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Biomedical subjects

G D Novack

Publications and source records attributed to G D Novack.

At least 55 records · Page 3Linked to original sources

A combination of levobunolol and dipivefrin for the treatment of glaucoma.

This double-masked prospective study compared the ocular hypotensive efficacy and the safety of 0.5% and 1% levobunolol hydrochloride with 0.5% timolol maleate when each was administered topically twice daily in combination with 0.1% dipivefrin hydrochloride. Forty-three patients whose intraocular pressure was previously controlled by concomitant treatment with timolol and dipivefrin were randomly assigned to receive 0.5% or 1% levobunolol and 0.1% dipivefrin, or to continue to receive 0.5% timolol and 0.1% dipivefrin for three months. In the groups receiving levobunolol and dipivefrin concurrently, continued intraocular pressure control was achieved equal to that attained with timolol and dipivefrin before study entry. We concluded that concomitant treatment with levobunolol and dipivefrin is equal in both efficacy and safety to concomitant treatment with timolol and dipivefrin.

Drug Combinations↗

Prophylactic treatment of intraocular pressure elevations after neodymium: YAG laser posterior capsulotomies and extracapsular cataract extractions with levobunolol.

The prophylactic effect of topical 0.5% levobunolol on intraocular pressure (IOP) elevations after neodymium:YAG (Nd:YAG) laser posterior capsulotomies and extracapsular cataract extractions (ECCEs) was investigated in two separate, double-masked, placebo-controlled studies. In study 1, 42 patients received either levobunolol or vehicle 1 hour before a unilateral Nd:YAG laser posterior capsulotomy. Elevated IOP (greater than or equal to 10 mmHg) occurred in up to 38% of those in the vehicle group and none in the levobunolol group. Mean IOP increased up to 6 mmHg in the vehicle group, whereas it decreased up to 3 mmHg in the levobunolol group. In study 2, 41 patients received either levobunolol or vehicle immediately after a unilateral ECCE involving the use of a viscoelastic preparation and the implantation of a posterior chamber intraocular lens (PC IOL). The incidence of IOP elevations (greater than or equal to 10 mmHg) was up to 40% in the vehicle group and 19% in the levobunolol group. Mean IOP increased up to 9 mmHg in the vehicle group and up to 2 mmHg in the levobunolol group. Thus, marked elevations in IOP after posterior capsulotomies or ECCEs may be minimized by prophylactic treatment with levobunolol.

Cataract Extraction↗

Ocular hypotensive efficacy of 0.25% levobunolol instilled once daily.

The authors evaluated the efficacy of once-daily treatment with levobunolol in patients with primary open-angle glaucoma or ocular hypertension in an open-labeled, two-phase titration clinical trial. All patients started the study using 0.25% levobunolol administered once daily for 3 months (phase I). If a patient's intraocular pressure (IOP) was not controlled with this concentration of levobunolol, the concentration was increased to 0.5% administered once daily for 3 months (phase II). During phase I, a significant reduction in IOP was observed in 21 of the 29 patients (72%), with an average IOP reduction of 24%. During phase II, in six patients whose IOP was reduced inadequately with 0.25% levobunolol, one had a significant reduction in IOP with 0.5% levobunolol. The authors concluded that levobunolol, instilled once daily at a concentration of 0.25%, was effective in significantly reducing IOP in the majority of the patients evaluated.

Adult↗

[Comparison of the effectiveness and safety of levobunolol and timolol in ocular hypertension and chronic open-angle glaucoma].

Twenty-six patients with open-angle glaucoma or ocular hypertension were studied in a concomitant double-masked clinical trial lasting three months, in which the ocular hypotensive efficacy and safety of levobunolol (0.5%) and timolol (0.5%), topically administered twice daily, were compared. At all follow-up examinations there was a significant decrease in mean intraocular pressure from baseline in both treatment groups, with no significant difference between them in this regard. Few changes were seen in either treatment group in cup/disk ratio, visual fields, visual acuity, biomicroscopy, or ophthalmoscopy. In both groups slight decreases in mean blood pressure were observed. Levobunolol and timolol were similarly effective and safe in reducing intraocular pressure in patients with chronic open-angle glaucoma and those with ocular hypertension.

Adult↗

Levobunolol compared with timolol: a four-year study.

Fifty-one patients with raised intraocular pressure (IOP) were treated for up to four years with one of three ophthalmic solutions: 0.5% levobunolol, 1% levobunolol, or 0.5% timolol. The study was conducted as a double-masked, randomised trial in which medications were administered twice daily to both eyes. Levobunolol and timolol were equally effective in reducing overall mean IOP; reductions were greater than 8.8 mmHg in all three treatment groups. The study showed levobunolol to be as safe and effective as timolol in the long-term control of raised IOP.

Aged↗

Effect of changing medication regimens in glaucoma patients.

When glaucoma medication fails to adequately control intraocular pressure (IOP), a second medication is frequently added. Before adding a second drug to patients whose IOP was no longer controlled by 0.5% timolol, we tested the effect of switching to another beta blocker, levobunolol (0.5 or 1%). We also evaluated the effect of study participation on compliance in the control group continuing to receive 0.5% timolol. In each treatment group, the IOP of approximately 30-40% of the patients was successfully controlled for the 3-month study period. The remaining patients did not exhibit significant pressure reductions and were dropped from the study within 2 weeks. We concluded that (1) the results of 'switch' studies without a control group must be interpreted carefully, and (2) the initiation of a 'new regimen' with an equieffective beta blocker may be sufficient to increase compliance and thereby control IOP.

Aged↗

A multicenter evaluation of levobunolol (Vistagan) in Germany.

We evaluated the efficacy and safety of 0.5% levobunolol HC1 (Vistagan) in 2,041 glaucoma patients at 143 sites in the Federal Republic of Germany. This study was a 3-month, open-label, noncomparative trial of levobunolol administered twice daily. Eighty-five percent of the patients completed the study period with well-controlled intraocular pressure (IOP). Treatment was discontinued in the remaining 15%: 7% for adverse reactions, 1% for lack of drug efficacy, and 7% for reasons unrelated to the study treatment. Efficacy, ocular drug tolerance, and systemic safety were judged as good to very good in approximately 80% of the patients. This large, postapproval study confirms previous findings of several well-controlled clinical trials indicating that levobunolol is an effective drug for the treatment of elevated IOP and is safe and comfortable for most patients.

Drug Administration Schedule↗

The effect of levobunolol on aqueous humor dynamics.

We evaluated the acute effects of installation of 0.5% levobunolol on aqueous humor dynamics in a double-masked study in 18 patients with ocular hypertension. Aqueous flow was measured by fluorophotometry and total outflow facility by tonography. Aqueous flow decreased approximately 29% in the eyes treated with levobunolol. Total outflow facility and episcleral venous pressure measurements were similar in levobunolol-treated eyes and contralateral eyes treated with vehicle. A 36% decrease in intraocular pressure was observed in the levobunolol-treated eyes and a slight intraocular pressure reduction was seen in the vehicle-treated eyes. The results of this study indicate that, similar to timolol, levobunolol lowers intraocular pressure primarily by decreasing aqueous humour production.

Adrenergic beta-Antagonists↗

Dihydrolevobunolol is a potent ocular beta-adrenoceptor antagonist.

The ocular beta-adrenoceptor antagonist activity of dihydrolevobunolol (DHLB), the major ocular and systemic metabolite of levobunolol was investigated by determining its ability to block isoproterenol-induced ocular hypotension in normotensive rabbits. Topically-applied 0.001% and 0.01% DHLB virtually abolished the response to isoproterenol, indicating a beta-blocking potency similar to that of timolol. Thus, the ocular metabolism of levobunolol leads to the formation of a highly potent beta-adrenoceptor antagonist that may contribute to its clinical efficacy.

Adrenergic beta-Antagonists↗

Levobunolol and metipranolol: comparative ocular hypotensive efficacy, safety, and comfort.

Topical levobunolol 0.5% was compared with topical metipranolol 0.6% for efficacy, safety, and comfort in 46 patients with open angle glaucoma or ocular hypertension. The study was of parallel design, randomised, double-masked, and of three months' duration. After a washout interval the study medications were instilled twice daily in both eyes. The overall mean decrease in intraocular pressure (IOP) was approximately 7 mmHg in both groups. More than 90% of patients in both groups successfully completed the study. Both agents caused slight decreases in heart rate and blood pressure. More complaints of burning and stinging were reported in the metipranolol group than in the levobunolol group. This three-month, 46-patient study showed levobunolol 0.5% and metipranolol 0.6% to be similarly effective ocular hypotensive agents.

Administration, Topical↗

Plasma levobunolol levels following topical administration with reference to systemic side effects.

We determined the plasma level of levobunolol in normal volunteers after a single topical instillation of 0.5 or 1% levobunolol in both eyes, and after twice-daily instillations for 1 week. Levobunolol levels were detected within 1 h following acute instillation. During the study, mean plasma levels ranged from 0.1 to 0.3 ng/ml for the 0.5% group and 0.3 to 0.6 ng/ml for the 1% group. The highest individual plasma level was 1.2 ng/ml, which occurred in 1 patient receiving 1% levobunolol. After 1 week of twice-daily instillation mean plasma levels were similar to those observed after acute instillation. Minimal cardiovascular changes were observed in the 0.5% group while decreases in heart rate and systolic blood pressure were observed in the 1% treatment group.

Administration, Topical↗

Treatment of elevated intraocular pressure with concurrent levobunolol and pilocarpine.

Between July 1983 and January 1986, 54 patients with open-angle glaucoma or ocular hypertension were treated for 3 months with 2% pilocarpine hydrochloride (given four times daily) and one of two beta-adrenoceptor blocking drugs, levobunolol hydrochloride (0.5% [17 patients] or 1% [19 patients]) or 0.5% timolol maleate (18 patients), given twice daily. Before entry into the study all patients had had stable intraocular pressure (IOP) with treatment with 0.5% timolol and 2% pilocarpine. Stable IOP was successfully maintained in up to 88% of the patients in the two levobunolol-pilocarpine groups and in 83% of those in the timolol-pilocarpine group. Two patients experienced adverse reactions: one, who received timolol and pilocarpine, suffered blepharoconjunctivitis, and the other, who received 1% levobunolol and pilocarpine, experienced bradycardia. The results indicate that the levobunolol-pilocarpine regimens were as safe and effective as the timolol-pilocarpine regimen in stabilizing IOP.

Adrenergic beta-Antagonists↗

Epinephrine-induced memory facilitation: attenuation by adrenoceptor antagonists.

The present study examined the relative importance of alpha- and beta-adrenoceptors in the memory modulatory effects of epinephrine. Posttraining epinephrine administration enhanced retention performance of a one-trial inhibitory avoidance response. Further pretraining injections of a variety of adrenoceptor antagonists, including selective alpha 1-, alpha 2-, beta 1- and/or beta 2-adrenoceptor antagonists, attenuated the retention enhancing effects of posttraining epinephrine. These results suggest that alpha- and beta-adrenoceptors of both subtypes are involved in the memory-modulating effects of epinephrine.

Adrenergic alpha-Antagonists↗

Glaucoma treatment with once-daily levobunolol.

Although twice-daily instillation of topical beta-blockers is the standard regimen for treatment of increased intraocular pressure, once-daily therapy might improve patient compliance and provide greater safety. In a three-month, double-masked clinical trial, 92 patients with open-angle glaucoma or ocular hypertension received levobunolol 0.5% or 1% or timolol 0.5% once daily, in both eyes. Overall mean decreases in intraocular pressure were significantly greater in the groups treated with levobunolol than in the group treated with timolol. Intraocular pressure decreases averaged 7.0 mm Hg with levobunolol 0.5%, 6.5 mm Hg with levobunolol 1%, and 4.5 mm Hg with timolol. The intraocular pressures of 72% (18 of 25 patients) of those treated with levobunolol 0.5%, 79% (22 of 28 patients) of those treated with levobunolol 1%, and 64% (16 of 25 patients) of those treated with timolol were successfully controlled during the study. Heart rate and blood pressure decreases were minimal with both levobunolol and timolol. Study results indicated that once-daily treatment with levobunolol and, to a lesser extent, timolol is sufficient to control intraocular pressure successfully and safely.

Actuarial Analysis↗

Levobunolol for the long-term treatment of glaucoma.

Systemically, levobunolol is as effective as propranolol for cardiovascular indications, with a greater potency and greater duration of action. Ocularly, levobunolol is as effective and as safe as topical timolol for the long-term treatment of elevated IOP. The utility of topical levobunolol as an additional, effective beta-blocker for the treatment of glaucoma will be determined by additional research and use by ophthalmologists in countries where levobunolol is approved.

Airway Resistance↗

[Local subjective tolerance of levobunolol and metipranolol in a double-blind comparative study in patients with increased intraocular pressure].

We evaluated the ocular comfort of 0.5% levobunolol hydrochloride and 0.6% metipranolol hydrochloride ophthalmic solutions in a randomized, double-masked, paired-comparison clinical trial. The drugs were given twice daily for 7 days to 16 patients with open-angle glaucoma or ocular hypertension. Patients rated comfort in terms of the severity of burning and/or stinging. For both drugs, the severity rating of ocular discomfort was low, averaging between 1 and 2 on a scale of 0-10. At initial and follow-up visits, the mean severity rating of burning or stinging with metipranolol was 2, slightly greater than the mean score of 1 with levobunolol. At 55% (26 of 47) of the patient visits, the patients rated levobunolol as more comfortable than metipranolol. Metipranolol (Betamann; Mann) was rated as more comfortable than levobunolol at only 9% (4 of 47) of the patient visits. The duration of burning and stinging was also rated as longer lasting with metipranolol treatment than with levobunolol (Vistagan; Pharma-Allergan) treatment. Although little ocular discomfort was reported for either drug, the majority of the patients tested rated levobunolol the more comfortable of the two drugs.

Clinical Trials as Topic↗