Overview of clinical trials of dilevalol in essential hypertension.

The efficacy, tolerability and safety of dilevalol in essential hypertension has been documented in an international clinical trials programme which was conducted with doses up to 1600mg daily. Initial double-blind trials confirmed the superiority of dilevalol over placebo in essential hypertensive patients and documented the suitability of a once-daily dosage. Almost all of the subsequent trials have been randomised, double-blind comparative trials of dilevalol versus established anti-hypertensive agents with the duration of treatment ranging from four weeks up to one year. The recommended dosage range of dilevalol, of 200-400 mg once-daily, has generally been shown to be at least as effective at lowering raised blood pressure as established antihypertensive agents given according to their recommended doses. In one study in elderly hypertensives, dilevalol was significantly more effective than atenolol in lowering systolic blood pressure. Safety data is available from a consolidated database of 2011 dilevalol-treated patients representing over 500 patient-years exposure. Overall, dilevalol was well tolerated and evidence of dose-related adverse effects became apparent only for nausea and dizziness above the recommended dose range. The most common adverse effects considered probably or definitely related to treatment were fatigue (2.5%), nausea (1.9%), headache (1.8%) and dizziness (1.7%). 'Typical' beta-blocker adverse effects were observed, though many of these effects were less frequent than seen with comparator beta-blockers. Evidence of excessive vasodilation was rarely found, consistent with the counter-balancing effect of beta-blockade.(ABSTRACT TRUNCATED AT 250 WORDS)