Current medical research and opinion
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In Chapter 14, blind alleys in acute anti-migraine drug development were discussed. In this chapter, future therapies are covered. ⋯ Some of the targets discussed in this chapter have been in early efficacy trials and others are in first human dose stages. Large-scale efficacy and safety trials are eagerly awaited.
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Randomized Controlled Trial Clinical Trial
Dose response and safety of cizolirtine citrate (E-4018) in patients with pain following extraction of third molars.
The objectives of this study were to determine the dose response and safety of the oral analgesic cizolirtine citrate (E-4018) in patients with postoperative pain after third molar extraction. This was a placebo-controlled, double-blind, randomised, parallel-group study. Doses of E-4018 were 50 mg, 100 mg, or 150 mg. ⋯ We conclude that there was a dose-related trend in the percentage of patients requiring paracetamol within five hours of their study medication, and in the percentage of patients that recorded the treatment as providing good or excellent treatment of pain. There was, however, no firm evidence of a dose-related analgesic effect over the dose range of Cizolirtine chosen for this study. E-4018 was well tolerated in all patients.
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Clinical Trial
Lacidipine in the treatment of hypertension in black African people: antihypertensive, biochemical and haematological effects.
This is an open trial investigating the efficacy and metabolic effects of 3 months' treatment with lacidipine in 25 Nigerian Africans with mild to moderate hypertension. There was a significant fall in sitting diastolic blood pressure, with treatment (p = 0.01). ⋯ All biochemical and haematological indices remained essentially unchanged during therapy. Lacidipine therefore proved an efficacious and metabolically neutral antihypertensive in mild to moderate hypertension in Africa.
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Angiotensin converting enzyme (ACE) inhibitors have been avoided as an initial therapeutic option in the treatment of hypertension in African-Americans. A major reason for this has been the widespread perception of clinicians that these agents have poor blood pressure (BP) lowering efficacy in this population. Remarkably uniform and pervasive interpretations of clinical trial data have formed the basis of this clinical perception and can be summarised as follows: (1) there has been a lesser BP lowering effect of ACE inhibitors in African-Americans compared to whites, particularly at low doses; and (2) short-acting ACE inhibitors like captopril prescribed at the midpoint of its maximal total daily dose lower BP less effectively than higher doses of calcium antagonists in African-Americans. ⋯ Thus, ACE inhibitors can effectively lower BP in African-Americans. These data suggest that the clinician should not avoid these agents in African-Americans because of a presumed lack of BP lowering efficacy. Rather, we should recognise the importance of adequate drug dosing and modest reductions in dietary sodium intake in augmenting the BP lowering effect of ACE inhibitors in hypertensive African-Americans.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Efficacy and safety of a fixed combination phytomedicine in the treatment of the common cold (acute viral respiratory tract infection): results of a randomised, double blind, placebo controlled, multicentre study.
The common cold (acute viral respiratory tract infection) is one of the most frequent diseases in man, world-wide. Clinically relevant efficacy should include early improvement of all symptoms. Results of a clinical trial of a commercially available fixed combination herbal remedy (Radix echinaceae, Radix baptisiae, Herba thujae) are reported here. The aim of this study was to verify clinical efficacy shown in recent studies under (i) good clinical practice (GCP) quality assurance and (ii) common situations at family doctors. ⋯ This study shows that the herbal remedy is effective and safe. The therapeutic benefit consists of a rapid onset of improvement of cold symptoms. If patients with colds are able to start the application of the herbal remedy as soon as practical after the occurrence of the initial symptoms, the benefit would be expected to increase (e.g. self-medication).