Author: VWheelock

294. Drugs for Blood Pressure: Be Very Careful

Systolic Blood Pressure Intervention Trial (SPRINT) Two years ago, the results of SPRINT were announced in the New England Journal of Medicine (NEJM) (1). In this trial, the blood pressure (BP) medication is adjusted to achieve a target systolic BP of 120 millimeters of mercury (mm Hg). The investigation continued for 8 years and the total cost was $157 Million. In the announcement by National Heart, Lung and Blood Institute (NHLBI), the funding body it was claimed that the treatment resulted in reduced rates of cardiovascular events, such as heart attack and heart failure, as well as stroke, by almost a third. The risk of death was reduced by almost a quarter, as compared to the target systolic pressure of 140 mm Hg (2). According to Dr Lawrence Fine, Chief of the Clinical Applications and Prevention Branch at NHLBI: “Our results provide important evidence that treating blood pressure to a lower goal in older or high-risk patients can be beneficial and yield better health results overall.” It was concluded that the results of the SPRINT study reaffirm the critical importance of blood pressure control as the best approach to reduce complications of high blood pressure like heart attacks and strokes (3). Doubts emerge However within days of the publications, there were criticisms levelled at the conduct of the trial and the implications drawn from the results. In an article...

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293. Treating Type 2 Diabetes (T2D)

I have just noticed a paper, which was designed to compare an intensive lifestyle intervention with standard care for the treatment of T2D. A secondary objective was to study the impact on the amount of medication used for, glucose-lowering. Unfortunately the paper are behind a paywall so I have not been able to access the finer details but the protocols are available in a previous paper (2) and the key results in the abstract are sufficient for me to draw conclusions. The procedures The trial was conducted in Copenhagen with 2 groups of patients that have been diagnosed with T2D.  It lasted for 12 months. One is simply given the standard treatment for diabetics in Denmark. But the other was encouraged to adopt an intensive lifestyle based on the following components: Increased levels of structured and supervised training Antidiabetic diet Increased levels of basal physical activity Increased sleep duration Self-monitoring of behaviours related to components 1–4 as well as perceived stress level, mood and motivation Diabetes management education and networking. Physical activity The physical activity expected is unbelievable. This consisted of four aerobic training sessions per week of 45–60?minute duration. On top of this there were two more sessions made up of aerobics for 30-35 minutes plus another 30 minutes of resistance training. The training was structured with supervision throughout the period. The participants worked in groups of 4-8...

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292. The Vioxx Scandal

In 1999, the pharmaceutical company Merck introduced the drug Vioxx (Rofecoxib) to be used as an anti-inflammatory treatment for pain associated with osteoarthritis. It was claimed to be effective and safer than other treatments already available. Subsequently it was found to increase the risks and deaths due to cardiovascular disease and was withdrawn from the market. Harlan Krumholtz and colleagues were involved in the legislation that resulted, which gave them access to company documents that provided valuable insight into the relevant background. Their conclusions were summarised in a paper published in the BMJ (1). The Merck studies Studies conducted during 1996/7 raised the possibility that the drug increased the risk of thrombus formation. Despite this the company failed to explore this aspect in greater depth. In fact it cobbled together results from a range of limited studies to prepare marketing material used to promote the cardiovascular safety of the drug to the medical profession. This “cardiovascular card” was criticised by US Congressman Henry Waxman because it falsely minimised the cardiovascular risks and had never been approved by the FDA. In January 1999, the VIGOR study was started. This was designed to show that Vioxx would have fewer gastrointestinal side effects than a competitor drug, naproxen, for the treatment of rheumatoid arthritis. However it was clear that the study was initiated without any proper procedures for collecting information on cardiovascular...

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291. Is the Statin Bubble about to Burst?

Merck kills off new cholesterol-lowering drug I have just come across a very interesting item entitled: “Check the Obits: Lipid Research Died Last Week” (1). It is published by a mainstream medical magazine “Medpage Today”. The article was in response to the decision by Merck, one of the major pharmaceutical companies that it would not pursue the approval of anacetrapib for clinical use. The entire programme for commercialization of the drug was scrapped. The article has been written by Milton Parker MD, who acts as a consultant for Big Pharm and presumably therefore represents some of the thinking in the industry. The background is that the drug lowers LDL cholesterol and nearly doubles HDL cholesterol. It was tested in a trial of 30,449 patients who were already taking a statin and were followed for an average of 4.1 years. The results showed those patients treated with anacetrapib had a lower risk of the composite of coronary death, myocardial infarction or coronary revascularization (P=0.004). The drug was well tolerated and there were no important safety issues. Anacetrapib is given as a single oral tablet once daily. There are no injections. The business perspective The question posed by the author is: “Why would a company abandon a drug that was safe, effective and easy to use and improved cardiovascular outcomes?” His primary explanation is that after many halcyon years when sales...

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290. More Insight into Diet and Cancer

The Warburg Effect It is clear that diet plays a major role in the development of cancer and that a change in diet may sometimes play a part in treatments that are successful. Otto Warburg has proposed that cancer cells depend on anaerobic fermentation to provide an adequate energy for their survival. This means they require a continual supply of glucose, which originates from the sugar and carbohydrates present in the diet. Hence it follows that the cancer cells can be starved of glucose by adjusting the diet so that it contains very little sugar and carbohydrates. Over the years I have posted several case histories of individuals who have made these dietary changes and overcome their cancer. Nevertheless we still have a long way to go before we have a detailed understanding of the use of diet in the prevention and treatment of the various types of cancer. However I have just been watching a video of the presentation by Dr Dawn Lemanne at the held earlier this year. This takes us some way beyond the Warburg Effect and brings us up to date on the latest thinking on the subject (1). The title is “Carbohydrate Restriction in Cancer Therapy”. In this post I will highlight some of the key points. Which cancers are diet-related? First of all, it is clear that certain cancers, such as cancers of...

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