IS AN EPHEDRINE CAFFEINE TREATMENT CONTRAINDICATED IN HYPERTENSION

OBJECTIVES: To examine how the slimming drug, Letigen(R), containing e phedrine (E) 20 mg and caffeine (C) 200 mg (E+C), affects blood pressu re in normotensive and hypertensive patients treated with adrenergic b eta-receptor blocking drugs and/or other antihypertensive agents, duri ng a period of six weeks. DESIGN: A double-blind, randomised, placebo controlled study of five parallel groups of overweight patients from g eneral practices. SUBJECTS: One hundred and thirty-six patients with B ody Mass Index (BMI) > 25 kg/m(2) were included consecutively by 25 ge neral practitioners in Denmark and randomized into five groups: (1) Hy pertensive patients treated with betablockers and E+C; (2) Hypertensiv e patients treated with antihypertensive agents other than betablocker s, and E+C; (3) Normotensive patients treated with E+C; (4) Hypertensi ve patients under any antihypertensive treatment + placebo; and (5) No rmotensive patients + placebo. All patients were instructed in a 1200 kcal (= 5040 kj) diet. RESULTS: Of a total of 136 patients aged 20-74 y, 112 completed the study protocol. Fluctuations in systolic: and dia stolic blood pressure were seen in all groups. The systolic blood pres sure was reduced significantly (5.5 mmHg) in the patients treated with antihypertensive agents other than betablockers, plus E+C. In the oth er hypertensive groups the reduction in blood pressure was not signifi cant. In normotensive patients treated with E+C, the systolic and the diastolic blood pressure declined significantly (4.4/3.9 mmHg). At the end of the treatment period heart rate had increased significantly (4 .9 beats/min) in the group of normotensive patients treated with E+C. Blood pressure and heart rate measured by the patient at home showed s imilar fluctuations from baseline prior to and during treatment with E +C or placebo. A mean loss of weight of approximately 4 kg in 6 weeks was significant for all the groups. There was no significant differenc e between the groups during this short period of treatment. In 56% of the patients treated with E+C complaints/side-effects related to the m edical treatment were found at questioning. Corresponding complaints o ccurred in 21% of the placebo treated patients. In the E+C treated gro up 7% dropped out due to side-effects. In the placebo group there were no drop-outs. CONCLUSIONS: This study does not support the assumption that E+C should cause rises in blood pressure, acutely or during shor tterm treatment, in either normotensive or hypertensive obese patients . The antihypertensive effect of the betablockers was not reversed by E+C.