A multicenter, randomized controlled trial comparing a single intra-articular injection of Gel-200, a new cross-linked formulation of hyaluronic acid, to phosphate buffered saline for treatment of osteoarthritis of the knee.

OBJECTIVE: To compare the safety and efficacy of a single intra-articular (IA) injection of a new cross-linked hyaluronic acid product, Gel-200, with phosphate buffered saline (PBS, control) in a multi-center randomized controlled trial in patients with symptomatic osteoarthritis (OA) of the knee. DESIGN: Patients were randomized 2:1 to receive a single injection of Gel-200 or PBS, after joint aspiration. The primary measure of effectiveness was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscores by 100-mm Visual Analog Scale (VAS); secondary outcomes included: total WOMAC, physical function, and stiffness subscores; patient and physician global assessments of disease activity, Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responders, as well as safety of Gel-200. RESULTS: Of 379 patients randomized, safety was evaluated in 377 and efficacy in 375 (98.9% randomized) in the intent-to-treat population. Effectiveness of Gel-200 by WOMAC pain subscores was statistically significant at week 13 (P=0.037). Mean improvements from baseline in WOMAC pain subscores consistently favored Gel-200 at each visit. Effectiveness of Gel-200 treatment was statistically significant over weeks 3-13 by WOMAC total score, physical function, and physician global evaluations (P<0.05). The number of "strict" OMERACT-OARSI responders was statistically significant from weeks 6 to 13 (P=0.022). Adverse events were not significantly different between treatment groups, including serious adverse events considered related to study treatment. CONCLUSIONS: This trial demonstrated that a single injection of Gel-200 was well tolerated and relieved pain associated with symptomatic OA of the knee over 13 weeks. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NTC 00449696.

Streptozocin plus fluorouracil versus doxorubicin therapy for metastatic carcinoid tumor.

EST 5275 is a phase II and III study of fluorouracil plus streptozocin (5-FU plus STZ) or doxorubicin in patients with measurable progressive carcinoid tumor. Among one hundred seventy-two cases with no prior chemotherapy and no heart disease, the response rate was 22% for 5-FU plus STZ and 21% for doxorubicin, while the median response duration and median survival were 31 weeks and 64 weeks for the combination and 26 weeks and 48 weeks for doxorubicin. Thirty-three patients who failed 5-FU plus STZ crossed over to doxorubicin and achieved an 18% response. Of the thirty-five patients who failed on doxorubicin, 29% responded to 5-FU plus STZ. Hematologic toxicity was similar for both treatments; however, the 5-FU plus STZ patients experienced more vomiting but acceptable renal toxicity. Both chemotherapy regimens have antitumor activity in carcinoid tumors.

An Eastern Cooperative Oncology Group evaluation of combinations of methyl-CCNU, mitomycin C, Adriamycin, and 5-fluorouracil in advanced measurable gastric cancer (EST 2277).

In a prospectively randomized trial, patients with advanced locally recurrent or metastatic gastric adenocarcinoma were randomized to receive 5-fluorouracil (5-FU) and methyl-CCNU; 5-FU, Adriamycin (Adria Laboratories, Columbus, Ohio), and methyl-CCNU; 5-FU, Adriamycin, and mitomycin C; or Adriamycin and mitomycin C alone. One hundred eighty-three previously untreated evaluable patients were randomized among the four arms. An additional 39 patients previously treated with 5-FU, were assigned to treatment directly to Adriamycin and mitomycin C. Response rates were 14%, 29%, 39%, and 29%, respectively, among previously untreated patients and 21% for Adriamycin and mitomycin C among previously treated patients. 5-Fluorouracil, Adriamycin, and mitomycin C, the arm containing the largest number of responders (18), was the combination associated with the longest median survival. A larger proportion of patients in this arm survived one year or more. In addition, the 5-FU, Adriamycin, and mitomycin C program had the lowest rate of severe or worse toxicity of any of the treatments and was effective in patients who were less than fully ambulatory and in those who had lost weight. 5-Fluorouracil, Adriamycin, and mitomycin C appear to be a likely combination to be considered in a surgical adjuvant program.

Serial levels of CA 19-9 and CEA in colonic cancer.

The use of serial carbohydrate antigen (CA) 19-9 assays was assessed by comparison with serial carcino-embryonic antigen (CEA) levels on the plasmas of 53 patients with colorectal carcinoma. The patients had all undergone resection for their primary tumors and in six instances subsequent resections for hepatic metastases. Initial CA 19-9 levels were greater than or equal to 37 U/mL in 22 of the 53 patients (41%) and in 68% of the patients with metastatic disease. Similar trends of serial CA 19-9 and CEA levels were found in 79% of the 53 patients. One patient with initially normal CEA levels had elevated CA 19-9 levels from the start. In ten of the 53 patients (19%), serial CA 19-9 levels remained low despite tumor recurrence or progression, and despite increasing CEA levels above 5 ng/mL. The increasing serial CEA trends predicted recurrence in 88% and increasing CA 19-9 trends in 50% of cases, which was increased to 70% by including trends of CA 19-9 levels below 37 U/mL. Following hepatic lobectomy, both serial CEA and CA 19-9 levels decreased rapidly. Used alone, serial CA 19-9 levels did not appear to be as sensitive as standard CEA in this retrospective study of selected patients.

The effect of aspartame as part of a multidisciplinary weight-control program on short- and long-term control of body weight.

This study investigated whether the addition of the high-intensity sweetener aspartame to a multidisciplinary weight-control program would improve weight loss and long-term control of body weight. One hundred sixty-three obese women were randomly assigned to consume or to abstain from aspartame-sweetened foods and beverages during 16 wk of a 19-wk weight-reduction program (active weight loss), a 1-y maintenance program, and a 2-y follow-up period. Women in both treatment groups lost approximately 10% of initial body weight (10 kg) during active weight loss. Among women assigned to the aspartame-treatment group, aspartame intake was positively correlated with percentage weight loss during active weight loss (r = 0.32, P < 0.01). During maintenance and follow-up, participants in the aspartame group experienced a 2.6% (2.6 kg) and 4.6% (4.6 kg) regain of initial body weight after 71 and 175 wk, respectively, whereas those in the no-aspartame group gained an average of 5.4% (5.4 kg) and 9.4% (9.4 kg), respectively. The aspartame group lost significantly more weight overall (P = 0.028) and regained significantly less weight during maintenance and follow-up (P = 0.046) than did the no-aspartame group. Percentage weight losses at 71 and 175 wk were also positively correlated with exercise (r = 0.32, P < 0.001; and r = 0.34, P < 0.01, respectively) and self-reported eating control (r = 0.37, P < 0.001; and r = 0.33, P < 0.01, respectively). These data suggest that participation in a multidisciplinary weight-control program that includes aspartame may facilitate the long-term maintenance of reduced body weight.

Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group.

The prognostic effect of weight loss prior to chemotherapy was analyzed using data from 3,047 patients enrolled in 12 chemotherapy protocols of the Eastern Cooperative Oncology Group. The frequency of weight loss ranged from 31 percent for favorable non-Hodgkin's lymphoma to 87 percent in gastric cancer. Median survival was significantly shorter in nine protocols for the patients with weight loss compared to the patients with no weight loss. Chemotherapy response rates were lower in the patients with weight loss, but only in patients with breast cancer was this difference significant. Decreasing weight was correlated with decreasing performance status except for patients with pancreatic and gastric cancer. Within performance status categories, weight loss was associated with decreased median survival. The frequency of weight loss increased with increasing number of anatomic sites involved with metastases, but within categories of anatomic involvement, weight loss was associated with decreased median survival. These observations emphasize the prognostic effect of weight loss, especially in patients with a favorable performance status or a limited anatomic involvement with tumor.

A prognostic factor study of disease-free interval and survival following enucleation for uveal melanoma.

Prognostic indicators of uveal melanoma disease-free interval and survival following enucleation were evaluated for 267 patients. The median follow-up time was 17 years. Analysis involved Kaplan-Meier survival curves based on time to tumor-related deaths and multivariate proportional hazards analysis, which provides an estimate of the "force of mortality." Prognostic indicators considered included demographic, clinical, and histopathological factors. Cell type was classified according to the number of epithelioid cells present per high-power field (HPF) on light microscopy. Various classifications of size of the tumor were compared for prognostic value. The five leading predictors of survival in order of importance were as follows: (1) number of epithelioid cells per HPF, (2) largest dimension of the tumor, (3) location of the anterior margin of the tumor, (4) invasion to the line of transection, and (5) degree of pigmentation. Risk categories for survival were constructed based on the three leading prognostic factors.

Chemotherapy of gastric and pancreatic carcinoma: a controlled evaluation of combinations of 5-fluorouracil with nitrosoureas and "lactones".

By random assignment a total of 176 eligible patients with advanced nonmeasurable pancreatic carcinoma were treated with 5-fluorouracil (5-FU) either alone or in combination with a nitrosourea (streptozotocin), in combination with a "lactone" (spironolactone), or in combination with both. By random assignment a total of 179 patients with advanced nonmeasurable gastric carcinoma were treated with 5-FU either alone or in combination with a nitrosourea (methyl CCNU), in combination with a lactone (testolactone), or in combination with both. The median survival period for all pancreatic carcinoma patients was 17 weeks, and for all gastric carcinoma patients 30 weeks. The addition of the nitrosoureas or the lactones or a combination of both produced no improvement in length of patient survival for either primary carcinoma when compared to treatment with 5-FU alone.

Comparison of serum CA 125, clinical impression, and ultrasound in the preoperative evaluation of ovarian masses.

The ability to differentiate a malignant from a benign ovarian mass was assessed for four diagnostic procedures: serum CA 125, clinical examination, original ultrasound, and reviewer ultrasound interpretation. When these tests were used individually, the sensitivity and specificity of CA 125 levels were equal to those of a review ultrasound. Overall, the sensitivity of clinical impression and original ultrasound was poor. Sensitivity and specificity were highest for CA 125 assays in postmenopausal patients, especially when these were used as the second diagnostic test. Positive and negative predictive values significantly increased among postmenopausal patients when CA 125 was added to any of the other diagnostic tests examined. In conjunction with such tests, measurement of serum CA 125 significantly increased diagnostic accuracy and may thus have an important role in the preoperative evaluation of women with ovarian masses.

CA 125 for the monitoring of ovarian carcinoma during primary therapy.

Thirty-one patients with ovarian cancer were monitored with the CA 125 antigenic determinant in the interval between cytoreductive surgery and the completion of subsequent chemotherapy. Distinct CA 125 assay trends have emerged from prospective serial monitoring. Among patients who were clinically and surgically free of disease after the completion of cytoreductive chemotherapy, the CA 125 assay always fell to levels under 35 U/mL within the first three months of cytoreductive chemotherapy, and stayed at low levels. Patients with partial cytoreduction operations had decreases in serum CA 125 levels only if there was a response to further therapy. The rate of fall of the CA 125 levels correlated with clinical outcome. All 13 patients with serum CA 125 above 35 U/mL after three months of treatment invariably had persistent tumors after subsequent chemotherapy, whereas in patients showing reduction of the CA 125 to levels below 35 U/mL, there were no surgically detectable tumors. Measurement of CA 125 during treatment might permit an early change to alternative and optimal forms of therapeutic management. The CA 125 level three months after treatment appears to be a critical predictor of response to therapy.

CA 125 serum levels correlated with second-look operations among ovarian cancer patients.

CA 125, which is an antigenic determinant expressed by many epithelial ovarian cancers, is measured in serum using a solid phase immunoradiometric assay. Sera from 55 patients who were in clinical remission and underwent a second-look operation to assess disease status after chemotherapy were studied prospectively. All patients had the CA 125 assay performed within one week before their second-look operation. Twenty-four patients (44%) had no histologic or cytologic evidence of disease, seven patients (13%) had microscopic disease, 13 patients (24%) had disease measuring 1 mm to 1.5 cm, and ten patients (18%) had disease greater than or equal to 1.5 cm in maximum tumor dimension. None of the 24 patients with a negative second-look operation had a positive CA 125 antigen level (greater than or equal to 35 U/mL), compared with six of 20 patients (30%) with less than 1.5 cm disease, and six of ten (60%) with greater than or equal to 1.5 cm disease (P less than .0001). All 12 patients with an elevated CA 125 antigen level (greater than or equal to 35 U/mL) had disease discovered at their second-look operation. Thus, in this setting the predictive value of a positive CA 125 titer (greater than or equal to 35 U/mL) was 100%. The predictive value of a negative CA 125 antigen level (less than 35 U/mL) was 56%, ie, the test did not exclude the presence of disease in 44% of patients with a positive second look. The maximum tumor size associated with at least one prior negative antigen level was 1.9 cm.(ABSTRACT TRUNCATED AT 250 WORDS)

The new era in breast cancer. Invasion, size, and nodal involvement dramatically decreasing as a result of mammographic screening.

OBJECTIVE: To describe the magnitude of changes and opportunities that may arise for simplified surgical procedures for women with breast cancer because of the decreasing size and lymph node involvement in invasive breast cancer and earlier presentation of noninvasive and invasive breast cancer. DESIGN AND MAIN OUTCOME ASSESSMENT: Cases (N=1001) of breast cancer from a tertiary and a community hospital between 1989 and 1993 were analyzed for invasion, size, nodal status, and change over time. RESULTS: Ductal carcinoma in situ constituted 14% and 18% of the cancers at the two hospitals. At the tertiary and community hospitals, the mean maximum diameters were 2.1 and 2.0 cm, respectively, and the median maximum diameters were 1.5 and 1.7 cm, respectively, for invasive breast cancer. Twenty-nine percent and 28%, respectively, were 1 cm or less in diameter. Axillary nodal metastases occurred in only 31% of the invasive cancers (tertiary hospital); only 10% had more than three nodal metastases. In the T1a and T1b cases, nodal metastases occurred in only 10% and 43% of the positive nodes were solitary; only 16% had more than three nodal metastases. The proportion of ductal carcinoma in situ, T1a and T1b, and node-negative cases increased significantly over time. CONCLUSIONS: Within the next decade, the proportion of all breast cancers that are ductal carcinoma in situ will approach 33%, and invasive cancers will approach 1 cm in median maximum diameter. Therapy simplification will be logical because of very small size, low risk of recurrence after breast conservation, and excellent prognosis, and might include increased breast conservation, avoidance of axillary nodal dissection, and omission of radiation therapy to conserve breasts. Adjuvant therapy will be based on the prognostic features of the primary cancer and findings from careful histologic examination of the sentinel lymph nodes.

Technical and biological factors in disease-free survival after hepatic resection for colorectal cancer metastases.

Careful patient selection for hepatic resection of colorectal cancer metastases is essential to improve current poor results. Carcinoembryonic antigen level and number of metastases were significant preoperative prognostic indicators of 5-year disease-free survival in patients selected clinically for hepatic surgery. Surgical margin, weight of hepatic tissue resected, carcinoembryonic antigen level, and flow cytometry were significant postoperative prognostic indicators. Patients with a carcinoembryonic antigen level less than 200 ng/mL, 1-cm surgical margins, and less than 1,000 g of liver tissue removed had a greater than 50% estimated 5-year disease-free survival rate. If the metastases were diploid on flow cytometry, an additional survival advantage may have been gained. Inadequate surgical margins led to high rates of liver-only recurrence. Nonhepatic recurrence was unrelated to surgical margins. Intraoperative liver examination by ultrasound during primary colon cancer resection and adjuvant chemotherapy may offer earlier selection of biologically appropriate patients and improved outcome; both recommendations require clinical trials.

Role of myocardial temperature measurement in monitoring the adequacy of myocardial protection during cardiac surgery.

Inadequate myocardial protection continues to be encountered despite improved methods of cardioplegia delivery. Although myocardial temperature is commonly monitored to assess the adequacy of cardioplegia delivery, its relationship to the metabolic status of the myocardium has not been investigated. We prospectively reviewed patients who underwent valvular heart surgery with blood (n = 47) or crystalloid (n = 48) cardioplegia and continuous measurement of intraoperative myocardial tissue pH and temperature. We previously demonstrated a high correlation (r = 0.99) between extracellular myocardial pH, levels of intracellular hydrogen ion concentration, and a lowering of tissue ATP during coronary occlusion. Clinically, optimal metabolic protection was defined as the absence of myocardial tissue acidosis during the period of aortic occlusion as quantified by a temperature-corrected integrated mean pH of 6.8 or greater, which has been shown to be predictive of a favorable postoperative outcome. Age, bypass time, myocardial temperature, myocardial tissue pH at the onset of aortic occlusion, cross-clamp time, and volume of cardioplegia were not significantly different between blood and crystalloid groups. Linear regression analysis demonstrated no significant correlation between mean myocardial tissue pH and the corresponding mean myocardial temperature in either group during aortic occlusion. There was also no correlation between the mean myocardial tissue pH and volume of cardioplegia delivered in both groups. These data demonstrate wide intercardiac and intracardiac variability in the degree of regional tissue acidosis encountered during of hypothermic cardioplegia. Cardioplegia delivery guided by measurement of myocardial temperature or by standardized protocol did not prevent the occurrence of tissue acidosis and thus, did not ensure optimal metabolic protection of the heart. In 95 patients undergoing valvular heart surgery with cold blood or crystalloid cardioplegia, there was no correlation between myocardial tissue pH and mycardial temperature or between myocardial tissue pH and volume of cardioplegia administered. Temperature is a poor indicator of the metabolic state of the myocardium.

Treatment of metastatic renal cell carcinoma with autolymphocyte therapy. Low toxicity outpatient approach to adoptive immunotherapy without use of in vivo interleukin-2.

Thirty-six patients with Stage IV renal cell carcinoma were treated with autolymphocyte therapy (ALT). This new form of adoptive immunotherapy is based on the infusion of relatively small numbers of autologous lymphocytes that are depleted of suppressor cells and immunized in vitro by a method designed for antigen-specific activation using a 3M KCl extract of autologous tumor and an autologous lymphokine mixture. Patients received six monthly infusions of immunized lymphocytes, all on an outpatient basis. The majority of patients experienced no toxicity. The few reactions that occurred were minor and self-limiting; none required any medical intervention or subsequent delay in therapy. Patients also received oral cimetidine to reduce in vivo suppressor cell function. Survival at twenty-four months is 36 percent. Median survival is fifteen months, a significant improvement over the natural history of this disease. A multi-site, randomized, controlled trial of ALT in renal cell carcinoma has been initiated to confirm that this treatment causes a significant prolongation of survival with virtually no toxicity in these patients.

Comparison of the efficacy and tolerability of Prinivil and Procardia XL in black and white hypertensive patients.

The efficacy and tolerability of Prinivil and Procardia XL were compared in 135 (67 black, 68 white) patients with mild to moderate uncomplicated essential hypertension. The goal of therapy was to achieve and maintain a supine diastolic blood pressure (SDBP) of > 90 mmHg or a decrease in SDBP > or = 10 mmHg. Patients received Prinivil 10 to 40 mg once daily or Procardia XL 30 to 120 mg once daily during a titration period of 2 to 8 weeks to achieve the goal blood pressure before a 4-week maintenance period. The mean baseline supine systolic/diastolic blood pressures were 151/97 mmHg in patients receiving Prinivil and 153/99 mmHg in patients receiving Procardia XL. Ninety-one percent of patients receiving Prinivil and 95% of those receiving Procardia XL achieved SDBP control at the end of titration therapy. At the end of the maintenance treatment period, 79% of patients receiving Prinivil and 80% of those receiving Procardia XL had SDBP control. Mean decreases in SDBP from baseline were comparable for both treatment groups. At the end of the titration period, mean decreases were 9.6 mmHg in patients receiving Prinivil and 11.3 mmHg in patients receiving Procardia XL; at the end of the maintenance period, mean decreases were 10.8 mmHg and 12.1 mmHg, respectively. There were no differences in treatment responses in either the black or white hypertensive subgroups. Thus both drugs were equally effective in black and white patients with mild to moderate essential hypertension. Both drugs were generally well tolerated, but the number of adverse experiences requiring discontinuation of therapy was significantly higher (P = 0.03) in patients receiving Procardia XL.

Comparison of the efficacy and tolerability of lisinopril and sustained-release verapamil in older patients with hypertension.

The efficacy and tolerability of lisinopril and sustained release (SR) verapamil hydrochloride were compared in 68 patients (mean age, 60 years) with mild to moderate uncomplicated essential hypertension. The goal of therapy was to achieve and maintain a supine diastolic blood pressure (SDBP) of less than 90 mmHg or a fall in SDBP greater than or equal to 10 mmHg. Patients received lisinopril (10 to 40 mg QD) or verapamil SR (120 to 480 mg QD) during a variable titration period (two to eight weeks) to achieve goal blood pressure prior to a four-week maintenance treatment period. Among the 62 patients who completed the titration period, the mean baseline supine systolic/diastolic blood pressures were 155/97 mmHg for the lisinopril group and 150/95 mmHg for the verapamil SR group. Ninety-seven percent of patients in the lisinopril group and 100% of patients in the verapamil SR group achieved SDBP control at the end of titration therapy. At the end of the maintenance treatment period, 82% of the lisinopril-treated patients and 81% of the verapamil SR-treated patients had SDBP control. Mean decreases in SDBP from baseline were comparable for both treatment groups. At the end of titration, mean decreases were 11.3 mmHg for the lisinopril group and 10.7 mmHg for the verapamil SR group; at the end of maintenance treatment, mean decreases were 10.5 mmHg and 8.5 mmHg. Thus both drugs were equally effective in older patients with mild to moderate essential hypertension. Both drugs were generally well tolerated. One patient in the lisinopril group and four patients in the verapamil SR group experienced adverse effects that required withdrawal from the study.

The efficacy and tolerability of famotidine and ranitidine on the healing of active duodenal ulcer and during six-month maintenance treatment, with special reference to NSAID/aspirin-related ulcers.

The subjects of this multicenter study were 160 patients with endoscopically confirmed active duodenal ulcers, randomly assigned to receive 40 mg of famotidine or 300 mg of ranitidine nightly for four to eight weeks. During a subsequent six-month maintenance treatment phase, the patients received 20 mg of famotidine or 150 mg of ranitidine nightly. After eight weeks of treatment, ulcer healing was endoscopically confirmed in 94% of the 81 famotidine-treated patients and in 80% of the 79 ranitidine-treated patients (P less than 0.01). During the first week of treatment, daytime and nighttime pain scores were significantly lower in the famotidine-treated than ranitidine-treated patients. During the maintenance treatment phase, the ulcer in 79% of 58 famotidine-treated patients and in 81% of 52 ranitidine-treated patients remained healed. Multivariate analysis of factors such as age, sex, smoking, alcohol and coffee consumption, use of nonsteroidal anti-inflammatory drugs (NSAIDs), history of ulcer, and ulcer size and number showed that they had no significant effects on the differences in healing rates between the two treatment groups. The ulcers were all healed in the famotidine-treated patients whose ulcers were associated with the prior use of NSAIDs. The results of this and many other studies indicate that, unless ulcer healing is confirmed by endoscopy, treatment of active duodenal ulcers should continue for six to eight weeks.

Efficacy and tolerability of a combination of enalapril and hydrochlorothiazide in the treatment of hypertension measured manually and with an ambulatory blood pressure monitor.

The efficacy and tolerability of an enalapril maleate-hydrochlorothiazide combination (EM-HCTZ) were evaluated in a prospective, open-label study in 26 patients with uncomplicated essential hypertension (mean baseline sitting systolic/diastolic blood pressure: 153/103 mmHg) requiring two agents to reduce sitting diastolic blood pressure (SDBP) below 90 mmHg. Their mean age was 52 years. Patients received enalapril 5 mg daily, which was increased to 10 mg if SDBP was not reduced to < 90 mmHg during a 5-week titration period following washout. If blood pressure did not reach that goal, 25 mg hydrochlorothiazide was added. Only patients who required enalapril 10 mg and hydrochlorothiazide 25 mg for control (SDBP < 90 mmHg) at the end of titration received open-label EM-HCTZ as maintenance therapy for 6 weeks. The SDBP of 19 of the 26 patients (73%) who began titration was controlled at the end of titration, and they received maintenance therapy. During maintenance, the mean SDBP decreased from baseline 13.2 mmHg at week 2, 13.3 mmHg at week 4, and 10.1 mmHg at week 6. All changes from baseline were significant. At the end of the maintenance period, SDBP was controlled in 8 (42%) of 19 patients enrolled. One patient was withdrawn from the study because blood pressure was poorly controlled. Ambulatory blood pressure (ABP) was monitored, average outcome was computed for each patient during the 24-hour interval, and with a paired comparison, baseline and follow-up data were compared with the data measured manually. The mean baseline ABP was 9 mmHg lower than the baseline SDBP measured manually (r = 0.58, P = 0.01). Following treatment with EM-HCTZ, mean diastolic blood pressure fell 10 mmHg and mean systolic blood pressure fell 15 mmHg. In summary, EM-HCTZ was highly effective and generally well-tolerated in a substantial proportion of participants whose SDBP remained > 90 mmHg on enalapril 10 mg. Important differences between blood pressure measured manually and with a monitor were also demonstrated.

Comparison of the efficacy and tolerability of lisinopril and sustained-release verapamil in black patients with hypertension.

In this clinical study the efficacy and tolerability of lisinopril and sustained-release (SR) verapamil hydrochloride were compared in black patients with mild-to-moderate uncomplicated essential hypertension. The goal of therapy was to achieve a supine diastolic blood pressure (SDBP) of less than 90 mmHg or a greater than or equal to 10-mmHg fall in SDBP. Forty-three patients completed the titration phase, 23 in the lisinopril group and 20 in the verapamil SR group. The mean baseline supine systolic/diastolic blood pressures were 147/98 mmHg for the lisinopril group and 155/100 mmHg for the verapamil SR group. At the end of a two- to eight-week titration period, 87% of the lisinopril-treated patients and 90% of the verapamil SR-treated patients had achieved SDBP control. Six patients were excluded from maintenance therapy: four in the lisinopril group (one because of urticaria and three because of failure to reach goal blood pressure) and two in the verapamil SR group (because of failure to reach goal blood pressure). After eight weeks of maintenance therapy, 68% of the lisinopril-treated patients and 72% of the verapamil SR-treated patients had achieved SDBP control. The mean decreases in SDBP were comparable for both treatment groups. At the end of titration, the mean decreases from baseline were 10.5 mmHg for the lisinopril group and 12.6 mmHg for the verapamil SR group. At the end of maintenance, the mean decreases from baseline were 7.8 mmHg for the lisinopril group and 9.2 mmHg for the verapamil SR group. Adverse experiences were few.(ABSTRACT TRUNCATED AT 250 WORDS)