Her research looked at safety at 535 hospitals in four large states between 2005 and 2016. She called the results disappointing noting improvement based on suggestions in the 1999 report in only 21% of the hospitals surveyed and worsening in 7%. Most of her work involved the staffing and role of nurses which is critical to the quality of the care an institution provides.

Staffing or the ratio of patients cared for per nurse per shift is a critical component of safe patient care. Once a nurse on a non-critical care unit is asked to care for more than four patients the time spent at the bedside nursing diminishes. You cannot recognize problems, complications or changes in your patient’s condition if you are not spending time with them.

It seems to me as a clinician caring for patients in the outpatient and inpatient setting for 40 years that the more time nurses get to spend with patients the better the patients do. Maybe it’s time for government to separate the insurer’s ability to pay hospitals and JCAHO accreditation. Maybe the millions of dollars spent per inspection would be better spent on hiring more nurses per shift plus giving them the clerical and technical support they need to spend more time and care for their patients?

Vitamin D Supplements Do Not Reduce Falls, Fractures or Improve Bone Density

Much has been written about the benefits of supplementing Vitamin D in patients. The World Health Organization sets its normal blood level at 20 while in North America it is listed at over 30. Under normal circumstances when your skin is exposed to sunlight your kidneys produce adequate amounts of Vitamin D.

Over the last few years low vitamin D levels have been associated with acute illness and flare-ups of chronic illness. The Vitamin D level is now the most ordered test in the Medicare system and at extraordinary expense. Supplementing Vitamin D has become a major industry unto itself.

The October 4^th edition of the Lancet Diabetes and Endocrinology contained an article written by New Zealand researchers that looked at 81 randomized research trials containing almost 54 thousand participants. “In the pooled analyses, researchers found that Vitamin D Supplementation did not reduce total fracture, hip fracture, or falls – even in trials in which participants took doses greater than 800 IU per day.” Vitamin D supplementation did not improve bone mineral density at any site studied (lumbar spine, hip, femoral neck, forearm or total body).

They concluded that there is little justification for the use of Vitamin D Supplements to maintain or improve musculoskeletal health, and clinical guidelines should reflect these findings.

Sleep and Cardiovascular Health

Several recent publications and presentations of data on the relationship between sleep patterns and vascular disease occurred at the recent meeting of the European Society of Cardiology. The PESA (Progression of Early Subclinical Atherosclerosis) study performed by Dr Fernando Dominguez, MD, of the Spanish National Center for Cardiovascular Research in Madrid talked about the dangers of too little or too much sleep.

The principal researcher, Valentin Fuster, MD PhD, looked at 3,974 middle-aged bank employees known to be free of heart disease and stroke. They wore a monitor to measure sleep and activity. Interestingly, while only about 11% reported sleeping six or fewer hours per night, the monitor showed the true figure was closer to 27%. They found those who slept less than six hours per night had more plaque in their arteries than those people who slept six to eight hours. They additionally looked at people who slept an average of greater than eight hours.

Sleeping longer had little effect on men’s progression of atherosclerosis but had a marked effect of increasing atherosclerosis in women. Researchers then adjusted the data for family history, smoking, hypertension, hyperlipidemia, diabetes and other known cardiovascular risk factors. They found that there was an 11% increase in the risk of diagnosis of fatal or non-fatal cardiovascular disease in people who slept less than six hours per night compared to people who slept 6-8 hours per night. For people who slept an average of greater than eight hours per night they bore a 32% increased risk as compared to persons who slept 6-8 hours on average. Their conclusion was distilled down into this belief: “Sleep well, not too long, nor too short and be active.”

In a related study, Moa Bengtsson, an MD PhD student at the University of Gothenburg in Sweden presented data on 798 men who were 50 years old in 1993 when they were given a physical exam and a lifestyle questionnaire including sleep habits. Twenty one years later 759 of those men were still alive and they were examined and questioned. Those reporting sleeping five hours or less per night were 93% more likely to have suffered an MI by age 71 or had a stroke, cardiac surgery, and admission to a hospital for heart failure or died than those who averaged 7-8 hours per night.

While neither study proved a direct cause and effect between length of sleep and development of vascular disease, there was enough evidence to begin to believe that altering sleep habits may be a way to reduce future cardiovascular disease.

Shortening the Discomfort of Sore Throats

There has been a strong movement in the United States to limit resistance to antibiotics by insuring that we prescribe them appropriately for bacterial infections only and make sure we educate our patients to complete the course of the antibiotics to prevent the bacteria from surviving and developing resistance patterns. We have been taught that a “strep throat” is rarely seen in adults unless they are caring for children age 2-7 that are sick with a sore throat.

The patient should have a fever, swollen glands in the neck and an exudate on the tonsils or oropharynx. This constellation of findings and symptoms represents “Centors’ Triad” which conveys a high probability that a quick streptococcal assay or culture will be positive. For all other sore throats we are taught to treat it with lozenges, warm fluids and time. There is a definite and distinct effort to train doctors to not prescribe an antibiotic or a “Z Pack” for these non-beta hemolytic streptococcal sore throats.

It is with this background or preamble that I report on an article out of the October 17, 2018 International Journal of Clinical Practice that discusses the use of an experimental throat lozenge versus a placebo throat lozenge. The experimental troche contained a small dose of an antibiotic, tyrothricin plus benzalkonium chloride and benzocaine (an anesthetic). Tyrothricin is an antibiotic used overseas to treat gram positive organisms. It is incorporated into lozenges designed for children with non-streptococcal sore throats. This antibiotic has not demonstrated any issues with bacteria developing resistance yet.

In a clinical trial, patients 18 years of age and older with a painful sore throat which was not due to “strep” were randomly assigned to the study drug or placebo. The results were striking with more relief of pain at two hours in the study group than placebo, less difficulty swallowing and more resolution of symptoms at three days with the study drug than a placebo.

The medication used in the study is not currently available in the USA. If it is as successful as this study implies then when will it be introduced in the USA for symptomatic relief of those uncomfortable non-strep sore throats?

Office Hours, After Hours Phone Calls, E-Mail Communications

For clarity purposes, my office is open at 8:00 a.m. through 5:00 p.m. Monday through Friday with staff present. The practice does not close for lunch. The telephone lines are open from 8:00 a.m. through 4:30 p.m., Monday through Friday.

During normal business hours please call the office phone number rather than my cell phone number. My staff will answer the call and bring it to my attention immediately if it is an emergency, or in-between patients if it is not an emergency. Please know there may be times when a consulting physician or hospital nurse may call the doctor’s cell phone directly during your visit. I recognize this may be an inconvenience and will be as efficient as possible while on the call.

If you call before 8:00 a.m. or after 4:30 p.m. the calls are forwarded to my cell phone number if you choose option #2 when listening to the voice message. There is also an option to leave a message.

When calling my cell phone, I will answer immediately if possible. Otherwise, I will return your call within 30 minutes. If you do not receive a return phone call within 30 minutes please call back. There are areas in hospitals and the community that do not have adequate cell phone service so I may not have received your initial call.

If you are having a medical emergency (e.g., heart attack, stroke, major loss of blood, loss of consciousness, breathing difficulty or intractable pain etc.) call 911 immediately and if possible then notify me.

When feeling ill, sick or there is a change in your condition; please call 561.368.0191 rather than sending an email to inform us of the problem. Email communications do not meet Federal privacy law standards.

If your work hours or personal schedule are such that the normal business hours don’t work for you, please call my office manager, Judi Stanich, so we can make arrangements to accommodate your schedule.

Because I have to visit my hospitalized patients during the early morning, I am typically unable to offer appointments prior to 8:00 a.m.

Although I provide 24×7 direct access, you should use discretion when calling me outside of normal office hours. Generally, after hours calls should be when you have a real health concern or an emergency.

Inflammation and Increased Risk of Cardiovascular Disease

For years, experts have noted that up to 50% of men who have a heart attack do not have diabetes, high blood pressure, high cholesterol, do not smoke and are active. This has led to an exploration of other causes and risk factors of cardiac and cerebrovascular disease.

In recent years, studies have shown an increased risk of cardiovascular disease in patients with rheumatoid arthritis, in untreated psoriatic arthritis and in severe psoriasis. We can also add atopic eczema to the list of cardiovascular risk factors.

In a publication in the British Medical Journal, investigators noted that patients with severe atopic eczema had a 20% increase risk in stroke, 40 – 50% increase risk of a heart attack, unstable angina, atrial fibrillation and cardiovascular death. There was a 70% increased risk of heart failure. The longer the skin condition remained active the higher their risks.

The study looked at almost 380,000 patients over at least a 5 year period and their outcomes were compared to almost 1.5 million controls without the skin conditions. Data came from a review of medical records and insurance information in the United Kingdom.

It’s clear that severe inflammatory conditions including skin conditions put patients at increased risk. It remains to be seen whether aggressive treatment of the skin conditions with immune modulators and medications to reduce inflammation will reduce the risks?

It will be additionally interesting to see what modalities cardiologists on each side of the Atlantic suggest we should employ for detection and with what frequency? Will it be exercise stress testing or checking coronary artery calcification or even CT coronary artery angiograms? Statins have been used to reduce inflammation by some cardiologists even in patients with reasonable lipid levels? Should we be prescribing statins in men and women with these inflammatory skin and joint conditions but normal lipid patterns?

The correlation of inflammatory situations with increased risk of vascular disease currently raises more questions with few answers at the present time.