1 The objective of this double-blind parallel-group study was to compare the tolerability of isradipine and amlodipine, specifically, the side-effects known to be related to the use of dihydropyridine calcium antagonists. 2 A total of 205 patients with mild-to-moderate essential hypertension were randomized to receive either the sustained-release (SRO) formulation of isradipine (n = 103) or amlodipine (n = 102), both at dosages of 5 mg once daily. Blood pressure measurements were taken at the end of the dosing interval to assess the antihypertensive efficacy of the two drugs. 3 Adverse reactions were assessed in two ways: a) spontaneously reported adverse events were recorded and investigated in depth for severity, duration, relation to the study drug, and outcome; b) a questionnaire was used to elicit specific adverse reactions known to be related to the use of dihydropyridine calcium antagonists which were evaluated for severity, duration, relation to the study drug, and outcome.4 After 6 weeks of active treatment, both isradipine and amlodipine reduced mean sitting systolic/diastolic blood pressure: from 165.1/100.1 to 145.2/89.7 mm Hg with isradipine; and from 164.1/100.6 to 145.7/90.5 mm Hg with amlodipine. There was no difference in antihypertensive effect between isradipine and amlodipine (95% CI: -3.73 to 4.73 and -1.89 to 3.49 for differences in systolic and diastolic blood pressure, respectively). 5 The number of patients spontaneously reporting adverse events was significantly higher (P = 0.02; 95% CI: 3.1 to 26.7%) with amlodipine (33.3%) than with isradipine (18.4%). 6 The incidence of spontaneously reported ankle oedema was statistically significantly greater with amlodipine than with isradipine (14.7% vs 5.8%, respectively, P = 0.04). In addition, the severity (P = 0.02) and duration (P = 0.03) of the ankle oedema was greater with amlodipine than with isradipine. Moreover, eight patients taking amlodipine discontinued treatment due to this side-effect compared with none of the patients taking isradipine. 7 By questionnaire, the severity (P = 0.03) and duration (P = 0.02) of nausea as well as the severity of ankle oedema (P = 0.04) were greater with amlodipine than with isradipine.

In this randomized double-blind trial, two new antifungal compounds were compared in patients with interdigital or more extensive forms of tinea pedis. Two weeks of oral treatment with either terbinafine, an allylamine and new chemical entity, 250 mg daily, or itraconazole 100 mg daily, was given to 366 patients (184 terbinafine, 182 itraconazole). Of 13 patients who did not return after the first visit, 11 were lost to follow-up (five on terbinafine, six on itraconazole) and two reported adverse events. Another nine patients (three on terbinafine and six on itraconazole) were excluded because it was uncertain to which group they were randomized. A central laboratory performed both the mycology and safety tests. In 355 patients who received the study medications and were available for analysis of side-effects, 18 out of 179 (10.0%) in the terbinafine group and 10 out of 176 (5.7%) in the itraconazole group reported adverse events. No new clinically significant laboratory abnormalities were seen after treatment. At week 8 the efficacy analysis in 117 patients with mycologically confirmed dermatophyte infections (51 on terbinafine, 66 on itraconazole) showed that clinical symptoms were absent or minimal in 94.1% of the terbinafine and 72.7% of the itraconazole group (P = 0.0095); mycology was negative in 86.3% of the terbinafine and 54.5% of the itraconazole group (P = 0.0002). With terbinafine, negative mycology at week 8 was 81.3% in the interdigital and 88.6% in the more extensive forms of tinea pedis; with itraconazole mycology was negative in 65.0% and 50.0% of patients, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

The addition of dexamethasone significantly increases the complete response rate of both acute and delayed emesis in patients who have incomplete disease control with tropisetron alone.

The efficacy and the safety of bromocriptine 7.5 mg daily were investigated in a double-blind versus placebo trial in 32 patients with troublesome symptoms from benign prostatic hypertrophy. Differences between the treatments in respect of uroflowmetry, residual urine and safety parameters were not statistically significant. Differences in respect of nocturia, daytime frequency and overall efficacy were statistically significant in favour of bromocriptine. There could be a place for bromocriptine in the palliative treatment of the functional disability caused by benign prostatic hypertrophy when surgery is refused or contraindicated.

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