Methodology For Assesing Antihypertensive Drug Treatment Requirement As an Outcome Parameter To Evaluate the Efficacy of A Personalized Food Avoidance Dietary Approach to Stop Hypertension

[Speaker] Michael T Okafor:1
[Co-author] Chioli P Chijioke:2, Mercy N Gbenimachor:3, Nnamdi I Nwosu:4, Nkeiruka C Mbadiwe:4, Anthony A Eze:5, Uzoamaka A Okoli:6, Nkoyo I Nubila:7, Ifeoma C Onah:8, Nnenna N Chigbo:9
1:Department of Pharmacology and Therapeutics, College of Medicine University of Nigeria Enugu Campus, Nigeria, 2:Department of Pharmacology and Therapeutics, university of Nigeria Enugu Campus, Nigeria, 3:Department of Pharmacy University of Nigeria Teaching Hospital, Nigeria, 4:Department of Medicine University of Nigeria Teaching Hospital, Nigeria, 5:Chiolive International Medical Research, Nigeria, 6:Department of Medical Biochemistry University of Nigeria Enugu Campus, Nigeria, 7:Department of Pharmacology and Therapeutics University of Nigeria Enugu, Nigeria, 8:Chiolive International Medical Research Organization, Nigeria, 9:Department of Physiotherapy and Exercise Immunology University of Nigeria Teaching Hospital, Nigeria

BACKGROUND: Waxing pandemic of non-communicable diseases, with systemic arterial hypertension at the forefront, mandates urgent attention to the aetiopathogenic mechanism rather than relying on suppressive drug therapies. Indeed, drug treatments to suppress disease phenotype may have unreliable efficacy because they do not address the aetiopathogenic gene - environment interaction. We are conducting clinical trials to address the diet-genome interaction in the aetiopathogenesis of essential hypertension, by evaluating a Personalized Food Avoidance modification of the Dietary Approach to Stop Hypertension (PFA-DASH). Dietary factors which promote immune dysfunction are avoided on a personalized basis, after appraising immune tolerances and intolerances for each study participant. Antihypertensive drug treatment requirement (ADTR) is expected to decline with an effective dietary intervention. Our objective was to develop and validate a method of measuring ADTR.
METHODS: The open controlled trial of a personalized food avoidance dietary approach to stop hypertension has been approved by UNTH ethics committee. Unitary daily dosages were defined for antihypertensive drugs corresponding to the usual starting dosages. Drug treatment parameters assessed include: Antihypertensive drug prescription (total unitary daily dosages of prescribed antihypertensive drugs), Adherence (No. of doses taken/No. of doses prescribed over relevant time period) and Actual treatment score (No. of unitary dosages of antihypertensive x adherence). ADTR was determined by adding 0.1 to Actual treatment score for every mmHg that average systolic automated office blood pressure or average systolic home blood pressure (whichever is higher) exceeds 120 mmHg. 0.1 is subtracted for every mmHg that average systolic AOBP or home BP (whichever is lower) goes below 100 mmHg.
RESULTS: Drug treatment parameters: Prescribed treatment, actual treatment score and ADTR showed a significant negative association with dietary compliance (P<0.05), without significant impact from potential confounders.
CONCLUSION: We conclude that antihypertensive drug treatment requirement scores are useful tools in clinical research to assess the impact of dietary interventions which address the aetiopathogenic diet - genome interaction in essential hypertension. This enables differentiation between blood pressure lowering by drugs and that due to dietary intervention. ADTR measurements may also be useful in routine practice to ensure antihypertensive drug prescription commensurate with clinical needs of patients.
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