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Tolerability of Amlodipine

A Meta-Analysis

  • Section 2: Clinical Efficacy and Tolerability
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We examined the tolerability and safety of amlodipine in a large population of patients (n = 12 831) by performing a meta-analysis of 16 consecutive studies in which this drug was used for treatment of hypertension (n = 9638; 75%) or ischaemic heart disease (n = 3193; 25%) and data were standardised and referred to a central core laboratory. Adverse events were reported by patients in response to an open questionnaire and completed at standardised times after starting amlodipine.

Overall, the percentage of patients who experienced amlodipine-related adverse effects was about 15%, and only 3% of patients were withdrawn from amlodipine therapy because of drug intolerance.

Four adverse events (peripheral oedema, headache, flushing and altered heart rate) occurred in 1% or more of amlodipine recipients; these are typical of dihydropyridines and are predominantly related to arteriolar vasodilation.

Rare adverse events attributable to idiosyncratic or allergic response (skin rash) were reported.

Other adverse events (gastrointestinal disorders, tremor, polyuria, cough, etc.) were ill defined, and their nature was unclear.

Finally, the percentage of patients with amlodipine-related adverse effects was not influenced by drug dosage or disease status, and a comparison of amlodipine’s tolerability with that of alternative calcium antagonists, β-blockers or ACE inhibitors showed a significantly lower occurrence (17.3 vs 39.7% of patients, p < 0.001).

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  1. Murdoch D, Heel RC. Amlodipine: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in cardiovascular disease. Drugs 1991; 41: 478–505

    Article  PubMed  CAS  Google Scholar 

  2. Heber ME, Bridgen G, Al-Khawaja I, et al. 24-hour blood pressure control with the once-daily calcium antagonist, amlodipine. Br J Clin Pharmacol 1989; 27: 59–65

    Article  Google Scholar 

  3. Mrozek WJ, Burris JF, Allenby KS. A double-blind evaluation of the effect of amlodipine on ambulatory blood pressure in hypertensive patients. J Cardiovasc Pharmacol 1988; 12 Suppl. 7: 579–84

    Google Scholar 

  4. Chaine RA, Feldman RL, Giles TD, et al. Randomized placebo-controlled trial of amlodipine in vasospastic angina. J Am Coll Cardiol 1993; 21: 1365–70

    Article  Google Scholar 

  5. Hosie J, Bremner AD, Fell PJ, et al. Comparison of early side effects with amlodipine and nifedipine retard in hypertension. Cardiology 1992; 80 Suppl. 1: 54–9

    Article  PubMed  Google Scholar 

  6. Waeber B, Borges ET, Christeler P, et al. Amlodipine compared to nitrendipine in hypertensive patients: the effects on toleration in relationship to the onset of action. Cardiology 1992; 80 Suppl. 1: 46–53

    Article  PubMed  Google Scholar 

  7. Berlin JA, Laird NM, Sacks HS, et al. A comparison of statistical methods for combining event rates from clinical trials. Stat Med 1989; 8: 141–51

    Article  PubMed  CAS  Google Scholar 

  8. Struyker-Boudier HA, Smits JFM, De Mey GR. The pharmacology of calcium antagonists: a review. J Cardiovasc Pharmacol 1990; 15 Suppl. 4: 1–10

    Article  Google Scholar 

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Perna, G.P., Stanislao, M. & De Luca, G. Tolerability of Amlodipine. Clin. Drug Invest. 13 (Suppl 1), 163–168 (1997).

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