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The Treatment of Severe Hypertension with Trandolapril, Verapamil, and Hydrochlorothiazide

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The Treatment of Severe Hypertension with Trandolapril, Verapamil, and Hydrochlorothiazide Journal of Human Hypertension (1997) 11, 477–481 1997 Stockton Press. All rights reserved 0950-9240/97 $12.00 ORIGINAL ARTICLE The treatment of severe hypertension with trandolapril, verapamil, and hydrochlorothiazide HA Punzi1 and BA Novrit2 for the Trandolapril/Verapamil Multicenter Study Group 1Trinity Hypertension Research Center, Trinity Medical Center, Carrollton, TX; and 2Knoll Pharmaceutical Company, Mt Olive, NJ, USA A multiple drug regimen consisting of trandolapril, vera- than the decrease observed for the TV combination, pamil and hydrochlorothiazide (HCTZ) were sequentially which was significantly (P = 0.001) greater than the added in an open-label evaluation of patients with sev- decrease observed for trandolapril monotherapy. Clini- ere hypertension. Ninety patients (58 white and 32 black cal responder rates were 44.8%, 56% and 77.7% for tran- patients) were titrated on one or more drugs and fol- dolapril monotherapy, trandolapril + verapamil combi- lowed for a 19-week maintenance period. Statistically nation therapy and triple therapy, respectively. Black significant (P = 0.001) mean (± s.d.) decreases in supine and white patients had similar response rates, but black diastolic blood pressure (DBP) were 9.0 (±9.3) mm Hg patients appeared to benefit more from the addition of for trandolapril, 13.9 (±11.0) mm Hg for the trandolapril HCTZ; 20% of black patients achieved a post-treatment + verapamil (TV) combination, and 19.0 (±12.3) mm Hg supine DBP ,90 mm Hg compared to 12.8% of white when hydrochlorothiazide was added to the combi- patients. This study demonstrates that the addition of nation. The decrease in BP observed on TV combination verapamil to trandolapril has an additive effect on BP therapy plus HCTZ was significantly (P = 0.001) greater that is maintained throughout the day. Keywords: verapamil; trandolapril; hydrochlorothiazide; severe hypertension; blood pressure; black patients Introduction hypertensives,4–6 while racial responses to verapa- mil are similar.7 Hence, results for black and white The physician today has a wide range of choices for patients are reported separately. the treatment of severe or resistant hypertension. The most frequently employed regimen has con- sisted of a diuretic, a sympatholytic agent, and a per- Patients and methods 1 ipheral vasodilator. But often this regimen does not Study design reduce blood pressure (BP) to acceptable levels or leads to untoward side effects that result in discon- This was an open-label, multicenter study to evalu- tinuation of the drug regimen by the patient. Thus, ate the safety and efficacy of trandolapril monother- the ideal combination therapy should not only offer apy (2 mg, 4 mg, or 8 mg) and trandolapril in combi- synergistic antihypertensive effects, but also an nation with slow release verapamil (180 mg) in acceptable side effect profile. Recent publications patients with severe hypertension. The study con- have shown that when angiotensin-converting sisted of a 3- to 14-day single-blind, placebo run-in enzyme (ACE) inhibitors are combined with calcium period, a 5-week, open-label dose-titration period, channel blockers, the antihypertensive properties of and a 19-week maintenance period. A diagram of the the combination have been impressive.1–3 study design is presented as Figure 1. This paper reports the results of an evaluation of the safety and efficacy of the non-sulfhydryl ACE- Patient population inhibitor trandolapril in combination with the cal- cium antagonist verapamil in the treatment of Patients could be enrolled in the study if they were patients with severe hypertension. Trandolapril is between 21 and 70 years of age and had documented a prodrug which is rapidly hydrolyzed to its active severe hypertension (supine diastolic BP: 115 to 135 diacid metabolite, trandolaprilat. Previous clinical mm Hg). Patients were excluded from enrollment if trials have demonstrated that black hypertensives do they had a cerebrovascular accident, convulsive dis- not respond as well to ACE inhibitors as white order, or hypertensive encephalopathy within the previous year; experienced a myocardial infarction within 3 months of the study, or had severe cardiac Correspondence: Henry A Punzi, Trinity Hypertension Research abnormalities, ie, congestive heart failure (CHF), Center, Trinity Medical Center, Professional Plaza II, 4333 N. arrhythmias, conduction abjormalities, or atrioven- Josey Lane, Suite 300, Carrollton, TX 75010, USA tricular (AV) block; had evidence of renal, hepatic, Trandolapril/verapamil in severe hypertension HA Punzi and BA Novrit 478 Figure 1 Diagram of study design. (O) Trandolapril dose doubled in black patients. (K) Hydrochlorothiazide could be added if supine DBP was not <90 mm Hg after 2 weeks. hematological, or other metabolic abnormalities that administered higher doses of trandolapril than the could interfere with study drug absorption, metab- white patients.6 olism, or excretion; had a history of drug abuse or The titration period began with the administration addiction. Patients were also excluded if they of a low dose of trandolapril, 2 mg qAM in the case required the concomitant use of other antihyperten- of the white patients and 4 mg qAM in the case of sives, digitalis glycosides, antiarrhythmics, antide- the black patients. If adequate control of BP was not pressant drugs, central nervous system stimulants achieved after 1 week, the dose of trandolapril was and depressants, chronic non-steroidal anti- doubled for both white and black patients. BP was inflammatory drugs and analgesics, as well as any considered adequately controlled if supine DBP was medication that could elevate BP. <90 mm Hg. If after 2 weeks at the high dose of tran- The protocol was approved by the appropriate dolapril, the patient’s BP was still not adequately institutional review committee and all patients gave controlled, 180 mg qAM of the calcium channel written informed consent. blocker verapamil was added. The daily dose of ver- apamil remained constant for the duration of the study. If a satisfactory response was not achieved Study procedures after 2 weeks of combined trandolapril plus verapa- At the initial visit prior to entry into the study, BP mil therapy, the investigator could add 12.5 mg to was recorded in both arms. The arm with the highest 25 mg of hydrochlorothiazide (HCTZ) or discon- sitting diastolic BP (DBP) was used for all sub- tinue the patient from the study. sequent measurements throughout the study. At the principal investigator’s discretion, patients Patients who had been newly diagnosed or who had could be titrated more rapidly than indicated in the been previously treated for severe hypertension, dis- protocol to achieve faster BP control. Patients exhib- continued all antihypertensive medications and iting a satisfactory response to either trandolapril or entered into a single-blind, placebo run-in period of to trandolapril/verapamil combined therapy (with at least 3 days but no longer than 14 days duration. or without HCTZ) at the completion of the dose- During the run-in period, patients were adminis- titration period, continued to receive this therapy tered placebo once a day. At the end of the placebo during the 19-week maintenance period. run-in period, patients with documented severe Patient visits were scheduled every week during hypertension advanced into a 5-week, open-label, the 5-week dose-titration period, and at weeks 1, 3, dose-titration period. Qualifying DBP of between 7, 9, 11, 15, and 19 of the 19-week maintenance per- 115 and 135 mm Hg was determined as the mean of iod. At each visit, a physical examination was per- three consecutive supine DBP measurements taken formed, vital signs and BP were measured, com- 2 min apart. In order to be advanced into the dose- pliance was evaluated, and the patient was titration period, qualifying BP had to be docu- questioned about the occurrence of adverse reac- mented on the last visit of the placebo run-in period. tions. The patient’s cardiac status was monitored The first dose of trandolapril could be administered periodically throughout the study by 12-lead ECG. immediately after severe hypertension was docu- Routine clinical laboratory evaluations were also mented at the time points indicated above. All sub- performed. sequent doses were administered between 08.00 and BP measurements were trough readings taken 10.00 hours for the duration of the study. immediately prior to the day’s administration of Since it has been reported that black patients do scheduled study drug dose. At each study visit, after not respond as well to ACE inhibitors as white having the patient rest in a supine position for a patients, the black patients in this study were minimum of 10 min, systolic/diastolic BP and heart Trandolapril/verapamil in severe hypertension HA Punzi and BA Novrit 479 rate were measured. Standing BP measurements bination therapy with trandolapril and verapamil were also made, but are not reported here. during the study. Seventy-one patients (79%) were titrated to com- bination therapy plus HCTZ by the completion of Measures of efficacy the study. Equal percentages of white and black The primary measure of efficacy was mean change patients, 62% and 63%, respectively, were titrated in trough supine DBP from baseline to post-treat- to the highest doses of TV combination therapy ment. Baseline was considered the last BP measure- plus HCTZ. ment taken prior to the first open-label dose. Post- Forty-one patients (46%) discontinued therapy treatment was the last trough BP measurement on a before the end of the 19-week maintenance period: particular treatment. 11 during monotherapy (T), five during combination In addition to evaluating the mean change in therapy (TV), and 25 during combination therapy supine DBP, patients meeting the definition of plus hydrochlorothiazide (TV/HCTZ). ‘responder’ were tabulated. For the purpose of this study, a responder was defined as a patient whose post-treatment trough supine DBP was ,90 mm Hg, BP response or who had at least a 10 mm Hg decrease in supine Eighty-seven of the 90 patients enrolled in the study DBP from baseline to post-treatment.
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