Implementing Single-Pill Combination Therapy for Hypertension: A Scoping Review of Key Health System Requirements in 30 Low- and Middle-Income Countries

Bruyn, Eleanor; Nguyen, Long; Schutte, Aletta E.; Murphy, Adrianna; Perel, Pablo

doi:10.5334/gh.1087

Cited by 15 publications

(15 citation statements)

References 46 publications

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“…However, antihypertensive single-pill combinations are still rather uncommon [ 22 ]. Their implementation into national essential medicines lists and national hypertension guidelines as well as availability on the market would represent key facilitators to promote this treatment strategy [ 23 ].…”

Section: Discussionmentioning

confidence: 99%

Single-Pill, Triple Antihypertensive Therapy in Rural Sub-Saharan Africa: Preliminary Experience

Stroppa,

Hunjan,

Umulisa

et al. 2024

Cardiol Ther

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Introduction Worldwide, arterial hypertension is the foremost preventable and modifiable cardiovascular risk factor. In addition to lifestyle changes, recent international guidelines recommend single-pill, low-dose combinations as initial treatment strategy. We investigated whether this approach is feasible in a rural sub-Saharan Africa setting. Methods Diagnosis of hypertension was established over three sets of blood pressure measurements, performed according to the European Society of Hypertension recommendations by trained personnel, using a validated, automated, oscillometric device OMRON M7 IT-HEM-7322-E. In 98 individuals with arterial hypertension, a once-daily, single-pill combination of olmesartan, amlodipine, and hydrochlorothiazide was prescribed at an appropriate dose. Patients were instructed on its administration and potential side effects and encouraged towards lifestyle modifications. The treatment regimen was adjusted, if needed, at each outpatient clinic scheduled after 4, 8, 12, and 16 weeks. Results Seventy-nine patients (aged 61 [53–70] years; median and interquartile range) strictly adhered to the treatment schedule, while 19 individuals (70 [65–80] years) dropped out. Blood pressure was < 140/90 mmHg after 4 weeks in 44 (56%), after 8 weeks in 62 (78%), after 12 weeks in 69 (87%), and after 16 weeks in 74 (94%) participants. Excellent tolerance was reported. Conclusions These results provide real-life evidence that hypertension management with a once-daily, single-pill combination of olmesartan, amlodipine, and hydrochlorothiazide as initial treatment is feasible and effective also in a rural sub-Saharan setting. Single-pill combinations should be made available also in rural and remote areas in low- and middle-income countries as a reliable first-line treatment strategy.

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Section: Discussionmentioning

confidence: 99%

Single-Pill, Triple Antihypertensive Therapy in Rural Sub-Saharan Africa: Preliminary Experience

Stroppa,

Hunjan,

Umulisa

et al. 2024

Cardiol Ther

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“…9,12,14 Lisinopril/hydrochlorothiazide is one of the commonly prescribed FDC tablets for first-line therapy in patients with Grade 2 hypertension, comorbidities, and with cardiovascular risk factors. 9,13,17,18 In this study, we compared the bioequivalence of FDC tablets of lisinopril and hydrochlorothiazide in a 10:12.5 ratio (test and reference) in the fasting and postprandial states based on the PK characteristics of 96 subjects. One subject in the fasting group withdrew prior to Cycle II dosing, and his Cycle II was not included in the analysis of PK parameters.…”

Section: Discussionmentioning

confidence: 99%

“…The combination of drugs is a widely used treatment option for hypertension, 5,17 offering not only effective blood pressure control and improved patient compliance, 6 but also protection against cardiovascular disease 9,12,14 . Lisinopril/hydrochlorothiazide is one of the commonly prescribed FDC tablets for first‐line therapy in patients with Grade 2 hypertension, comorbidities, and with cardiovascular risk factors 9,13,17,18 …”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetic and Bioequivalence Study of Lisinopril/Hydrochlorothiazide Tablet Under Fasting and Postprandial Conditions in Healthy Chinese Subjects

Yang,

Mi,

et al. 2023

Clinical Pharm in Drug Dev

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The objective of this research was to evaluate and compare the pharmacokinetic profiles and safety of lisinopril/hydrochlorothiazide (10 mg/12.5 mg) tablets in the test and reference formulations administered to participants in both fasting and postprandial states and to evaluate the bioequivalence of the 2 products in healthy Chinese volunteers. This study employed a single‐center, randomized, open‐label, single‐dose dosing trial involving a cumulative 96 healthy adult participants (60 in the fasting group and 36 in the postprandial group). Each group comprised 2 sequence sets, and a 2‐week washout period was implemented. There were no statistically significant differences in time to maximum concentration and terminal elimination half‐life between the test and control groups under fasting and postprandial conditions (P > .05), and the 90% CIs for area under the plasma concentration–time curve and maximum plasma concentration were within the bioequivalence range of 80%‐125%. Pharmacokinetic results indicate a large food effect for lisinopril, meaning that there is a loss of approximately 20%‐25% of systemic exposure from fasting to postprandial administration for both preparations. The study demonstrated that a single oral dose of generic lisinopril/hydrochlorothiazide is bioequivalent to the reference product and well tolerated, with no significant adverse events observed, and that both products are similarly safe in a cohort of healthy Chinese male and female participants, following administration under fasting and postprandial conditions.

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“…First-line treatment with combination therapy has been associated with a significant (34%) risk reduction of cardiovascular events or all-cause death, when compared to those who received delayed combination treatment initiation due to initial monotherapy treatment This was primarily due to the more rapid and effective BP control. Combination therapy is also associated with lower healthcare resource use, which is particularly important for LMICs ( 6 ).…”

Section: Discussionmentioning

confidence: 99%

The Effects of Single Pill Combinations on Adherence and Blood Pressure Control in Hypertensive Patients

Naser¹,

Jatić²,

Avdic³

2022

Mater Sociomed

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Background: Hypertension is the most important risk factor for cardiovascular morbidity and mortality. Blood pressure control rates are as low as 17% to 31% in patients diagnosed with hypertension in high-income countries; control rates are likely poorer in low- to middle- and low-income countries. Blood pressure control rates are as low as 17% to 31% in patients diagnosed with hypertension in high-income countries; control rates are likely poorer in low- to middle- and low-income countries. Overall, 43% to 66% of patients fail to adhere to their prescribed antihypertensive medications, and after 1 year, ≈40% of patients with hypertension may stop their initial drug treatment. Objective: The aim of the study was to evaluate the effects of single pill combination antihypertensive drugs on the adherence to treatment, blood pressure control and cardiovascular events vs. free-combination therapy. Methods: We enrolled 192 adult hypertensive patients not older than 79 years, with untreated or uncontrolled hypertension despite previously receiving free combination antihypertensive therapy, between November 2020 and March 2022. Patients treated with single pill combination (SPC) were compared with an arm of the same size (n = 96) and matched by age and gender who received a standard free combination (FC) antihypertensive therapy. Results: There were significant reductions from baseline to month 6 of follow-up in office SBP in the SPC group vs. reduction in FC group (21.9 vs. 13.1 mmHg; p < 0.0001). There were significant reductions from baseline to month 6 of follow-up in office DBP in the SPC group vs. group with free-combination therapy (13.7 vs. 8.0 mmHg; p < 0.0001). At 6 months, 94 participants (98%) were still prescribed the SPC therapy. At the final 6-month study visit, 84.2% of patients in the SPC therapy group were adherent to the prescribed antihypertensive therapy vs. 52% of patients in the FC group. Target BP values (mean 24h ambulatory systolic/diastolic BP < 130/80 mmHg) were reached by more recipients of SPC than free-combination therapy (78.2% vs. 46.3%, p < 0.05) at month 6 of follow-up. Conclusion: Treatment with single pill combinations (SPC), is the emerging best practice for safe, effective, rapid, and convenient hypertension control. It improves the affordability, adherence and control of arterial hypertension.

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Implementing Single-Pill Combination Therapy for Hypertension: A Scoping Review of Key Health System Requirements in 30 Low- and Middle-Income Countries

Cited by 15 publications

References 46 publications

Single-Pill, Triple Antihypertensive Therapy in Rural Sub-Saharan Africa: Preliminary Experience

Single-Pill, Triple Antihypertensive Therapy in Rural Sub-Saharan Africa: Preliminary Experience

Pharmacokinetic and Bioequivalence Study of Lisinopril/Hydrochlorothiazide Tablet Under Fasting and Postprandial Conditions in Healthy Chinese Subjects

The Effects of Single Pill Combinations on Adherence and Blood Pressure Control in Hypertensive Patients

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