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Results for “randomized crossover trial”

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PubMed2001

A Comparative Study of Blood Pressure Control with Short In-Center versus Long Home Hemodialysis.

We conducted a randomized crossover trial to establish, within patients, whether long-slow hemodialysis (HD) was associated with better blood pressure (BP) control than standard HD. Nine home HD patients, not on antihypertensive drugs, were dialyzed to the same eKt/V(urea) and target weights for 6-8 h (LD) at home and for 3.5-4.5 h (SD) in the dialysis center 3 times weekly in randomized sequence, with each phase lasting 8 weeks. Ambulatory BP, bioimpedance, neurohormones and autonomic function were measured in each phase. Pre- and postdialysis systolic, ambulatory systolic and diastolic BP were all higher with SD than with LD and intradialysis hypotension was more common. Weight, ECF volume and neurohormones did not differ between treatments. Muscle sympathetic activity was increased in both phases and cardiac sympathetic activity tended higher during SD. These findings suggest that additional factors to ECF volume may contribute to the superior BP control produced by long-slow HD.

Adult↗

PubMed2000

Serum lipid effects of a high-monounsaturated fat diet based on macadamia nuts.

BACKGROUND: Recent studies have identified potential beneficial effects of eating nuts, most of which have substantial amounts of monounsaturated fats. Macadamia nuts are 75% fat by weight, 80% of which is monounsaturated. OBJECTIVE: To examine variations in serum lipid levels in response to a high-monounsaturated fat diet based on macadamia nuts. METHODS: A randomized crossover trial of three 30-day diets was conducted in 30 volunteers aged 18 to 53 years from a free-living population. Each was fed a "typical American" diet high in saturated fat (37% energy from fat); an American Heart Association Step 1 diet (30% energy from fat); and a macadamia nut-based monounsaturated fat diet (37% energy from fat) in random order. Serum total cholesterol, high-density lipoprotein cholesterol, and triglyceride levels were measured. RESULTS: Mean total cholesterol level after the typical American diet was 5.20 mmol/L (201 mg/dL). After the Step 1 diet and the macadamia nut diet, total cholesterol level was 4.99 mmol/L (193 mg/dL) and 4.95 mmol/L (191 mg/dL), respectively. Low-density lipoprotein cholesterol level was 3.37 mmol/L (130 mg/dL) (typical diet), 3.21 mmol/L (124 mg/dL) (Step 1 diet), and 3.22 mmol/L (125 mg/dL) (macadamia nut diet). High-density lipoprotein cholesterol level was 1.43 mmol/L (55 mg/dL) (typical), 1.34 mmol/L (52 mg/dL) (Step 1), and 1.37 mmol/L (53 mg/dL) (macadamia nut). Lipid values after the Step 1 and macadamia nut diets were significantly different from those after the typical diet (P<.05). CONCLUSIONS: The macadamia nut-based diet high in monounsaturated fat and the moderately low-fat diet both had potentially beneficial effects on cholesterol and low-density lipoprotein cholesterol levels when compared with a typical American diet.

Adolescent↗

PubMed1985

High-dose alizapride versus high-dose domperidone: a double-blind comparative study in the management of cis-platinum-induced emesis.

A double-blind, randomized crossover trial was carried out in 44 cancer patients receiving chemotherapy with cis-platinum to compare the anti-emetic effectiveness and tolerance of alizapride and domperidone given in high dosage. Patients received 5 administrations of either 4 mg alizapride/kg body weight or 0.6 mg domperidone/kg during a chemotherapy session and then the alternative anti-emetic during the next session. Treatment order was randomized. Patients were followed-up for 12 hours and details recorded of the total time during which there was some nausea, the duration of mild and severe nausea, and the number of episodes of mild and severe vomiting. A note was also made of the duration of mild and moderate sedation, and the incidence and severity of any other side-effects either probably or possibly related to anti-emetic medication. The investigator gave an overall assessment of the severity of nausea and vomiting experienced during each chemotherapy session and an opinion on the comparative effectiveness of the two anti-emetics. At the end of the two sessions, patients were asked to state a preference, if any, for one or other treatment and to select which they would like to have for their next chemotherapy session. The results showed that whilst both alizapride and domperidone appeared to be equally effective in limiting mild nausea, alizapride was significantly better in preventing severe nausea and episodes of vomiting. In those cases where a positive choice between treatments was made, alizapride was considered to be significantly better than domperidone by the investigator and more patients preferred alizapride and would select it for their next session.(ABSTRACT TRUNCATED AT 250 WORDS)

Antiemetics↗

PubMed2002

The effects of control of thermal balance on vascular stability in hemodialysis patients: results of the European randomized clinical trial.

BACKGROUND: Many reports note that the use of cool dialysate has a protective effect on blood pressure during hemodialysis (HD) treatments. However, formal clinical trials in which dialysate temperature is tailored to the body temperature of appropriately selected hypotension-prone patients are lacking. METHODS: We investigated the effect of thermal control of dialysate on hemodynamic stability in hypotension-prone patients selected from 27 centers in nine European countries. Patients were eligible for the study if they had symptomatic hypotensive episodes in 25% or more of their HD sessions, assessed during a prospective screening phase over 1 month. The study is designed as a randomized crossover trial with two phases and two treatment arms, each phase lasting 4 weeks. We used a device allowing the regulation of thermal balance (Blood Temperature Monitor; Fresenius Medical Care, Bad Homberg, Germany), by which we compared a procedure aimed at preventing any transfer of thermal energy between dialysate and extracorporeal blood (thermoneutral dialysis) with a procedure aimed at keeping body temperature unchanged (isothermic dialysis). RESULTS: One hundred sixteen HD patients were enrolled, and 95 patients completed the study. During thermoneutral dialysis (energy flow rate: DeltaE = -0.22 +/- 0.29 kJ/kg x h), 6 of 12 treatments (median) were complicated by hypotension, whereas during isothermic dialysis (energy flow rate: DeltaE = -0.90 +/- 0.35 kJ/kg x h), the median decreased to 3 of 12 treatments (P < 0.001). Systolic and diastolic blood pressures and heart rate were more stable during the latter procedure. Isothermic dialysis was well tolerated by patients. CONCLUSION: Results show that active control of body temperature can significantly improve intradialytic tolerance in hypotension-prone patients.

Aged↗

PubMed1996

Treatment of refractory diarrhoea in AIDS with acetorphan and octreotide: a randomized crossover study.

OBJECTIVE: To compare the efficacy and tolerance of acetorphan, an orally active enkephalinase inhibitor whose antidiarrhoeal properties derive from a purely antisecretory activity, to that of octreotide, a subcutaneously administered somatostatin analogue, in the treatment of refractory diarrhoea in AIDS patients. DESIGN: An open randomized crossover trial. SETTING: The inpatient medical units of three hospitals. PATIENTS: Thirteen adult inpatients with AIDS and refractory diarrhoea that lasted for 35 +/- 8 weeks despite use of traditional antidiarrhoeal agents and was characterized by 7.0 +/- 1.2 stools/day, weighing 1033 +/- 174 g/day with a lipid output of 18.8 +/- 3.5 g/day. INTERVENTIONS: Acetorphan (100-300 mg thrice daily) and octreotide (50-150 micrograms thrice daily) were given in random order during two 1-week periods. MAIN OUTCOME MEASURES: Response was defined as a reduction by at least one-third of both daily stool number and weight. RESULTS: The mean daily stool number was reduced to 4.6 +/- 1.1 with acetorphan (P < or = 0.05) but was 5.6 +/- 1.2 with octreotide (NS). Whereas two patients responded to both treatments, two responded to acetorphan alone and one to octreotide alone. Daily lipid output in faeces was reduced non-significantly with acetorphan (11.5 +/- 2.3 g) but was nearly doubled with octreotide (33.7 +/- 12.0 g). Acetorphan was very well tolerated. CONCLUSION: Enkephalinase inhibitors may be a useful alternative to somatostatin analogues in the management of refractory diarrhoea in AIDS.

Adult↗

PubMed1994

Effects of intravenous medium-chain triglycerides on pulmonary gas exchanges in mechanically ventilated patients.

OBJECTIVE: In mechanically ventilated patients, pulmonary gas exchange was investigated during the administration of total parenteral nutrition containing medium-chain triglycerides or long-chain triglycerides as fat emulsions. DESIGN: Prospective, randomized, crossover trial (two lipid infusion periods of 8 hrs). SETTING: Intensive care unit in a university hospital. PATIENTS: Six mechanically ventilated patients, using the pressure-support mode. INTERVENTIONS: Total caloric intake was adapted according to measured energy expenditure. Fat emulsion provided 50% of the energy expenditure. Patients were infused with 50% medium-chain/50% long-chain triglycerides or 100% long-chain triglycerides in a random sequence. MEASUREMENTS AND MAIN RESULTS: Oxygen consumption, CO2 production, and minute ventilation were measured by indirect calorimetry. PaO2 and PaCO2 were determined in blood samples. Medium-chain triglycerides increased oxygen consumption by 27.8% and minute ventilation by 14.3% at the end of the protocol. CO2 production, PaO2, and PaCO2 were not different between groups. CONCLUSIONS: Medium-chain triglycerides cause an increase in metabolic demand in mechanically ventilated patients when they are infused over a short period. Postoperative or intensive care unit patients with a low pulmonary reserve should receive infusions of medium-chain triglycerides over a more prolonged period than long-chain triglycerides.

Aged↗

PubMed2006

Calcium absorption is not increased by caseinophosphopeptides.

BACKGROUND: One of the suggested health benefits of caseinophosphopeptides (CPPs) is their ability to enhance calcium absorption. This possibility is based on the assumption that they resist proteolysis in the upper gastrointestinal tract and maintain calcium in a soluble form at alkaline pH in the distal ileum. OBJECTIVE: The effects of CPP-enriched preparations (containing candidate functional food ingredients) on calcium absorption from a calcium lactate drink were tested. DESIGN: A randomized crossover trial was undertaken in 15 adults in whom we measured the absorption of calcium from a calcium lactate drink (drink A: 400 mg Ca as lactate) and 2 preparations enriched with forms of CPP (1.7 g each; drinks B and C). Both drinks B and C contained 400 mg Ca as calcium lactate plus approximately 100 mg CPP-derived calcium). Each volunteer received the 3 drinks in random order. Absorption was measured by the dual-label calcium stable-isotope technique. RESULTS: The quantity of calcium absorbed was significantly lower from drink A (103 mg) than from drink B (117 mg; P = 0.012) or drink C (121 mg; P = 0.002), which indicated a positive effect of the CPPs. However, because the CPP preparations contributed additional calcium besides that found in the calcium lactate (drink A), fractional absorption of calcium from drink B (23%) was slightly but significantly (P = 0.015) lower than that from drink A (26%). CONCLUSIONS: The differences in calcium absorption are unlikely to have any biological significance. CPPs are unsuitable as candidate ingredients for functional foods that are designed to deliver improved calcium nutrition.

Adolescent↗

PubMed2003

A randomized controlled trial of supplemental oxygen versus air in cancer patients with dyspnea.

CONTEXT: The symptomatic benefits of oxygen in patients with cancer who have nonhypoxic dyspnea are not well defined. OBJECTIVE: To determine whether or not oxygen is more effective than air in decreasing dyspnea and fatigue and increasing distance walked during a 6-minute walk test. PATIENTS AND METHODS: Patients with advanced cancer who had no severe hypoxemia (i.e., had an O2 saturation level of > or = 90%) at rest and had a dyspnea intensity of > or = 3 on a scale of 0-10 (0 = no shortness of breath, 10 = worst imaginable shortness of breath) were recruited from an outpatient thoracic clinic at a comprehensive cancer center. This was a double-blind, randomized crossover trial. Supplemental oxygen or air (5 L/min) was administered via nasal cannula during a 6-minute walk test. The outcome measures were dyspnea at 3 and 6 minutes, fatigue at 6 minutes, and distance walked. We also measured oxygen saturation levels at baseline, before second treatment phase, and at the end of study. RESULTS: In 33 evaluable patients (31 with lung cancer), no significant differences between treatment groups were observed in dyspnea, fatigue, or distance walked (dyspnea at 3 minutes: P = 0.61; dyspnea, fatigue, and distance walked at 6 minutes: P = 0.81, 0.37, and 0.23, respectively). CONCLUSIONS: Currently, the routine use of supplemental oxygen for dyspnea during exercise in this patient population cannot be recommended.

Adult↗

PubMed2000

A randomized crossover study of silver-coated urinary catheters in hospitalized patients.

BACKGROUND: Urinary tract infections (UTIs) account for 30% to 40% of nosocomial infections resulting in morbidity, mortality, and increased length of hospital stay. OBJECTIVE: To assess the efficacy of a silver-alloy, hydrogel-coated latex urinary catheter for the prevention of nosocomial catheter-associated UTIs. METHODS: A 12-month randomized crossover trial compared rates of nosocomial catheter-associated UTI in patients with silver-coated and uncoated catheters. A cost analysis was conducted. RESULTS: There were 343 infections among 27,878 patients (1.23 infections per 100 patients) during 114,368 patient-days (3.00 infections per 1000 patient-days). The relative risk of infection per 1000 patient-days was 0.79 (95% confidence interval, 0.63-0.99; P =.04) for study wards randomized to silver-coated catheters compared with those randomized to uncoated catheters. Infections occurred in 291 of 11,032 catheters used on study units (2.64 infections per 100 catheters). The relative risk of infection per 100 silver-coated catheters used on study wards compared with uncoated catheters was 0.68 (95% confidence interval, 0.54-0.86; P =.001). Fourteen catheter-associated UTIs (4.1%) were complicated by secondary bloodstream infection. One death appeared related to the secondary infection. Estimated hospital cost savings with the use of the silver-coated catheters ranged from $14,456 to $573,293. CONCLUSIONS: The risk of infection declined by 21% among study wards randomized to silver-coated catheters and by 32% among patients in whom silver-coated catheters were used on the wards. Use of the more expensive silver-coated catheter appeared to offer cost savings by preventing excess hospital costs from nosocomial UTI associated with catheter use. Arch Intern Med. 2000;160:3294-3298.

Adult↗

PubMed2005

Comparison of the effects of immediate-release omeprazole powder for oral suspension and pantoprazole delayed-release tablets on nocturnal acid breakthrough in patients with symptomatic gastro-oesophageal reflux disease.

BACKGROUND: Many patients treated with a proton-pump inhibitor for gastro-oesophageal reflux disease or erosive oesophagitis still have substantial night-time gastric acidity. A previous trial of a new immediate-release omeprazole oral suspension suggested that nocturnal gastric acidity could be more effectively controlled with a bedtime dose of immediate-release omeprazole than with a delayed-release proton-pump inhibitor administered before dinner or at bedtime. AIM: To compare the ability of immediate-release omeprazole with pantoprazole to control nocturnal gastric acidity, when they were dosed once daily and twice daily. METHODS: Thirty-six patients with nocturnal gastro-oesophageal reflux disease symptoms received immediate-release omeprazole and pantoprazole in this open-label, randomized-crossover trial. Median gastric pH, the percentage of time with gastric pH > 4 and the percentage of patients with nocturnal acid breakthrough, were evaluated with 24-h pH monitoring. RESULTS: Repeated once daily (bedtime) dosing with immediate-release omeprazole suspension produced significantly better nocturnal gastric acid control than repeated once daily (predinner) or twice daily (prebreakfast and bedtime) dosing with pantoprazole delayed-release tablets (median pH: 4.7 vs. 2.0 and 1.7; percentage of time pH > 4: 55 vs. 27 and 34; nocturnal acid breakthrough: 53 vs. 78 and 75). Twice daily dosing (prebreakfast and bedtime) with immediate-release omeprazole 20 and 40 mg achieved the best night-time control of gastric acidity. Repeated once daily bedtime dosing with immediate-release omeprazole 40 mg and twice daily dosing with pantoprazole 40 mg gave similar 24-h pH control. No safety issues were associated with either drug in this trial. CONCLUSIONS: Dosed once daily at bedtime, immediate-release omeprazole reduced nocturnal gastric acidity to a degree not observed with once daily dosing of delayed-release proton-pump inhibitors.

2-Pyridinylmethylsulfinylbenzimidazoles↗

PubMed1988

Comparison of encainide and quinidine for supraventricular tachyarrhythmias.

The antiarrhythmic efficacy and tolerability of encainide and quinidine were compared in an open-design study in which 50 patients with recurrent supraventricular tachyarrhythmias received intravenous encainide in an initial phase and oral encainide and quinidine in a subsequent, randomized crossover phase. Oral encainide (75 to 200 mg/day), administered to 47 patients for an average of 4.7 months, was effective in 77%, and oral quinidine (1,200 mg/day), administered to 44 patients for an average of 3.2 months, was effective in 66% of the patients (difference not significant). When the duration of therapy at each crossover period was compared, the percentage of patients who continued to take encainide was consistently higher than the percentage who continued to take quinidine (p less than 0.01). Twenty-nine percent of the patients discontinued encainide treatment, 23% because of clinical inefficacy and 6% because of adverse effects. Fifty-nine percent of the patients discontinued quinidine treatment, 20% because of inefficacy and 39% because of adverse effects. Based on antiarrhythmic efficacy, encainide is at least as effective as quinidine in the treatment of patients with supraventricular tachyarrhythmias. However, because of encainide's much greater tolerability, it was distinctly superior in terms of clinical use. This study was an open-design, randomized crossover trial to compare the efficacy and tolerability of encainide with those of quinidine in the treatment of supraventricular tachyarrhythmias.

Administration, Oral↗

PubMed1991

Telematic transmission of computerized blood glucose profiles for IDDM patients.

OBJECTIVE: To improve the analysis of self-monitoring of blood glucose (SMBG) and its communication between patients and physicians by a telematic transmission of computerized SMBG and to study the consequences of its use on glucose control of insulin-dependent diabetic (IDDM) patients. RESEARCH DESIGN AND METHODS: A prospective randomized crossover trial with two 3-mo periods, one with SMBG recorded on traditional booklets (booklet period) and another with computerized SMBG transmitted to a central data base through a telematic network (telematic period), comprised the study. During the latter phase, patients could receive computerized SMBG analysis on individual terminals connected to the telephone network (Minitel system). Blood glucose recordings and HbA1c were measured at inclusion and end of each period. Eleven pairs of IDDM patients on intensified insulin therapy were randomized within each pair to start with the telematic period (group A) or the booklet period (group B). RESULTS: Telematic transmissions were successful (less than 1% failure rate). Although initial HbA1c was low (6.7%), it declined during the telematic period (delta = -0.41%) compared with the booklet period (delta = +0.37%, P = 0.05). The percentage of low (less than 3.3 mM) blood glucose values correlated with HbA1c changes during the telematic period (r = 0.714, P = 0.0014) but not the booklet period. The patients favored the telematic tool to analyze SMBG. CONCLUSIONS: Telematic transmission of SMBG is feasible. It can improve SMBG analysis and perhaps glucose control, therefore offering a new way of communication between diabetic patients and their physicians.

Blood Glucose↗

PubMedDate not supplied

Insuflon versus subcutaneous injection for cytokine administration in children and adolescents: a randomized crossover study.

Pain is a frequent complication of subcutaneous cytokine injections in children. A randomized crossover trial was conducted to determine the least painful and preferred method of cytokine administration for children and young people. The current standard practice of subcutaneous injection was compared with the use of Insuflon (Maersk Medical, Roskilde, Denmark), a subcutaneous indwelling catheter. Children aged between 1 month-and 18 years undergoing treatment within the oncology/hematology unit of a single tertiary hospital and receiving cytokines were eligible for the study. Twenty children participated in the study, each child receiving both administration methods in random order during sequential cytokine treatment courses. There was a trend toward higher pain scores when using subcutaneous injections for drug administration compared to Insuflon. Seventy-five percent (n = 15) of the children who completed the trial and their families preferred using insuflon for subcutaneous drug administration. Consideration needs to be given, however, to those who refused to enter the study, withdrew, or continued because of a preference for subcutaneous injections. Current practice at the Women's and Children's Hospital is to allow the child and parents to choose their preferred treatment modality for subcutaneous drug administration.

Adolescent↗

PubMed1983

Induction of remission in hepatocellular carcinoma. A comparison of VP 16 with adriamycin.

Following a pilot study of VP-16.213 (180 mg/m2 on 3 consecutive days at 2 weekly intervals) in the treatment of patients with hepatocellular carcinoma, the efficacy of the drug was compared with that of adriamycin in another 35 patients in a randomized crossover trial. Each drug gave a similar response rate (18 and 28%, respectively) but the duration of response was significantly longer in those receiving Adriamycin. Some patients who had not responded to treatment with Adriamycin had worthwhile remission with VP 16.

Adolescent↗

PubMed1999

Tolerability and safety of 0.1% diclofenac plus 0.3% tobramycin fixed-dose ophthalmic solution: a randomized, comparative, controlled study in healthy volunteers.

The purpose of this double-blind, observer-masked, randomized, crossover trial was to compare the tolerability and safety of a fixed-dose ophthalmic solution of 0.3% tobramycin plus 0.1% diclofenac versus Tobrex (tobramycin sulfate ophth) and Voltaren (diclofenac sodium). Control treatments included a saline solution and a control solution of 0.3% tobramycin prepared by Alcon Cusí. Ten healthy volunteers received three consecutive instillations of 1 drop of a given ophthalmic solution at 08:00, 11:00 and 14:00 h to the same eye; after a washout period of 18 h, the next ophthalmic solution was tested according to a randomized sequence. Occurrence, intensity, and duration of ocular irritation and conjunctival hyperemia at baseline and after the three instillations were recorded. Slit lamp biomicroscopy examination, measurement of intraocular pressure (IOP) changes, visual acuity, and examination of the fundus of the eye were performed after each third instillation by an ophthalmologist. Side effect incidence and patient and investigator opinions were also recorded. Results showed that Voltaren instillation induced statistically significant ocular irritation (p = 0.0077); the remaining ophthalmic solutions tested caused no ocular irritation (Physiological Saline Braun, p = 0.9808; Tobrex, p = 0.8826; control 0.3% tobramycin solution, p = 0.8327; and 0.1% diclofenac plus 0.3% tobramycin, p = 0.5399). None of the ophthalmic solutions tested caused severe conjunctival hyperemia. Analysis of the sum of conjunctival parameters of both eyes for all ophthalmic solutions studied showed no statistically significant differences (p = 0.4688). Moderate superficial punctate keratitis was observed after instillation of Voltaren and of 0.1% diclofenac plus 0.3% tobramycin (1 subject each) that spontaneously resolved within 2 days. Slit lamp biomicroscopy, visual acuity and IOP values showed no statistically significant changes. No systemic side effects related to the study treatments were recorded. In conclusion, the ophthalmic solution containing 0.1% diclofenac plus 0.3% tobramycin was well tolerated under the study conditions. Its tolerability was equivalent to that of Braun physiological saline, Tobrex and a control 0.3% tobramycin solution and was better than that of Voltaren.

Adolescent↗

PubMed1983

Effect of moderate dietary sodium restriction on patients with mild hypertension in general practice.

Eighteen patients with mild hypertension in general practice restricted their sodium intake for eight weeks while taking part in a double-blind randomized crossover trial of sodium and placebo tablets. There was no difference in blood pressure between the two periods of the trial despite a substantial difference in sodium intake. Sodium restriction is not indicated in the management of patients with this degree of hypertension.

Blood Pressure↗

PubMed1998

An endoscopic photographic comparison of nasal drug delivery by aqueous spray.

There is general agreement that the delivery of topical nasal medication by sprays is suboptimal. This study examines the distribution of spray to the anterior end of the middle turbinate as a guide to the distribution to the middle meatus by means of an endoscopic photographic comparison using dyed aqueous nasal spray. The technique was found to be reproducible. The effect of vigorously inhaling whilst spraying was studied by means of a randomized crossover trial and was found to have no significant effect. This technique could be used in conjunction with other means of assessing intranasal distribution when assessing improved topical nasal drug delivery systems.

Administration, Intranasal↗

PubMed1996

Insulin lispro: its role in the treatment of diabetes mellitus.

OBJECTIVE: To introduce a rapid-acting human insulin analog, insulin lispro; to review its pharmacology, therapeutics, pharmacokinetics, dosing guidelines, adverse effects, and drug interactions; and to summarize the clinical trials of its efficacy and safety alone and in comparison with regular human insulin in the treatment of diabetes mellitus. DATA SOURCES: A MEDLINE database search was completed to identify all relevant articles, including reviews; Eli Lilly and Co.; published articles and abstracts; and review chapters from medical textbooks. STUDY SELECTION: Due to the relatively few citations listed in MEDLINE (12 as of December 1995), most of the studies reported were found from abstracts summarizing the clinical action, adverse effects, or pharmacokinetics of insulin lispro in healthy volunteers or patients with diabetes mellitus. A few of the studies used patients with diabetes mellitus in multicenter, randomized, crossover trials of insulin lispro. DATA EXTRACTION: All clinical trials that were available prior to submission of this manuscript for publication, including unpublished reports, were reviewed. DATA SYNTHESIS: The human insulin analog, insulin lispro, which is biosynthetically made by inverting the amino acid sequence of human insulin at B-28 and B-29, is more effective than regular human insulin in improving postprandial glucose control. Subcutaneous injections of insulin lispro result in decreased blood glucose peaks following meals and a potential decreased risk of hypoglycemic episodes, including nighttime hypoglycemia in patients with type 1 diabetes. Insulin lispro in comparison with regular human insulin provides equal or slightly better blood glucose control. When compared with subcutaneous injections of regular human insulin, the peak serum insulin concentration of insulin lispro is three times higher, time to peak is 4.2 times faster, the absorption rate constant is double, and the duration of action is half as long. Insulin lispro is similar to regular human insulin with reference to dose, toxicity, adverse effects, drug interactions, and immunogenicity. When insulin lispro is mixed with human NPH (isophane) or Lente insulins, insulin lispro should be drawn into the syringe first, mixed with the long-acting insulin, and injected immediately after mixing. Patients using insulin lispro perceive an improvement in their well-being and quality of life due to flexible injection times and less frequent hypoglycemic reactions. Insulin lispro is believed to be suitable for patients using insulin infusion pumps. CONCLUSIONS: Insulin lispro is equipotent to human insulin and has a much more rapid onset and shorter duration of action than human insulin does, which may reduce the risk of hypoglycemia. In addition, insulin lispro improves the dosing convenience for patients with diabetes and provides a more natural control of blood glucose concentrations. Insulin lispro is a useful new agent in the treatment of diabetes mellitus.

Blood Glucose↗