Analysis of Recent Papers in Hypertension
Jan N. Basile, MD, Senior Editor

The Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation and Treatment of High Blood Pressure recommends that once blood pressure is at goal levels and stable, follow-up visits can usually occur at 3–6 month intervals unless the patient has associated comorbidities or the need for laboratory tests that influence the frequency of visits. A study involving 50 family practices from Canada was performed to evaluate if there was a difference in blood pressure control, patient satisfaction, and adherence to drug treatment when follow-up visits occurred either every 3 months or every 6 months. This randomized study evaluated 502 patients aged 30–74 years with essential hypertension between November 1997 and July 2002. They were receiving at least one antihypertensive drug and blood pressure had been controlled for at least 3 months. Patients were assigned to return every 3 months or every 6 months with earlier follow-up occurring if blood pressure became uncontrolled or if drug therapy was changed. Mean blood pressure and blood pressure control rates were similar in the two groups over a 33-month follow-up period. About 20% of both groups had uncontrolled hypertension during the study. Patients in both groups visited their physicians more frequently than they were assigned. As expected, the every 6-month group had fewer office visits over the 3 years of the study than the every 3-month group (average 16.2 visits vs. 18.8 visits, respectively), although they both required more office visits than expected (they should have been seen six and 12 times, respectively). Patient satisfaction, measured by a standard questionnaire, was similar between groups as was adherence to therapy. Although not an end point of the study, 52% of patients in the 3-month group and 57% in the 6-month group were measuring their blood pressures at home. These readings were similar to the physicians' measurements in the office. Follow-up every 6 months in patients with hypertension whose blood pressure is controlled while taking antihypertensive therapy leads to equivalent blood pressure control, adherence to therapy, and patient satisfaction, as does follow-up every 3 months. Twenty percent of both groups were uncontrolled at any time during the study; frequency of follow-up visits may not be the most important factor in the control of hypertension.—Birtwhistle R, Godwin M, Delva D, et al. Randomized equivalence trial comparing three month and six month follow up of patients with hypertension by family practitioners. BMJ. 2004;328:204–206. Comment Multiple consensus guidelines, including the Canadian, British, and US reports, currently recommend an interval of between 3 and 6 months for follow-up of patients with hypertension once blood pressure is controlled. This recommendation for two to three visits per year in controlled patients has been advocated for many years in the US guidelines. This study evaluated which of these strategies was best in patients whose hypertension was controlled for at least 3 months by at least one antihypertensive drug. Office blood pressure measurements at the end of each year and at the end of the 3-year study were similar between the two groups, with about 20% of each group not controlled. Of interest, blood pressure measurements taken at home were similar to those taken in physicians' offices. Adherence to therapy and patient satisfaction were similar. Once blood pressure is controlled, patients who are seen every 6 months experience the same outcome as those seen every 3 months. Additional factors other than the time interval between follow-up visits in patients with controlled hypertension appear to be important determinants of overall blood pressure control. Multiple observational reports have consistently demonstrated a reduction in cardiovascular mortality with light to moderate consumption of alcohol both in primary and secondary prevention studies in the general population. Whether these same benefits also apply to persons with hypertension, where heavy alcohol use has been associated with elevations in blood pressure, is controversial and has not been well studied. To evaluate this question, investigators examined data from The Physician's Health Survey, a randomized, double-blind, clinical trial of low-dose aspirin (325 mg every other day) and β-carotene use (50 mg every other day) in the primary prevention of cardiovascular disease and cancer. Enrollment consisted of 88,842 male physicians who resided in the United States and who in 1982 provided questionnaire information on several health measures, including information on frequency of alcohol intake (beer, wine, or liquor). From this cohort, the investigators identified 14,125 men with a history of current or past treatment of hypertension none of whom had a history of myocardial infarction, stroke, cancer, or liver disease. For the purposes of analysis, these subjects were divided into four categories of self-reported alcohol intake: rarely/never (17%), monthly (1–3 drinks per month, 11%), weekly (1–6 drinks per week, 40%), and daily (>1 drink per day, 32%). The main outcome measures were comparisons of total and cardiovascular mortality using rarely/never drinkers as a reference group. Men who reported daily alcohol use tended to be older than the other men, to be former or current smokers, and to report more physical activity, less diabetes, and greater aspirin use. During a mean follow-up of 5.4 years (a total of 75,710 patient-years) there were 1018 deaths (7.2%), including 579 (56.9%) from cardiovascular causes. After adjusting for both age and multivariate risk factors, there was an inverse correlation between increasing alcohol consumption and both total and cardiovascular mortality. Compared with rarely/never drinkers, those with monthly, weekly, and daily alcohol consumption had relative risks (RRs) for cardiovascular mortality of 0.83 (95% confidence interval [CI], 0.62–1.13), 0.61 (95% CI, 0.49–0.77), and 0.56 (95% CI, 0.44–0.71), respectively. For total mortality, the corresponding RRs were 0.86 (95% CI, 0.67–1.10), 0.72 (95% CI, 0.60–0.86), and 0.73 (95% CI, 0.61–0.87), respectively. Further adjustment for elevated levels of serum cholesterol did not change the results. Total and cardiovascular mortality were similar in patients with lower blood pressures and in subjects who reported poorly controlled hypertension, defined as systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg. A subgroup of subjects who reported consuming at least two alcohol drinks per day had a RR for cardiovascular disease mortality of 0.72 (95% CI, 0.49–1.10). No significant association was identified between moderate alcohol consumption and cancer mortality. Light to moderate alcohol consumption is associated with a decreased risk of cardiovascular and total mortality among male physicians. These benefits do not appear to be dependent on blood pressure control.—Malinski MK, Sesso HD, Lopez-Jiminez F, et al. Alcohol consumption and cardiovascular disease mortality in hypertensive men. Arch Intern Med. 2004;164:623–628. Comment The association between alcohol consumption and cardiovascular disease is complex. Most epidemiologic studies have found a U-shaped relationship between alcohol consumption and cardiovascular disease, with moderate drinkers (usually defined as one drink per day in women and one to two drinks per day in men) having a lower risk than those who either never drink or drink heavily. Heavy alcohol use, usually defined as at least three drinks per day, has also been associated with elevations in blood pressure. Although subjects who consumed daily alcohol in this study had slightly higher blood pressures than rare/never users, their risk of cardiovascular mortality was reduced 44%. This apparent paradox can be explained by the relatively small difference in BP between the groups (no more than 2 mm Hg in systolic blood pressure) and the paucity of heavy drinkers in this cohort of male physicians. It appears that the potentially cardioprotective effects of low-level alcohol consumption, including increased levels of high-density lipoprotein cholesterol, decreased platelet aggregation, increased fibrinolytic activity, and reduced levels of the inflammatory markers C-reactive protein and interleukin-6, outweigh any potential effects that occur with small increases in blood pressure. This may not be the case with heavier alcohol consumption (or binge drinking) where larger increases in blood pressure and elevation of the inflammatory markers noted above might lead to a less beneficial effect on cardiovascular risk. Although this study has a number of inherent limitations (self-report of alcohol use, inclusion of only men, limited data on exact pattern of alcohol use), it seems reasonable to allow men with hypertension to drink small to moderate amounts of alcohol (one to two drinks per day). Current Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure guidelines recommend that for the prevention and treatment of hypertension, men should limit their alcohol consumption to no more than two drinks per day and women and lighter-weight persons to one drink per day (12 oz beer, 5 oz wine, or 1.5 oz 90-proof liquor). These recommendations seem appropriate until confirmed by large-scale, prospective, randomized studies evaluating outcomes of alcohol consumption in patients with hypertension. Measurement of office blood pressure (OBP) has been used for years in epidemiologic studies to determine the prognostic relationship between blood pressure elevation and cardiovascular disease risk. In addition, reduction of OBP has been the standard used in all of the clinical studies that have demonstrated the benefit of antihypertensive therapy. Home blood pressure (HBP) measurements using a printer-equipped, semiautomatic, digitized cuff device has potential advantages over measurement in the office, including measurement precision and reproducibility. Only one prospective study, in Japan, has demonstrated that HBP measurement may be superior to OBP measurement in predicting cardiovascular risk. The Self-Measurement of Blood Pressure at Home in the Elderly: Assessment and Follow-Up (SHEAF) study was a 3-year observational, prospective cohort study to determine the relative prognostic value of HBP and OBP measurements. The cohort consisted of 4939 elderly patients with treated hypertension (mean age 70 years; 49% men) who were taking at least one antihypertensive medication and being monitored by general practitioners in France. No specific recommendations were made concerning management. The study involved two successive phases. In the first phase, each patient underwent a 2-week evaluation where his or her blood pressure was measured twice both in the office and at home. During the office visits, a physician measured blood pressure in triplicate on each of two visits (six readings total) using a mercury sphygmomanometer. Using a well validated home blood pressure oscillometric monitor with digital printout, patients were asked to perform home readings. They were asked to take three readings twice daily (at 8 a.m. and 8 p.m.) over a 4-day period (24 readings total) and to keep all digital printouts for evaluation. To be included in the study, patients had to have at least 15 valid measurements; with at least six measurements in the morning and six measurements in the evening. The second phase was a 3-year follow-up of patients during which time the patient's usual practitioner observed the patient for cardiovascular end points with no specific protocol recommendations concerning the use of specific antihypertensive drugs or the monitoring of achieved blood pressures. The primary end point was cardiovascular mortality. Secondary end points were total mortality and combined cardiovascular events (cardiovascular mortality; nonfatal myocardial infarction; nonfatal stroke; transient ischemic attack; and hospitalization for angina or heart failure, percutaneous transluminal coronary angioplasty or coronary artery bypass graft). For the purposes of analysis, uncontrolled hypertension on entry was defined as an average blood pressure ≥140/90 mm Hg for OBP and ≥135/85 mm Hg for HBP. On entry, patients were classified into four groups: those with controlled hypertension (blood pressure below the limit for each of the methods, seen in 14% of subjects); those with uncontrolled hypertension (blood pressure greater than or equal to the limit for each of the methods, seen in 63% of subjects); those with blood pressure below the normal limit for HBP and greater than or equal to the normal limit for OBP, seen in 13% of subjects; and those whose blood pressure was below the normal limit for OBP but greater than the normal limit for HBP, seen in 10% of subjects. After an average of 3.2 years of follow-up, status was known for 99.9% of the patients. At least one cardiovascular event had occurred in 324 patients (22.2/1000 patient-years). Neither home nor office blood pressure was predictive of cardiovascular mortality—the primary end point—or total mortality—a secondary end point. For HBP measurement, each increase of 10 mm Hg systolic increased the risk of cardiovascular events by 17.2% (95% confidence interval [CI], 11.0%–23.8) and each increase of 5 mm Hg diastolic increased the risk of cardiovascular events by 11.7% (95% CI, 5.7%–18.1%). For OBP measurement, the same increases in blood pressure were not associated with an increase in the risk for cardiovascular events. Multivariate analysis was done, adjusting for other cardiovascular risk factors and using patients with both controlled OBP and HBP (controlled hypertension) as a reference group. In this analysis, patients with elevated HBP and OBP (uncontrolled hypertension) had a hazard ratio (HR) for cardiovascular events of 1.96 (95% CI, 1.27–3.02). Patients with an elevated OBP and normal HBP (isolated office hypertension, also known as white coat hypertension) had no increase in cardiovascular events (HR, 1.18; 95% CI, 0.67–2.10) while patients with elevated HBP and normal OBP (masked hypertension, reversed white coat effect) had an HR of 2.06 (95% CI, 1.22–3.47). These results suggest that HBP measurement is of greater prognostic utility than OBP measurement for predicting cardiovascular events. Regardless of the presence of OBP elevation, it is the elevation of HBP that correlates with cardiovascular risk. Treatment and follow-up of patients with elevated blood pressure at home but not in the office needs to be studied in a clinical trial.—Bobrie G, Chatellier G, Genes N, et al. Cardiovascular prognosis of “masked hypertension” detected by blood pressure self-measurement in elderly treated hypertensive subjects. JAMA. 2004;291:1342–1349. Comment This observational study with follow-up fuels the debate on whether the use of out-of-office blood pressure measurements should guide antihypertensive therapy. While previous epidemiologic data linking elevation of blood pressure with cardiovascular risk has been obtained using OBP readings, this study found that regardless of the OBP value, it was the elevation in HBP that correlated with cardiovascular risk; neither HBP nor OBP was specifically predictive of cardiovascular or total mortality. This study therefore confirms the relatively favorable prognosis recently seen in those with the so-called white coat effect (elevated OBP but normal HBP) using ambulatory blood pressure measurement in untreated patients. Recent evidence suggests that 24-hour home ambulatory monitoring may also have greater prognostic value than measurement of OBP. HBP measurement, however, has many clear advantages over ambulatory blood pressure monitoring, including availability, convenience, and cost. Until this report, HBP measurement had only been shown to have prognostic relevance in one Japanese study that evaluated a normotensive population. This study suggests that HBP measurement may have more prognostic relevance than OBP measurement. It also sheds light on a very important group of patients with hypertension: those whose blood pressure is controlled in the office but elevated at home. These patients with so-called masked hypertension, reverse white-coat hypertension, or isolated home hypertension had a risk of cardiovascular events comparable to those with uncontrolled hypertension both in the office and at home. The importance of masked hypertension is not well recognized, but was present in 10% of patients in this study and was found to have prognostic significance. While only 27 measurements defined HBP and six measurements defined OBP, the SHEAR investigators found no association with either HBP or OBP and the predetermined primary end point of cardiovascular mortality. Although the strength and consistency of the association between HBP measurements and a composite of cardiovascular events suggest that clinicians should feel increasingly confident using HBP measurement as a guide to the adequacy of antihypertensive therapy, a well designed treatment and outcome study of patients with elevated HBP but normal OBP needs to be conducted before we change the basis of treatment of hypertension. Coffee is the most consumed beverage in the world. Whether chronic coffee consumption increases the long-term risk of developing diabetes was the subject of a recent study. A prospective study by researchers from Finland combined three surveys conducted every 5 years (1982, 1987, and 1992). It involved 6674 Finnish men and 7655 Finnish women aged 35–64 years who had no history of stroke, coronary heart disease, or diabetes mellitus at baseline. During a mean follow-up of 12 years, with 175,682 person-years of follow-up, the study reported that women who drank more than five to six cups of coffee per day had a 61% reduced risk of developing diabetes; for the same consumption, risk was reduced by 30% in men. The benefit of coffee increased with consumption: women who drank 10 or more cups per day had nearly an 80% lowered risk for diabetes, whereas in men the same consumption reduced the risk by 55%. When genders were combined, the multivariate-adjusted inverse association persisted when stratified by age younger and older than 50 years; smokers and never smokers; ideal weight and overweight; alcohol drinker and non-drinker; and those drinking filtered and nonfiltered coffee. Coffee drinking has a graded inverse association with the risk of developing type 2 diabetes, and the risk reduction tends to be somewhat stronger in women than in men. The mechanistic reasons for this risk reduction remain unclear—Tuomilehto ], Hu G, Bidel S, et al. Coffee consumption and risk of type 2 diabetes mellitus among middle-aged Finnish men and women. JAMA. 2004;291:1213–1219. Comment Type 2 diabetes mellitus has reached epidemic proportions in this country. A prudent lifestyle remains the optimal method for preventing diabetes, including maintaining ideal body weight and engaging in regular physical activity. Chronic coffee consumption does not appear to increase the long-term risk for developing hypertension. This study, from a country with the world's highest rate of coffee consumption, adds to other recently published studies suggesting that drinking five to six cups of coffee per day or more reduces the risk of developing type 2 diabetes. In a recent Dutch study, persons who drank at least seven cups of coffee every day were half as likely to develop type 2 diabetes as those who drank two cups daily. Another study from the Harvard School of Public Health using food questionnaires completed every 2–4 years found that compared with nondrinkers, men who drank more than six cups of regular coffee each day decreased their risk of diabetes by more than 50% while women decreased their risk by 30%. This effect was minimized by decaffeinated coffee. Researchers remain unsure how coffee protects against the development of diabetes. Some theories are that chlorogenic acid, which is found in coffee, helps regulate serum glucose. Coffee also contains ingredients such as potassium, magnesium and antioxidants that may favorably affect glucose metabolism and insulin sensitivity. Until the biologic basis for these findings are better understood, it remains premature to recommend drinking coffee to prevent type 2 diabetes. Physicians should continue to recommend a healthful diet, weight control, and exercise before giving patients gift certificates for the local coffee franchise in an effort to prevent diabetes.

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