Perceived control over ejaculation is central to treatment benefit in men with premature ejaculation: results from phase III trials with dapoxetine.

OBJECTIVES: To assess the utility of perceived control over ejaculation ('control') in the evaluation of treatment benefit in men with premature ejaculation (PE), and to compare effects associated with a two-category or greater increase in this variable between men receiving dapoxetine and placebo. PATIENTS AND METHODS: This subanalysis used combined data from all treatment groups in an integrated analysis of two identically designed, 12-week, double-blind, randomized, placebo-controlled trials of dapoxetine. Men (2614) met the Diagnostic and Statistical Manual of Mental Disorders (fourth edition, text revision) criteria for PE, had a stopwatch-measured intravaginal ejaculatory latency time (IELT) of < or =2 min in > or =75% of events in a 2-week baseline period, and self-reported moderate or severe PE. Men received placebo or dapoxetine 30 or 60 mg, 1-3 h before intercourse. The stopwatch-measured IELT was recorded for each episode; the patient-reported global impression of change (PGI; 7-point scale, 'much worse' to 'much better'), control and satisfaction with sexual intercourse (5-point scales, 'very poor' to 'very good') were assessed monthly. The utility of a two-category or greater increase in control was evaluated by examining the relationship of this variable with IELT and satisfaction with sexual intercourse. RESULTS: Of 2341 men with baseline and endpoint assessments, 96.8% reported 'very poor' or 'poor' control at baseline, and 748 (32%) reported a two-category or greater increase in control after treatment. More than 95% of those men rated their PE as 'slightly better', 'better', or 'much better' on the PGI; 67.1% gave ratings of 'better' or 'much better.' They also had greater improvements in IELT than men with less than a two-category increase in control, with a mean (sd) change from baseline of 3.7 (4.3) vs 0.77 (1.8) min, respectively, and a greater percentage reported good or very good satisfaction with sexual intercourse than men with less than a two-category increase in control (74% vs 19%, respectively). Nausea, headache and upper respiratory tract infection were the most common adverse events reported by men with a two-category or greater increase in control (15.8%, 7.4% and 6.6%, respectively) and those without (8.5%, 5.5% and 6.5%, respectively). The proportions of men with a two-category or greater increase in control with dapoxetine 30 and 60 mg were 36.3% and 44.5%, respectively (vs 15% with placebo). CONCLUSIONS: A two-category or greater increase in control (5-point scale) is useful for assessing the treatment benefit in men with PE; it corresponds with improvements in the man's perception of his condition, substantially greater prolongation of IELT, and higher levels of satisfaction with sexual intercourse.

Incidence and duration of side effects and those rated as bothersome with selective serotonin reuptake inhibitor treatment for depression: patient report versus physician estimate.

BACKGROUND: Selective serotonin reuptake inhibitors (SSRIs) are widely used as the first-line treatment for depression. Information regarding their side effects is mostly based on controlled clinical trials. METHOD: Patients who received an SSRI for a new or recurrent case of depression (ICD-9 code 296.2 or 311) between December 15, 1999, and May 31, 2000 were interviewed by telephone 75 to 105 days after initiation of SSRI therapy. Using closed-ended questions, investigators asked patients if they experienced any of 17 side effects commonly associated with SSRIs, how bothersome they were, and what their duration was. Prescribing physicians completed a written survey providing their estimates about frequency of side effects associated with SSRIs and how bothersome those side effects are. RESULTS: Of 401 patients who completed the phone interview, 344 patients (86%) reported at least 1 side effect, and 219 patients (55%) experienced 1 or more bothersome side effect(s). The most common bothersome side effects were sexual dysfunction and drowsiness (17% each). While most side effects first occurred within the first 2 weeks of treatment, the majority of patients were still experiencing the same side effects at the time of interview, most notably blurred vision (85%) and sexual dysfunction (83%). Overall, physicians (N = 137) significantly underestimated the occurrence of the 17 side effects explored, and they tended to underrate how bothersome those side effects were to their patients. CONCLUSION: Side effects associated with SSRIs are common and bothersome to patients. Treatment-emergent side effects tend to persist during the first 3 months of treatment.

Impact of a collaborative care model on depression in a primary care setting: a randomized controlled trial.

To measure the effects of a collaborative care model that emphasized the role of clinical pharmacists in providing drug therapy management and treatment follow-up to patients with depression, we conducted a randomized controlled trial at a staff model health maintenance organization. We compared the outcomes of subjects treated in this collaborative care model (75 patients, intervention group) with subjects receiving usual care (50 patients, control group). After 6 months, the intervention group demonstrated a significantly higher drug adherence rate than that of the control group (67% vs 48%, odds ratio 2.17, 95% confidence interval 1.04-4.51, p=0.038). Patient satisfaction was significantly greater among members randomly assigned to pharmacists' services than among controls, and provider satisfaction surveys revealed high approval rates as well. Changes in resource utilization were favorable for the intervention group, but differences from the control group did not achieve statistical significance. Clinical improvement was noted in both groups, but the difference was not significant. Clinical pharmacists had a favorable effect on multiple aspects of patient care. Future studies of this model in other health care settings appear warranted.

Discontinuation of use and switching of antidepressants: influence of patient-physician communication.

CONTEXT: Although current depression treatment guidelines recommend continuing antidepressant therapy for at least 4 to 9 months, many patients discontinue treatment prematurely, within 3 months. OBJECTIVES: To investigate the relationship between patient-physician communication and the continuation of treatment with antidepressants and to explore the demographics, adverse effects, therapeutic response, and frequency of follow-up visits. DESIGN, SETTING, AND PATIENTS: A total of 401 telephone interviews of depressed patients being treated with selective serotonin reuptake inhibitor (SSRI) therapy between December 15, 1999, and May 31, 2000, were conducted and 137 prescribing physicians completed written surveys from Northern California Kaiser Permanente health maintenance organization outpatient clinics. MAIN OUTCOME MEASURES: Patient-physician communication about therapy duration and about adverse effects; therapy discontinuation or medication switching within 3 months after start of SSRI therapy. RESULTS: Ninety-nine physicians (72%) reported that they usually ask patients to continue using antidepressants for at least 6 months, but 137 patients (34%) reported that their physicians asked them to continue using antidepressants for this duration and 228 (56%) reported receiving no instructions. Patients who said they were told to take their medication for less than 6 months were 3 times more likely to discontinue therapy (odds ratio [OR], 3.12; 95% confidence interval [CI], 1.21-8.07) compared with patients who said they were told to continue therapy longer. Patients who discussed adverse effects with their physicians were less likely to discontinue therapy than patients who did not discuss them (OR, 0.49; 95% CI, 0.25-0.95). Patients who reported discussing adverse effects with their physicians were more likely to switch medications (OR, 5.60; 95% CI, 2.31-13.60). Fewer than 3 follow-up visits for depression, adverse effects, and lack of therapeutic response to medication were also associated with patients' discontinuing therapy. CONCLUSIONS: Discrepancies exist between instructions that physicians report they communicate to patients and what patients remember being told. Explicit instructions about expected duration of therapy and discussions about medication adverse effects throughout treatment may reduce discontinuation of SSRI use. Our finding that patients with 3 or more follow-up visits were more likely to continue using the initially prescribed antidepressant medication suggests that frequent patient-physician contact may increase the probability that patients will continue therapy.

Impact of a collaborative pharmacy practice model on the treatment of depression in primary care.

The effects of a collaborative pharmacy practice model, in which clinical pharmacy specialists provided medication maintenance and follow-up patient care services at a clinic, on patients' adherence to treatment and satisfaction and costs were studied. A cohort of 13 primary care providers (PCPs) was designated to refer patients diagnosed with depression to the practice model at a staff-model health maintenance organization (HMO) immediately after the initiation of antidepressant medications. Clinical pharmacy specialists proceeded to coordinate follow-up with the patients for six months through a combination of scheduled office visits and telephone calls. Working closely with psychiatric liaisons, pharmacists were granted limited prescribing privileges to provide medication comanagement. These patients' adherence to treatment and satisfaction and costs to the HMO were compared with a control group of patients being treated for depression by the remaining 17 PCPs at the facility. A total of 91 patients were referred to the intervention group and received care from the pharmacists during the 10-month enrollment phase; 129 patients were included in the control group. There were no significant differences between groups regarding age, sex and chronic disease scores. An intent-to-treat analysis of medication adherence revealed that adherence was significantly higher in the intervention group (medication possession ratio, 0.81 versus 0.66) (p = 0.0005). Medication switch rates were higher among intervention patients as well (24% versus 5%) (p = 0.0001). There was a greater decline in the number of visits to PCPs for patients in the intervention group (39% versus 12%) (p = 0.029). A collaborative practice model in which clinical pharmacy specialists managed the medication therapy of patients with mild to moderate depression increased patients' adherence to treatment and their satisfaction and reduced the patients' subsequent visits to PCPs.

Discontinuing or switching selective serotonin-reuptake inhibitors.

OBJECTIVE: To describe reasons for discontinuing or switching selective serotonin-reuptake inhibitors (SSRIs) at 3 and 6 months after starting treatment, and to identify information provided to patients that may help prevent premature discontinuation of medication. METHODS: Telephone surveys were conducted at 3 and 6 months after patients (n = 672) were started on an SSRI for a new or recurrent case of depression. RESULTS: Significantly more patients discontinued or switched their SSRI because of an adverse effect within the first 3 months of starting (43%) compared with the second 3 months (27%; p = 0.023). The adverse effect most frequently reported as the reason for early discontinuation or switching was drowsiness/fatigue (10.2%), followed by anxiety, headache, and nausea - all at just over 5%. The odds ratio for discontinuation was 61% less in patients who recalled being told to take the medication for at least 6 months compared with those who did not (OR 0.39; p < 0.001). Patients who recalled being informed of potential adverse effects increased their reported incidence of mild to moderate adverse effects by 55% (OR 1.55; p < 0.05) without affecting rates of premature discontinuation (OR 1.06; p = 0.77). CONCLUSIONS: Adverse effects are the most frequent reason for discontinuing or switching SSRIs within the first 3 months of treatment. Patients are more likely to continue taking their antidepressant if they fully understand how long to take the medication. Informing patients of potential adverse effects does not appear to prevent premature discontinuation, but may increase the patient's awareness and reporting of mild to moderate adverse effects.

Relationship of clinical factors to the use of Cox-2 selective NSAIDs within an arthritis population in a large HMO.

OBJECTIVE: To investigate the degree to which physicians use clinical factors to focus use of Cox-2 selective NSAIDs within an arthritis population. METHODS: Diagnostic codes in the medical records of a large group-model HMO in northern California with approximately 3 million members were examined to identify patients with either rheumatoid arthritis (RA) or non-RA (osteoarthritis or degenerative joint disease). RA and non-RA patients were stratified in deciles of relative risk for gastrointestinal (GI) complications according to patient characteristics identified on the Standardized Calculator of Risk for Events (SCORE) that were associated with use of Cox-2 selective NSAIDs. (The SCORE tool stratifies patients by risk of serious GI complications using patient characteristics that are assigned points during an office visit, including age, health status, diagnosis of rheumatoid arthritis, corticosteroid use, and history of GI ulcer or bleed.) The second stage of analysis examined the percentage of arthritis patients in each SCORE-risk decile who received a Cox-2 selective NSAID, lower-risk NSAID, or traditional NSAID during calendar year 1999. RESULTS: The study population consisted of 144,360 members with an arthritis diagnosis, approximately 4.8% of members in this HMO. The mean age was 62.8 years (SD = 14.1), 61% were female, 10,449 (7%) had rheumatoid arthritis (RA), and 133,911 (93%) had non-rheumatoid arthritis. A diagnosis of RA was the most significant predictor of Cox-2 NSAID use (OR=2.4; 95% CI=1.6-3.5), followed by a history of GI problems (OR=1.5; 95% CI=1.4- 1.6). Female gender, chronic steroid use, and age each increased the odds of receiving a Cox-2 selective NSAID by about 35% (P<0.001 for all). Approximately 8.3% of patients in the highest decile of risk and 1.5% of patients in the lowest decile of risk received a Cox-2 selective NSAID. CONCLUSIONS: Clinical characteristics of patients identified on the SCORE (GI-risk) tool were strongly associated with use of Cox-2-selective NSAIDs in this HMO. A 5.5-fold difference in utilization of Cox-2 selective NSAIDs was found among patients determined to be in the highest-risk decile versus patients in the lowest-risk decile. Future research should investigate how nonclinical factors play a role in the treatment decisions made by physicians.