Felodipine-metoprolol combination tablet: maintained health-related quality of life in the presence of substantial blood pressure reduction.
BACKGROUND
Most treated hypertensive patients do not achieve adequate blood pressure (BP) control. Initiating therapy with two drugs has been suggested when BP is >20/10 mm Hg above goal. To ensure patients' compliance, such treatment needs to be well tolerated and must not compromise health-related quality of life (HRQL). The primary objective of this study was to compare the effects on HRQL of initiating treatment with felodipine + metoprolol (F+M) fixed combination tablets, or enalapril (E), or placebo (P).


METHODS
A total of 947 patients of both sexes with primary hypertension (diastolic BP 95 to 110 mm Hg), aged 20 to 70 years, participated in this randomized, double-blind, parallel group, 12-week, multicenter trial. Treatment was initiated with F+M 5 + 50 mg, or E 10 mg, or P. Doses were doubled after 4 or 8 weeks if diastolic BP was >90 mm Hg. The HRQL was measured at baseline and at the last visit using two validated questionnaires: the Psychological General Well-being Index (PGWB) and the Subjective Symptom Assessment Profile (SSA-P). Office BP was measured at trough, that is, 24 h after the previous dose.


RESULTS
The HRQL was high at baseline and generally well maintained during the study. For example, the mean (SD) PGWB total score was 104 (16) at baseline and 105 (16) at 12 weeks in all three treatment groups. The BP reductions after F+M (18/14 mm Hg) and E (12/9 mm Hg) were significantly greater than after P (7/7 mm Hg), and the reduction after F+M was significantly greater than after E.


CONCLUSIONS
The HRQL is maintained in the presence of substantial BP reduction during antihypertensive treatment with F+M fixed combination tablets.
Dahlöf
Björn
B
Clinical Experimental Research Laboratory, Department of Medicine, Sahlgrenska University Hospital/Ostra, Göteborg, Sweden.
Degl' Innocenti
Alessio
A
Elmfeldt
Dag
D
Puig
Juan Garcia
JG
Gundersen
Torstein
T
Hosie
James
J
Januszewicz
Wlodzimierz
W
Lindström
Carl-Johan
CJ
Magometschnigg
Dieter
D
Tanser
Paul
P
Toutouzas
Pavles
P
Waeber
Bernhard
B
Wiklund
Ingela
I
D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D015736:Felodipine / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008790:Metoprolol / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D010349:Patient Compliance; D011788:Quality of Life; D013607:Tablets; D016896:Treatment Outcome
D000319:Adrenergic beta-Antagonists; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D013607:Tablets; D008790:Metoprolol; D015736:Felodipine