Tuesday, November 29, 2016

More guidance on statins for primary CVD prevention

- Kenny Lin, MD, MPH

Previous AFP Community Blog posts discussed the 2013 American College of Cardiology/American Heart Association cholesterol treatment guideline, provided additional perspectives on its 7.5% 10-year CVD event risk threshold for starting a statin, and noted that existing cardiovascular risk calculators tend to overestimate risk by significant margins. The ACC/AHA guideline has remained controversial in primary care. The American Academy of Family Physicians gave it a partial endorsement with qualifications (disclosure: I am a member of the AAFP Commission that made this recommendation), and a 2014 guideline from the U.S. Departments of Veterans Affairs and Defense recommended higher thresholds for considering (6%) or starting (12%) statins.

Two weeks ago, the U.S. Preventive Services Task Force weighed in with a new recommendation statement on the use of statins for primary prevention of cardiovascular events. The recommendations are similar to those from the ACC/AHA; the USPSTF recommends initiating low- to moderate-dose statins in adults aged 40 to 75 years with at least one CVD risk factor (dyslipidemia, diabetes, hypertension, or smoking) and a calculated 10-year CVD event risk of 10% or greater ("B" recommendation). They recommend shared decision making and selective statin prescribing for similar adults with a 7.5% to 10% CVD risk ("C" recommendation).

The USPSTF's higher risk thresholds for statin therapy compensate for uncertainty regarding the accuracy of CVD risk calculators, and the "C" recommendation recognizes that in persons at lower risk, the benefits of statins are less likely to outweigh the harms, which include liver enzyme abnormalities and muscle toxicity and a small increased risk of new-onset type 2 diabetes.

Although a prior USPSTF statement had recommended screening for lipid disorders in adults as early as 20 years of age, a new systematic review found no direct evidence on the benefits and harms of screening for or treatment of dyslipidemia in adults aged 21 to 39 years. So when should family physicians start checking cholesterol levels in asymptomatic adults, if statins don't become a treatment option until age 40? This is an area to exercise one's clinical judgment on a case-by-case basis, keeping in mind that healthy lifestyle counseling is more likely to be beneficial in adults with CVD risk factors than in adults without known risks.

Monday, November 21, 2016

Efforts underway to restrain rising prescription drug costs

- Mara Lambert

In a recent blog post, AAFP President-Elect Michael Munger, MD, addressed an all-too-familiar scenario physicians are encountering in their practices: when medications become too expensive, patients stop taking them. Over the past several years, Americans have faced exorbitant price increases on common treatments such as inhalers for asthma and insulin for diabetes. A Reuters report from this past April found that the prices of four of the top-10 most widely used drugs in the United States increased by more than 100% over the past five years, while six others rose by more than 50%. When steep price hikes for Daraprim and EpiPen made headlines during the past year, the public was justifiably concerned.

Pharmaceutical companies attribute price increases to the cost of researching, developing, and approving new drugs; however, there is a lack of transparency about how these prices are set. Medical societies and other organizations are now upping their efforts to remove the secrecy surrounding drug pricing with the ultimate goal of easing the burden on consumers.

In July, the American College of Physicians released a position paper that outlined various ways to reduce the increasing costs of prescription drugs. Then earlier this month, the American Medical Association announced the TruthinRx campaign to “uncover the truth behind prescription drug pricing.” The campaign’s mission is to improve transparency and restore affordability to medications by educating lawmakers and the public. Website visitors can send a pre-populated e-mail message to their senators and representatives asking them to support calls for increased transparency from pharmaceutical companies and health insurers.

In a similar vein, the Campaign for Sustainable Rx Pricing (CSRxP) is a nonpartisan coalition of physicians, employers, hospitals, nurses, patients, and payers striving to increase awareness of drug pricing and to promote transparency and competition. AAFP leadership met with CSRxP representatives in October to discuss their mutual concerns about drug costs.

The Fair Accountability and Innovative Research (FAIR) Drug Pricing Act (H.R. 6043) of 2016 and the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S. 3056) of 2016 are two current bills endorsed by CSRxP. The FAIR Act would require drug companies to disclose price increases greater than 10% and to provide supporting explanations for the increases, whereas the CREATES Act would close a loophole that prevents generic drug companies from accessing samples of branded drugs for research purposes, hence stifling competition.

These initiatives are a start. In the meantime, physicians should remain vigilant about asking patients whether they can afford their medications. In an AFP editorial from earlier this year, Steven R. Brown, MD, outlined five strategies for practicing high-value prescribing, including exercising skepticism and caution when prescribing new drugs, applying STEPS and knowing drug prices, prescribing generics and comparing value, restricting access to drug reps and office samples, and prescribing conservatively. Each of these actions can play a part in keeping costs down for patients and reducing health care spending at large.


Mara Lambert is Senior Associate Editor of AFP.

Monday, November 14, 2016

Getting babies to sleep: strategies for fatigued parents

- Jennifer Middleton, MD, MPH

With a four-month-old of my own, I read the POEM on Getting an Infant to Sleep in the November 1 issue of AFP with more interest than I might have before becoming a parent. Prior studies have not found one sleep strategy to be superior to another. This latest study adds to the mix by finding that graduated extinction and sleep fading are not only effective but are well-tolerated by babies and parents alike.

Graduated extinction involves placing the infant down for bedtime while drowsy but still awake. Parents then wait a progressively increasing amount of time (2 minutes, then 4 minutes, then 6 minutes) before checking on the child. With sleep fading, parents progressively move bedtime later until the child falls asleep within 15 minutes of being laid down. The POEM study compared these two interventions in 6-month-olds with sleep difficulties to a control group and found that the time it took to fall asleep shortened with both methods. Infant and maternal stress also improved with both interventions. After 12 months, parent-child attachments were unaffected, and there was no change in the risk of emotional or behavioral problems.

Once infants are old enough to consider implementing a sleep strategy (usually around 4-6 months of age), having several to suggest allows family physicians to work with parents to find an agreeable starting point. I especially appreciate being able to reassure families that, whatever they do, most babies will be sleeping through the night by 1 year of age. There's an AFP By Topic on Sleep Disorders in Children if you'd like to read more. 

Monday, November 7, 2016

300 posts and still going strong

- Kenny Lin, MD, MPH

Today's post is the 300th for the AFP Community Blog, which I began writing in August 2010. Fellow medical editor Jennifer Middleton, MD, MPH because our second regular contributor in April 2013. In recognition of this milestone, I thought I would revisit some earlier wayposts - namely, our 100th, 150th, 200th, and 250th posts - and provide updates.

#100 - The spiritual assessment: unnecessary or essential? (9/20/12)

While one reader opined that spiritual concerns have "little to do with improving the health of our patients," another countered, "I do not think this article goes far enough in promoting this type of spiritual health assessment." ... Some readers expressed concerns that physicians might seek to impose their religious beliefs on vulnerable patients, while another suggested that "many physicians seem to have more fear of [discussing] spiritual issues than the patients do."

The debate continues about how best to incorporate the spiritual assessment into clinical practice. Earlier this year, the National Cancer Institute's Physician Data Query (PDQ) database published a comprehensive review of spirituality in cancer care that included a list of standardized assessment measures and suggested options for assisting patients with spiritual concerns.

#150 - Preventing recurrent kidney stones (11/4/13)

Researchers examined 28 studies regarding prevention of recurrent nephrolithiasis ... and found that water works fine for preventing the second episode after an initial event. But after the second episode, water by itself didn't do as well. Participants with multiple stone episodes who added a thiazide diuretic, a citrate, or allopurinol to their 2 liters of water a day, though, had fewer recurrences.

A related POEM in the January 15, 2015 issue of AFP discussed a randomized controlled trial that concluded that ultrasonography is the best initial imaging test for kidney stones in the emergency department (ED), reducing overall radiation exposure compared to initial computed tomography (CT) without differences in rates of return to the ED, pain scores, or complications.

#200 - Lung cancer screening (11/18/14)

Shared decision-making is increasingly recommended by screening guidelines, but I worry that these difficult discussions may not actually take place, even if family physicians are paid to initiate them with patients eligible for LDCT [low-dose computed tomography] screening. Will clinicians merely go through the motions and just order the test?

A 2016 study in a University of Minnesota–affiliated health system found that counseling and shared decision making were documented in less than half of outpatient visits for patients who underwent LDCT for lung cancer screening after publication of the USPSTF guidelines. Although we don't know if this experience is representative of national practice, it certainly isn't good news.

#250: SPRINT and lower systolic BP goals (11/23/15)

Aggressively adjusting medication doses based on what may be inaccurate office BP readings could potentially cause patients significant harm. Most of the time, the JNC 8 guidelines are likely to be more applicable to the patients in our offices than SPRINT's narrowly defined parameters.

No new hypertension guidelines have been issued since the publication of the SPRINT trial, but in August 2016, a majority of cardiologists at the European Society of Cardiology meeting gave a "thumbs down" to lowering blood pressure targets based on the trial's results. An article published in Circulation explained how the measurement technique used in SPRINT would have led to blood pressure readings 5-10 mm Hg lower than in clinical practice.