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Treatment of isolated systolic hypertension: the SHELL study results
Ettore Malacco1, Giuseppe Mancia, Alessandro Rappelli
1Department of Internal Medicine III, University of Milan, L. Sacco Hospital, Milan, Italy. ettore.malacco@tiscalinet.it
Insights
Lacidipine and chlorthalidone effectively lower blood pressure in elderly patients with isolated systolic hypertension. Both treatments demonstrated similar cardiovascular outcomes and total mortality rates in this comparative study.
Area of Science:
- Cardiology
- Geriatrics
- Pharmacology
Background:
- Isolated systolic hypertension is a prevalent condition in the elderly.
- Effective blood pressure management is crucial for reducing cardiovascular events in this demographic.
Purpose of the Study:
- To compare the cardiovascular outcomes and blood pressure-lowering effects of lacidipine and chlorthalidone in elderly patients with isolated systolic hypertension.
- To evaluate lacidipine versus chlorthalidone for primary cardiovascular events and secondary blood pressure control.
Main Methods:
- A prospective, open-design study involving 1882 elderly outpatients (>= 60 years) with isolated systolic hypertension (systolic BP >= 160 mmHg, diastolic BP <= 95 mmHg).
- Participants were randomized to receive either chlorthalidone 12.5 mg once daily or lacidipine 4 mg once daily.
- The primary endpoint was a composite of cardiovascular and cerebrovascular events, with blood pressure reduction as a secondary parameter.
Main Results:
- Both lacidipine and chlorthalidone significantly reduced systolic and diastolic blood pressure. Mean systolic reduction was 36.8/8.1 mmHg for chlorthalidone and 38.4/7.9 mmHg for lacidipine.
- The overall incidence of primary endpoints (cardiovascular and cerebrovascular events) was similar between the two treatment groups (9.3%).
- Total mortality rates were also comparable between patients treated with lacidipine and those treated with chlorthalidone.
Conclusions:
- Lacidipine and chlorthalidone are equally effective in reducing blood pressure in elderly patients with isolated systolic hypertension.
- Neither medication showed a significant difference in the incidence of cardiovascular events or total mortality, suggesting comparable long-term safety and efficacy profiles for blood pressure control in this population.
Objective:
Our aim was to compare the effect of lacidipine and chlorthalidone on cardiovascular outcome as a primary parameter and blood pressure as a secondary in elderly patients with isolated systolic hypertension in a prospective study with an open design.
Methods:
1882 males and females outpatients > or = 60 years were randomly assigned to the administration of chlorthalidone 12.5 mg o.d. or lacidipine 4 mg o.d. Patients were recruited if sitting systolic blood pressure was > or = 160 mmHg with a diastolic blood pressure equal or lower than 95 mmHg. Primary endpoint was a composite of cardiovascular and cerebrovascular events.
Results:
At randomization mean systolic blood pressure was 178.1 mmHg in the lacidipine and 178.2 mmHg in the chlorthalidone group, the corresponding mean diastolic values being 86.9 and 86.8 mmHg. In both lacidipine and chlorthalidone groups treatment caused a significant (p < 0.001) and marked systolic blood pressure reduction which was maintained throughout the treatment period with a significant (p < 0.001) and steady although less marked reduction in diastolic blood pressure as well. At the end of treatment period (median 32 months), the reduction was 36.8/8.1 mmHg (systolic/diastolic) in the chlorthalidone and 38.4/7.9 mmHg in the lacidipine group, the final on treatment blood pressures being 142.0/79.2 and 143.2/79.5 mmHg, respectively. Treatments were similarly effective in males and females and in age groups between 60 and 69 years (n = 763), 70 and 79 years (n = 744) and > or = 80 years (n = 375). Similar reductions were obtained in a subgroup of patients (n = 209) followed in double-blind fashion for 1 year. The overall incidence of the primary endpoints was 9.3% with no significant between-group difference. Total mortality was also similar between groups.
Conclusions:
In elderly patients with isolated systolic hypertension, administration of lacidipine or chlorthalidone markedly reduced systolic blood pressure with no difference in the incidence of cardiovascular events and total mortality.