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Comorbid Condition Percent of Total (n = 424)* * Number of patients with hypertension in the data set. Hyperlipidemia 54.5 Heart disease 40.1 Any rheumatologic problem (other than arthritis and chronic back pain) 39.4 Urinary tract or kidney disease 34.7 Arthritis 32.8 Chronic obstructive pulmonary disease or asthma 25.2 Any digestive trouble (other than peptic disease or reflux) 24.8 Diabetes 23.6 Peptic disease or reflux 18.6 Chronic back pain 17.2 Anxiety disorder 16.5 Depression 15.3 Cancer 14.9 Thyroid disease 14.9 Skin disease 13.9 Anaemia 9.7 Migraine or chronic headache 9.2 Any other chronic problem 36.6 RCT Inclusion Criteria Exclusion Criteria BP = blood pressure; BMI = body mass index; ACE = angiotensin-converting enzyme. Appel et al14 Persons not taking antihypertensive medication who had a systolic BP of 120–159 mm Hg and diastolic BP of 80–95 mm Hg Age ≥ 25 y BMI of 18.5–45.0 kg/m2 Regular use of drugs that affect BP Renal damage and/or diabetes Use of weight-loss medications Previous cardiovascular event Congestive heart failure Angina Cancer diagnosis or treatment in past 2 y Consumption of alcoholic drinks > 2 L/wk Pregnancy, planned pregnancy, or lactation Hansson et al15 Age 50–80 y Hypertension and diastolic BP between 100 mm Hg and 115 mm Hg None reported Wing et al16 Age 65–84 y Any life-threatening illness Free of hypertensive drugs for ≥ 1 wk before study-entry visits Contraindication to ACE inhibitor or diuretic Systolic BP of ≥ 160 mm Hg or diastolic BP of ≥ 90 mm Hg (if systolic BP was ≥140 mm Hg) Plasma creatinine concentration >2.5 mg/dL Malignant hypertension Absence of cardiovascular events within previous 6 mo Dementia ALLHAT study17 Age ≥55 y Stage 1 or stage 2 hypertension At least 1 additional risk factor for coronary heart disease History of hospitalized or treated symptomatic heart failure and/or known left ventricular ejection fraction of < 35% Sacks et al18 Age ≥22 y Average systolic BP of 120–159 mm Hg and average BP of 80–95 mm Hg Heart disease Renal insufficiency Poorly controlled hyperlipidemia or diabetes mellitus Diabetes requiring insulin Special dietary requirements Intake of alcoholic drinks > 14/wk Use of antihypertensive drugs or other medications that would affect BP or nutrient metabolism Saguenay Data Set Randomized Controlled Trial Potential Sample* n Eligible Patients†n Eligible Patients With Comorbidity n (%) No. of Chronic Conditions in Eligible Patients With Comorbidity‡ Mean ± SD * Patients with hypertension meeting the specified age for the randomized controlled trial. † After applying inclusion and exclusion criteria. ‡ Hypertension included. § Included patients with normal arterial tension. Appel et al14 944§ 326§ 290 (89) 5.5 ± 3.3 Hansson et al15 332 171 170 (99) 8.2 ± 4.2 Wing et al16 (age range 65–74 y) 114 74 74 (100) 9.7 ± 4.1 Wing et al16 (age range 75–84 y) 71 43 43 (100) 10.7 ± 4.8 ALLHAT study17(age range 55–64 y) 107 105 104 (99) 8.6 ± 4.6 ALLHAT study17(age ≥ 65 y) 210 207 207 (100) 11.7 ± 5.3 Sacks et al18 956§ 372§ 331 (89) 5.8 ± 3.5
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The Article in Brief
Background Randomized controlled trials, or RCTs (studies in which research participants are randomly selected to receive different treatments or approaches) are often used to help develop guidelines for treating medical conditions. Many RCTs may be of limited usefulness, however, because they exclude participants with multiple medical conditions (comorbidities), or they do not assess the effect of the treatment/approach on more than one medical condition. This report looks at the rate of multiple medical conditions among patients who were eligible to participate in RCTs studying treatment of hypertension (high blood pressure).
What This Study Found Eighty-nine to 100% of patients eligible for 5 RCTs of hypertension treatment had more than 1 chronic medical condition. The RCTs, however, did not fully report how many patients with multiple conditions were included or excluded.
Implications
- Excluding participants with multiple medical conditions from randomized controlled trials makes it more difficult to apply the results to a wide variety of patients.
- Randomized controlled trials should report whether participants with multiple conditions were included or excluded.
- If research results are going to be applied in medical practice, studies must focus on the realities of the types of patients who need care.
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