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PubMed1982

Combination therapy of gastric carcinoma with radiation and chemotherapy.

The concurrent combination therapy of radiation and chemotherapy was performed in a total of 134 cases of stomach cancer. Radiation response of tumor was remarkable in 35 (37%) of 95 cases, irradiated more than 5,000 rad. Yearly survival rates in 81 cases, in which the scheduled curative treatment was completed, were 63% in one, 31% in two, 21% in three, 17% in four and 13% in five years. These rates were intimately correlated to tumor size and cancer type. However, this combination therapy accompanied some fatal complications in a few percent. From the results, it was concluded that this combination therapy should be valuable to prolong the life of patients high gastric cancer, and that the curable indications for this treatment should be T1-T3: M0 cases with radio-responsive tumor.

Adenocarcinoma↗
PubMed2006

Meta-analysis on inoperable pancreatic cancer: a comparison between gemcitabine-based combination therapy and gemcitabine alone.

AIM: To compare gemcitabine-based combination therapy and gemcitabine (GEM) alone in patients with advanced pancreatic cancer (APCa) through meta-analysis. METHODS: MEDLINE and EMBASE searches were supplemented by information from trial registers of randomized controlled trials (RCTs) for GEM-based combination therapy and GEM alone for APCa. A quantitative meta-analysis was carried out by two reviewers based on the inclusion criteria from all available RCTs. The meta-analysis involved overall survival (OS), objective remission rate (ORR), clinical benefit rate (CBR), time to progress/progress free survival (TTP/PFS) and toxicity. RESULTS: The meta-analysis included 22 RCTs. There was significant improvement in the GEM combination group with regard to the 6-mo survival rate (RD = 0.04, 95% CI 0.01-0.06, P = 0.008), 1-year survival rate (RD = 0.03, 95% CI 0.01-0.05, P = 0.01), ORR (RD = 0.04, 95% CI 0.01-0.07, P = 0.02), CBR (RD = 0.10, 95% CI 0.02-0.17, P = 0.01) and 6-mo TTP/PFS (RD = 0.07, 95% CI 0.04-0.10, P < 0.00001). However, the Grade 3-4 toxicity set by WHO was higher for the GEM combination group for neutropenia (RD = 0.05, 95% CI 0.01-0.10, P = 0.02), thrombocytopenia (RD = 0.05, 95% CI 0.02-0.08, P = 0.002) and vomiting/nausea (RD = 0.03, 95% CI 0.00-0.05, P = 0.02). CONCLUSION: GEM-based combination therapy may improve the overall survival and palliation in optimal patients with APCa as compared with GEM alone.

Antimetabolites, Antineoplastic↗
PubMed1981

Combination therapy of hormone and cytotoxic agents in advanced breast cancer.

The effectiveness of combination therapy with diethylstilbestrol, cyclophosphamide, and 5-fluorouracil (DES + CTx + FU) was compared with DES alone or CTx + FU in 87 postmenopausal women with advanced breast cancer. Therapy was randomized according to the tumor estrogen-receptor (ER) status. In 30 patients with ER-rich tumors and 35 patients with ER-unknown tumors, combination therapy yielded a higher response rate than DES therapy (87% vs. 64% and 59% vs. 23%, respectively). The pooled data from these two groups of patients suggest that the improved response rate from DES + CTx + FU against DES becomes more apparent in patients with visceral involvement (89% vs. 47%) (P less than 0.025) and that patients treated initially with combination therapy (DES + CTx + FU) appeared to have a longer survival than those treated with sequential therapy (DES leads to CTx + FU) (P = 0.06). The survival data in 22 patients with receptor-poor tumors were significantly inferior to those with receptor-rich tumors (P = 0.001). The ER status and presence of visceral metastases are significant factors in the selection of treatment programs.

Aged↗
PubMed2003

Additive antiproteinuric effect of combination therapy with ACE inhibitor and angiotensin II receptor antagonist: differential short-term response between IgA nephropathy and diabetic nephropathy.

In previous studies, the synergistic antiproteinuric effect of the combination therapy of ACE inhibitors and angiotensin II receptor antagonists (ATRAs) has been inconsistent in relation to underlying renal diseases. The influence from the blood pressure (BP) - reducing effect in some studies might also contribute to this inconclusiveness. To examine the possibility of the benefit being different according to underlying renal diseases, we undertook a crossover therapeutic trial of the combination therapy in two selected homogenous groups of patients with diabetic and non-diabetic renal diseases. The BP-reducing effect was excluded during the study. Nineteen biopsy-proven IgA nephropathy, as examples of non-diabetic renal diseases, and 24 type 2 diabetic nephropathy patients were selected as the study subjects. The subjects had to meet the follow criteria: a creatinine clearance (Ccr) between 25 - 90 ml/min/1.73 m2, 24-hr urinary protein excretion rate over 1.0 g/day and a BP maintained at less than 130/80 mmHg, with more than six-month therapy of ramipril, (5.7 +/- 0.4 mg/day, 13 +/- 2 month). The baseline data between the two groups showed no significantly differences. After a 12-week stabilization period (control period), 4 mg, once daily, dose of candesartan (combination period) followed by a placebo (placebo period), or vice versa, were administered in addition to the ramipril, for 12 weeks. The combination, with candesartan, did not change the Ccr, BP, serum and urinary electrolytes or the urea. The 24 hour urinary protein excretion rate was significantly reduced by the combination therapy in the patients with IgA nephropathy (3.1 +/- 0.3 g/day in combination, 4.2 +/- 0.3 in control, and 4.3 +/- 0.2 in placebo; p < 0.05). However, the patients with diabetic nephropathy showed no reduction in their proteinuria with the combination therapy (3.8 +/- 0.2 g/day in combination, 3.9 +/- 0.3 in control, and 4.1 +/- 0.3 in placebo; p=NS). The changes in proteinuria showed no relationship with the changes in the BP in IgA nephropathy. In conclusions, the benefit of combination therapy of its antiproteinuric effect was different between IgA and diabetic nephropathy over the 12-week trial. The difference in the pathophysiological role, and the importance of the renin- angiotensin system, between the two diseases might contribute to the discrepancy in the result. We suggest the discrimination of the underlying renal diseases in the study subjects is an important prerequisite for future studies on this issue.

Adult↗
PubMed2004

Combination therapy of dyslipidemia in non-insulin-dependent diabetes mellitus and the metabolic syndrome.

Non-insulin-dependent diabetes mellitus (NIDDM) and the metabolic syndrome separately and additively increase the risk for atherosclerotic cardiovascular disease. Considering the high cardiovascular risk associated with NIDDM and the metabolic syndrome, aggressive therapy of dyslipidemia with tailored combination therapy should be considered given informed consent and discussion of risks. In addition to statins, niacin, and fibrates, therapies shown to decrease the risk for atherosclerotic cardiovascular disease include omega-3 fatty acids, diet, exercise, and optimal blood pressure control with thiazides and blockers of the renin-angiotensin system. These therapies should also be considered to reduce the high cardiovascular risk associated with NIDDM and the metabolic syndrome.

Diabetes Mellitus, Type 2↗
PubMed2006

Dosage dependent hormonal counter regulation to combination therapy in patients with left ventricular dysfunction.

UNLABELLED: The present study attempts to assess the efficacy combination therapy for heart failure. Genuine dose-response studies on combination therapy are not available and published studies involved adding one drug on top of 'usual treatment'. Sixteen different dosage combinations of trandolapril and bumetanide was tested in a double blind, double placebo-controlled, randomized, multiple cross-over study in a 16 times six balanced incomplete Latin square design. Patients reported optimal quality of life on the sub maximal dose bumetanide. Bumetanide decreased left ventricular function and increased heart rate and plasma noradrenaline in a dose dependent manner. Doses of bumetanide of more than 0.5 mg, given twice daily significantly decreased the quality of life and increased diuresis. Weight loss was maximal on 0.5 mg bumetanide twice daily. Trandolapril significantly reduced systolic blood pressure with the maximal effect at 0.5 mg daily. Both drugs significantly increased renin concentration with a significant potentiating interaction. It was not possible to detect beneficial effects of combination therapies. The optimal dosage of Bumetanide appeared to be 0.5 mg twice daily based on its effect on quality of life and weight loss. Estimated by the reduction in systolic blood pressure the optimal dosage of Trandolapril appeared to be 0.5 mg once daily. CONCLUSIONS: It appears that patients should be given less than the usually recommended dosages. Patients may be treated with a low dose loop diuretic, if signs of water retention are present or if symptomatic relief is desired.

Aged↗
PubMed2005

[Efficacy of combination therapy with interferon-alpha and ribavirin for chronic hepatitis C in relation to liver fibrosis and serum aminotransferase activity].

The aim of the study was to evaluate the efficacy of interferon alpha (IFNalpha)-2b in combination with oral ribavirin for treatment of chronic hepatitis C in relation to age, sex, liver enzymes activity as well as to grading and staging of liver disease in histologic examination. There were 154 adult patients assigned for the retrospective analysis including 69 females and 85 males of 16 to 70 years of age (mean age 43.3 +/- 12 years) treated with IFNalpha and ribavirin for 24 or 48 weeks. Sustained virological response was achieved in 66 patients (42.9%) and sustained biochemical response rate was 44%. Sustained response correlated with younger age, lower baseline AST, GT and ALP activities as well as with lower staging of liver disease. Combination treatment with interferon and ribavirin was significantly more effective in patient under 40 years of age and in patients without cirrhosis. Sex, baseline ALT activity and histological grading of liver disease did not differ between sustained responders and non-responders. Sustained virological response on combination therapy was achieved in 5 out of 7 previous monotherapy relapsers (71.4%) whereas only 5 patients out of 22 monotherapy non-responders benefited from combination therapy (22.7%). In conclusion, efficacy of combination therapy with IFNalpha and ribavirin in patients with liver cirrhosis is less effective and should be considered in chosen situations, especially in younger patients. Normal ALT activity should not be an exclusion criterion to therapy. Combination retherapy in previous monotherapy non-responders seems to be ineffective whereas in monotherapy relapsers good sustained response can be achieved.

Adolescent↗
PubMed2002

Combination therapy of alpha-glucosidase inhibitor and a sulfonylurea compound prolongs the duration of good glycemic control.

The aim of this study was to investigate whether combination therapy of alpha-glucosidase inhibitor and a sulfonylurea (SU) drug can prolong the duration of good glycemic control compared with SU alone in patients with type 2 diabetes. The open prospective study included 124 Japanese patients with type 2 diabetes and inadequate glycemic control (hemoglobin A(1c) [HbA(1c)] gt; 7.0%). Patients were given either voglibose plus a SU compound (glibenclamide or gliclazide, n = 61) or SU drug alone (n = 63). The first 6-month run-in period (targeted to HbA(1c) </= 7.0%) was followed by treatment for 3 years. The endpoint was deterioration of glycemic control (HbA(1c) >/= 8.0%). Fifty patients on combination therapy and 48 patients on SU alone completed the trial. During the follow-up, 21 patients on combination therapy and 30 patients on SU alone showed deterioration of glycemic control and reached the endpoint (P =.04). The combination therapy significantly prolonged the duration of good glycemic control (HbA(1c) < 8.0%) compared with SU alone by Kaplan-Meier estimated survival analysis using a log-rank test (P =.02). Thus, combination therapy with voglibose and a SU agent prolongs the duration of good glycemic control compared with SU alone in patients with type 2 diabetes.

Blood Glucose↗
PubMed2002

Latanoprost and timolol combination therapy vs monotherapy: one-year randomized trial.

OBJECTIVE: To compare the efficacy and safety of a fixed combination of 0.005% latanoprost and 0.5% timolol maleate administered once daily vs monotherapy with either 0.005% latanoprost once daily or 0.5% timolol twice daily. METHODS: Patients with either primary or secondary open-angle glaucoma or ocular hypertension participated in a 6-month, randomized, double-masked, multicenter study with 3 parallel treatment groups. The double-masked period was preceded by a 2- to 4-week "run-in" treatment with timolol. Subjects could receive fixed combination therapy during a 6-month open-label extension. MAIN OUTCOME MEASURE: The difference between groups in mean diurnal intraocular pressure reduction in study eye(s) from baseline through 6 months of treatment. RESULTS: Overall, 418 patients were enrolled in the study; 332 completed the open-label phase. Diurnal intraocular pressure levels were similar at baseline, but at week 26, they were 19.9 +/- 3.4 mm Hg in the fixed combination therapy group, 20.8 +/- 4.6 mm Hg in latanoprost-treated patients, and 23.4 +/- 5.4 mm Hg in timolol-treated patients (data are given as mean +/- SD). The mean change from baseline was greater among patients receiving fixed combination therapy compared with each monotherapy group (P<.01). Fixed combination therapy effectively lowered intraocular pressure levels for up to 1 year. All treatments were well tolerated. CONCLUSION: The combination of 0.005% latanoprost and 0.5% timolol administered once daily is effective and well tolerated for up to 12 months.

Adult↗
PubMed1998

Combination therapy with fluconazole and flucytosine for cryptococcal meningitis in Ugandan patients with AIDS.

We performed a randomized trial in which combination therapy with fluconazole and short-term flucytosine was compared with fluconazole monotherapy in 58 patients with AIDS-associated cryptococcal meningitis (CM). Thirty of these patients were randomized to receive combination therapy with fluconazole, 200 mg once a day for 2 months, and flucytosine, 150 mg/(kg.d) for the first 2 weeks, and 28 were randomized to receive monotherapy with fluconazole at the same dose for 2 months. Patients in both groups who survived for 2 months received fluconazole as maintenance therapy at a dose of 200 mg three times per week for 4 months. The combination therapy prevented death within 2 weeks and significantly increased the survival rate among these patients (32%) at 6 months over that among patients receiving monotherapy (12%) (P = .022). The combination therapy also resulted in a significant decrease in the severity of headache after 1 month of treatment, compared with monotherapy (P = .005). No serious adverse reactions were observed in patients receiving either regimen. These data indicate that treatment with fluconazole and short-term flucytosine is a cost-effective and safe regimen that improves the quality of life for patients with AIDS-associated CM in developing countries where human immunodeficiency virus is endemic.

AIDS-Related Opportunistic Infections↗
PubMed2004

Practical considerations and guidelines for dosing sulfonylureas as monotherapy or combination therapy.

BACKGROUND: Oral antidiabetic agents are the initial and most commonly used therapy for type 2 diabetes mellitus. To effectively utilize the oral antidiabetic agents, familiarity with the efficacy and side effects of each agent is essential so that strategies for effective therapy with 1 or more agents can be developed when transitioning is needed either with monotherapy or to combination therapy with another antidiabetic agent. OBJECTIVES: The purposes of this article were to review the efficacy and adverse-event profile of sulfonylureas, the most widely used class of oral antidiabetic agents in the United States, and to provide a simple set of guidelines for use in transitioning patients between sulfonylureas or to combination therapy. METHODS: A comprehensive search of the MEDLINE and PubMed databases for the years 1966 to present and a thorough review of abstracts of recently presented clinical trials were used to identify relevant literature on dosing conversion and equivalence between sulfonylureas. Search terms used were as follows: sulfonylureas, dosing conversion, equivalence, glyburide, glipizide, glimepiride, and combination therapy. Strategies are provided for switching patients between sulfonylureas so that switching within the sulfonylurea class or to a combination tablet can be accomplished efficaciously and safely. Recommendations for dosing conversion were based on the results of the literature and abstract search, manufacturer recommendations for each available agent, and the author's clinical experience. RESULTS: When switching between agents or starting combination therapy, it is important to monitor for hypoglycemia. Fasting serum glucose levels and glycosylated hemoglobin should also be monitored to determine the optimal dose of sulfonylurea for each patient Patients not achieving adequate control on a single agent should be transferred to combination therapy. CONCLUSION: When transferring a diabetic patient to a combination tablet, improved compliance, cost savings, and better glycemic control may be achieved.

Administration, Oral↗
PubMed1994

The efficacy and toxicity of combination therapy in rheumatoid arthritis. A meta-analysis.

OBJECTIVE: To evaluate the efficacy and toxicity of combination therapy, compared with single second-line drug therapy, in rheumatoid arthritis. METHODS: This study was a meta-analysis of published trials that evaluated combinations of full-dose second-line drugs and compared them with single second-line drugs at full dose. Using a random effects model, we summarized the difference between improvement with combination therapy and improvement with single-drug therapy. RESULTS: Five trials that met inclusion criteria, which contained 749 entering patients and 516 completing patients, were identified. The mean +/- SEM difference in improvement in tender joint count between combination and single-drug therapy at end of trial (24-52 weeks) was 2.4 +/- 0.7 joints (out of 60) (P < 0.001). At end of trial the difference between therapies in swollen joint counts was 1.0 +/- 1.2 joints (P = 0.42). The difference in grip strength improvement was 3.7 +/- 4.3 mm Hg (P = 0.40), and for erythrocyte sedimentation rate it was 3.4 +/- 3.1 mm/hour (P = 0.27). In general, the differences in efficacy between combination and single-drug therapy were clinically marginal. Nine percent more combination therapy-treated patients experienced side effect-related discontinuation of therapy than patients receiving single-drug therapy (P = 0.008). CONCLUSION: Combination therapy, as it has been used in recent clinical trials, does not offer a substantial improvement in efficacy, but does have higher toxicity than single drug therapy. These combination therapy regimens are not recommended for widespread use. Other more aggressive regimens with additional drugs or higher drug doses than have been studied might be more efficacious, but with an even higher rate of toxicity.

Adult↗
PubMed1986

Ureidopenicillins, aztreonam, and thienamycin: efficacy as single-drug therapy of severe infections and potential as components of combined therapy.

The ureidopenicillins (piperacillin, mezlocillin, and azlocillin), aztreonam, and thienamycin are new broad-spectrum beta-lactams with more potent antibacterial activity than the older cephalosporins and penicillins. However, therapy of severe infections with the ureidopenicillins alone is limited by the potential for emergence of resistant organisms, while monotherapy with aztreonam does not provide adequate coverage for Gram-positive aerobic organisms and anaerobes. In combination therapy with the aminoglycosides, the ureidopenicillins may be preferred to carbenicillin or ticarcillin in the treatment of Pseudomonas aeruginosa infections and in institutions with a high prevalence of carbenicillin or ticarcillin-resistant organisms. Double beta-lactam therapy with piperacillin plus either latamoxef (moxalactam) or ceftazidime may be advantageous in patients for whom aminoglycoside toxicity is a concern. Thienamycin is the most promising of the new beta-lactams for single-agent therapy of severe infections but may also be associated with the emergence of resistant P. aeruginosa during monotherapy. In febrile granulocytopenic patients or other severely ill patients at risk of severe P. aeruginosa infections, thienamycin or another antipseudomonal beta-lactam should be combined with an aminoglycoside.

Aminoglycosides↗
PubMed1991

The role of combination therapy with mexiletine and procainamide in patients with inducible sustained ventricular tachycardia refractory to intravenous procainamide.

This study evaluated the role of serial electropharmacological testing on combination therapy with mexiletine and procainamide in 20 patients with inducible sustained ventricular tachycardia (VT) refractory to intravenous procainamide. The clinical arrhythmias were cardiac arrest in five patients, sustained VT in 11 patients, and recurrent syncope of presumably arrhythmic origin in four patients. The mean left ventricular ejection fraction (LVEF) was 0.40 +/- 0.12 (mean +/- SD). All patients had inducible sustained VT at baseline and after administration of intravenous procainamide. All 20 patients underwent electropharmacological testing on combination therapy with mexiletine and procainamide. The mean cycle length of inducible sustained VT was 251 +/- 48 ms at baseline, 324 +/- 81 ms on intravenous procainamide (P less than 0.014 vs baseline), and 365 +/- 82 ms on combination therapy (P less than 0.0001 vs baseline, P = NS vs intravenous procainamide). Combination therapy did not suppress VT inducibility, nor did it make VT more difficult to induce in 19 of 20 patients. The remaining one patient had a partial response (runs of nonsustained VT, longest 10 seconds). Furthermore, combination therapy did not significantly prolong the VT cycle length over and above that observed during testing with intravenous procainamide. Therefore, in patients with inducible sustained VT refractory to procainamide during initial electropharmacological testing, mexiletine in combination with procainamide appears to be of little or no value and serial electropharmacological testing on these drugs is of limited usefulness. Early initiation of alternative therapy may be the preferred clinical option.

Adult↗
PubMed2006

Model-based analysis of trial data: microfilaria and worm-productivity loss after diethylcarbamazine-albendazole or ivermectin-albendazole combination therapy against Wuchereria bancrofti.

OBJECTIVES: To determine the efficacies of combinations of ivermectin or diethylcarbamazine and albendazole, which are recommended for use in mass treatment programmes against lymphatic filariasis. METHOD: Review of published trends in microfilarial (mf) intensities after treatment with these combination therapies. By fitting a mathematical model of treatment effects to the trial data, we quantified the efficacy of treatment, distinguishing between the killing of mf (mf loss) and a reduction in mf production by adult worms (worm-productivity loss). After diethylcarbamazine-albendazole treatment mf density dropped immediately, then slowly but steadily decreased further (four trials). After ivermectin-albendazole treatment, mf densities immediately dropped to near-zero levels, followed by a small increase (five trials). For diethylcarbamazine-albendazole treatment the average mf loss was approximately 83% (ranging from 54% to 100% in the different studies) and worm-productivity loss was 100% (in all studies). For ivermectin-albendazole treatment, average mf loss was 100% (ranging from 98% to 100%) and worm productivity loss was 96% (ranging from 83% to 100%). The effects were dose-dependent. Sensitivity analysis showed that the estimates did not depend on assumptions on worm lifespan or premature period and little on assumptions on mf lifespan. CONCLUSION: The two therapies differ with respect to their direct effect on mf, but both are highly effective against adult worms. If mass treatment with these combination therapies achieves high coverage, they can have a large impact on lymphatic filariasis transmission.

Adolescent↗
PubMed2002

Trimodal combination therapy for maxillary sinus carcinoma.

PURPOSE: This study was conducted to evaluate the effectiveness of trimodal combination therapy (radiotherapy, intra-arterial chemotherapy, antrotomy) for the treatment of primary maxillary sinus carcinoma. METHODS AND MATERIALS: Between 1977 and 1996, 110 patients with maxillary squamous cell carcinoma were treated with trimodal combination therapy at Tokyo Medical and Dental University Hospital. All tumors were classified according to the 1997 UICC TNM staging system. Eighty percent of patients had T3 or T4 tumors. The T3 and T4 tumors were also classified into three groups according to their location, as visualized using computed tomography: the posterior-lateral (P) group, the medial (M) group, and the upper (U) group. Eight patients received additional radiotherapy, and 37 patients underwent a second surgical procedure, in addition to the trimodal combination therapy. RESULTS: The 5-year cause-specific survival and local control rates were 71% and 65%, respectively. The 5-year local control rate was 80% for the T1+2 tumors, 64% for the T3 tumors, and 52% for the T4 tumors (p = 0.06). Patients in the P+M group who received a 5-fluorouracil (5-FU) dosage of more than 3500 mg had a better 5-year local control rate than patients who received a 5-FU dosage of less than 3500 mg (p = 0.01). No improvement in the local control rate after a second surgical procedure or additional irradiation treatment was observed in any of the groups. CONCLUSION: Trimodal combination therapy provides good local control, with the final outcome depending on the T stage of the tumor and the dosage of 5-FU.

Adult↗
PubMed2003

Radiotherapy versus combined therapy in early stages with bulky disease aggressive malignant lymphoma.

The purpose of this study was to evaluate the use of radiotherapy compared with combined therapy (radiotherapy followed by chemotherapy) in early stages (I and II) in patients with diffuse large cell lymphoma and bulky disease. One hundred and thirty patients were randomly assigned to receive either radiotherapy involved field doses range from 40 to 48 Gy (median 44.5 Gy) or the same radiation therapy following chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisone, by six cycles. Complete response (CR) was achieved in 58 out of 61 patients (95%) of the patients whose received radiotherapy, that was no different to 91% (63 out of 69 patients) in the combined therapy arm. However, at 10-years event-free survival (EFS) was 68% (95% confidence interval (CI): 61-73%) in the radiotherapy arm that was statistical different to 90% (95% CI: 86-94%) in the combined therapy group (p < 0.01). Overall survival (OS) showed statistical differences: 72% (95% CI 67-76%) in the radiotherapy group compared to 89% (95% CI: 84-93%) in the combined therapy arm (p < 0.01). Toxicity was mild in both groups, at this time, no second neoplasm or acute leukemia has been observed. We conclude that combined therapy appear to be superior in patients with early stages and bulky disease in patients with aggressive malignant lymphoma.

Adult↗
PubMed1996

Virologic and immunologic benefits of initial combination therapy with zidovudine and zalcitabine or didanosine compared with zidovudine monotherapy. Wellcome Resistance Study Collaborative Group.

A randomized controlled study was done to determine whether initial combination therapy with zidovudine and zalcitabine or zidovudine and didanosine would delay the emergence of zidovudine-resistant virus. Human immunodeficiency virus (HIV)-1-infected patients with <300 CD4 cells/mm3 and <4 weeks of prior zidovudine therapy were randomized to zidovudine, zidovudine plus zalcitabine, or zidovudine plus didanosine. Combination therapy did not delay the emergence of zidovudine-resistant virus isolates. However, combination therapy resulted in a significant increase in CD4 cells through 72 weeks compared with zidovudine monotherapy and a greater and more sustained decline in serum HIV-1 RNA. Although this trial was not designed as a clinical end-point study, patients assigned to zidovudine plus didanosine combination therapy experienced a significant delay in time to first AIDS-defining event or death compared with those assigned to zidovudine monotherapy.

Adult↗