Novartis Blood Pressure Medication Runs into Trouble by Gary Pepper, M.D. Editor, Metabolism.com In 2007 a new type of blood pressure lowering medication was brought to market by Novartis Pharmaceutical Company. This medication by the brand name Tekturna (aliskiran) works by blocking hormones that make up a circuit from the kidney to the blood vessels know as the RAAS system. This mechanism is distinct from all other blood pressure lowering medications available. By working via a completely novel pathway to lower blood pressure doctors were given another potent weapon in the war on high blood pressure. A second medication, Valturna, which combines an established blood pressure medication with Tekturna, was released by Novartis to the public in 2009. These drugs have been extremely popular due to their effectiveness and apparent freedom from serious side effects. A warning about this class of drug was issued by Novartis, 2 weeks ago when it was forced to end the Altitude drug study due to apparent unforeseen complications in patients using Tekturna and Valturna. The study found a small but significant increase in stroke in diabetics with renal disease who were using these drugs. Although the group of patients in the Altitude study are up to 12 times more likely to develop stroke or heart attack under normal circumstances, Novartis had no choice but to end the study and issue a warning to the health care community about limiting the use of these drugs.
In my own practice I have found Tekturna and Valturna to be extremely effective and well tolerated. A survey of my colleagues revealed the same findings. Diabetes and high blood pressure very commonly occur together and national guidelines stress the need for excellent blood pressure control for diabetics to help prevent heart, kidney and eye complications of this disease. For doctors treating diabetics who recognize these patients as particularly high risk, having to significantly cut back or eliminate the use of Tekturna and Valturna is creating major concerns. Within the past week I have had to counsel numerous individuals about these issues and the solution is far from easy. For instance, one man with diabetes and early kidney disease and heart disease, with borderline high blood pressure despite using 4 different types of blood pressure medication including Tekturna has to decide with me, which is the greatest risk, going off the medication resulting in a rise in his blood pressure or continuing a drug which may pose a risk of its own.
These discussions are going on in doctor’s offices throughout the country with no good solution in sight. The only certainty is a flood of ads by lawyers which begin, “Have you ever been on Tekturna or Valturna….”.
Suzi has hypothyroidism and high blood pressure. She sends the following story describing how t3 treatment appeared to help normalize her blood pressure. This is the first time I have come across this effect and thought it would be helpful to share her story on the main blog. Does anyone else have a similar (or contradictory) experience?
I was diagnosed hypothyroid 2 years ago and given levothyroxine. On diagnosis I had lots of symptoms and my BP was 175/115 despite my whole family having low BP. After some months on T4 I did feel an improvement in a lot of ways and my BP got better. Then after a year, things started going wrong, as if my body didn’t like T4.
I tried reducing my dose of T4 back down to 75µg but went hypo. But each time I increased above 75µg my BP increased again, then on 112µg it became a serious problem, especially the diastolic. I still had fatigue, constipation, red eyes, swollen legs and so on.
About 3 weeks ago I started on 10µg T3 and reduced my T4 from 112 to 75µg and pretty much immediately felt clearer headed and more energy, the constipation went etc….. My BP has gone down by an average of 20, which I know because I check it regularly myself. I’m doing a 24-hour BP monitor this week too, because my doctor put me on Amlopidine 6 weeks ago after being shocked by the monitor results from then while on 112µg T4 (only took Amlopidine for 2 weeks after terrible side-effects incl. overwhelming fatigue and massively swollen legs).
So, it looks as though my body goes weird on T4 tablets when the dose is above 75µg, but if I stuck to that dose I’d be really hypothyroid. The T3 has changed my life completely!!
Now I’m wondering what the ideal balance T4 / T3 tablets would be? Is that possible to say or does it depend on each individual body and genetics? My typical BP now is around 120/ 95; it goes down after eating, and gets worse when I’m hungry or tired. The T3 reduced my BP so much more than the Amlopidine did, and on T3 I feel great whereas on Amlopidine I felt half dead. I’d like to get my BP back to before I got hypo, so that’d be 110/70.
All I need to do now is find my ideal dose of T4 and T3, could you possibly advise me on that? If I started 20µg T3 instead of 10µg, would you advise a reduction in T4 from 75µg? ( I’ll be doing a TSH, fT3 and fT4 test in about 5 weeks’ time, maybe I should wait till then?).
A while back one of our members, Sylvia, described some troubling new symptoms she was experiencing. A recent contribution to her thread on the message board here at metabolism.com made me re-read Sylvia’s original post. What she described was recent onset of weight gain, depression, high blood pressure and ankle swelling (edema). Her concern was that although her thyroid blood tests were described as “normal”, that the thyroid was the source of her new problems.
On second review the thought occurred to me that the combination of problems Sylvia described is typical of an over-active adrenal gland. This is referred to as Cushing’s Syndrome. With Cushing’s, due to persistently elevated levels of adrenal hormones including cortisol, DHEA, androsteinedione etc., complications develop that include the very ones Sylvia identified; high blood pressure, swelling, weight gain, and depression. Other developments may also include diabetes (high blood sugar), easy bruising, osteoporosis, unusual and severe infections, muscle weakness, and purple stretch marks.
Cushing’s can be diagnosed by obtaining a 24 hour collection of urine for cortisol measurement and by measuring levels of cortisol in the blood in the early morning and late at night. With Cushing’s, urine cortisol levels will be high and there is a loss of the daily high to low transition of blood cortisol levels (diurnal variation).
Sylvia….if you are still reading metabolism.com you should think about the possibility of Cushing’s Syndrome and take it up with your own health care professional. Posting a follow-up of your progress would be very helpful to us all.
Thanks,
Dr. G. Pepper, editor-in-chief, metabolism.com
These comments are for educational purposes only and are not intended as medical treatment. The disclaimer at metabolism.com applies to all comments at this website.
The adrenal glands sitting on top of the kidneys make several hormones critical to life. The central part of the adrenal makes the hormone we refer to as adrenalin, technically from the group known as catecholamines. This is the stress responsive hormone causing rapid heart rate, sweating, increased mental alertness, preparing the body for “fight or flight”. The outer portion of the adrenal makes the hormone cortisol, also known as cortisone. Cortisol maintains, among other things, the blood pressure, fluid and salt balance. Without sufficient cortisol production by the adrenals, life cannot be sustained. What is surprising is that excess cortisol can be as harmful to health as insufficient cortisol.
Deficient cortisol production is referred to as adrenal insufficiency (Addison’s disease is one form of this), while excess adrenal function is termed Cushing’s Syndrome. During certain types of stress such as severe infection the adrenal gland can produce up to 10 times the normal amount of cortisol. If cortisol levels remain elevated for prolonged periods of time the hormone’s destructive nature is revealed by the break down of soft tissue such as skin and muscle and weakening of the immune system with frequent and aggressive infections occurring sometimes with fatal outcome. Heart disease has not been associated with high cortisol levels until a recent study suggested this possibility.
Researchers from the U.K. examined morning cortisol levels in 1066 men and women with Type 2 diabetes participating in the Edinburgh Type 2 Diabetes Study. A positive relationship was discovered between cortisol levels and the occurrence of heart disease such as heart attack and angina. The higher the cortisol levels were the greater the risk of heart disease. Cortisol levels in diabetics were found to be higher than in non-diabetics, in general. The researchers could not explain why the cortisol levels caused heart disease or why levels were higher in diabetics. (From the April edition of the Journal of Clinical Endocrinology and Metabolism 95:1602-1608).
‘Adrenal fatigue’ is a recently proposed diagnosis used to explain a variety of general symptoms such as fatigue, moodiness, muscle aches, and diminished mental function. Supposedly, adrenal fatigue results from mild impairment of cortisol production. Practitioners who diagnose “adrenal fatigue” are prescribing synthetic versions of cortisol as treatment. The possibility of heart disease resulting from excess cortisol should be a factor that patients and medical professionals must consider before embarking on adrenal “supplementation” programs.
This information is for educational purposes only and is not intended as medical advice or treatment.
Imagine locking the family dog in a cage for a week with an endless supply of its favorite treats. What would you expect at the end of the week? It’s obvious, isn’t it? A fat and possibly very ill pooch.
Subject a human counterpart to similar conditions and expect the same thing to happen. Yet, unbelievably, there is a huge industry devoted to creating this kind of environment and we pay a fortune to support it. It’s called the cruise industry.
During summers thirty years ago in the New York metropolitan area, many of my parent’s friends spent their vacation time in the Catskills. The Catskills is an area of rolling hills and farms and at that time years ago also the scene of a vibrant hotel industry. Hot, tired and stressed New Yorker could eat and drink themselves silly for a week or two while feeling they were healthier for breathing the fresh, cool mountain air. Because the hotels were set in an apparent wilderness vacationers had no guilt about never moving their bodies outside the compound. Eating, “schmoozing” and taking in the nightly Borscht Belt entertainment were the only activities available.
Fast forward to the present. The Catskill hotels have been replaced by mammoth floating hotels called cruise ships. The original beauty of these ships as a method of refined transportation to Europe or the islands has been lost. In transforming from Borscht Belt hotel to gigantic cruise ship merely substitute ocean for mountains. Sequestered on board the ship with no risk of being required to move more than a few hundred steps in any direction, what else to do but consume what is constantly in your face…massive quantities of food and drink and passive entertainment.
It is my impression (supported by numerous studies) that the average weight of our population is growing steadily. Paralleling the phenomena of the growing size of the average person is the ever increasing size of the cruise ships. Last week the most obscenely massive cruise ship of them all made its debut in Florida. Oasis of the Seas is 40% bigger than the next largest cruise ship and 5 times bigger than the Titanic. Oasis of the Seas will confine together 6300 passengers and 2800 crew members. Despite its size, being alone on this ship will be like trying to find a quiet corner in Times Square on New Years Eve. Looking at the ship one wonders how something so big could float. It is oddly shaped, no sleekness to this vessel with more vertical than horizontal lines. Maybe we shouldn’t call it a boat, at all. In fact I would put it into a different category altogether…something I would call a “bloat” for being a really big, big, floating boat.
I am troubled by the existence of the ‘bloat’ because as the size of the population and cruise ships increases so has the incidence of diabetes. Since I treat diabetes as a profession, I get the feeling my job is increasingly hopeless as more and more of my patients jump on board the cruise craze. As cruising has become a generally accepted way of vacationing with a vast advertising budget glamorizing this lifestyle, my advice about diet and exercise is drowned out. Once on board, there are few people who could resist the urge to say, “I paid for this, so I might as well do what everyone else is doing”.
I expect more bloats to be commissioned in the future, each one a miracle of engineering and excess. If things continue in this direction we may wind up wiping ourselves out with metabolic diseases like diabetes, coronary disease and high blood pressure. In our wake we will leave behind colossal deserted monuments of our civilization, pyramids of the sea.
Dr. DeSilva posts a great question about someone with high blood pressure and thyroid disease who needs to gain weight.
Dr. DeSilva asks:
I would like your advice about a lady who is hypothyroid and is taking the T3/T4 and is very underweight, 80-100 lbs. she also has some hypertension and is on drugs for this. can you suggest a way for her to gain weight?? please let me know.thanks
The mission of the The Thyroid Project is to encourage sharing of information and experience between the public and the medical community about the treatment of hypothyroidism (low thyroid function). For at least the past few decades there is a growing awareness of “something missing†in the way suffers of hypothyroidism are treated for their disease.
Too many patients, as documented in an on-line study of 12,000 individuals conducted by the American Thyroid Association published in June 2018, (https://doi.org/10.1089/thy.2017.0681) , complain of persistent symptoms of hypothyroidism despite what their doctors believe is successful treatment with levothyroxine (brands include Synthroid, Unithroid, Tirosent, Levoxl). We believe something needs to be done to resolve this conflict between patients and their doctors.
Diabetes can be defined simply as elevated blood sugar levels. What exactly is high blood sugar and when should someone be concerned about their level? Does having prediabetes mean diabetes is around the corner? Metabolism.com tackles this tricky but important topic in this comprehensive review.
By Gary M. Pepper, M.D. Ozempic, Rybelsus, Trulicity, Wegovy, Saxenda are the central players in the weight loss craze sweeping across the globe. Metabolisim.com has been monitoring this phenomenon from its beginnings in 2008 with its report “Lizard Spit Reduces Blood Sugar and Appetite”, regarding the first drug in this class, Byetta (exenatide). Caught In the middle of the current chaos are the medical experts who treat diabetes and have been prescribing these medications for more than a decade. Here is a brief commentary from one such board certified endocrinologist; “I started treating Type 2 diabetics with GLP-1 agonists more than 10 years ago. In some respects, these medications have revolutionized the treatment of diabetes by lowering blood sugar effectively and promoting weight loss at the same time, a unique combination of benefits. Not everyone benefits from these drugs to the same degree unfortunately, and I have seen lots of patients experience unacceptable side effects from them. Nothing though, has prepared me for what is happening now. Too often, I find myself confronting someone who expects me to prescribe one of these drugs just so they can lose weight. Sadly, one extreme example was someone who, despite battling a life threatening medical condition, was insistent on getting a prescription. At the same time my diabetic patients are scrambling to find a place to buy their medications if they can even afford it. It is disheartening, to say the least, and I dread the negative interactions with some of my patients I now face almost daily.”
Off- Label Use
The FDA is the U.S. government’s department tasked with evaluating and approving drugs for specific medical conditions. When a new medication is approved for treating a medical condition by the FDA the agency will, at the same time, set strict guidelines for exactly which patients may use the newly approved drug. When a medication is used “off-label” it means that these limitations are being overridden by the provider for a potential benefit which outweighs the drugs risks. It is a general misconception that off-label means illegal; it does not. This practice has been going on for ages and more than 20% of prescriptions in the United States are prescribed off-label. A common example is the use of beta-blockers (approved for heart problems) for the treatment of performance anxiety.
GLP-1 agonist drugs, as discussed recently by metabolism.com. were originally approved for the treatment of Type 2 diabetes in adults. In the past few years most of these same medications have gained unprecedented popularity for their “off-label” weight loss benefit. Of the 5 GLP-1 agents presently in U.S. pharmacies only Wegovy (semaglutide) and Saxenda (liraglutide) are FDA approved for treating obesity. Of these two, Wegovy is the newer and had been much more popular that its sister drug Saxenda, probably due to being dosed only once weekly compared to daily for Saxenda and less likely to cause side effects. Due to Wegovy’s soaring popularity, its manufacturer, Novo Nordisk, increased the price of Wegovy two times since its initial release.
by Gary M. Pepper, M.D. and Sam Jeans, MSc The global anti-obesity drug market, in 2021was valued at over $2 billion. Within one year this figure had skyrocketed to $8 billion and is expected to climb to nearly $ 20 billion by 2027. This astounding growth is a reflection of soaring obesity rates, and the arrival of a new class of weight loss medication fueling a craze both in the USA and across the world.
The FDA and global health regulators, until very recently, had maintained a very tight ship when it comes to treating obesity with medication, placing the emphasis on diet and exercise rather than weight loss drugs. Since the 80s, anti-obesity drugs continued to be controversial, and a more stringent FDA implemented ongoing safety trials along with other precautions. There is some speculation that a shift in attitude toward approval of weight loss medication by the FDA , is underway
Weight loss drug controversies are far from over and, in fact, may soon rival the amphetamine crisis of the 70’s. For that reason, metabolism.com has felt it important to provide our guide to weight loss drug issues, past and present.
Anti-Obesity Drugs Timeline
Prescription drugs for lifestyle diseases such as obesity were marketed heavily throughout the 1950s to the 1970s. Amphetamines entered the public domain after the Second World War where they were used extensively in the military.
In the 50s, walk-in clinics prescribed diet pills with other medications almost at random, with or without genuine concern for one’s weight. These brightly colored pills became known as “rainbow pills”.
In the 1960s and 1970s, the so-called “rainbow pill diet” of pills was finally coming to an end as the FDA began to systematically ban many of the drugs involved. A high-profile expose by investigative journalist Susanna Mcbee, published in Life magazine, brought attention to this new modern public health crisis.
The rainbow pill diet combined amphetamines, laxatives, thyroid hormones, and even diuretics to produce extreme weight loss, combined with benzodiazepines, barbiturates, and steroids to reduce side effects, and antidepressants to suppress medication-induced insomnia and anxiety.
In 1968, rainbow pills were linked to over 60 deaths, with numerous accounts of their devastating impact surfacing in the news and media. Within just two months, 48 million pills were seized and destroyed. Nevertheless, amphetamine-based diet pills remained extremely popular throughout the 1970s. In 1978, some 3.3 million prescriptions for amphetamines were written each year, with some 50 million pills a year ending up in the black market.
In 1979, the FDA banned amphetamines as a weight loss aid, but that is hardly the end of the USA’s love affair with obesity medication.
Here’s a brief timeline of recent anti-obesity drugs:
