398 - Managing Stage 1 HTN, Low Value Care Overuse, CKD Treatment

A Recommendation Statement from the American Heart Association

1)  Managing Stage 1 Hypertension

In 2017, the ACC/AHA along with some other organizations published an updated guideline for the prevention, detection, evaluation, and management of high blood pressure in adults. In comparison to the JNC7 recommendations, notable 2017 recommendations included:

• BP should be categorized as normal, elevated, or stage 1 or 2 HTN to prevent and treat high BP (1/B-NR). Updated categorizations include:

After initial BP Evaluation:

• Adults with stage 1 HTN who have an estimated 10-year ASCVD risk of > 10% should be managed initially with a combination of nonpharmacological and antihypertensive drug therapy and have a repeat BP evaluation in 1 month (1/B-R).
• Adults with an elevated BP or stage 1 HTN (130-139 and/or 80-89) who have an estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk < 10% should be managed with nonpharmacological therapy and have a repeat BP evaluation within 3-6 months (1/B-R)
• For initiation of antihypertensive drug therapy, first-line agents include thiazide diuretics, CCBs, and ACE inhibitors or ARBs (1/A-SR).
• In black adults with HTN but without HF or CKD, including those with DM, initial antihypertensive treatment should include a thiazide-type diuretic or CCB (1/B-R).
• Initiation of antihypertensive drug therapy with a single antihypertensive drug is reasonable in adults with stage 1 HTN and BP goal <130/80 mm Hg with dosage titration and sequential addition of other agents to achieve the BP target (2a/C-EO).

It was noted at that time that the 2017 Guideline did not specify how to manage the patient with Stage 1 HTN with an ASCVD risk < 10% who have not reached their target BP after 3-6 months of non-pharmacological therapy. Stage 1 hypertension is common among young and middle-aged adults, and the majority of these individuals will progress to stage 2 hypertension, with an even higher risk of ASCVD. Among middle-aged adults (35–59 years of age) in China with stage 1 hypertension, 65% progressed to stage 2 hypertension within 15 years. In addition, >26% of all CVD deaths and 13% of all deaths were attributed to stage 1 hypertension.

To that end, the AHA recently published updated guidance as to how to manage this situation. Recommendations include:

• Clinicians should consider the use of medication for adults with untreated stage 1 HTN (130–139/80–89) whose 10-year risk for ASCVD is <10% and who fail to meet the blood pressure goal of <130/80 mm Hg after 6 months of guideline-based lifestyle therapy
• Healthy lifestyle changes to lower blood pressure include achieving ideal body weight, exercising (30 min of moderate to vigorous physical activity on most days, if possible), limiting dietary sodium, enhancing potassium intake, limiting alcohol intake, smoking cessation, and following the Dietary Approaches to Stop Hypertension (DASH) diet
• Recommendation medication classes are those of the 2017 Guideline (see above)

Mark’s Comments:

The guidance notes there is a lack of RCTs that have evaluated CVD outcomes among individuals with stage 1 hypertension and a low 10-year risk. Because age is such a strong CVD risk factor, many of these patients are young adults. The long duration to the first CVD event and overall low CVD event rates for most young people would require trials with a large sample size or long-time horizon to be adequately powered to detect differences in important clinical outcomes. Associated costs and logistical challenges make it unlikely that such trials will be conducted in the current research environment. As a result of these obstacles, the medical community must rely on findings from population studies, health services research, clinical trials with surrogate end points, and inferences from clinical trials performed in higher- risk groups for treatment guidance in this population. In other words, this is the best we’ve got and that’s not likely to change.

As discussed in last week’s Take 3, there are great challenges in obtaining consistently accurate BP measurements outside of the research environment. Thus, I’m not sure what yet to do with this guidance, other than perhaps not be satisfied with BP readings consistently approaching 140/90 in younger patients. And perhaps that’s a good enough first step.

References:

• Jones D, et al. Management of Stage 1 HTN in Adults With a Low 10-Year Risk for CVD: Filling a Guidance Gap: A Scientific Statement From the AHA. Hypertension. Published online 29 April 2021. Article

• Whelton PK, et al. 2017 ACC/AHA Guideline for the Prevention, Detection, Evaluation, and Management of High BP in Adults. J Am Coll Cardiol and HTN 2017. Guideline

From the Literature

2)  Measuring Resource Overuse in the Medicare Population

In its 1999 report entitled “To Err Is Human”, the Institute of Medicine categorized three types of “error” in health services utilization: underuse (not using a proven treatment when indicated), misuse (implementing an intervention incorrectly), and overuse (using an intervention for an inappropriate or no indication). The Choosing Wisely campaign is one attempt to reduce overuse and misuse and what has come to be known collectively as “low value care.”

A recent study examined the utilization of some of the “D” grade recommendations (a recommendation against the service) from the US Preventive Services Task Force in the Medicare population. The authors picked seven of these services based on their ability to reliably detect their use in the data: asymptomatic bacteriuria screening, vitamin D supplementation for women to prevent fractures, prostate cancer screening in men 75 years and over, cervical cancer screening in women 65 years and over, COPD screening, EKG screening to detect cardiovascular disease, colorectal cancer screening over age 85. Remember that these recommendations are meant to be applied to asymptomatic populations – not those with other indications for the services.

The researchers looked at the National Ambulatory Medical Care Survey – a nationally-representative database of clinical visit information (not just claims) – for the years 2007-2016. Because several of the recommendations changed over time, the authors adjusted their data to reflect the recommendation in effect at the time. They did a lot of work to narrow the populations to average-risk, asymptomatic patients and adopted a very conservative approach to exclusions to get the best data. Finally, they used Medicare prices to define the costs of each of the services. The survey is designed to be a representative sample of medical care in the US, so the authors report the results as an estimate of actual care in the US over this time.

The study found that the rate of use of these D recommended services is estimated at approximately 8%, which equates to 30 million episodes per year, and 13 episodes per 100 Medicare visits. The cost for this care is estimated at almost $478 million, accounted for largely by asymptomatic bacteriuria screening and vitamin D supplementation (which were the most common AND the costliest of the set). Colon cancer screening in over 85-year-olds was the third most costly, despite being the least common – which is due to the cost of the frequently-employed colonoscopy for this screening. The authors note some limitations to the data but make a strong argument that the clinical-encounter-derived data improves the discrimination of low value care services over the more frequently used claims data.

John’s Comments:

Low value care has an important immediate cost, but one of the missing pieces in this article is the consideration of “downstream” effects of low value care – the needless additional testing, procedures, labelling, adverse effects as well as the additional costs that may occur because of one of these services. This is harder to study, but we should view the results from this study as a ‘floor’ estimate of the impact of low value care.

Our own health services researcher in Family & Community Medicine, Michelle Rockwell, PhD, RD, studies low value care, and offers the following comments on this study: These findings support the authors’ previous finding that low-cost-but-high-volume services are making up the vast majority of low value care spending (screening for asymptomatic bacteriuria- $12 and vitamin D supplements for fracture prevention- $7, together > $250 million/year). Colon cancer screening in > 85-year-olds was not really very common at all – just expensive.

I think the vitamin D supplements measure is particularly messy. It sounds like the authors counted any vitamin D supplement on the med list as prescribed for fracture prevention unless the patient had vitamin D deficiency (in which case they were omitted). As we know, there are lots of reasons vitamin D is prescribed…many of which are not about skeletal health.

References:

1. Oronce CIA, et al. The Utilization and Costs of Grade D USPSTF Services in Medicare, 2007–2016. J Gen Intern Med [Internet]. 2021 Apr 14. Link

A Brief From the US Food and Drug Administration (FDA)

3)  FDA Approves Treatment for Chronic Kidney Disease

The FDA recently approved dapagliflozin (Farxiga) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression. This approval was based on a study published in October in which the primary outcome of decline of ≥50% in eGFR, new ESRD, renal mortality, or CVD mortality was reduced by 39% with a NNT of 19 over a mean follow-up of 2.4 years.

Mark’s Comments:

In 2019 canagliflozin (Invokana) was approved for the treatment of CKD in those with T2D. This is the first approval for a SGLT2 inhibitor to be approved for use to reduce CKD decline in patients without diabetes. It should be noted that all patients in this study were on an ACE-I or ARB medication. To provide context, it is important as well to note that the GoodRx price for a 1-month supply of dapagliflozin is $514. While the expanding potential for the “flozins” is exciting, at that price, the impact across a population is questionable.

References:

• US Food and Drug Administration Press Release. April 30, 2021. Link
• Heerspink, et al. "Dapagliflozin in patients with chronic kidney disease". NEJM. 2020. 383(13):1436-1446. Article

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Mark and John

Carilion Clinic Department of Family and Community Medicine

Feel free to forward Take 3 to your colleagues. Glad to add them to the distribution list.

Email: mhgreenawald@carilionclinic.org