JAMA published the long-awaited Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure-8 (JNC-8) guidelines December 18, 2013. They recommended blood pressure lowering drug treatment for patients ≥ 60-years-old with systolic blood pressure (SBP) ≥ 150 or diastolic blood pressure (DBP) ≥ 90 mm Hg. For patients < 60-years-old, they recommended medications for DBP ≥ 90 mm Hg. They classified both of these recommendations as “Grade A” (strong). To say the least, the evidence-basis for the drug treatment recommendations for mild hypertension in this report is in dispute.
The JNC-8 authors simply ignored a systematic review that I co-authored in the Cochrane Database of Systematic Reviews that found no evidence supporting drug treatment for patients of any age with mild hypertension (SBP: 140-159 and/or DBP 90-99) and no previous cardiovascular disease, diabetes, or renal disease (i.e., low risk).
The JNC-8 hypertension guidelines are not endorsed by the National Heart, Lung, and Blood Institute (NHLBI), the American Heart Association, the American College of Cardiology, nor any other authoritative body. They are endorsed only by the 17 JNC-8 panelists and various individuals such as Dr. Howard Bauchner, editor-in-chief of JAMA and two colleagues from the journal’s editorial staff who authored an editorial accompanying the new BP guidelines. The editorial mentioned that the guidelines, “appropriately acknowledged the areas of controversy.” However, there was no mention in the guidelines about controversy concerning the BP threshold of initiating drug treatment in low risk people.
Notably, the JAMA systematic review editor invited my Cochrane review colleagues and me last spring to submit a synopsis of our systematic review of drug treatment for mild hypertension. In the summer, after several drafts of the synopsis were circulated to and from the editor, she withdrew the offer stating, “the studies we reviewed were old and that they didn’t think these studies were sufficient to address whether drugs worked or not.”
JNC-8 report matter-of-factly acknowledged 2 limitations, but did not elaborate on the implications of those huge flaws that go to the essence of what is meant by “evidence-based”:
- “The evidence review did not include observational studies, systematic reviews, or meta-analyses, and the panel did not conduct its own meta-analysis based on prespecified inclusion criteria. Thus, information from these types of studies was not incorporated into the evidence statements or recommendations.”
- “Although adverse effects and harms of antihypertensive treatment documented in the randomized controlled trials (RCTs) were considered when the panel made its decisions, the review was not designed to determine whether therapy-associated adverse effects and harms resulted in significant changes in important health outcomes.”
In effect, these limitations mean that the JNC-8 guidelines were not based on a systematic review of the data, and there was not a thorough analysis of the adverse effect and harms of drugs used for hypertension.
The division of the JNC-8 drug treatment recommendations according to age (≥ 60 years old versus < 60 years old) is new compared with previous JNC guidelines (JNC-1 – JNC-7). It is completely unsupported by RCT evidence. For patients ≥ 60 years-old, the JNC-8 panel raised the threshold for drug treatment from 140/90 mm Hg to 150/90 mm Hg. In relation to this changed drug treatment threshold recommendation, the JNC-8 panel cited 6 RCTs. The first 3 of these placebo controlled RCTs (Staessen, Beckett, and SHEP) involve only patients with stage 2 hypertension (SBP ≥ 160) rather than mild (stage 1) hypertension. RCTs of stage 2 patients say nothing about the important issue, which is whether the threshold to begin drug treatment should be at SBP = 140, 150, or 160. The widely acknowledged benefits of drugs for stage 2 hypertension were inappropriately extrapolated to apply to patients with stage 1 hypertension. The last 3 RCTs (Jatos, Ogihara, and Verdecchia) involved almost exclusively stage 2 hypertension patients and had no placebo control arms. These studies tell us nothing about the efficacy and safety of drugs for mild hypertension.
The JNC-8 authors referenced 5 RCTs as providing “high quality evidence” to support their strong (Grade A) recommendation for drug use above a threshold of DBP ≥ 90:
- The hypertension detection and follow up program (HDFP) was excluded from our Cochrane review of drugs for mild hypertension because it did not have a placebo or no treatment arm in the trial and it mixed stage 1 and 2 patients.
- The U.K. Medical Research Council Working Party trial (DBP 90-109) mixed the results of stage 1 and 2 patients. For our Cochrane review of drugs for mild hypertension, we included about 40% of the patients in this study because we could obtain individual subject data on treatment and outcomes. We found no significant benefit in stroke, health attacks of other cardiovascular disease outcomes.
- The Hypertension-Stroke Cooperative Study Group study found no benefit from blood pressure lowering drugs in patients after a stroke.
- The “Australian therapeutic trial in mild hypertension” combined stage 1 and stage 2 hypertension patients. We were able to get patient level data. In the about half of the patients that had stage 1 hypertension, there was no benefit of drugs.
- The “Effects morbidity of treatment on hypertension study” mixed stage 1 and 2 patients.
As I noted in a guest post for Health News Review titled, “The Economics & Politics of Drugs for Mild Hypertension,” there is no evidence that drugs benefit tens of millions of low risk Americans with mild hypertension. About 2 million low cardiovascular disease risk Americans with stage 1 hypertension (about 9% of those taking drugs) suffer side effects from blood pressure lowering drugs severe enough for them to stop treatment. The cost for drugs and clinic visits to comply with these JNC-8 guidelines over the next 10 years is projected from American Heart Association data to be almost $500 billion.
I call for JAMA to retract the JNC-8 guidelines, because they are demonstrably not evidence-based and are likely to harm patients medically and financially.
David K. Cundiff is an internal medicine physician and author of Money Driven Medicine Test and Treatments That Don’t Work.