Advertisement

Drug Investigation

, Volume 4, Issue 2, pp 184–191 | Cite as

Once-Daily Monotherapy of Hypertension with Nifedipine Sustained Release (20mg to 100mg)

  • Albert A. Carr
  • Peter B. Bottini
  • Peter U. Feig
  • Miltiades L. Karlos
  • Lawrence A. Schwartz
  • Seamus Mulligan
  • John G. Devane
  • Lloyd Fisher
  • E. Paul MacCarthy
Original Research Article
  • 7 Downloads

Summary

A 2-centre double-blind randomised clinical study was conducted to evaluate the efficacy and tolerability of fixed doses of a new sustained release (SR) formulation of nifedipine compared with placebo in 207 patients with mild to moderate uncomplicated essential hypertension. After a 3- to 6-week placebo washout period, patients were randomised to receive either placebo, nifedipine SR 20mg, nifedipine SR 50mg or nifedipine SR 100mg. All doses were taken once daily in the morning without food. Among the 157 patients who completed 6 weeks of active therapy, the mean diastolic blood pressure reductions from baseline at 24 hours postdose were 5.3mm Hg, 9.3mm Hg, 9.7mm Hg and 11.1mm Hg in the placebo and nifedipine SR 20mg, 50mg and 100mg groups, respectively (p < 0.01). Nifedipine SR given in fixed doses once daily produced a relatively uniform antihypertensive effect throughout the 24-hour dosing interval, as determined by ambulatory blood pressure monitoring. All 3 dosages of nifedipine SR were generally well tolerated. A major finding of this study was the efficacy and safety of the once-daily 20mg dose.

Keywords

Nifedipine Sustained Release Drug Invest Ambulatory Blood Pressure Monitoring Joint National Committee 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Aoki K, Sato K, Kawaguchi Y, Yamamoto M. Acute and longterm hypotensive effects and plasma concentrations of nifedipine in patients with essential hypertension. European Journal of Clinical Pharmacology 23: 197–201, 1982PubMedCrossRefGoogle Scholar
  2. Black HR. Prescribing for compliance: the role of fixed-dose combinations. Consultant 1-4, June 1988Google Scholar
  3. Collins R, Peto R, MacMahon S, Hebert P, Fiebach NH, et al.Google Scholar
  4. Blood pressure, stroke and coronary heart disease. Part 2: Shortterm reductions in blood pressure: overview of randomized drug trials in their epidemiological context. Lancet 1: 827–838, 1990Google Scholar
  5. Cramer JA, Mattson RH, Prevey ML, Scheyer RD, Ouellette VL. How often is medication taken as prescribed. Journal of the American Medical Association 261: 3273–3277, 1989PubMedCrossRefGoogle Scholar
  6. Cummings DM, Amadio P, Nelson L, Fitzgerald JM. The role of calcium channel blockers in the treatment of essential hypertension. Archives of Internal Medicine 151: 250–259, 1991PubMedCrossRefGoogle Scholar
  7. Eisen SA, Miller DK, Woodward RS, Spitznagel E, Przybeck TR. The effect of prescribed daily dose frequency on patient medication compliance. Archives of Internal Medicine 150: 1881–1884, 1990PubMedCrossRefGoogle Scholar
  8. Elan Pharmaceutical Research Corporation, Gainesville, Georgia. Data on fileGoogle Scholar
  9. Frishman WH, Charlap S, Goldberger J, Kimmel B, Stroh J, et al. Comparison of diltiazem and nifedipine for both angina pectoris and systemic hypertension. American Journal of Cardiology 56: 41H–46H, 1985PubMedCrossRefGoogle Scholar
  10. Frishman WH, Stroh JA, Greenburg S, Suarez T, Karp A, et al. Calcium channel blockers in systemic hypertension. Medical Clinics of North America 72: 449–499, 1988PubMedGoogle Scholar
  11. Fujii J, Akira S. Compliance and compliance-improving strategies in hypertension: the Japanese experience. Journal of Hypertension 3 (Suppl.): 19–22, 1985CrossRefGoogle Scholar
  12. Joint National Committee. The 1988 Report of the Joint National Committee on detection, evaluation, and treatment of high blood pressure. Archives of Internal Medicine 148: 1023–1038, 1988CrossRefGoogle Scholar
  13. Kaplan NM. Calcium entry blockers in the treatment of hypertension. Journal of the American Medical Association 262: 817–823, 1989PubMedCrossRefGoogle Scholar
  14. MacMahon SW, Cutler JA, Furberg CD, Payne GH. The effects of drug treatment for hypertension on morbidity and mortality from cardiovascular disease: a review of randomized clinical trials. Progress in Cardiovascular Diseases 29 (Suppl. 1): 99–118, 1986PubMedCrossRefGoogle Scholar
  15. Neal WW. Reducing costs and improving compliance. American Journal of Cardiology 63: 17B–20B, 1989PubMedCrossRefGoogle Scholar
  16. Opsahl JA, Halstenson CE, Abraham PA. Antihypertensive and humoral effects of nifedipine in essential hypertension uncontrolled by hydrochlorothiazide alone. Hypertension 2: 828–833, 1989Google Scholar
  17. Prisant LM, Carr AA, Bottini PB, Kaesemeyer WH. Nifedipine GITS (gastrointestinal therapeutic system) bezoar. Archives of Internal Medicine 151: 1868–1869, 1991PubMedCrossRefGoogle Scholar
  18. Pullar R, Birtwell AJ, Wiles PG, Hay A, Feely MP. Use of a pharmacologic indicator to compare compliance with tablets prescribed to be taken once, twice or three times daily. Clinical Pharmacology and Therapeutics 44: 540–545, 1988PubMedCrossRefGoogle Scholar
  19. Simmons GF. Introduction to topology and modern analysis. McGraw-Hill, New York, 1963Google Scholar
  20. Sokolnikoff IS. Mathematics of physics and modern engineering. McGraw-Hill, New York, 1958Google Scholar
  21. Working Group on Health Education and High Blood Pressure Control, National High Blood Pressure Education Program. The physician’s guide: improving adherence among hypertensive patients. US Department of Health and Human Services; National Heart, Lung, and Blood Institute, Bethesda, 1987Google Scholar

Copyright information

© Adis International Limited 1992

Authors and Affiliations

  • Albert A. Carr
    • 1
  • Peter B. Bottini
    • 1
  • Peter U. Feig
    • 2
  • Miltiades L. Karlos
    • 2
  • Lawrence A. Schwartz
    • 2
  • Seamus Mulligan
    • 3
  • John G. Devane
    • 3
  • Lloyd Fisher
    • 4
  • E. Paul MacCarthy
    • 2
  1. 1.Hypertension SectionMedical College of GeorgiaAugustaUSA
  2. 2.Pharmaceutical DivisionMiles Inc.West HavenUSA
  3. 3.Elan Pharmaceutical Research CorporationGainesvilleUSA
  4. 4.University of WashingtonSeattleUSA

Personalised recommendations