Posts Tagged "Statin Therapy"

statins

Individuals prescribed statin therapy for high cholesterol levels have increased their caloric intake by nearly 10% and their intake of fat by 14% over a recent 10-year period, while no changes in eating habits have been observed among statin nonusers, a new study shows.

In addition, researchers report that individuals prescribed a statin had a larger increase in body-mass index (BMI) than those who weren’t taking the lipid-lowering medication.

Presenting their findings April 24, 2014 here at the Society of General Internal Medicine Meeting , the researchers say the study showed that statin users were consuming an extra 192 kcal per day in 2009–2010 than they were in 1999–2000, and this could have contributed to the increase in BMI, which was the equivalent of a 3- to 5-kg weight gain.

“Since the guideline recommends that patients should prevent weight gain, the observed increase in caloric intake and more rapid increase in BMI among statin users are of concern,” write Dr Takehiro Sugiyama (University of Tokyo, Japan) and colleagues in JAMA: Internal Medicine, where the study was published to coincide with the presentation. “According to the guidelines, people who receive statin therapy also should take steps to reduce fat intake, but we did not observe a pattern of combining statin use with dietary control.”

Dr Rita Redberg (University of California, San Francisco), the editor of JAMA: Internal Medicine, said she has treated many patients with statins over the years and has observed a “false reassurance” among those who receive the cholesterol-lowering medications. There is a perception, she writes, that “statins can compensate for poor dietary choices and a sedentary life.” The new data raise concerns of a potential hazard with statins, where the focus on “cholesterol levels can be distracting from the more beneficial focus on healthy lifestyle to reduce heart-disease risk,” suggests Redberg.

Using data from the National Health and Nutrition Examination Survey (NHANES), Sugiyama and colleagues examined the temporal trend in food intake among statin users and nonstatin users between 1999 and 2010. During this time period, the proportion of patients taking statins increased from 7.5% in 1999 to 16.5% in 2010. Statin users tended to be older, male, and white and have less education, a diagnosis of diabetes, and a higher BMI than their counterparts not taking statins.

In 1999–2000, statin users consumed 2000 kcal/day and ate 71.7 g/day of fat, both of which were significantly less than that consumed by individuals not taking statins. By 2009–2010, however, there was a significant increase in the number of calories consumed and the amount of fat eaten by statin users, whereas dietary habits were unchanged among those not taking the cholesterol-lowering medications. In 2009–2010, there was no significant difference in the amount of food consumed by statin users and nonusers, nor was there any difference in the amount of fat consumed. Similar findings were observed when the researchers restricted the analysis to saturated fat and cholesterol intake.

Regarding obesity, there was a 1.3-kg/m2 increase in BMI from 1999–2000 to 2009–2010 in the statin users and a 0.4-kg/m2 increase among statin nonusers.

Although the paper is limited by its cross-sectional design, Sugiyama and colleagues state that it is reasonable to conclude the average American treated with statins is eating more calories and more fat than the average American taking statins was doing a decade ago. At present, they can only speculate as to the reasons for this.

“One possibility is that statin use may have undermined the perceived need to follow dietary recommendations. Patients who recognized that their LDL-cholesterol levels were lowered drastically by statins may have lost the incentive to pursue dietary modifications,” write the researchers. “Physicians might have contributed to this process by shifting the focus of consultations from diet to statin regimen adherence once statin treatment had begun.”

Dr Mahesh Patel (Duke University School of Medicine, Durham, NC), who was not affiliated with the study, said the new analysis is interesting because it explores something that is rarely studied in medicine, that being the interaction between medication and lifestyle habits. However, he is cautious about making firm conclusions based on the data.

“It is tempting to conclude that patients prescribed statins adopted a more liberal diet than the individuals who were not taking the drugs, but the study only reflects population averages” and does not track the same patients over the 10-year period, he told heartwire .

Dr Sekar Kathiresan (Massachusetts General Hospital Heart Center, Boston) agreed with the need for caution. The analysis, which is based on a somewhat “sexy hypothesis,” tends to fit with people’s preconceived notions about the ill effects of medication use. The lament often heard is that people will simply abandon moderation when it comes to diet because they are now being treated with a statin.

“The flaw is that this is a nonrandomized, observational study, and the statin use might simply be marking a subset of patients who ate more over a 10-year period,” Kathiresan told heartwire . As such, the observational nature of the NHANES analysis makes it impossible to imply causality, whereby taking a statin had the unintended effect of people eating more. Like Patel, Kathiresan noted that the researchers did not follow the same group of patients from 1999 to 2010, a major limitation of the data.

Previous studies have shown that the use of statins is associated with a modestly increased risk of diabetes. Kathiresan said that an increased BMI might be one of the possible reasons for this association but again urged restraint about reading too much into the data.

Both Patel and Kathiresan agreed that physicians need to be vigilant in getting patients to understand their risk factors. To heartwire , Patel said that patients should be reminded “they are not off the hook because they’re on a statin and their LDL-cholesterol levels are better” and that physicians should not “let off the gas” once their patients are treated with a moderate- or high-dose statin as recommended by the clinical guidelines.

Source: Medscape

statins

Among men with high cholesterol and erectile dysfunction, a short course of statin therapy was associated with improvements in both measures, shows a new meta-analysis. The study was presented at the American College of Cardiology (ACC) 2014 Scientific Sessions and simultaneously published online in the Journal of Sexual Medicine

These findings “may improve adherence to statin therapy . . . [because] we know that in primary prevention a large proportion of patients stop talking [a statin] or take a much lower amount than prescribed,” lead investigator Dr John B Kostis (Rutgers Robert Wood Johnson Medical School New Brunswick, NJ) said during a press briefing. For example, in a 90 000-patient study, 35% took less than a quarter of prescribed statins and 60% took less than half, and in an 11 000-patient study, 47% of patients stopped taking the statin, he said.

Erectile dysfunction is often the first sign of CVD, like the canary in the coal mine, Kostis pointed out. “What do you do with a person who has erectile dysfunction? You evaluate them for CVD.”

“Over the years, it’s become apparent that erectile dysfunction is an indication of decreased vascular health in men and is considered by many to be a significant CV risk factor,” moderator Dr Jeffrey Kuvin (Tufts Medical Center, Boston, MA) echoed. “Whether erectile function improves due to a reduction in LDL-C or perhaps other pleiotropic effects of statins still remains unclear. I think [this] meta-analysis strongly shows that statin therapy improves erectile dysfunction after only a short duration of therapy.”

Erectile dysfunction affects an estimated 18 to 30 million American men, more often after age 40, and common causes include heart disease, high cholesterol, high blood pressure, diabetes, obesity, tobacco use, depression, and stress, according to an ACC statement.

Many older men have erectile dysfunction along with diabetes and atherosclerotic disease, for which they are frequently prescribed statins, Kostis noted. Previous research has suggested, however, that statin therapy may lower testosterone levels.

The investigators searched for randomized controlled trials that examined the effect of statin therapy on erectile function. They identified 11 such trials in which men completed the International Inventory of Erectile Function survey, which consists of five questions, each scored on a five-point scale, where low values represent poor sexual function.

The trials had an average of 53 patients per study, for a total of 647 patients. Men had an average age of 57.8 years and received statins for about 3.8 months.

During this time, average LDL-C levels dropped significantly from 138 to 91 mg/dL in the treated men but were virtually unchanged in control groups.

In men who took statins, erectile-function scores increased by 3.4 points, from 14.0 to 17.4 points—a 24.3% increase. The increase in erectile-function score was about one-third to one-half of that reported with phosphodiesterase inhibitors, such as sildenafil (Viagra, Pfizer), tadalafil (Cialis, Lilly), or vardenafil (Levitra, Bayer/GlaxoSmithKline), and larger than the effect of lifestyle modification or testosterone, Kostis said.

Some people have called statins a “double-edged sword,” he noted. On one hand, they improve endothelial function, which may improve blood flow to the penis; but on the other hand, they lower the level of cholesterol, a precursor of testosterone. However, these 11 studies showed that “the beneficial effect [of statins on erectile dysfunction] predominates.”

Strengths of the meta-analysis were that it included all published randomized trials about the topic, and the benefit remained after multiple sensitivity analyses. However, limitations were the inclusion of small studies with few participants and diverse statins, treatment duration (1.5 to six months), and patient types.

“A well-powered, placebo-controlled trial with a factorial design (for example, phosphodiesterase inhibitors, testosterone, and statin) would clarify the effect of statins in relevant patient subsets,” Kostis concluded. These drugs are not recommended as a primary treatment for erectile dysfunction in patients with normal cholesterol levels, he cautioned—another potential area for further rigorous research.

Source: Medscape

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A new study published in the New England Journal of Medicine reports that the 2013 American College of Cardiology and the American Heart Association (ACC/AHA) guidelines for the treatment of cholesterol would increase the number of U.S. adults eligible for statin therapy by nearly 13 million. Older adults without cardiovascular disease would comprise the majority of the increase.

The previous Third Adult Treatment Panel (ATP III) guidelines of the National Cholesterol Education Program (ATP-III) recommended statin therapy for patients with cardiovascular disease or diabetes and low-density lipoprotein (LDL) cholesterol levels of >100mg/dl. For primary prevention, LDL cholesterol level plus the Framingham risk score (10-year cardiovascular disease risk calculator) were used to determine whether statin therapy was warranted.

The new ACA/AHA guidelines recommend the following:

  • Statin      therapy to all adults with known cardiovascular disease regardless of LDL      cholesterol level;
  • Statin      therapy for patients with an LDL cholesterol level of ≥190mg/dL      (4.91mmol/L);
  • Statin      therapy for patients 40–75 years of age with diabetes or a 10-year risk of      cardiovascular disease of >7.5% with an LDL cholesterol level of      ≥70mg/dL (1.81mmol/L) or higher.

Michael J. Pencina, PhD, from the Duke Clinical Research Institute, and colleagues analyzed fasting sample data from 3,773 individuals ages 40–75 in the National Health and Nutrition Examination Surveys (NHANES) collected from 2005–2010. Of the total patients,1,583 (42.0%) were receiving or would be eligible for statin therapy based on the ATP III guidelines, vs. 2,135 participants (56.6%) who would be eligible based on the 2013 ACA/AHA recommendation. Using these statistics, the authors estimate that nearly half of the adult U.S. population between the ages of 40–75 with triglyceride level of <400mg/dL would be eligible for statin therapy (56 million, 48.6%). This is a net increase of 12.8 million potential new statin users and an increase of 11.1 percentage points over those eligible under the ATP III guidelines.

With the increase in adults eligible for statin therapy, the authors suggest that there will be higher treatment rates among both those who are and are not expected to have future cardiovascular events, particularly in men. The effect would be seen in older (ages 60–75) vs. younger (ages 40–59) cohorts, as 77% in the older age group would be eligible compared to 30% in the younger group.

Read more in the New England Journal of Medicine here.

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