Abstract

Both hypertension and left ventricular hypertrophy (LVH) are associated with increased risk of cardiovascular events. Antihypertensive therapies, which can lower this risk, may impose treatment-related symptoms that impact on health-related quality of life (HRQOL) and can affect adherence and persistence with therapy.

The LIFE Study is a double-blind, randomized trial to compare losartan and atenolol on reduction of cardiovascular events in hypertensive patients with ECG-documented LVH. In the HRQOL substudy, HRQOL and symptom bother were measured at baseline, and over the first 12 months to evaluate treatment-related effects of therapy, especially on the domain of vitality and symptom bother related to fatigue. HRQOL was measured with the Hypertension Battery of Scales (reduced) with domains of general health, psychological general well-being (including a vitality subdomain), sleep disturbance, social function, sexual function, cognitive function and a symptom bother inventory (SBI). LVH was measured with the ECG Cornell voltage-duration product and the Sokolow-Lyon criteria and categorized based on the number of criteria positive at baseline. We compared baseline HRQOL for demographic, baseline study measures (SBP, DBP, LVH), and comorbidities.

Among 465 subjects, 54% were female, 14% reported smoking, 11% had a history of an MI, 3% had a history of stroke, and 22% were diabetic. At baseline, the mean (SD) age was 66 (7), SBP was 171 (14) and DBP was 96 (9) mm Hg. All patients met CP or SL criteria on the pre-study ECG. At baseline, 7% were positive for both, 70% for 1 criteria and 22% were negative for both criteria. There were no significant differences between patients in the QOL Substudy and the remainder of the US patients. SBP, DBP and LVH were not associated with vitality at baseline, or with other HRQOL domain scores. Baseline HRQOL was significantly lower for women and patients with a history of MI, stroke or diabetes. Of 33 items in the SBI, the most frequently reported at baseline included: nocturia (46%), tiredness, feeling weary or fatigue (31%), blocked or runny nose (25%), pain in joints of hands (23%) and dry mouth (23%). Fatigue was more prevalent in women, and those with baseline comorbidities but was not associated with baseline SBP, DBP or LVH.

While HRQOL and symptom bother were not associated with baseline LVH or blood pressures they were related to gender and baseline comorbidities. Understanding patterns of baseline HRQOL and symptom burden will help to elucidate the relationships of hypertensive therapy and treatment-related changes in HRQOL.

Other Financial or Material Support: Merck & Co., Inc. Employee