[The "LOTHAR" study: evaluation of efficacy and tolerability of the fixed combination of amlodipine and losartan in the treatment of essential hypertension].
OBJECTIVE
The LOTHAR study evaluated medium and long term (one year) efficacy, tolerability and metabolic effects of the fixed combination of amlodipine and losartan compared to amlodipine or losartan alone.


METHODS
Brazilian multicenter, randomized, double-blind and comparative trial performed with 198 patients in stage 1 and 2 essential hypertension.


RESULTS
The fixed combination has a high antihypertensive efficacy that is sustained in the long term with very low percentage of loss of blood pressure control. This percentage is incidentally lower than that of the two monotherapy comparative regimens. In the long term, more than 60% of the patients treated with the fixed combination remained with DBP < or = 85 mmHg, and the antihypertensive effect, when assessed by ABPM persisted for 24 hours with a trough-to-peak ratio of 76.7%. The frequency of adverse events was quite low in this group, and the long-term incidence of leg edema was approximately four-fold lower than that observed with amlodipine alone. The fixed combination did not change glucose and lipid metabolism in the medium or in the long term.


CONCLUSIONS
Based on these results, we can say that the combination of amlodipine and losartan--the first fixed combination of a calcium channel blocker and an angiotensin II receptor blocker available in the pharmaceutical market, is an excellent option for the treatment of a wide range of hypertensive patients.
Kohlmann
Osvaldo
O
Universidade Federal de São Paulo, São Paulo, SP. kohlmann@hrim.com.br
Oigman
Wille
W
Mion
Décio
D
Rocha
João Carlos
JC
Gomes
Marco Antonio Mota
MA
Salgado
Natalino
N
Feitosa
Gilson Soares
GS
Dallaverde
Ernesto
E
Ribeiro
Artur Beltrame
AB
D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage* / Q000009:adverse effects / Q000378:metabolism; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000378:metabolism; D018660:Blood Pressure Monitoring, Ambulatory; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005947:Glucose / Q000378:metabolism; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000378:metabolism / Q000503:physiopathology; D050356:Lipid Metabolism; D019808:Losartan / Q000008:administration & dosage* / Q000009:adverse effects / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D018709:Statistics, Nonparametric; D013997:Time Factors
D000959:Antihypertensive Agents; D017311:Amlodipine; D005947:Glucose; D019808:Losartan