Blood pressure responder rates versus goal rates: which metric matters?

Basile, Jan

doi:10.1177/1753944708101552

Cited by 9 publications

(5 citation statements)

References 106 publications

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“…The efficacy of the drug was initially determined by the differences in the diastolic (DBP) and systolic (SBP) BPs before and after drug administration in the clinic. In addition, the responder rate was defined as a DBP <90 mmHg or decreased by ≥10 mmHg, and the goal rate was defined as a combined SBP/DBP <140/90 mmHg and <130/80 mmHg in patients with diabetes mellitus and renal disease, respectively [18]. All patients were asked about the number of drugs left when they visited the clinic and compliance was calculated by dividing the actual number of administrations by the planned number and was defined as excellent (100 %), very good (90–99 %), good (80–89 %), and poor (<80 %).…”

Section: Methodsmentioning

confidence: 99%

Safety and Efficacy of Fimasartan in Patients with Arterial Hypertension (Safe-KanArb Study)

Park

Sung

Kang

et al. 2013

Am J Cardiovasc Drugs

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BackgroundAngiotensin II receptor blockers (ARBs) play a key role in hypertension therapy. Recently, fimasartan, the ninth ARB, was developed, but its safety and efficacy have not been well established.ObjectiveThe objective of this study was to determine whether age, sex, concomitant disease, and current antihypertensive medications affect the safety and efficacy of fimasartan in patients with arterial hypertension.MethodsThis was a large-scale, open-label observational study to determine the safety and efficacy of fimasartan in patients with hypertension. Patients who were treated for more than 2 months with fimasartan (60 or 120 mg, once daily) were recruited, and the data were systematically collected using electronic case report forms. Written informed consent forms were obtained from all patients.ResultsA total of 14,151 patients (50.7 % males; mean age 59 ± 12 years) were evaluated, of whom 37.9 % were never treated with fimasartan, 53.5 % were switched to fimasartan, and 8.5 % had fimasartan added to their treatment. Overall, fimasartan reduced systolic blood pressure (SBP) from 145.4 ± 18.1 to 126.8 ± 12.6 mmHg and diastolic blood pressure (DBP) from 88.7 ± 11.8 to 79.0 ± 8.7 mmHg (all p < 0.001). The pulse rate decreased from 74.4 ± 10.3 to 71.9 ± 9.2 beats/min in comparison with before treatment (p < 0.001). The reductions were similar between sexes, age groups, and patients with and without co-morbidities, and were not dependent on prior or concomitant treatment with other antihypertensive drugs. Adverse events were reported in 3.31 % (treatment-emergent) and 2.35 % (drug-related) of patients; there were no dose differences for adverse events. The most frequent adverse events were dizziness (1.55 %) and headache (0.52 %); other adverse events were rare. The responder rate (DBP to <90 mmHg or a reduction of ≥10 mmHg) and the goal rate (combined SBP/DBP <140/90 mmHg) were 85.0 and 75.6 %, respectively. Global drug compliance was rated as excellent, very good, good, and poor in 68.1, 26.9, 3.4, and 1.7 % of patients, respectively.ConclusionThe safety, efficacy, and compliance of fimasartan were found to be excellent in a large patient population that included patients potentially at higher risk for adverse events.Electronic supplementary materialThe online version of this article (doi:10.1007/s40256-013-0004-9) contains supplementary material, which is available to authorized users.

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Section: Methodsmentioning

confidence: 99%

Safety and Efficacy of Fimasartan in Patients with Arterial Hypertension (Safe-KanArb Study)

Park

Sung

Kang

et al. 2013

Am J Cardiovasc Drugs

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“…A commonly used threshold to measure efficacy of antihypertensive therapy in clinical trials is based on DBP, defined as ≥10 mm Hg reduction from baseline. 27 With recent evidence on the importance of SBP and DBP, we also looked at SBP reduction ≥10 mm Hg to assess clinical response. 28 The most clinically relevant measure is the percent reaching goal blood pressure <140/90 mm Hg.…”

Section: Clinical Significancementioning

confidence: 99%

“…28 The most clinically relevant measure is the percent reaching goal blood pressure <140/90 mm Hg. 27 Home blood pressure of <140/90 mm Hg was considered an appropriate therapy goal, because none of the study participants had compelling indications that would lead to a lower blood pressure target.…”

Section: Clinical Significancementioning

confidence: 99%

Race-Specific Comparisons of Antihypertensive and Metabolic Effects of Hydrochlorothiazide and Chlorthalidone

Chekka

Chapman

Gums

et al. 2021

The American Journal of Medicine

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“…The responder rate in the telmisartan group was higher (47.1%) than that in cilnidipine group (26.3%) based on ABPM data. The reported responder rate for ARBs ranges between 33-79%, while for calcium-channel blockers it ranges between 43-95% [ 28 ]. For telmisartan, the rate was within the reported range, while for cilnidipine, it was much below the observed rates.…”

Section: Discussionmentioning

confidence: 99%

A Prospective, Randomized Open-Label Study for Assessment of Antihypertensive Effect of Telmisartan Versus Cilnidipine Using Ambulatory Blood Pressure Monitoring (START ABPM Study)

et al. 2023

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Background The antihypertensive agent telmisartan is an angiotensin II receptor blocker with a terminal elimination half-life of 24 h and has a high lipophilicity, thereby enhancing its bioavailability. Another antihypertensive agent, cilnidipine is a calcium antagonist and has dual mode of action on the calcium channels. This study aimed at determining effect of these drugs on ambulatory blood pressure (BP) levels. Methods A randomized, open-label, single-center study was conducted during 2021 - 2022 on newly diagnosed adult patients with stage-I hypertension, in a mega city of India. Forty eligible patients were randomized to telmisartan (40 mg) and cilnidipine (10 mg) groups, with once daily dose administered for 56 consecutive days. Ambulatory blood pressure monitoring (ABPM) (24 h) was performed pre- and post-treatment, and the ABPM-derived parameters were compared statistically. Results Statistically significant mean reductions were observed in all BP endpoints in telmisartan group but only in 24-h systolic blood pressure (SBP), daytime and nighttime SBP, and manual SBP and diastolic blood pressure (DBP) in cilnidipine group. The mean change from baseline to day 56 between two treatment groups showed statistical significance in last 6-h SBP (P = 0.01) and DBP (P = 0.014), and morning SBP (P = 0.019) and DBP (P = 0.028). The percent nocturnal drop within and between groups was statistically nonsignificant. Also, the between group mean SBP and DBP smoothness index differed nonsignificantly. Conclusions Telmisartan and cilnidipine once daily were effective and well tolerated in the treatment of newly diagnosed stage-I hypertension. Telmisartan provided sustained 24-h BP control and may offer advantages over cilnidipine in terms of BP reductions, particularly over the 18- to 24-h post-dose period or critical early morning hours.

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Blood pressure responder rates versus goal rates: which metric matters?

Cited by 9 publications

References 106 publications

Safety and Efficacy of Fimasartan in Patients with Arterial Hypertension (Safe-KanArb Study)

Safety and Efficacy of Fimasartan in Patients with Arterial Hypertension (Safe-KanArb Study)

Race-Specific Comparisons of Antihypertensive and Metabolic Effects of Hydrochlorothiazide and Chlorthalidone

A Prospective, Randomized Open-Label Study for Assessment of Antihypertensive Effect of Telmisartan Versus Cilnidipine Using Ambulatory Blood Pressure Monitoring (START ABPM Study)

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