FDA Assessment of Pressor Effects of Drugs Guidance for Industry

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Draft — Not for Implementation 1 Assessment of Pressor Effects of Drugs 1

2 Guidance for Industry 3 4 5 6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 8 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 10 for this guidance as listed on the title page. 11 12 13 14 I. INTRODUCTION 15 16 The purpose of this guidance is to advise sponsors on the premarketing assessment of a drug’s 17 effect on blood pressure. Elevated blood pressure is known to increase the risk of stroke, heart 18 attack, and death. The effect of a drug on blood pressure can therefore be an important 19 consideration in benefit-risk assessment. 20 21 This guidance is intended to address precision of blood pressure measurements in the assessment 22 of the effects of a drug in development. This guidance recommends systemic characterization of 23 the effect of a drug on blood pressure during drug development. 24 25 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 26 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 27 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 28 the word should in Agency guidances means that something is suggested or recommended, but 29 not required. 30 31 32 II. BACKGROUND 33 34 Information from multiple sources indicates that elevated systolic and diastolic blood pressures 35 increase cardiovascular risk. Epidemiologic evidence demonstrates that even a 2- to 3-millimeter 36 of mercury (mm Hg) increase in existing high blood pressure increases rates of stroke, heart 37 attack, and death. MacMahon et al. (1990) evaluated the relationship between diastolic blood 38 pressure and rates of stroke and coronary heart disease (CHD) in nine major, prospective, 39 observational studies. Diastolic blood pressures that were lower by 5, 7.5, and 10 mm Hg were 40 associated with 34 percent, 46 percent, and 56 percent less stroke, respectively, and 21 percent, 41 29 percent, and 37 percent less CHD. Of note, within the range of diastolic blood pressure 42 studied (70 to 110 mm Hg), the relative reduction in risk associated with a particular decrease in 43 diastolic blood pressure was similar across all levels of diastolic blood pressure, including levels 1

This guidance has been prepared by the Office of Drug Evaluation I in the Center for Drug Evaluation and Research at the Food and Drug Administration.

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